FDA: Page 58
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Generon moving ahead with Phase 3 trial following SPA
The FDA has agreed to the study protocol, which will test the Chinese biotech's lead candidate as a treatment for chemotherapy-induced neutropenia.
By Jacob Bell • Oct. 11, 2017 -
Flexion secures US approval for osteoarthritis drug
The biotech is highlighting the drug as a non-opioid, non-surgical option for knee pain associated with the chronic condition.
By Ned Pagliarulo • Oct. 9, 2017 -
EMA warns relocation could deliver major hit to budget
The EU drugs regulator has cautioned that moving its headquarters to a new country could lead to "massive staff losses," an event that might batter its budget.
By Suzanne Elvidge • Oct. 9, 2017 -
Prescribed Reading: DMD, MS and other acronyms
Another DMD drug struggles to get closer to market, a blockbuster MS drug now faces multiple generic competitors, and a deal is inked to increase competition in the Tyk2 inhibitor space.
By Lisa LaMotta • Oct. 6, 2017 -
Teva hit with surprise Copaxone generic, Mylan celebrates
The Israeli drugmaker is now facing generic competition to its best-selling product, putting more than $4 billion of revenue in jeopardy.
By Lisa LaMotta • Oct. 4, 2017 -
Elizabeth Regan/BioPharma Dive
10 Topics pharma execs were talking about in Q3
With the third quarter coming to a close, BioPharma Dive revisits the stories that sparked the most reader interest during the July-to-September period.
By Lisa LaMotta • Oct. 3, 2017 -
With Price out at HHS, talk turns to replacement candidates
Names being circulated include FDA Commissioner Scott Gottlieb, Veterans Affairs Secretary David Shulkin and CMS Administrator Seema Verma.
By Shannon Muchmore • Oct. 2, 2017 -
FDA looking to clear path to market for complex generics
In his latest blog post, Commissioner Scott Gottlieb outlined how the agency will work to increase competition for pricey pharmaceuticals.
By Jacob Bell • Oct. 2, 2017 -
Deep Dive
Time for PTC to shift gears?
With a negative review from an FDA advisory committee and low prospects for approval, the time may have arrived for PTC Therapeutics to reevaluate its business plan.
By Lisa LaMotta • Sept. 29, 2017 -
Courtesy of Eli Lilly
Lilly's abema gets FDA OK, setting it up for blockbuster status
Verzenio comes as the third CDK 4/6 inhibitor to market, facing competition from Pfizer's Ibrance and Novartis' Kisqali, but it could be best in class.
By Jacob Bell • Sept. 29, 2017 -
Prescribed Reading: No such thing as unicorns
Both closely watched Axovant and Intarcia had major setbacks this week, despite high hopes that their therapies would be game-changers.
By Lisa LaMotta • Sept. 29, 2017 -
Intarcia loses some of its sparkle with FDA rejection
The FDA flagged issues with the biotech unicorn's manufacturing practices, denting the blockbuster promise of its diabetes drug-device combo.
By Lisa LaMotta • Sept. 28, 2017 -
PhRMA supports script limits to cut opioid abuse
The industry lobbying group came out in favor of a seven-day cutoff for first-time users, touted as part of the fight against opioid abuse.
By Suzanne Elvidge • Sept. 28, 2017 -
Who will host the EMA? A brief guide to the leading contenders
Nineteen cities have bid to become the regulatory agency's new home, now that Brexit has forced the European Medicines Agency to relocate from London.
By Suzanne Elvidge • Sept. 27, 2017 -
FDA targets illegal online pharmacies as part of global crackdown
In a recent enforcement effort, the U.S. regulator sent 13 warning letters to the operators of 401 websites peddling illegal or counterfeit medicines.
By Suzanne Elvidge • Sept. 27, 2017 -
J&J, Roche among companies selected for FDA digital health pilot
The regulator hopes to improve how it reviews digital medical devices, aiming to streamline the path to market for new health tools.
By Jeff Byers • Sept. 26, 2017 -
FDA
Intellipharmaceutics receives painful FDA rejection
The agency said it needs more data demonstrating extended-release oxycodone's abuse deterrence profile.
By Jacob Bell • Sept. 25, 2017 -
Following negative adcomm, J&J's sirukumab rejected
The rheumatoid arthritis drug, which has already lost GSK support, gets a thumbs down from the regulator.
By Suzanne Elvidge • Sept. 25, 2017 -
Prescribed Reading: Consolidation, clinical holds and landmark results
The FDA continues its clinical hold spree for PD-1/L1s, consolidation is rampant in the CDMO space and RNAi may become a reality very soon.
By Lisa LaMotta • Sept. 22, 2017 -
Korean drugmaker used employees to test potentially harmful ointment, FDA says
Firson Co. Ltd. is one of two Asian pharma manufacturers recently flagged by the agency for manufacturing violations.
By Jacob Bell • Sept. 21, 2017 -
Split adcomm vote leaves Pfizer's Sutent in limbo
An FDA advisory panel voted six in favor, six against a new indication for the drugmaker's cancer med.
By Jacob Bell • Sept. 19, 2017 -
GSK's respiratory business boosted by lung drug approval
The three-in-one inhaler should help GlaxoSmithKline stay competitive in respiratory disease as rival therapies erode sales of its blockbuster drug Advair.
By Ned Pagliarulo • Sept. 19, 2017 -
Samsung Bioepis first to secure EMA backing for Herceptin biosimilar
A final decision on marketing authorization will be made by the European Commission in the coming months.
By Ned Pagliarulo • Sept. 15, 2017 -
Amgen, Allergan win first approval of cancer biosimilar in US
The drug, which will be marketed as Mvasi, is a biosimilar version of Roche's top-selling biologic Avastin.
By Ned Pagliarulo • Sept. 14, 2017 -
FDA calls for industry input on continuous manufacturing guidelines
Biopharmas largely haven't adopted the speedier and more adaptable approach to drug manufacturing, relying instead on tried-and-true batch production methods.
By Ned Pagliarulo • Sept. 14, 2017
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