Tag Archives: fremanezumab

At Big Neuro Meeting, Migraine Drug Competitors to Make Oral Arguments

The first new class of migraine drugs in decades won FDA approval last year. But the companies who commercialized these new therapies and their potential competitors are already planning new, more convenient versions, taken as pills instead of injectoins just below the skin, and they will present key data in the next few days at […]

Bio Roundup: Biogen’s Strategy, Drug Price Convo, NASH News & More

The road to every new drug approval is littered with the remains of earlier failures. Biopharmaceutical companies don’t like to talk about the failures. But it’s earnings season now, so some of them don’t have much choice. Biogen’s (NASDAQ: BIIB) earnings call this week was the first since its Alzheimer’s drug aducanumab failed in a Phase […]

Posted in Boston blog main, Boston top stories, Boulder/Denver blog main, Boulder/Denver top stories, Detroit blog main, Detroit top stories, Indiana blog main, Indiana top stories, National, National blog main, National top stories, New York blog main, New York top stories, Raleigh-Durham blog main, Raleigh-Durham top stories, San Diego blog main, San Diego top stories, San Francisco blog main, San Francisco top stories, Seattle blog main, Seattle top stories, Texas blog main, Texas top stories, Wisconsin blog main, Wisconsin top stories | Tagged AbbVie, adalimumab (Humira), aducanumab, Aduro BioTech, Affordable Care Act, Alez Azar, Alzheimer's disease, Antibiotics, axial spondyloarthritis, Bausch Health, Biogen, Biotech, Boston University, Bristol-myers Squibb, cancer, cancer immunotherapy, CAR-T immunotherapy, Cell Therapy, clinical trials, cluster headache, CRISPR, deals, Diagnostics, Digital Health, dihydroergotamine, Dimitry Nuyten, drug prices, Eddingpharm, Eli Lilly, Elizabeth Holmes, fremanezumab, Fulcrum Therapeutics, Gene Therapy, generic drugs, Gilead Sciences, GlaxoSmithKline, halobetasol proprionate, Health and Human, Histogenics, Immunotherapy, Institute for Clinical Economic Review, Ipilimumab, IQVIA Holdings, ixekizumab, Johnson & Johnson, Kaiser Family Foundation, Life Sciences, losmapimod, Lynne Kelley, medicare, Merck, Michel Vounatsos, Migraine, Multiple Myeloma, Multiple Sclerosis, naloxone, Nivolumab, nonalcoholic steatohepatitis, Novartis, opioid, pembrolizumab, pembrolizumab Keytruda, Poseida Therapeutics, risankizumab, Rochester Drug Cooperative, Satsuma Pharmaceuticals, Seema Verma, selonsertib, Sherlock Biosciences, startups, Steve Pearson, tazarotene, Teva Pharmaceutical, The University of Texas MD Anderson Cancer Center, Theranos, X4 Pharmaceuticals, Zolgensma | Comments Off

Teva’s Approved Migraine Drug Fails Again to Blunt Rarer Headache

With a second big clinical failure, Teva Pharmaceutical is abandoning efforts to extend the use of its approved migraine drug to the treatment of cluster headaches, a rarer form of headache that typically affects one side of the head around the eye or the temple. Teva (NYSE: TEVA) said Tuesday that an interim analysis of […]

Posted in Indiana blog main, National blog main, New York, New York blog main, New York top stories, Seattle blog main | Tagged Alder BioPharmaceutical, Amgen, Biotech, calcitonin gene-related peptide, chronic cluster headache, clinical trials, cluster headache, Eli Lilly, episodic cluster headache, eptinezumab, FDA, fremanezumab, Life Sciences, Migraine, Teva Pharmaceutical | Comments Off

Bio Roundup: Gottlieb’s Goodbye, AACR Recap, Migraine Drug Fight & More

Scott Gottlieb’s last day as FDA commissioner is today. His resignation announcement last month surprised some, given the earlier denials about leaving. But after two years of commuting between Connecticut, where his family remained, and the FDA’s Maryland headquarters, he decided to step down from the agency. What will Gottlieb’s legacy be? His efforts to […]

Posted in Boston blog main, Boston top stories, Boulder/Denver blog main, Boulder/Denver top stories, Detroit blog main, Detroit top stories, Indiana blog main, Indiana top stories, National, National blog main, National top stories, New York blog main, New York top stories, Raleigh-Durham blog main, Raleigh-Durham top stories, San Diego blog main, San Diego top stories, San Francisco blog main, San Francisco top stories, Seattle blog main, Seattle top stories, Texas blog main, Texas top stories, Wisconsin blog main, Wisconsin top stories | Tagged Aaron Osborne, Adverum Biotechnologies, Alder Biopharmaceuticals, American Association for Cancer Research, American Enterprise Institute, Amgen, Arteaus Therapeutics, Atlas Venture, Aura Biosciences, Biogen, Biotech, Breast Cancer, Bristol-myers Squibb, Bruce Booth, CAR-T, Celgene, Charles Wagner, Cigna, Cyclerion Therapeutics, deals, Dr. Reddy's Laboratories, drug prices, Dyne Therapeutics, erenumab, FDA, fremanezumab, Gene Therapy, Genentech, Glass Lewis, Hunter Syndrome, IFM Tre, Inflammatory Disease, Institute for Clinical Economic Review, Institutional Shareholder Services, Insulin, investing, Ironwood Pharmaceuticals, Life Sciences, Lung Cancer, Merrimack Pharmaceuticals, Migraine, Muscular Dystrophy, NGM Biopharmaceuticals, nonalcoholic steatohepatitis, Novartis, nusinersen, Ortho-Clinical Diagnostics, Pancreatic Cancer, Patrick Soon-Shiong, Pfizer, primary choroidal melanoma, rare disease drugs, Richard Pazdur, Roche, Royalty Pharma, Sangamo Therapeutics, Scott Gottlieb, Sorrento Therapeutics, SpringWorks Therapeutics, Starboard Value, startups, Teva Pharmaceutical, Venture Capital, Vertex Pharmaceuticals | Comments Off

Report: Express Scripts Shuts Out Teva Migraine Drug, Prefers Rivals

[Updated 10/17/18, 2:52 p.m. See below.] Express Scripts has just exerted its influence over the emerging market battle between drug makers trying to sell a new class of migraine-preventing medicines. The pharmacy benefits manager (PBM) is excluding a new drug from Teva Pharmaceutical from coverage while favoring two rival treatments instead, according to a report […]

Eli Lilly Migraine Drug Approved, the Third in New Class of Medicines

[Updated, 9/28/18, 12:54 p.m. See below.] An Eli Lilly drug developed to prevent migraine headache pain before it starts has won FDA approval. The FDA decision announced late Thursday marks the third drug in this new class of medicines to receive the regulatory nod this year. Two weeks ago, the FDA approved a migraine drug […]

Posted in Indiana, Indiana blog main, Indiana top stories, National blog main | Tagged Amgen, Biotech, calcitonin gene-related peptide, chronic migraine, clinical trials, Drugs, Eli Lilly, episodic migraine, erenumab, Evercore ISI, FDA, fremanezumab, Life Sciences, Migraine, Teva Pharmaceutical, The Institute for Clinical and Economic Review, Umer Raffat | Comments Off

Teva Wins FDA Nod for Migraine Drug, Sets Price in Line with Amgen’s

A Teva Pharmaceutical migraine-prevention drug has won FDA approval, the second therapy in this new drug class to receive the regulatory nod this year. The Friday approval for the Teva (NYSE: TEVA) drug fremanezumab (Ajovy) came a little earlier than expected; the target date for the FDA decision was Sept. 16. The drug is part […]

Posted in Indiana blog main, National, National blog main, National top stories, Seattle blog main | Tagged Alder Biopharmaceuticals, Amgen, Biotech, calcitonin gene-related peptide, clinical trials, Eli Lilly, eptinezumab, erenumab, Evercore ISI, FDA, fremanezumab, galcanezumab, Life Sciences, Migraine, Teva Pharmaceutical, Umer Raffat | Comments Off

Bio Roundup: Duchenne Data, Roche Buys Foundation, IPO Wave & More

Biotech financing is a cyclical thing. Two years ago, the IPO window was unlatched but a number of companies ended up withdrawing their stock offerings. Others that pushed their IPOs through couldn’t sell shares at the price they wanted. This year, the IPO window is wide open. A total of 93 IPOs have priced as […]

Posted in Boston blog main, Boston top stories, Boulder/Denver blog main, Boulder/Denver top stories, Detroit blog main, Detroit top stories, Indiana blog main, Indiana top stories, National, National blog main, National top stories, New York blog main, New York top stories, Raleigh-Durham blog main, Raleigh-Durham top stories, San Diego blog main, San Diego top stories, San Francisco blog main, San Francisco top stories, Seattle blog main, Seattle top stories, Texas blog main, Texas top stories, Wisconsin blog main, Wisconsin top stories | Tagged Addgene, amazon, Amyotrophic Lateral Sclerosis (ALS), Anika Therapeutics, Autolus Therapeutics, Berkshire Hathaway, Biotech, Brainstorm Cell Therapeutics, CAR-T, Charlie Baker, chronic cluster headaches, Cingal, Decibel Therapeutics, Deval Patrick, dry age-related macular degeneration, Eidos Therapeutics, electroCore, Elizabeth Holmes, Emulate, Foundation Medicine, fremanezumab, investing, IPO, Joanne Kamens, JPMorgan Chase, Kallyope, Life Sciences, Medical Device, Migraine, Ortho Dermatologics, plaque psoriasis, Puma Biotechnology, Purdue Pharma, Ramesh Balwani, Renaissance Capital, right to try, Robert Gadimian, Roche, Sarepta Therapeutics, Solid Biosciences, startups, Stealth BioTherapeutics, Teva Pharmaceutical, Theranos, Tim Draper, Valeant Pharmaceuticals, Venture Capital, Ziopharm Oncology | Comments Off

Teva’s Migraine Drug Fails in Phase 3 for Chronic Cluster Headaches

Teva Pharmaceutical’s bid to add a new therapeutic application for its experimental migraine-prevention drug has faltered in a late-stage study. Israel-based Teva (NYSE: TEVA) said Friday that it is stopping a Phase 3 clinical trial testing its drug, fremanezumab, for prevention of chronic cluster headaches. According to the company, an analysis found that the study […]

Posted in Indiana blog main, National, National blog main, San Francisco blog main, Seattle blog main | Tagged Amgen, Biotech, calcitonin gene-related peptide, chronic cluster headache, Clinical Trial, cluster headache, episodic cluster headache, erenumab, FDA, fremanezumab, Life Sciences, Migraine, National Organization for Rare Disorders, Teva Pharmaceutical | Comments Off

Drug Price Watchdog ICER Deems Amgen Migraine Drug “Cost-Effective”

As Amgen approached an FDA decision last month for its migraine-prevention treatment, concern mounted that the drug would come at premium. In setting a price thousands of dollars less than expected, Amgen has won over one of the pharmaceutical industry’s fiercest drug price critics. The non-profit Institute for Clinical and Economic Review (ICER) assessed the […]

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