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New Study Provides Personalized Breast Cancer Risk Information for Women with ATM Gene Mutations

THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain.

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Lexicon Pharmaceuticals Receives Fast Track Designation From the FDA for LX9211 for Diabetic Peripheral Neuropathic Pain

FRAMINGHAM, Mass., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel self-assembling wound care and biosurgical devices, announced today that it will be presenting at the 13th annual LD Micro Main Event investor conference. This investor conference will take place December 14-15, 2020, on the Sequire Virtual Events platform.

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Arch Therapeutics to Present at the 13th Annual LD Micro Main Event Conference

MONTREAL, Dec. 11, 2020 (GLOBE NEWSWIRE) -- ExCellThera Inc., a clinical-stage molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that ECT-001 Cell Therapy has been granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for use in urgent allogeneic haematopoietic stem cell transplants.

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ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 Cell Therapy

MELBOURNE, Australia, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce a successful $15 million placement (“Placement”), led by a $10m investment from experienced healthcare investor BioScience Managers through the BioScience Managers Translation Fund I (BMTFI). BMTFI has a mandate to invest in Australian based innovative healthcare technology and this investment will allow Cynata to significantly expand its clinical development pipeline and scale their operations in Australia. The Placement is being undertaken at an offer price of $0.70 for each new share and will be followed by a 1 for 15 non-renounceable entitlement offer at the same offer price as the Placement.

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Cynata Secures $15m Placement Led By $10m from Healthcare Investor BioScience Managers to Expand Development Pipeline

Company announcement – No. 59 / 2020

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Financial calendar for Zealand Pharma in 2021

Successfully completed listing on US Nasdaq and raised over $150 million during recent IPO and preceding crossover round

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Galecto Reports Third Quarter 2020 Operating & Financial Results and Provides a Corporate Update

BOSTON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced the appointments of Camille L. Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors.

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Rhythm Pharmaceuticals Announces Appointments of Camille L. Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors

Please read the full announcement in PDF

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New sales reporting structure introduced. 2020 organic sales growth outlook now expected at 0%, from previously -2% to +2%

Soleno intends to submit plans to FDA to conduct further analyses of clinical data from completed and ongoing studies of DCCR, together with external, natural history studies Soleno intends to submit plans to FDA to conduct further analyses of clinical data from completed and ongoing studies of DCCR, together with external, natural history studies

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Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome

– Immune Stimulation Augmented by +1,300% at 6-months Post-NPS Treatment –

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SELLAS Announces Positive Follow-up Data from the Randomized Phase 2 VADIS Trial of Nelipepimut-S (NPS) in Women with Ductal Carcinoma In-Situ of the...

CHMP recommends approval of Plavix® (clopidogrel) with aspirin in adults for certain types of strokes

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CHMP recommends approval of Plavix® (clopidogrel) with aspirin in adults for certain types of strokes

NEW YORK and LONDON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces new data on the efficacy and safety profile of long-term self-administration of nomacopan for treatment of patients with PNH.

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Akari Therapeutics Announces New Clinical Data that Show Long-Term Self-Administered Nomacopan is Well-Tolerated and Substantially Reduces Transfusion...

NEW YORK and LONDON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced financial results for the third quarter ended September 30, 2020, as well as recent clinical progress.

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Akari Therapeutics Reports Third Quarter 2020 Financial Results and Highlights Recent Clinical Progress

RESEARCH TRIANGLE PARK, N.C., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Asklepios BioPharmaceutical, Inc. (AskBio), a leading, clinical-stage adeno-associated virus (AAV) gene therapy company, today announced that its President and Chief Scientific Officer, Jude Samulski, PhD, has been honored as Triangle Business Journal’s (TBJ) 2020 Business Person of the Year.

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AskBio CSO Jude Samulski Named 2020 Business Person of the Year by Triangle Business Journal

NEW YORK, NY, Dec. 11, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating, diversified life sciences company, with a proprietary line of functional “supplement” chewing gums (Flavors: Pomegranate, Blood Orange, Peach-Lemon, Pear Bellini, Mint, Black Currant) as well as two ongoing Biotechnology initiatives, today announced that it has commenced the development of a Vegan, Cannabidiol (“CBD”) infused Pet Food Treat (“Pet Treat”).  The Company has contracted an industry expert to help with: formulations, specifications, designs, regulations, and certifications.  The Company’s aim is to commercially launch its proposed Pet Treat product, during March 2021.

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Tauriga Sciences Inc. Commences Development of Vegan, CBD Infused Pet Treat

Exodus Effect CBD Oil is made of 100% natural ingredients that are specially formulated to alleviate pain. Find out yourself in our review. Exodus Effect CBD Oil is made of 100% natural ingredients that are specially formulated to alleviate pain. Find out yourself in our review.

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Exodus Effect Review - CBD Oil launched – Product Review by Mike Vaughn

TORONTO, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos Group” or the “Company”), an innovative global cannabinoid company, today announced that Mike Gorenstein, Executive Chairman, will present at The Road Ahead, Preparation for 2021: MKM Partners Virtual Conference on Wednesday, December 16, 2020 at 12:30 p.m. EST.

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Cronos Group Inc. to Present at the MKM Partners Virtual Conference

Thats how Valerie Mitchell of Joliet is expressing the pre-holiday news that her son Owen Buell, 2, is showing no evidence of disease in regards to the neuroblastoma hes been fighting all year.

We are really happy, Mitchell said. I still cannot believe he is cancer-free. Everyone is really overjoyed about it, especially being around Christmastime.

On Friday, Owen had a number of scans including CT MRI, MIBG and an echocardiogram, along with bone marrow and hearing tests. Mitchell said. All scans came back clear, she said.

He fought as hard as he could and beat cancer, Mitchell said.

But Owen must remain cancer-free for the next five years before the word remission can be used, she said. In addition, Owen also has more treatments ahead of him: six months of immunotherapy, which Mitchell said will be extremely painful and hard on the body.

Owen will need a five to six-day stay in the hospital each month and a pain pump just to receive the treatments, Mitchell said. But the treatment is necessary to eliminate any remaining cancer cells in Owens body; otherwise new tumors or spots of cancer may form.

Were all really tired, Mitchell said. But we can push through knowing that hes going to be cancer-free. Its just one more step and then he should be good.

When Owen was diagnosed in February, he had two tumors and 21 spots of cancer, Mitchell said. His father Brian was working a job and a half at the time and he and Mitchell shared the family van.

Since then, Owen has undergone many scans, a central line placement, five rounds of chemotherapy, surgery to remove tumors, a stem cell harvest, two stem cell transplants that required a three-month hospital stay, 12 rounds of radiation and 10 days of being intubated in the hospitals intensive care unit, Mitchell said.

Owen now also has damage to one kidney and high blood pressure, Mitchell said. The COVID-19 pandemic made treatments even harder on Owen and his family, she added, especially since Owen's brothers Elliott and Bentley, age 4.were just 7 and 4 when Owen was diagnosed.

We didn't have the help everyone was offering in fear Owen would catch this virus, Mitchell wrote on her Facebook page. We couldn't go anywhere in between treatment to cheer Owen up. We couldn't bring him into the store to pick out a new toy or get him out of the house. He couldn't go swimming; he couldn't go to any arcades; he couldn't even have his father or siblings by his side undergoing surgery or chemo. It wasn't/ isnt fair that Owen had to suffer as much as he did. But we are happy he is still here.

Mitchell said the family celebrated Owens good news with pizza, cake and silly string. And she said Owen is going to go crazy with happiness when he sees all the Christmas gifts toys theyve bought for him.

In the meantime, Owen is enjoying the holiday season like any other 2-year-old.

Hes already playing with the Christmas tree bulbs, Mitchell said.

Donate to the "Help for baby Owen Buell and his Family" GoFundMe page at bit.ly/3n0MThy.

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Joliet 2-year-old gets pre-holiday gift: tests that show he's cancer-free - The Herald-News

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the new data from its Phase 3 PROTECTIVE-2 Study 106 demonstrating that plinabulin in combination with pegfilgrastim offers greater protection against chemotherapy-induced neutropenia (CIN) than the standard of care, pegfilgrastim alone. The study not only met the primary and key secondary objectives, as previously disclosed on Nov. 16, 2020, but also demonstrated that the combination was 53% more effective than pegfilgrastim alone in reducing the incidence of profound neutropenia (absolute neutrophil count or ANC < 0.1 x 10E9 cells/L), 21.6% vs. 46.4%, respectively, p=0.0001, in patients with breast cancer undergoing chemotherapy with TAC (docetaxel, doxorubicin, and cyclophosphamide). Profound neutropenia (PN) is a well-known risk factor to increase the rates of infection, febrile neutropenia (FN), and hospitalization among patients undergoing chemotherapy. Of clinical importance, the combination has shown to reduce the odds of having FN by 41% in comparison to pegfilgrastim, based on reduction of profound neutropenia.

It is clinically meaningful to reduce FN risk by 41% in the combination, compared to pegfilgrastim alone, which is the only major breakthrough advancement in CIN prevention in the last 30 years. The CIN protection from plinabulin added to pegfilgrastim, particularly in the first week of chemotherapy when 75% of CIN-related complications occur before the effect of pegfilgrastim kicks-in in Week 2, fills the treatment gap in current standard of care, said Douglas Blayney, M.D., Professor of Medicine at Stanford Medical School, and global PI for the plinabulin CIN studies. The combination of plinabulin with pegfilgrastim represents a major advancement in offering protection against CIN, with the potential to reduce FN risk, in the care of cancer patients.

The data were presented via a poster at the 2020 San Antonio Breast Cancer Symposium (SABCS): Superior and Clinically Meaningful Protection Against Profound Neutropenia with the Plinabulin/Pegfilgrastim (Plin/Peg) Combination versus Peg In Breast Cancer Patients ReceivingTAC Chemotherapy. Profound neutropenia, an exploratory endpoint representing the most severe form of CIN, is associated with significant risk to patients and may require antibacterial or antifungal prophylaxis [Flowers JCO 2013]. It is attributed to both febrile neutropenia (48%) and infection (50%) [Bodey Cancer 1978]. In BeyondSprings PROTECTIVE-2 studies, patients with profound neutropenia had close to nine times the risk of FN compared to patients with no profound neutropenia. The new data presented at SABCS included:

This trial is a global, multicenter, randomized, double-blinded study in patients with breast cancer undergoing myelosuppressive chemotherapy with TAC (docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and cyclophosphamide at 500 mg/m2) for the evaluation of protection against CIN, comparing plinabulin (40 mg) in combination with pegfilgrastim (6 mg) in 111 patients to pegfilgrastim alone (6 mg) in 110 patients. On Day 1, they received TAC and plinabulin or placebo, and on Day 2, they received pegfilgrastim. Topline data from the Protective-2 Phase 3 trial were reported on November 16, 2020 highlighting that the study met its primary endpoint as well as key secondary endpoints.

It is well recognized that CIN is directly related to chemotherapys ability to kill rapidly dividing cells. Unfortunately, fast dividing neutrophils in the bone marrow are adversely affected regardless of the chemotherapy type. As a result, we believe these outcomes are universally applicable to any chemotherapy, and are independent of cancer types, added Gordon Schooley, Ph.D., BeyondSprings Chief Regulatory Officer. As both the U.S. FDA and China NMPA recently awarded BeyondSprings Plinabulin CIN program with Breakthrough Therapy Designation status based on the interim phase 3 data of PROTECTIVE-2, and the Company now completing the PROTECTIVE-2 trial with positive and consistent results to the interim, we are well on track to submit our NDA for CIN in Q1 2021. The improved CIN prevention benefit of the Plinabulin/G-CSF combination would have the potential for CIN prevention of the myelosuppressive effects of different chemotherapeutic agents in millions of patients with multiple tumor types.

Ramon Mohanlal, M.D., Ph.D., BeyondSprings Chief Medical Officer and Executive Vice President, Research and Development concluded, Plinabulin represents a new treatment paradigm for CIN prevention, an area wherein G-CSF has established efficacy, but with short-comings due to its delayed onset of action, next day dosing requirement, bone pain induction, and platelet count reduction. Plinabulin has a fast onset mechanism of action, without causing relevant bone pain or thrombocytopenia, and can be given on the same day as chemotherapy. Plinabulin added to G-CSF offers superior prevention of CIN, and has the potential to avoid life-threatening infections and to improve short-term and long-term survival. Plinabulins anticancer activity from its immune-enhancing mechanism of action, together with its CIN preventive effects, has the potential to become a universal add-on to anti-cancer treatments in general.

The above data are available on BeyondSpringswebsite in the Posters section.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulins CIN data highlight the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin not only to treat CIN, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About CINPatients receiving chemotherapy typically develop chemotherapy-induced neutropenia (CIN), a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or FN), which necessitates ER/hospital visits. The updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, such as pegfilgrastim, to include not only high- risk patients (chemo FN rate>20%), but also intermediate-risk patients (FN rate between 10-20%) to avoid hospital/ER visits during the COVID-19 pandemic. The revision of the NCCN guidelines effectively doubles the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually. Plinabulin is designed to provide protection against the occurrence of CIN and its clinical consequences in week 1, for early onset of action after chemotherapy. CIN is the primary dose-limiting toxicity in cancer patients who receive chemotherapy treatment.

About BeyondSpringBeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSprings lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts

Investor Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 617-430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, Ph.D.LifeSci Communications+1 646-627-8387darren@lifescicomms.com

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BeyondSpring Announces New Positive PROTECTIVE-2 Phase 3 Registrational Trial Results at the 2020 San Antonio Breast Cancer Symposium - BioSpace