This is our Regulatory Landscape newsletter for September 2023 with our monthly insights on the evolving market for Regulatory professionals. For the month of August there were about 80 new Regulatory positions posted at smaller biotech and pharma companies in the US. This is up about 14% from last month and very similar to the[…]
In today’s market, it’s incredibly challenging to find the desired Regulatory talent for growing bio/pharma organizations. We’ve seen companies adjust levels, rapidly promote people, and lower their expectations. It’s an arduous process but once you finally are ready to make an offer, it’s becoming increasingly difficult to get the acceptance. The biggest challenge is that[…]
Genentech’s blood cancer drug Polivy earned an accelerated approval from the U.S. FDA due to the complete response rate shown during clinical trials. https://www.biospace.com/article/genentech-s-blood-cancer-drug-approved-two-months-ahead-of-pdufa-date/?s=61 The FDA approved Merk’s Keytruda as a frontline treatment for head and neck cancer. Keytruda was initially approved in 2014 for advanced melanoma and has since received approvals as treatment for[…]
Novartis’ Sandoz unit and Pear Therapeutics announced Monday that the FDA cleared their prescription-only mobile medical app, reSET-O, marking the first FDA-cleared prescription digital therapeutic for patients with opioid use disorder. https://www.firstwordpharma.com/node/1610616 Stealth BioTherapeutics announced that the FDA has granted Fast Track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related[…]
Ocular Therapeutix announced that the FDA has approved DEXTENZA (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. https://www.biospace.com/article/releases/ocular-therapeutix-announces-fda-approval-of-dextenza-for-the-treatment-of-ocular-pain-following-ophthalmic-surgery/?s=89 Roche’s checkpoint inhibitor Tecentriq got approval Thursday from the FDA in the first-line setting to treat non-squamous non-small cell lung cancer in combination with Avastin and chemotherapy. https://www.biopharmadive.com/news/roches-tecentriq-gets-first-line-lung-cancer-approval/543869/ The[…]
The US FDA has approved Astellas Pharma’s gilteritinib (XOSPATA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. https://www.raredr.com/news/fda-approves-gilteritinib-treatment-adult-relapsed-refractory-aml-a-flt3-mutation?utm Pfizer received FDA approval for Daurismo (glasdegib), an oral drug for the treatment of acute myeloid leukemia (AML). This is Pfizer’s[…]
The FDA granted accelerated approval to Merck’s checkpoint immunotherapy pembrolizumab (Keytruda) for the treatment of certain patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. https://www.cancerresearch.org/blog/november-2018/fda-approves-pembrolizumab-hcc-liver-cancer Exelixis, Inc. announced that its partner IPSEN received approval from the European Commission for CABOMETYX (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma in[…]
The US FDA has approved AcelRx Pharmaceuticals’ DSUVIA, despite abuse concerns. DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. https://www.npr.org/sections/health-shots/2018/11/02/663395669/despite-warnings-fda-approves-potent-new-opioid-painkiller Coherus BioSciences announced that the FDA has approved[…]
The US FDA has approved Novartis/Sandoz’s Hyrimoz, a biosimilar of Abbvie’s Humira, the world’s bestselling prescription medicine. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoztm-adalimumab-adaz TherapeuticsMD announced that the FDA has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women. https://www.businesswire.com/news/home/20181029005251/en/TherapeuticsMD-Announces-FDA-Approval-TX-001HR-BIJUVA%E2%84%A2-Estradiol[…]
The US FDA has approved a new treatment for the flu for the first time in nearly 20 years. Roche’s Xofluza (baloxavir marboxil) was approved in people 12 years of age or older. https://www.biospace.com/article/roche-snags-fda-approval-for-first-new-flu-drug-in-20-years/ Principia Biopharma announced that PRN1008, an oral, reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor, has been granted Orphan Drug Designation by[…]
