Nephros Announces Pricing of $5 Million Registered Direct Offering of Common Stock
By Dr. Matthew Watson
SOUTH ORANGE, NJ, Oct. 16, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Nephros, Inc. (Nasdaq: NEPH) (“Nephros” or the “Company”), a commercial-stage company that develops and sells high performance water purification products and pathogen detection systems to the medical device and commercial markets, today announced the pricing of a registered direct offering of 833,333 shares of common stock at a price to the public of $6.00 per share. The offering is expected to close on or about October 20, 2020, subject to the satisfaction of customary closing conditions.
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Nephros Announces Pricing of $5 Million Registered Direct Offering of Common Stock
Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
By Dr. Matthew Watson
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Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
Aimmune Receives Positive CHMP Opinion on PALFORZIA® for the Treatment of Patients with Peanut Allergy in Europe
By Dr. Matthew Watson
Final European Commission Decision on Marketing Approval Anticipated in Q4 2020 Final European Commission Decision on Marketing Approval Anticipated in Q4 2020
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Aimmune Receives Positive CHMP Opinion on PALFORZIA® for the Treatment of Patients with Peanut Allergy in Europe
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
By Dr. Matthew Watson
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
Beyond Air® Presents Positive New Preclinical Data for the Use of a Single Injection of Gaseous Nitric Oxide as a Novel In situ Cancer Vaccination
By Dr. Matthew Watson
GARDEN CITY, N.Y., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced new in vitro and in vivo preclinical data that suggest the Company’s innovative gNO-based treatment may treat lung cancer locally and its metastases systemically, potentially via stimulation of an anti-tumor immune response. These data were included in a presentation by Hila Confino, PhD of Beyond Air at the International Association for the Study of Lung Cancer’s (IASLC) North America Conference on Lung Cancer 2020 (NACLC 2020), which is being held from October 16th to 17th.
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Beyond Air® Presents Positive New Preclinical Data for the Use of a Single Injection of Gaseous Nitric Oxide as a Novel In situ Cancer Vaccination
Zogenix Receives Positive CHMP Opinion for FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Patients with Dravet Syndrome
By Dr. Matthew Watson
EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older. The European Commission (EC) is expected to make a final decision on the company’s Marketing Authorization Application (MAA) by the end of the year.
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Zogenix Receives Positive CHMP Opinion for FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Patients with Dravet Syndrome
Spero Therapeutics to Present Data for All Pipeline Programs at IDWeek 2020
By Dr. Matthew Watson
15 data presentations cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial 15 data presentations cover each of Spero’s three pipeline programs and include a late breaker oral presentation on the Phase 3 ADAPT-PO clinical trial
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Spero Therapeutics to Present Data for All Pipeline Programs at IDWeek 2020
Psychedelics Experiencing Renaissance, Offer Tremendous Treatment Potential
By Dr. Matthew Watson
NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- NetworkNewsAudio -- Cybin Corp. announces the availability of a broadcast titled, “Multi-Billion-Dollar Market Forecast in Psychedelic Therapeutics.”
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Psychedelics Experiencing Renaissance, Offer Tremendous Treatment Potential
SPACs Show Investors Faster, Simpler Way to Go Public
By Dr. Matthew Watson
NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- NetworkNewsAudio -- 180 Life Sciences Corp. announces the availability of a broadcast titled, “Blockbuster Year and Bright Horizons for SPACs.”
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SPACs Show Investors Faster, Simpler Way to Go Public
Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma
By Dr. Matthew Watson
NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced clinical updates on naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for CNS/leptomeningeal metastasis from neuroblastoma. Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children's Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”).
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Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma
German Federal Joint Committee (G-BA) Issues Nationwide Reimbursement Decision for EndoPredict® Breast Cancer Prognostic Test
By Dr. Matthew Watson
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Biomerica Reports Fiscal 2021 1st Quarter Financial Results
By Dr. Matthew Watson
IRVINE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today reported financial results for the fiscal quarter ended August 31, 2020.
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Biomerica Reports Fiscal 2021 1st Quarter Financial Results
Coherus BioSciences Announces New Employment Inducement Grants
By Dr. Matthew Watson
REDWOOD CITY, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today announced that effective October 15, 2020, the compensation committee of the Company’s board of directors granted a newly hired Executive Vice President an option to buy 150,000 shares of the Company’s common stock with a per share exercise price of $18.09, the closing trading price on the grant date, and 10,000 restricted stock units.
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Coherus BioSciences Announces New Employment Inducement Grants
Stabilization measures taken
By Dr. Matthew Watson
Orphazyme A/SCompany announcement No. 66/2020 Company Registration No. 32266355
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Stabilization measures taken
Mydecine Innovations Group Appoints Boustead Capital Markets LLP as Financial Advisor for its Planned Dual Listing on the London Stock Exchange
By Dr. Matthew Watson
VANCOUVER, British Columbia, Oct. 16, 2020 (GLOBE NEWSWIRE) -- MYDECINE INNOVATIONS GROUP, INC., (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”) is pleased to announce the appointment of UK-based Boustead Capital Markets LLP (“Boustead”) to commence the dual listing process on the London Stock Exchange (“LSE” or the “Exchange”) for the admission of the Company’s common shares to the Standard Segment of the Official List’s Main Market.
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Mydecine Innovations Group Appoints Boustead Capital Markets LLP as Financial Advisor for its Planned Dual Listing on the London Stock Exchange
Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute…
By Dr. Matthew Watson
– Agios Continues to Advance Two Phase 3 Combination Trials of TIBSOVO® in Newly Diagnosed AML Patients –
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Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute...
Eton Pharmaceuticals Announces Closing of Public Offering
By Dr. Matthew Watson
DEER PARK, Ill., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the closing of its previously announced offering of 3,220,000 shares of common stock at a public offering price of $7.00 per share. The total offering included 420,000 shares sold as a result of the underwriter’s exercise of its overallotment option in full.
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Eton Pharmaceuticals Announces Closing of Public Offering
Child Conceived To Donate Bone Marrow Saves 6-Year-Old Brother’s Life – NDTV
By daniellenierenberg
A one-year-old girl donated her bone marrow to her brother. (Representational)
A one-year-old girl, conceived by her parents through IVF technology specifically for the purpose of donating her bone marrow to their thalassemic son, has succeeded in saving her six-year-old brother's life.
Baby Kavya was born a year ago through In-Vitro Fertilisation (IVF) technique in Ahmedabad, under the concept known as "saviour sibling".
Her bone marrow was successfully transplanted to her brother Abhijeet Solanki in March this year and the boy is now "risk-free", doctors said on Thursday.
Abhijeet, the second child of Sahdev Singh Solanki and Alpa Solanki, was diagnosed with Thalassemia-major, a blood disorder, and was dependent on blood transfusion every month, they said.
Thalassemia-major patients require frequent blood transfusions and their life expectancy is also less.
His parents were advised bone marrow transplant as the last resort to treat the child, but they could not find the required HLA (human leukocyte antigen) match.
"Due to unavailability of matching HLA donors for the transplant, we opted for IVF with HLA matching," city-based Nova IVF Fertility's medical director Dr Manish Banker told PTI.
This process of HLA typing is an established method for conceiving a child, who may donate cord blood or hematopoietic stem cells for transplantation to save a sibling with a critical illness.
Abhijeet's father approached Mr Banker after he found that the bone marrow of his family members, including the boy's elder sister, was not matching.
"Bone marrow transplant from an HLA-identical donor is the best therapeutic option for thalassemia major patients. We took the challenge and created a healthy savior sibling to save her elder brother," Mr Banker said.
With the help of IVF, Abhijeet's mother delivered a healthy baby girl Kavya a year ago, who was found to be the HLA match for the sibling.
In March this year, after Kavya gained the required weight, a successful bone marrow transplant was done for Abhijeet at the CIMS Hospital, Mr Banker said.
"Now, Abhijeet is risk-free and doesn't require blood transfusion," Mr Banker said.
"This is the first case in India when an HLA matching baby was born through IVF specifically to save the thalassemia-major sibling," he said.
The siblings' father, who himself researched well about this technique, thanked Mr Banker and other expert doctorsfor saving his son.
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Child Conceived To Donate Bone Marrow Saves 6-Year-Old Brother's Life - NDTV
An Indian Baby ‘Savior Sibling’ Just Gave Her Brother Bone Marrow. But Is It Ethical? – The Swaddle
By daniellenierenberg
India just conducted its first successful experiment with savior sibling therapy, in which a baby was conceived through in-vitro fertilization for the purposes of donating bone marrow to an older ailing brother struggling with thalassemia, a condition characterized by low levels of hemoglobin in the blood that requires frequent blood transfusions. While the doctors involved in the therapy celebrated their success this week, some on social media challenged the ethics of such a therapy, in which a baby was essentially birthed to save her sibling.
In this case, the child with the genetic disorder needed a bone marrow transplant to cure his disease, and the chances of a successful cure are higher if coming from a person whose proteins (human leukocyte antigens, or HLA) exactly match those of the child. None of the childs existing family members was a match, further complicating the process of getting a bone marrow transplant an already difficult process to execute. The parents, in an effort to create a perfect bone marrow match for their child, underwent three cycles of in-vitro fertilization, out of which 18 embryos were created, and one perfectly matched that of the child, and was disease-free, using a technique called pre-implantation genetic diagnosis (PGD). The embryo was then implanted in the mothers uterus, carried to term, and a baby girl was born.
We had to wait for the baby to grow. She had to weigh 10 kg before we could draw bone marrow, Deepa Trivedi, program director of Sankalp Bone Marrow Unit in Ahmedabad, told The Hindu. Its been approximately seven months since the transplant, and the older sibling has not needed any more blood transfusions, indicating he has been cured of his thalassemia, his doctors announced.
Savior sibling therapy has already been used in countries such as the United Kingdom, the U.S.A., New Zealand, and France. Its mainly used to cure genetic blood disorders in children, such as sickle cell anemia or as seen in the Indian case, thalassemia major. The main way this is done, which is a departure from the Indian case, is by harvesting stem cells from a newborns umbilical cord, which are then injected into the bone marrow of the sibling with the disease, a practice that works 90% of the time. In case it doesnt, doctors can take bone marrow from the savior sibling as they grow, in a process that is painful but not known to be dangerous.
Related on The Swaddle:
Designer Babies Are Far From Reality, Even After the Gene-Edited Babies in China
The first ethical concern with this practice is treating a baby as a source for spare parts, as a means to an end, as a commodity. A study of the bioethics of savior sibling therapy, published in the Journal of Medical Ethics, surmised that treating a baby as a means to an end was not by itself a concern that devalued the utility of savior sibling therapy, as long as theyre also treated as human beings. Bioethicists surmise that using cord blood, something that is frequently discarded after birth, cannot endanger a newborn, or prove to be an ethical quandary used against the therapy.
But what has happened in the most recent case in India actually complicates the issue, because its not the umbilical cord blood that was harvested from the savior sibling at birth, but bone marrow 10 months into her life, which makes her an organ donor. This traverses thorny territory, as governments strictly regulate organ donation by minors due to issues related to consent. Can a baby consent to donating bone marrow to their sibling, or a 10-year-old consent to donating a kidney to their parent? It depends on where the individual resides, and how old the person being asked to donate is. In India, for example, it was only recently that the Delhi High Court ruled that minors could donate organs or tissues, as long as the procedure didnt pose a danger to their lives, and only in exceptional circumstances. However, where minors are mostly dependent upon their families, an element of coercion can also manifest. Also, determining whether a child rationally consented to donate an organ to their parent, for example, becomes difficult when we factor in the emotional element of their relationship that can perhaps override their judgments about their own safety.
Another concern is the well-being of the savior sibling throughout their life, both physical and psychological. Whats to stop a parent from asking the savior sibling to be on standby for their entire lives for their siblings health, available to be tapped for tissues and organs at any point in their lives? This is the plot of Jodi Picoults My Sisters Keeper (also turned into a film of the same name starring Cameron Diaz), but it is an unlikely scenario in real life, ethics experts have said. The aforementioned organ donation rules can prevent such an exploitative situation from arising, they say, with governments around the world tasked with ensuring the consent of the donor remains at the forefront of organ donation.
The third issue with savior sibling therapy arises out of the process itself if a parent can select an embryo that perfectly matches their child, whats to stop them from selecting an embryo for intelligence, or athleticism? This wades into the territory of the production of designer babies, which is an ethical slippery slope that critics have said goes against the natural reproductive order. However, the bioethics study asserts that the connection between savior sibling therapy and the production of designer babies is less of a slippery slope and more of a reach, as the technology might be similar, but the utility of both poles apart the former is used to save childrens lives, while the latter is a superficial, hypothetical fantasy.
For now, the world of savior sibling therapy, and its perception, remains similar to when parents first selected an embryo to create a savior sibling in the U.S. in 2000. As appeared in a New York Times article at the time, It is the kind of talk heard with every scientific breakthrough, from the first heart transplant to the first cloned sheep. We talk like this because we are both exhilarated and terrified by what we can do, and we wonder, with each step, whether we have gone too far. But though society may ask, How could you? the only question patients and families ask is, How could we not? 20 years later, savior sibling therapy still centers the children that can be saved, while government stipulations around the world try to ensure the savior siblings are protected, cared for, and treated as human beings, like any other child.
While a few critics argue for a ban, the bioethics study sums up the dilemma, and perhaps a solution to this ethical debate given that a ban will be fatal for a section of the population, the onus of proof rests clearly with the prohibitionists who must demonstrate that these childrens deaths are less terrible than the consequences of allowing this particular use of PGD.
You have got to have a very powerful reason to resist the means by which a childs life can be saved.
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An Indian Baby 'Savior Sibling' Just Gave Her Brother Bone Marrow. But Is It Ethical? - The Swaddle
Looking to save lives? Here’s how – The Mancunion
By daniellenierenberg
Cecelia Ahern, the author of P.S. I love you, once beautifully said: Moments are precious; sometimes they linger and other times theyre fleeting, and yet so much could be done in them; you could change a mind, you could save a life and you could even fall in love.
Helping save lives is what we decided to dedicate some of our lives to at Manchester Marrow.More specifically, we are the student-ran arm of the charity Anthony Nolan, which signs up students/young people (aged 16-30 years) to the stem cell register. This is required in finding matches for patients suffering from blood cancers and blood disorders who desperately need transplants. The more people we sign up for this register, the higher the chance of finding a blood stem cell or bone marrow match.
Anthony Nolan was initially founded by Shirley Nolan in 1974, realising the hardships associated with requiring an urgent bone marrow transplant. This was due to her three-year-old son suffering from a rare blood disorder known as Wiskott-Aldrich Syndrome. This inspired her to set up the worlds first register to match donors with people in desperate need. Today, there are over 800,000 people on Anthony Nolans UK register list, and each of these people could be a potential donor and save a life.
Although there are many resources at hand, without you, theres no cure! In Marrow, we have three important missions: raise awareness of Anthony Nolan and blood cancer within UK universities through our events, encourage every student to join stem cell register through our donor recruitment opportunities, and lastly, raise funds to help support this vital work.
As a student, in addition to signing up to the register, you have the amazing opportunity of volunteering for us and to save a life! One of our most outstanding achievements is signing up over 100,000 people to the Anthony Nolan register and raising over 92,000 in a year. Additionally, 1 in 4 people who go on to donate stem cells is recruited via Marrow!
Being a volunteer for us is no hard work. You could do many things, including spreading the word and talking to people about why they should sign up to the register. Furthermore, you need to inform them what the donation involves if they ever found a match, checking medical backgrounds for donor eligibility, assisting them with cheek swabs, and filling out an application form.
If youre interested in this opportunity, there will be several volunteer training sessions held throughout the year. Unfortunately, due to the current situation, all these events will be held online. We can assure you, however, that were doing our best to make the most of it.
To sign up to the register visit the Anthony Nolan website!
Make sure to follow Manchester Marrows social media accounts to keep updated with all the news and events:
Facebook: @ManchesterMarrow
Facebook: Manchester Marrow Volunteers Group
Instagram: @manchestermarrow
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Looking to save lives? Here's how - The Mancunion