FDA
Dec 20, 2022
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result
AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...
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Nov 29, 2022
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...
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Jun 22, 2021
Horizon/ Arrowhead Deal; Dr Reddy’s Lab’s Drug US Launch; Targovax’s ONCOS-102; RedHill’s Oral Opaganib in COVID-19
Horizon Dishes Out Million Dollars to get Arrowhead's RNAi Drug Arrowhead Pharmaceuticals and Horizon Therapeutics have announced a research and development collaboration to advance the treatment landscape for uncontrolled gout. Under the terms and conditions, Arrowhead is bound to receive an upfront sum of U...
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Jun 16, 2020
HCQ/ CQ failure; AZ/ Catalent’s deal; Sinovac’s CoronaVac and Lilly’s Olumiant trial results
The US FDA nullified the Emergency Use Authorization (EUA) granted to chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19. The regulatory authority had granted the EUA to malarial drugs to be used in hospitalized COVID-19 patients only when a clinical trial was unavailable, or participation in...
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Oct 29, 2019
AZ announces positive results for durvalumab and tremelimumab; FDA nods to extend LILETTA’s use to prevent pregnancy; Gilead, Glympse Bio teams up to advance NASH clinical development
AstraZeneca recently has announced the results of the clinical trials POSEIDON which included the study of a combination of drugs Imfinzi (durvalumab) and tremelimumab with chemotherapy in lung cancer. Imfinzi is a human monoclonal antibody which blocks the interaction of PD-L1 with PD-1 by binding itself with ...
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Oct 22, 2019
FDA approval to AZ’s Farxiga for heart failure; GSK divests two travel vaccines to Bavarian Nordic; New breakthrough therapy for Cystic Fibrosis
The US FDA today has given its nod to Trikafta (elexacaftor/ivacaftor/tezacaftor) of Vertex Pharmaceuticals, the first of its kind triple combination therapy for the patients with cystic fibrosis. The drug, Trikafta, has been approved for patients of age 12 years and older who have at least one F508del mutation...
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Oct 10, 2019
First oral GLP-1 treatment approved for type2 Diabetes
The US FDA has approved Rybelsus (semaglutide) oral tablets to improve blood sugar in adult patients with Type II Diabetes. Rybelsus is an oral glucagon-like peptide (GLP-1) receptor protein treatment which has been approved after 15 years of the approval first GLP-1 agonist. GLP-1 is a hormone found in insuffi...
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Oct 04, 2019
FDA is reviewing a dangerous way to treat Peanut Allergy
Peanut allergies (PA) are the most common and severe type of food allergies in children. Even a small fragment of this legume to an allergic person can result in permanent brain damage. The prevalence rate of the Peanut allergy, over the past two decades, has tripled. According to DelveInsight, total prevalen...
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Sep 20, 2019
Roche’s Gazyva receives FDA Breakthrough designation for Lupus nephritis
The US FDA has in a recent move granted Roche’s Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. Gazyva (obinutuzumab) is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Classified as a "monoclonal antibody", Gazyva is a CD20-directed cytolytic antibody. The drug...
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Sep 18, 2019
FDA approves Ibsrela to reduce the global burden of Irritable Bowel Syndrome
Recently the U.S. Food and Drug Administration has recommended the use of Ibsrela (tenapanor), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. A 50 mg, twice daily oral pill, Ibsrela is a small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen...
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