Top Regulatory News Stories – Week Ending May 17, 2019

The FDA will be launching an expanded access pilot dubbed ‘Project Facilitate’ by End of May.  This program is aimed at improving patient access to unapproved oncology drugs: https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-launch-expanded-access-pilot-project-facil?feed=Regulatory-Focus The FDA has granted Breakthrough Therapy Designation for Sunovion’s schizophrenia drug: http://www.wbjournal.com/article/20190513/NEWS01/190519988 Celgene reported that the FDA has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for[…]

Top Regulatory News Stories – Week Ending May 10, 2019

The FDA approved two oral formulations of the Pfizer drug tafamidis (to be sold as Vyndaqel and Vyndamax) for the treatment of transthyretin amyloidosis (ATTR), a debilitating rare genetic disease. https://xconomy.com/new-york/2019/05/06/fda-oks-pfizer-rare-disease-drug-sets-up-battle-with-alnylam-akcea/?mc_cid=2ebda5e74a&mc_eid=3e3fa57749 Jacobus Pharmaceutical Co won FDA approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. https://www.reuters.com/article/us-jacobus-fda/fda-grants-jacobus-pharma-approval-for-rare-disease-drug-idUSKCN1SC26U The European[…]

Top Regulatory News Stories – Week Ending May 3, 2019

The U.S. FDA gave Sanofi’s dengue vaccine Dengvaxia a very narrow approval on Wedneday.  The company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.  https://www.reuters.com/article/us-usa-fda-sanofi-fr/sanofi-wins-fda-approval-to-sell-dengue-shot-in-parts-of-u-s-idUSKCN1S74TI?feedType=RSS&feedName=healthNews Finch Therapeutics Group announced that the FDA has granted Fast Track designation to its Full-Spectrum Microbiota® (FSM®)[…]

Top Regulatory News Stories – Week Ending April 26, 2019

Hi folks!  I haven’t done my regulatory news blog in a few months but I’m hoping to make it a regular thing again.  Here are the top regulatory news stories this week: On Tuesday the FDA had approved Abbvie’s Skyrizi (risankizumab-rzaa) for severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.[…]

Top Regulatory News Stories – Week Ending December 14, 2018

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[…]

Top Regulatory News Stories – Week Ending December 7, 2018

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[…]

Top Regulatory News Stories – Week Ending November 30, 2018

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[…]

Top Regulatory News Stories – Week Ending November 16, 2018

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[…]

Top Regulatory News Stories – Week Ending November 8, 2018

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[…]

Top Regulatory News Stories – Week Ending November 2, 2018

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[…]