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 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[…]

Top Regulatory News Stories – Week Ending October 26, 2018

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[…]

Top Regulatory News Stories – Week Ending October 19, 2018

The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.  https://www.biospace.com/article/fda-approves-pfizer-s-talzenna-for-breast-cancer/ Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. https://www.biospace.com/article/amidst-strong-quarterly-growth-novartis-receives-fda-complete-response-letter-for-canakinumab/ Ocular[…]

Top Regulatory News Stories – Week Ending October 12, 2018

The US FDA gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi (inotersen), a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi was previously green-lit in Canada and the European Union.  https://www.biospace.com/article/akcea-therapeutics-and-ionis-pharmaceuticals-snag-fda-approval-for-tegsedi/ The FDA has approved Leadiant Biosciences’ Revcovi (elapegademase-lvlr) for the treatment of adults and children with[…]

Top Regulatory News Stories – Week Ending September 28, 2018

Verastem announced that the U.S. FDA has approved COPIKTRA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. https://www.marketwatch.com/press-release/verastem-oncology-receives-fda-approval-of-copiktratm-duvelisib-capsules-2018-09-24 Eli Lilly announced that the FDA has approved Emgality (galcanezumab-gnlm 120 mg injection) for the preventive treatment of migraine in adults. https://www.nasdaq.com/article/fda-approves-lillys-emgality-for-preventive-treatment-of-migraine-in-adults-20180927-01236 Pfizer[…]

Top Regulatory News Stories – Week Ending September 14, 2018

The US FDA approved AstraZenea’s Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia.  https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-approves-lumoxiti-moxetumomab-pasudotox-tdfk-for-certain-patients-with-relapsed-or-refractory-hairy-cell-leukaemia.html   Amryt announced that the FDA has granted IND clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis[…]