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 October 5, 2018

This was a big week for Paratek Pharmaceuticals which received US FDA approval for two new molecular entities.  On Monday Paratek announced that the FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. https://www.nasdaq.com/press-release/fda-approves-seysara-sarecycline-for-the-treatment-of-moderate-to-severe-acne-20181002-00547     Then on Wednesday Paratek[…]

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[…]