This week saw the approval for Sun Pharma’s first biologic program along with a supplemental approval for Seattle Genetics. Here is my recap of the top regulatory news stories for this week: The FDA on Monday officially launched its pilot project to publicly release portions of clinical trial-related summaries from pivotal trials, with initial data[…]

This week the FDA granted Breakthrough Therapy status to three development programs and halted two different clinical trials.  Here are the top regulatory news stories to follow this week: Ocular Therapeutix, which had its lead drug rejected by the FDA last summer said that it remains on track to resubmit its application to the FDA[…]

This week we saw the approval of a new molecular entity by the FDA along with the first marketing authorization approval for a genetic health risk assessment. Here is my recap of the top regulatory news stories for this week: The FDA approved TaiMed Biologics’ Trogarzo (ibalizumab-ulyk) for the treatment of adults with chronic HIV[…]

  Hi folks. This was a relatively quiet week without the approval of any new molecular entities. Here is my recap of the top regulatory news stories this week: The FDA agreed to expand the label for AstraZeneca’s immunotherapy Imfinzi (durvalumab) to reduce the risk of non-small-cell lung cancer progression in patients with stage III[…]

Hi folks, here are the top regulatory news stories to follow this week: GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, Shingrix: https://www.reuters.com/article/us-usa-fda-gsk/gsk-wins-u-s-shingles-vaccine-approval-uk-nod-for-gene-therapy-idUSKBN1CS0TU The FDA expanded its approval for Alexion’s blood-disorder drug Soliris to include treatment for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive.  Soliris was[…]

Here are the top regulatory news stories this week: The FDA approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb):  http://www.raps.org/Regulatory-Focus/News/2017/09/14/28467/FDA-Approves-First-Biosimilar-Cancer-Treatment/ FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to[…]

There was a lot of regulatory news this week including an extension of the PDUFA bill, FDA approval of two New Molecular Entities, and an approval of the first treatment for Chronic Graft Versus Host Disease. Here is my summary of the top regulatory stories this week: The US Senate passed a bipartisan bill to[…]

I am posting a bit early this week due to the long holiday weekend.  Here are the top regulatory news stories to follow this week: FDA’s biosimilars lead Leah Christl said last week at DIA’s annual conference in Chicago that she expects interchangeable biosimilars will come to market within the next two years: http://raps.org/Regulatory-Focus/News/2017/06/26/27969/FDA-Interchangeable-Biosimilar-Approvals-Expected-Within-2-Years/  […]