The mAbs in question are CRB-601 and CRB-602 that target integrins to inhibit activation of transforming growth factor β (TGFβ), a multifunctional cytokine involved in many cellular processes, including cell growth and differentiation, immune responses, wound healing, and tissue repair. Corbus said TGFβ plays a key role in fibrosis and also promotes cancer growth and
Drugs
The vaccine (called Comirnaty in the EU) was authorized in December for people aged 16+. On Friday, the CHMP recommended the extension of the vaccine to children aged 12-15. Earlier this month, the US and Canada also authorized the vaccine for this age group. 75% to 100% efficacy The EMA’s CHMP based its decision on
plinabulin Treatment for Neutropenia Associated with Chemotherapy BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN) NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer
pacritinib Treatment for Myelofibrosis CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis SEATTLE, June 1, 2021 /PRNewswire/ — CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia
EAST HANOVER, N.J., June 1, 2021 /PRNewswire/ — Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy1. This is the
vadadustat Treatment for Anemia Associated with Chronic Renal Failure Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ — Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with
BOSTON, June 01, 2021 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s
oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis DURHAM, N.C.–(BUSINESS WIRE) June 01, 2021 — Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today
Production capability for the mRNA drug substance is expected to be available by the first half of 2022 from Samsung Biologic’s Songdo facility, at which point the company will be able to provide everything from bulk drug substance to aseptic fill/finish including labelling and packaging, as well as cold chain storage. “mRNA has been the
The biomanufacturing technology provider and the Irish facility said that the rapid growth of cell and gene therapies (CGTs) together with the complexities of the manufacturing process has resulted in an urgent shortage for highly skilled CGT manufacturing staff. NIBRT will employ the fully operational scale-x carbo bioreactor for dedicated cell culture and viral manufacturing
Key to the vaccine’s success is a liposome the developers created called cobalt-porphyrin-phospholipid, or CoPoP. They are tiny spherical sacs, which are small enough to be considered nanoparticles, and they form the backbone of the vaccine platform. Described in a study published on May 24 by the Proceedings of the National Academy of Science, the
The company cited data from Biopharma Cold Chain Sourcebook, which predicts that cold chain trends will grow 48% between 2018 and 2024 for drugs that require at least 2-8°C storage and shipping. Additionally, cold chain services market growth is expected to accelerate over the next three years, said UPS, increasing by 24% by 2024, after
Lipids are a key component of mRNA-based vaccines and therapeutics and given the COVID-19 pandemic, there is a huge global demand for these constituents, said Andrew Bulpin, head of process solutions, Merck. The company is rolling out an enhanced synthetic cholesterol product to market nine months early, At the start of February this year, it
palovarotene Treatment for Fibrodysplasia Ossificans Progressiva Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP) PARIS, FRANCE, 28 May 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the
Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum WEST CHESTER, PA – May 28, 2021 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the
FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell
FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved Truseltiq (infigratinib) under the accelerated approval program for
Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark Research Triangle Park, NC, May 28, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug
May 26, 2021 Audience: Consumer May 26, 2021 — Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic
The study will evaluate two vaccine formulations: one against the original D.614 (Wuhan) virus and one against the B.1.351 (South Africa) variant. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. A booster study will
FDA Approves Pylarify (piflufolastat F 18) PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer May 27, 2021 — FDA has approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify, certain men with prostate
News FDA Alerts FDA Restricts Use of Ocaliva (obeticholic acid) in Primary Biliary Cholangitis Patients with Advanced Cirrhosis Due to Risk of Serious Liver Injury May 26, 2021 Audience: Patient, Health Professional, Pharmacy ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with
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