Tag Archives: priority review voucher

Cashing in On Duchenne Approval, Sarepta Sells Voucher to Gilead For $125M

Sarepta Therapeutics didn’t just get its first drug to market when the FDA approved the Duchenne muscular dystrophy drug eteplirsen (Exondys 51) last year—it got a potentially lucrative voucher from the FDA too. Today the Cambridge, MA, company cashed that in. Sarepta (NASDAQ: SRPT) this morning sold what’s known as a priority review voucher to […]

East Coast Biotech Roundup: X4, Rgenix, Alnylam, Intellia & More

What summer doldrums? It’s still not even Labor Day, yet the deals are already coming fast and furious. So fire up the grill and read on for some Series A rounds, crossover investments, data readouts, option-to-buy deals and more. —As Xconomy reported this week, a stealthy Cambridge, MA-based startup called X4 Pharmaceuticals raised a $37.5 […]

Posted in Boston, Boston blog main, National blog main, New York blog main, New York top stories | Tagged ALN-PCS, Alnylam Pharmaceuticals, Amgen, Amicus Therapeutics, aprepitant, Ariad Pharmaceuticals, Baxalta, Bristol-myers Squibb, Cholesterol, Columbia University, CRISPR-Cas9, deals, Emend, epidermolysis bullosa, Essential Tremor, Fibrosis, Gene editing, Genzyme, google, Henri Termeer, Intellia Therapeutics, Intercept Pharmaceuticals, Ivenix, Jeff Jonas, John Crowley, John Maraganore, Joslin Diabetes Center, Life Sciences, Masoud Tavazoie, Memorial Sloan-Kettering Cancer Center, Merck, Mozobil, obeticholic acid, Paula Ragan, PCSK9, plerixafor, Primary Biliary Cirrhosis, priority review voucher, Promedior, Regeneron Pharmaceuticals, Rgenix, RNAi, Rockefeller University, rolapitant, Roundups, Sage Therapeutics, Sanofi, ScioDerm, Shahram Seyedin-Noor, startups, Suzanne Bruhn, Tesaro, Tetraphase Pharmaceuticals, The Medicines Co., Varubi, VC, WuXi Healthcare Ventures, X4 Pharmaceuticals | Comments Off

With $229M Deal, Amicus Gets a New Drug And Perhaps a Voucher

Just how far has Amicus Therapeutics come in two years? In 2013, the Cranbury, NJ-based company was reeling from a trial failure and restructuring to conserve cash. Now, it’s eyeing its first drug approval and buying a startup in a nine-figure deal. Amicus (NASDAQ: FOLD) this morning is announcing the acquisition of Durham, NC-based Scioderm. […]

Posted in Boston blog main, National blog main, National top stories, New York, New York blog main, New York top stories, Raleigh-Durham blog main, Raleigh-Durham top stories | Tagged AbbVie, allantoin, Amicus Therapeutics, Biotech, collagen, deals, Dystrophic Epidermolysis Bullosa Research Association of America, epidermolysis bullosa, Fabry Disease, FDA, Leerink Partners, Life Sciences, Lotus Tissue Repair, migalastat, Morganthaler Ventures, priority review voucher, Robert Ryan, ScioDerm, Shire, startups, Technology Partners, Third Rock Ventures, United Therapeutics, VC | Comments Off

East Coast Biotech Roundup: StartUp Health, Constellation, Highline & More

Nothing like a little drama to end your summer, right? Market volatility dragged biotech down this week, and then lifted it back up—at least as of Friday morning. But if you’re confused by the tumult and looking for some distractions, we’ve got plenty of them below. Read on for details of some biotech and digital […]

Posted in Boston blog main, Boston top stories, National blog main, New York, New York blog main, New York top stories | Tagged Acorda Therapeutics, alirocumab, Amgen, Ampyra, Arlene Morris, atezolizumab, BioMarin Pharmaceutical, Biotech, Brent Stockwell, Briggs Morrison, Carlo Rizzuto, Columbia University, Constellation Pharmaceuticals, dalfampridine, deals, Digital Health, Drugs, Duchenne Muscular Dystrophy, entinostat, evolocumab, FDA, Genentech, Hayman Capital Management, Healthtech, High Line, Highline Therapeutics, IPO, Keith Dionne, Kyle Bass, Life Sciences, Merck, PCSK9, Praluent, priority review voucher, RainDance Technologies, Regeneron Pharmaceuticals, Repatha, Roundups, Sarepta Therapeutics, StartUp Health, Syndax Pharmaceuticals, Unity Stoakes, Verastem, Versant Ventures, Weill Cornell Medical College | Comments Off

East Coast Biotech Roundup: Seres, Editas, PureTech, Pronutria & More

Call it the calm before the storm. All eyes in biotech this weekend will turn to the year’s big cancer meeting, the American Society of Clinical Oncology’s annual bash in Chicago. There’ll be plenty of data to parse through over the next few days, as cancer immunotherapy once again takes center stage and hordes of […]

Posted in Boston, Boston blog main, Boston top stories, National blog main, New York blog main, New York top stories | Tagged Alexandria Center for Life Science, American Society of Clinical Oncology, Amicus Therapeutics, amino acids, Asklepion Pharmaceuticals, Biogen, BlueBird Bio, CAR-T, Cellectis, CRISPR-Cas9, deals, Editas Medicine, Fabry Disease, Five Prime Therapeutics, GlaxoSmithKline, IPO, Juno Therapeutics, Life Sciences, Michael Gilman, Microbiome, migalastat, Padlock Therapeutics, Pfizer, priority review voucher, Pronutria Biosciences, protein-arginine deiminases, PureTech, Retrophin, Robert Connelly, Roundups, Sanofi, seres Therapeutics, startups, Stromedix, VC | Comments Off

With Asklepion Deal, Retrophin Gets a New Drug—And a Voucher

It was a rough 2014 for Retrophin, which was busy moving on from its former CEO’s ouster. But things brightened up a bit this morning, as the company not only added a new drug to the fold, but also get ahold of an asset that’s been making waves in biotech over the past year—a so-called […]

Posted in National blog main, New York, New York blog main, New York top stories, San Francisco blog main, San Francisco top stories | Tagged Amgen, Asklepion Pharmaceuticals, bile acid synthesis disorder, BioMarin Pharmaceutical, Cholbam, cholic acid, deals, Drugs, FDA, focal segmental glomerulosclerosis, Gilead Sciences, Knight Pharmaceuticals, Leishmaniasis, Life Sciences, Martin Shkreli, Morquio A Syndrome, oxytocin, pantothenate kinase-associated neurodegeneration, priority review voucher, Regeneron Pharmaceuticals, Retrophin, Stephen Aselage, Turing Pharmaceuticals | Comments Off

East Coast Biotech Roundup: Yumanity, Biogen, Blizzards, & More

Funny thing happened on the East Coast this week. The so-called Blizzard of 2015 threw us New Yorkers into a panic before unexpectedly veering eastward in a post-Christmas miracle and giving the city little more than a dusting. We weren’t relieved; we were livid—at weathermen for scaring us, politicians for shutting the city down for […]

Posted in Boston, Boston blog main, National blog main, New York blog main, New York top stories | Tagged alirocumab, Alzheimer's, Amgen, Biogen Idec, BioMarin Pharmaceutical, bone cancer, Christoph Westphal, clinical trials, deals, dimethyl fumarate, evolocumab, Exosome Diagnostics, FDA, Flex Pharma, Gene Therapy, google, hemophilia, hypoparathyroidism, Intercept Pharmaceuticals, Life Sciences, Multiple Sclerosis, Natpara, nonalcoholic steatohepatitis, NPS Pharmaceuticals, obeticholic acid, Olivier Danos, Parkinson's, PCSK9, Praluent, priority review voucher, Regeneron Pharmaceuticals, Roundup, Sanofi, Shire, Tecfidera, Thomas McLain, Yeast, Yumanity Therapeutics | Comments Off

With Gilead’s $125M Purchase, FDA Voucher Program Gains Momentum

[UPDATED 11/19/14, 6:44pm. See below.] The next time Gilead Sciences (NASDAQ: GILD) has a drug ready for an all-important Food and Drug Administration review, it can jump the line. That’s because Gilead, the Foster City, CA-based maker of blockbuster drugs to treat HIV and Hepatitis C, paid a little-known Canadian drug company $125 million for […]

Posted in National blog main, National top stories, New York blog main, New York top stories, Raleigh-Durham blog main, Raleigh-Durham top stories, San Francisco, San Francisco blog main, San Francisco top stories | Tagged alirocumab, Amgen, BioMarin Pharmaceutical, Biotech, David Ridley, Duke University, Ebola, evolocumab, FDA, Gilead Sciences, Hepatitis C, HIV, Impavido, interferon, Knight Therapeutics, Lawsuit, Leishmaniasis, Life Sciences, miltefosine, MOrquio A, Paladin Labs, patent infringement, PCSK9, priority review voucher, Regeneron Pharmaceuticals, Sanofi, Sirturo, sofosbuvir, Sovaldi, Tuberculosis | Comments Off

An Intriguing Program Takes on Tropical Diseases—But Not Ebola

[Updated and corrected 9/10/14, 10:05 am. See below.] On August 28, Anthony Fauci, the U.S. National Institutes of Health’s top infectious disease specialist, announced a major trial in concert with GlaxoSmithKline (NYSE: GSK) to test new Ebola vaccines in humans. Fauci called it an “all-hands-on-deck response” to the growing global health emergency in which more […]

Posted in Boston blog main, Boulder/Denver blog main, Boulder/Denver top stories, Detroit blog main, Detroit 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 alirocumab, Amgen, Anthony Fauci, BARDA, bedaquiline, bill gates, BIO Ventures For Global Health, BioMarin Pharmaceutical, Biomedical Advanced Research and Development, Biotech, Christian Sandrock, Coartem, David Ridley, Davos, Department of Health and Human Services, Duke University, Ebola, evolocumab, GlaxoSmithKline, GSK, In Translation, J&J, Janssen Pharmaceuticals, Jennifer Dent, Knight Therapeutics, Life Sciences, Malaria, Mapp Biopharmaceutical, National Institute of Allergy and Infectious Disease, National Institutes of Health, neglected tropical disease, NIAID, No, Novartis, Paladin Labs, priority review voucher, rare pediatric disease voucher, Regeneron Pharmaceuticals, Sirturo, tropical disease, Tuberculosis, vaccines, World Health Organization, ZMapp | 2 Comments

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