Pharma News

Zydus Cadila announced that the company has received the Emergency Use Authorization from the Drug Controller General of India (DCGI) for ZyCoV-D the worlds first Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population.

SAN FRANCISCO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as “MSD” outside the United States and Canada).

CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE)  Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency.

TORONTO, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd.  (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that Revive has entered into an exclusive license agreement with Puerto Rico Science Technology and Research Trust , representing Universidad Central del Caribe  and St. Jude Children’s Research Hospital, for the intellectual property (International Patent Application No.

Orion Corporation and Alligator Bioscience announced  that they have entered into a research collaboration and license agreement to discover and develop together new bispecific antibody cancer therapeutics.

Merck known as MSD outside the United States and Canada announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The U.S. Food and Drug Administration approved a new indication for Xywav for idiopathic hypersomnia in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.