WAKEFIELD, Mass., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that the Company’s Phase 2 clinical trial of Brilacidin for treating COVID-19 is scheduled to begin next week.

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Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week

Global News Feed Comments Off on Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week | January 31st, 2021

HALIFAX, Nova Scotia, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the development of a rapid antibody test prototype that detects the presence of the neutralizing antibodies against the SARS-CoV-2 virus. These antibodies bind to the specific parts of the virus, decreasing the viral infectivity and potentially protecting the patient from the severe COVID-19 symptom presentation or future SARS-CoV-2 reinfection. Not all antibodies can block the virus from infecting the patient, and, according to the recent reports, the levels of neutralizing antibodies vary, so as the potency of the antibody protection. Once extensively validated, MedMira’s neutralizing antibody test can effectively pinpoint the antibodies with the blocking capability, thus, potentially, serving as a powerful tool for the qualitative assessment of the antibody status pre- and post-vaccination, as well as providing insights into one’s immunity to SARS-CoV-2. At this time, there is no guarantee that this product will meet all regulatory requirements and receive a subsequent regulatory approval.

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Progress Update on MedMira’s COVID-19 Product Family

Global News Feed Comments Off on Progress Update on MedMira’s COVID-19 Product Family | January 31st, 2021

From nourishing curl creams to moisturizers loaded with stem-cell technology.

It hardly seems possible that the first month of 2021 is behind us, but here we areand luckily, our beauty cabinets and drawers have never been better stocked. With the new year, weve dedicated precious shelf space to testing everything new in beauty, and there is plenty to be excited about. Whether youve been searching for a vitamin C serum to kiss those dark spots goodbye, a nourishing curl cream to help your texture pop, or perhaps a hydrating SPF to protect against sun damage and UV rays (remember, it is your most powerful anti-aging tool), there is something out there to fit in perfectly with your routine. Check out our picks for the 32 best beauty product launches of January.

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$145

The perennial favorite Dr. Barbara Sturm has finally released a vitamin C serum, which harnesses kakadu plum (more plums please!) to protect your cells from free-radical damage and lighten hyperpigmentation. The 5-percent formulation also contains two other sources of vitamin Coil-soluble THD ascorbate (a highly stable variety) and synthetic vitamin C in glycosidic form (aka ascorbyl glucoside). And the white, milky texture? Thats the added zinc, which helps your skin absorb the vitamin C faster and more effectively.

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$28

Posh is back with another addition to her clean collection of cosmetics. This mascara features a curved wand filled with short, almost teeth-like bristles that coat your lashes in a perfectly thin, even layer of formula. Do you want an ultra-voluminous lash look? This might not be the mascara for you. But for a gorgeous, minimalist, and clump-free effect, this launch delivers. And if you like adding product to your lower lashes but hate the potential smudging, be prepared to truly sing this mascaras praises.

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$20

Navigating between creams, gels, and oils can be tricky for anyone with curly hair, but this new milky serum is a serious gamechanger. Founder Babba C. Riveras recent launch not only gives you definition without the frizz, but the acai, chia seed, and castor-oil-rich formula also nourishes your hair for more flexibility and shine throughout the day. If youve yet to find your holy-grail texturizing product, give this one a try.

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$34

Finding an affordable, comfortable, and effective physical SPF can seem like the unreachable trifecta, but clean beauty brand Saie nails it with their first sunscreen. The formula has a silky, lightweight feel with zero white cast, and the added aloe vera, viola extract, argan, grapeseed, and vitamin E will have your skin feeling nourished and soft all day long. No more excuses for not wearing your daily SPF when it feels this good.

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$68

The trio of algae, licorice root, and hyaluronic acid makes this creamy formula ideal for dry under-eyes that are showing signs of premature aging (like darkness and fine lines). The delicate area is strengthened, dark circles are minimized, and dehydration is nowhere to be found. If youre new to eye creams, this is a great place to start.

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$28

Media maven Katherine Power has debuted her next product line to accompany Versed Skincare: Merit Beauty, a collection of EU-compliant, clean cosmetics for the minimalist-minded consumer. There are six products with a few various shade options plus a brush in the line, but its the creamy Flush Balm blush that has us swooning. The Cheeky shade, a cool, almost russet pink melts into your skin for a natural flush that lights up your whole face. You can even add a swipe to your lips for a monochromatic effect.

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$12

Clarifying shampoos are one of our favorite products to keep the scalp clean and free of buildupwhich in turn promotes strong, healthy hair. But that doesnt mean you have to drop a ton of money to find a quality formula. Clean beauty brand Odele debuts their first clarifying product utilizing a rising-star ingredient, quinoa, to help fortify and repair your hair. Swap out your go-to shampoo once a week for this formula, and admire your endless good hair days.

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$69

This serum contains .3 percent retinol, the highest recommended for topical retinoids, along with over a dozen other skin-nourishing and brightening ingredients. These include moisturizing humectants like glycerin, hydroxyethyl urea, and sodium hyaluronate, mango seed butter for nourishing fatty acids, and squalane to boost your skins moisture levels. Brighter, more even, and highly moisturized skin is in your future.

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$23

We all know that moment after you spent part of your morning perfecting your brow shape only to spot a droopy tail by lunchtime. Youll never have a hair out of place with this new translucent wax which provides long-lasting hold and a full, fluffy effect. Just gather the product onto the applicator, sweep it through your brows, and apply your color product after to fill in any gaps. The brows of your dreams are easier to achieve than ever before.

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$265

Master Perfumer Jacques Cavallier Belletrud has created a dreamy new fragrance for 2021, with notes of creamy osmanthus, Chinese magnolia blossom, and sensual jasmine. If youre looking to update your fragrance collection for spring, this sophisticated blend (in a gorgeous bottle) is the perfect addition.

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$58

Exfoliation is non-negotiable if you want skin thats free from congestion, which is why incorporating this alpha hydroxy acid and beta hydroxy acid serum into your routine is a wise idea (especially if you dont use an exfoliating cleanser on the regular). The AHA blend helps to loosen dead skin cells while the smaller BHA molecules dive deep into pores and clear out excess dirt and sebum. The boost of rosehip oil also keeps your skin from drying out or growing irritated. Use it a few nights a week to start, and watch your complexion begin to glow.

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$70

If you can bear to disturb this beyond-gorgeous palette, youll find that the powder duo gives you the kind of radiant flush that we thought only the women on Bridgerton could manage. The satiny peach highlighter gives you the kind of glow that says No, I havent been burrowed under blankets for the last six months, while the complementary coral orange blush brings a much-needed boost of energy to your complexion. CHANEL resident makeup artist Lucia Pica definitely nailed it with this spring collection.

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$32

Curly girls, rejoice, because Jen Atkin has finally dropped a curl cream for the Ouai line. After two years of formulation, the linseed and chia seed oil create soft definition for your texture, while a mix of babassu, coconut, and soybean oils hydrate and repair damage from the environment, heat, or your recent color appointment. Start with a pea-sized amount and work it through damp hair, adding more depending on your thickness and curl pattern, and enjoy the touchable, bouncy curls you always wanted.

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$10

Our at-home manicures are looking better than ever, but we sometimes struggle with getting the polish to last longer than a day or two. Enter this new vegan nail primer which promises a 20 percent increase in durability for your latest mani. The consistency is much thinner than what youre used to for a nail primermore like alcoholwhich is why the brush is shorter: It can easily evaporate before it reaches your nail bed, so founder Sarah Gibson-Tuttle made the process quicker and more manageable. Prep your nail with a thin coat, allow it to dry, and carry on with your favorite polisheasy!

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$110

Loaded with skin-renewing longoza flower and plenty of ceramides to rebuild and restore your skin, this rich moisturizer is a must for anyone battling a dry complexion this winter. The brand spent 20 years researching stem-cell technology to perfect their topical anti-aging blend of ingredients and has the clinical data to back it up. If impossibly radiant skin is what youre after, this cream will be a wise investment.

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$78

While its impossible to eliminate cellulite with a topical product (tear), it is doable to minimize the appearance and improve tone and definition. This new, patented serum from Susanne Kaufmann uses a blend of caffeine, tiger grass, and boldo (a South American tree known for its anti-inflammatory properties) to smooth and firm your skin. We recommend slathering on a generous layer following a relaxing bath.

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$25

Tracee Ellis Ross is back with her newest launch for Pattern: a lightweight conditioner for fine or thin hair (that still doesnt sacrifice moisture or nutrients for your curls). The rich, creamy texture feels almost mask-like in the shower, but once you rinse it out, you can immediately notice the difference in your hair fiberseverything is smoother, stronger, and once you style to your hearts content, frizz is minimized. It took the brand over 60 iterations to get the formula right, so rest assured that this launch is worth your coveted shower space.

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You cant beat a charcoal mask to rid your skin of dirt and buildup, which is why this new blend of Japanese charcoal and botanicals is high on our must-have list. Environ is a dermatologist and aesthetician favorite for a reason, and the soothing blend of botanicals and protective antioxidants have us asking our providers for a bottle ASAP. Use it a few times a week for a deep clean that gives your skin a much-needed reset.

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$16

Sake is slowly making its way onto each of our dinner tables, but did we ever think it would make its way into our skin-care routines? Certainly not, but we are so glad it has. Sake has a ton of skin-care benefits, including light exfoliating properties that will slough off dead skin cells and prebiotics to reintroduce balance in the skin. This body lotion has a pH level of about 5.75, making it ideal for maintaining the integrity of our skin as we battle winter dryness and flakiness.

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$95

We know you might be thinking a balm near your eyes is going to be way too greasy or stickyeven if it provides a boost of hydrationbut we were pleasantly surprised by the lightweight texture of this oil-free formula. Skin care is a new addition to the Hourglass lineup, but so far were enjoying the brands new product innovation. Keep the appearance of fine lines minimized with consistent hydration.

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$9

We all love applying heaping loads of hyaluronic acid to our faces, but have we ever stopped to wonder what the ingredient would look like in our hair-care routines? This new hair mask introduces hyaluronic acid for a surge of moisture in hair that is otherwise frizzy and dry. This is a fabulous weekly hydrating mask to protect dry, color-treated, or heat-damaged hair and works great as a deep conditioner on days where you feel you need an extra boost for parched stands.

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$19

Jess Hannah Rvszs cult-favorite polish line has debuted the first new color of 2021 with Patina, an ultra-pale green that is basically spring in a jar. The non-toxic formula provides a subtle pop of color that looks gorgeous on any skin tone and is a perfect addition to our at-home manicure kit. Dont be afraid of green polish! This is the perfect minimalist shade to try it out.

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$90

Chebula is a healing fruit extract with roots in Ayurvedic traditions. In skin care, chebula acts as a cascading antioxidant, meaning that as it fights off free radicals, its chemical composition evolves to fight off even more free radicals throughout the day. Its a potent protector against environmental stressors for those of us living in cities or for those with active lifestyles. With elderberry, ginger, and echinacea for additional antioxidant support and antibacterial properties, and both low and high molecular hyaluronic acid to hydrate the skin, this is the perfect addition to anyones routine which needs an extra protective pick-me-up.

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$34

Get you a lipstick that can do both. Charlotte Tilbury releases an innovative lipstick this month that delivers on color impact while also supplying the skin with beneficial skin-care ingredients. This lipstick balm penetrates the skin on the lips with hyaluronic acid, providing ample hydration to dry winter lips. Additionally, it washes the lips with color in a balmy yet pigmented way that feels like velvet during wear. Add a pat or two to your cheeks for some gorgeous complementary color.

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$135

Its time to energize with a sativa strainbut not in the way you might think. This creamy serum contains whole-flower cannabis sativa extract to soothe any inflammation in the skin and help it return to a glowing state of balance. In addition to being ultra soothing for your skin, this serum also contains chlorophyll, aloe, and squalane to lock moisture in for a radiant shine that never feels too heavy.

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$30

Its Aquarius season, and what better way to celebrate a time of eccentric energy than by dabbing some colorful metallic and matte shadows around your eyes? This cool-toned palette contains a range of shades that will work well with every eye color, whether you are looking for a vibrant liner on your lash line or a bold, technicolor halo. This formulation is highly pigmented and has a staying power that will last throughout the entire day.

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$275

If you cannot tell by now, we love retinol here at Coveteur. And why is that? Its a powerful ingredient that speeds the cell renewal process, igniting the production of skin-plumping collagen and elastin in the skin. Another thing we love about retinol is its ability to rid the complexion of post-hyperpigmentation, which is why we are so excited about RVives new dark-spot corrector. In addition to containing the powers of retinol, this night cream also contains vitamin C to improve the skins tone and peptides to provide the building blocks for a youthful, bouncy effect.

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$42

Cover FX enters the skin-care category this month, and we must admit that their first foray into such a congested industry is quite impressive. The lightweight moisturizer contains both prebiotics and probiotics to maintain the integrity of the skins microbiome. Simultaneously, ceramides protect against environmental stressors, and olive and jojoba oils moisturize the skin while adding a dewy glow. We love using this as a base for a seamless makeup application that makes skin look like skin.

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$11

Covergirls first full-coverage foundation is finally here, with 21 shades infused with SPF 18. Not only is it surprisingly breathable for being so full-coverage, but its also humidity- and transfer-proof, so no rubbing off on your mask if you need to travel anywhere. For a more minimal, dewy effect, we like adding equal parts moisturizer and blending with a makeup sponge. Skin looks impossibly airbrushed without draining your bank account. Its a win-win.

Buy

$42

For most people, winter skin care means amping up the rich moisturizers and oils in our routines, scaling back on heavy cleansers, and using all the hydrating masks we can get our hands on. Yet, some of these typical winter routines just wont cut it for those with oily skin, as they create a slickness in the skin that will inevitably clog pores. If you have oily skin and are looking for a great winter moisturizer, consider this one from founder Marianna Hewitt. Its formula is oil-free, meaning it will not exacerbate breakouts, and contains hyaluronic acid and ceramides for a plumping action that will last all day.

Buy

$28

We believe that our curls are beautiful, but they are sometimes so difficult to tame. In a perfect world, they would air-dry into perfect ringlets with shine and volume after every wash. Unfortunately, our hair dries in a frizzy and flat way most of the time, despite our best efforts. If your hair-care woes are anything like ours, consider this new defining gel as your hair savior. It holds curls natural shape without weighing them down or amping up their crunch factor. It also maintains curls integrity in high levels of humidity.

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$295

This month, Cl de Peau Beaut releases a mask that is as efficacious as it is luxurious. The Precious Gold Vitality Mask contains 24-karat gold to inhibit oxidation in the skin, resulting in a more youthful and even-toned appearance. Additionally, it envelops your skin in ginseng extract, which speeds up collagen production for a plumper feel. This mask is perfect for nourishing and restoring your skin as you nourish yourself with some self-care after a long and taxing day.

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The 32 Best Beauty Products That Launched in January - Coveteur

Skin Stem Cells Comments Off on The 32 Best Beauty Products That Launched in January – Coveteur | January 31st, 2021

Were starting the new year fresh with new skincare routines that help beat the harsh and dry winter, and beauty products to keep our glow on.Drunk ElephantThe Drunk Elephant Trunk 3.0 isnt exactly a new product. It came out in 2019, but the fully functional mini-fridge, which can chill (even warm!) your essential skincare products is still a favourite in our office. The trunk set comes with 10 best-selling, full-sized Drunk Elephant products, including the Sweet Biome Fermented Sake Spray.La MerLa Mers eye treatment combo is a lifesaver during the harsh winter days. The Eye Concentrate is a more advanced treatment that can help reduce dark circles and fine wrinkles even before visible damage begins. A pro tip: you could keep the eye treatment applicators in the fridge for a couple of minutes before you use them to massage the eye area for a quick microcirculation boost.DiorThe Dior Capture Totale Super Potent Rich Creme targets skin dryness with its heavily-researched science in mother cells and floral expertise. The rich creme combines bio-cellular technology with French peony oil extract.BenefitOur eyes and eyebrows are what most people tend to see these days, so its extremely pertinent that we keep our brows beautifully shaped and well-groomed. Benefits Brow Microfilling Pen mimics natural brow hair, comes in four versatile shades and is all-around the most essential beauty product you need these days.NarsNars is celebrating Chinese New Year with a new limited-edition collection that is beautifully packaged in a rich red floral design. To bring in good fortune for the Year of the Ox, the eyeshadow palette comes in soft neutral hues with a slight shimmer. There are two new shades of lipstick: Wen Wo (a brownish neutral shade) and China Rose (with a more rosy tint).TatchaTatchas Dewy Sin Creme is formulated with Hadasei-3, the brands proprietary complex of double-fermented Uji green tea, Akita rice and Mozuku algae. The result is super rich, smoothing cream that allows your make-up to glide on without a glitch.Laura MercierAlso perfect for Chinese New Year is Laura Merciers limited-edition beauty set, wrapped up in glorious shades of red and gold. The set comes with the Flawless Lumire Radiance-Perfecting Cushion, the Rouge Essentiel Silky Crme Lipstick, and the Translucent Loose Setting Powder that comes with a puff.YSL BeautyGlass skin was a term that came from K beauty to mean skin that appears poreless, luminous, clear as glass. YSL Beautys Soft Polish Double Essence is extremely gentle but comes with an effective peeling effect. Used alongside the Night Reboot serum and the Perfect Plumper Cream, glass skin is at your fingertips.AesopCold winter weather is not always the culprit sometimes, its the unpredictability of it, colder days and milder days, that disrupt our skin. Aesops latest winter skincare essentials are here to help. The selected products are gentle and nourishing on the skin, while keeping a balance, and comes in a range to suit different skin types.OribeOur focus is so often on skincare and make-up, but we shouldnt forget to care for our hair too. Available at Joyce Beauty, Oribes Signature Shampoo and Conditional set is a rich daily cleanser that is formulated to silken, detangle and protect.Este LauderThe Re-Nutriv Ultimate Diamond Transformative Eye Serum is part of Este Lauders premium line, and comes infused with Black Diamond Truffle Extract that lifts tired eyes instantly.Augustinus BaderFounded by Professor Augustinus Bader, globally recognized as one of the leaders in stem cell biology, theres no doubting the potency of the brands products. Its creams and oils are backed by 30 years of proprietary research, which resulted in its TFC8 complex, said to kickstart the skins natural abilities to rejuvenate itself. Available at Joyce Beauty.

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Unboxing: the Best Beauty Items We Tried in January - Prestige Online

Skin Stem Cells Comments Off on Unboxing: the Best Beauty Items We Tried in January – Prestige Online | January 31st, 2021

The SA Bone Marrow Registry (SABMR) says their ability to recruit new donors has been severely limited by the outbreak of the second Covid-19 wave.

SABMR head of donor recruitment Nadia Chalkley said they typically recruit a few hundred new donors each year from the Eastern Cape.

The shrinking pool of donors has had a material impact on our ability to match patients suffering from life threatening blood diseases with suitable donors, she said.

At any given time, there are more than 200 patients in SA that need a bone marrow transplant. The fewer donors we have, the lesser the chance of finding a match. For patients with leukemia, thalassemia and other blood disorders, a bone marrow transplant is their only hope of survival.

Chalkley said the the current odds of finding a successful match is about one in 100,000 and will only get worse as the donor pool continues to shrink.

Sadly, more than 70% of patients struggle to find a stem cell match within their own families, which means many rely on strangers for a second chance at life.

If local donors are not forthcoming, we have to look overseas for potential matches, which is costly.

She said SABMR was working hard to ensure the safety of donors and patients by allowing online registration.

We also offer at-home sampling kits, which only requires a cheek swab. These kits can be delivered and collected free of charge from anywhere in the country.

Once new donors have completed the online registration form, they will be contacted by one of our consultants to discuss the easiest way of dispatching and collecting the kits.

One of the biggest misconceptions with regards to bone marrow donation, according to Chalkley, is that it involves large needles being pushed into ones spine.

However, the most common form of donation is whats called peripheral blood stem cell collection, since the same blood-forming cells found in bone marrow are also present in circulating blood.

The process is similar to donating plasma and doesnt require surgery.

In order to register as a bone marrow donor, you must be between the ages of 16 and 45 and meet the required standards listed by the SABMR.

A full list of the criteria can be found at https://sabmr.co.za/.

Each of us have a role to play. This new year, put away frivolous resolutions and rather direct your energy into making a difference by signing up as a donor. The simple act could just make someones new years wish come true, Chalkley said.

Visit the SABMR website, call 021-447-8638 or email donors@sabmr.co.za

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Covid-19 leads to shortage of bone marrow donors - GO! and Express

Bone Marrow Stem Cells Comments Off on Covid-19 leads to shortage of bone marrow donors – GO! and Express | January 31st, 2021

Leukemia is the cancer of blood cells, usually white blood cells which fight and clears infections. It is also known as cancer of blood-forming tissues i.e lymphatic system and bone marrow. It is usually characterized by greatly increased numbers of abnormal white blood cells in circulating blood. It is a very serious disorder and the patient needs to change the blood regularly with normal blood from donors.

By Aysha Bibi

How does leukemia develop?

Our blood contains many different types of cells. These include red blood cells, white blood cells, and platelets. These cells are made on daily basis in the bone marrow. Leukemia happens when the body starts making white blood cells beyond its need. Immature white blood cells are released in the blood and these are non-functional. Moreover, as white blood cells increase in number, the number of red blood cells and platelets are not enough to maintain a healthy life and perform their normal functions.

Types of Leukemia

Leukemia has four main types

In the acute form of leukemia, cells multiply quickly in the bone marrow and enter the circulatory system too early but these cells are immature and non-functional. Chronic leukemia occurs when marrow produces mature cells and it progresses more slowly than other forms.

Lymphocytic leukemia is a type with an accumulation of apparently mature dysfunctional lymphocytes. Normally lymphocytes differentiate to form B-cells, T-cells, and natural killer cells which are the backbone of the immune system.

Myelogenous leukemia is a cancer of white blood cells usually granulocytes and monocytes. Either it is lymphocytic or myeloid, leukemia results in a compromised immune system, and the body cannot protect itself from different infections.

Acute lymphocytic leukemia(ALL) It is most common in children. It can spread to the central nervous system.

Acute myelogenous leukemia(AML) It is the second most common type of leukemia in children and also common in adults.

Chronic lymphocytic leukemia It is common in adults. This remains stable for many years but in some types, patients need treatment.

Chronic myelogenous leukemia(CML) Older people may are at higher risk for this type of leukemia.

Risk Factors

Some significant risk factors that can cause leukemia

Symptoms of Leukemia

Various types of leukemia can cause different symptoms. These symptoms usually not appear in the early stages, but they may include;

Diagnosis of Leukemia

CBC: with a blood test doctor looks at several different blood cells and their maturity. Immature cells may appear in the blood.

Bone marrow biopsy is done by taking bone marrow. With help of this doctor check the type and severity of leukemia.

CT scan and MRI are also done for the diagnosis of leukemia.

Treatment of Leukemia

Depending on the type of leukemia and its spreading, a doctor may look for the following options:

In a radiation treatment, high energy X-rays are used to kill leukemic cells. But normal cells are also affected.

In chemotherapy, different drugs are given to kill leukemic cells in blood and bone marrow. This may include a pill or injection in muscle or vein.

Targeted therapy is done to block the expression of some genes or proteins that are involved in the production of cancerous cells.

A Stem cell transplant involves a bone marrow transplant from a healthy donor. In this method, high-dose chemotherapy is done to destroy the leukemic cells of a patient. The healthy stems cells of donor are then injected to body.

Splenectomy is the removal of spleen and doctor may look for this option if spleen becomes fills with cancer cell and start affecting other body organs.

Preventing or reducing the risk of leukemia

Unfortunately, there is currently no cure for leukemia. Minimum exposure to pesticides and radiations may help to reduce the risk of leukemia. Leukemia can also be prevented by avoiding tobacco.

One can lower the risk of developing leukemia by following:

It is the best way to lower the risk of leukemia.

Studies have shown that overweight and obesity are also contributing factors to increasing the risk of developing leukemia.

Pollution, gasoline, car exhaust contains low levels of benzene. It is also found in offices and homes and found in paint, glue, etc. wearing a mask while using these may help you lower the risk of exposure.

Medical radiations like x-rays increase the risk of leukemia. Try to avoid unnecessary radiation exposure.

Your body and mind function at their best with a healthy diet. Proper nutrition provides energy fuel for body functioning, it also strengthens the immune system.

References:

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What Is Leukemia: And How To Prevent It? - Technology Times Pakistan

Bone Marrow Stem Cells Comments Off on What Is Leukemia: And How To Prevent It? – Technology Times Pakistan | January 31st, 2021

In KEYNOTE-598, the addition of ipilimumab to KEYTRUDA did not improve overall survival or progression-free survival, and patients who received the combination were more likely to experience serious side effects than those who received KEYTRUDA monotherapy, said Dr. Michael Boyer, chief clinical officer and conjoint chair of thoracic oncology, Chris OBrien Lifehouse, Camperdown, NSW, Australia. KEYTRUDA monotherapy remains a standard of care for the first-line treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

As a leader in lung cancer, we are pursuing a broad clinical program to better understand the potential of KEYTRUDA-based combinations to improve survival outcomes for patients with this devastating disease, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. KEYNOTE-598 is the first head-to-head study designed to answer the question of whether combining KEYTRUDA with ipilimumab provided additional clinical benefits beyond treatment with KEYTRUDA alone in certain patients with metastatic non-small cell lung cancer. The results are clear the combination did not add clinical benefit but did add toxicity.

These results were presented in the Presidential Symposium at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer on Friday, Jan. 29 and published in the Journal of Clinical Oncology. As previously announced in Nov. 2020, the study was discontinued due to futility based on the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of KEYTRUDA in combination with ipilimumab did not support continuing the trial. The DMC also advised that patients in the study discontinue treatment with ipilimumab/placebo.

KEYNOTE-598 Study Design and Additional Data (Late-Breaking Abstract #PS01.09)

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234) is a randomized, double-blind, Phase 3 trial designed to evaluate KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy as first-line treatment for patients with metastatic NSCLC without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 (TPS 50%). The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate (ORR), duration of response (DOR) and safety.

The study enrolled 568 patients who were randomized 1:1 to receive KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 35 cycles) in combination with ipilimumab (1 mg/kg IV on Day 1 of each six-week cycle for up to 18 cycles); or KEYTRUDA (200 mg IV on Day 1 of each three-week cycle for up to 35 cycles) as monotherapy. Non-binding futility criteria for the study were based on restricted mean survival time (RMST), an alternative outcome measure estimated as the area under the survival curve through a fixed timepoint. The pre-specified criteria were differences in RMST for KEYTRUDA in combination with ipilimumab and KEYTRUDA monotherapy of 0.2 at the maximum observation time and 0.1 at 24 months of follow-up.

As of data cut-off, the median study follow-up was 20.6 months. Findings showed the median OS was 21.4 months for patients randomized to KEYTRUDA in combination with ipilimumab (n=284) versus 21.9 months for those randomized to KEYTRUDA monotherapy (n=284) (HR=1.08 [95% CI, 0.85-1.37]; p=0.74). The differences in RMST for KEYTRUDA in combination with ipilimumab and KEYTRUDA monotherapy were -0.56 at the maximum observation time and -0.52 at 24 months, meeting the futility criteria for the trial and confirming the benefit/risk profile of the combination did not support continuing the study. Additionally, the median PFS was 8.2 months for patients randomized to KEYTRUDA in combination with ipilimumab versus 8.4 months for those randomized to KEYTRUDA monotherapy (HR=1.06 [95% CI, 0.86-1.30]; p=0.72). In both arms of the study, ORR was 45.4%; the median DOR was 16.1 months for patients randomized to KEYTRUDA in combination with ipilimumab versus 17.3 months for those randomized to KEYTRUDA monotherapy.

No new safety signals for KEYTRUDA monotherapy were observed. Treatment-related adverse events (TRAEs) occurred in 76.2% of patients treated with KEYTRUDA in combination with ipilimumab versus 68.3% of patients treated with KEYTRUDA monotherapy. Of these TRAEs, 35.1% vs. 19.6% were Grade 3-5, 27.7% vs. 13.9% were serious, 6.0% vs. 3.2% led to discontinuation of ipilimumab or placebo, 19.1% vs. 7.5% led to discontinuation of both drugs and 2.5% vs. 0.0% (no patients) led to death. Additionally, immune-mediated adverse events (AEs) and infusion reactions occurred in 44.7% of patients treated with KEYTRUDA in combination with ipilimumab versus 32.4% of patients treated with KEYTRUDA monotherapy. Of these immune-mediated AEs, 20.2% vs. 7.8% were Grade 3-5, 19.1% vs. 7.1% were serious, 1.8% vs. 1.1% led to discontinuation of ipilimumab or placebo, 12.1% vs. 4.3% led to discontinuation of both drugs and 2.1% vs. 0.0% (no patients) led to death.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

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Merck Presents Results From Head-to-Head Phase 3 KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA...

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Dr. Tyan Will Lead and Advance Organ Transplantation Therapeutic Program

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Immunologist and Clinical Transplant Expert, Dolly B. Tyan, PhD, Joins Aditxt as Senior VP of Clinical Development - Transplantation

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Nicosia, Cyprus, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals, Inc. OTC:(RAFA) is pleased to announce its joint venture with the entity known as The Pharmaceutical Industry Development Agency of Uzbekistan which is essentially the Health Department of Uzbekistan. Together the two organizations will produce medicines for use by public health institutions in the Republic of Uzbekistan. This will entail the acquisition of real property (10 hectares in the established Innovative Scientific Production Pharmaceutical Cluster known as “Tashkent Pharma Park”) and construction of a physical plant on the premises. Projected costs are currently at $82,000,000.

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Rafarma Secures Joint Venture Agreement with the Pharmaceutical Industry Development Agency of Uzbekistan

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NEW YORK, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Better Choice Company (BTTR) (“Better Choice”) (the “Company”), an animal health and wellness company, today announced an interview with Chairman Mike Young will air on The RedChip Money Report television program. The RedChip Money Report airs in 100 million homes on Sundays at 6 p.m. local time in every country in Europe on Bloomberg International.

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Better Choice Company Interview to Air on Bloomberg International on the RedChip Money Report

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The digital press release with multimedia content can be accessed here:

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Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple...

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Company Announcement

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CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis

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Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study

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Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction

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SOUTH SAN FRANCISCO, Calif., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ:CBIO) (the “Company”) today announced the closing of an underwritten public offering of 8,700,000 shares of its common stock, offered at a price of $5.75 per share to the public. The gross proceeds to the Company from this offering were approximately $50 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. All of the shares in the offering were sold by the Company.

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Catalyst Biosciences Announces Closing of Public Offering of Common Stock

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LEXINGTON, Mass., Jan. 29, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a global leader in the rapid detection of sepsis-causing pathogens, announced today that it issued an inducement award to Dr. Aparna Ahuja, the Company’s recently appointed Chief Medical Officer, in accordance with the terms of Dr. Ahuja’s employment offer letter.

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T2 Biosystems Reports Granting of Inducement Award

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MORRISVILLE, N.C., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that it has received written notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The notice indicated that, as a result of the closing bid price of the Company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from January 14, 2021 through January 28, 2021, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2).

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LA JOLLA, Calif., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company developing therapeutics that modulate endogenous signaling pathways, including the endocannabinoid system, today announced that it will be presenting at the LSX World Congress to be held virtually between February 1-5, 2021.

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Artelo Biosciences to Present at the LSX World Congress Virtual Conference

Global News Feed Comments Off on Artelo Biosciences to Present at the LSX World Congress Virtual Conference | January 29th, 2021

GUILFORD, Conn., Jan. 29, 2021 (GLOBE NEWSWIRE) -- BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 ™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announced that it has completed a non-brokered private placement of 400,000 common shares to a Canadian family office at a price of $0.50 per share for gross proceeds of $200,000.

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Bioasis Announces $200,000 Non-Brokered Private Placement

Global News Feed Comments Off on Bioasis Announces $200,000 Non-Brokered Private Placement | January 29th, 2021

AMF REGULATED INFORMATIONMontrouge, France, January 29, 2021

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Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF

Global News Feed Comments Off on Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF | January 29th, 2021

WOBURN, Mass., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Yield10 Bioscience, Inc. (Nasdaq: YTEN), an agricultural bioscience company, today announced it has commenced an underwritten public offering of shares of its common stock. The public offering is subject to market conditions, and there can be no assurance as to whether or when the public offering may be completed, or the actual size or terms of the public offering.

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Yield10 Bioscience Announces Proposed Public Offering of Common Stock

Global News Feed Comments Off on Yield10 Bioscience Announces Proposed Public Offering of Common Stock | January 29th, 2021