FDA: Page 60
-
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 -
FDA clears orphan drug backlog ahead of schedule
The agency is now turning its attention toward addressing criticisms of the Orphan Drug Act and the loopholes potentially exploited by pharma.
By Jacob Bell • Sept. 12, 2017 -
Analyst: Intercept safety concerns overblown
Shares of the biotech fell after it issued a 'Dear Health Care Provider' letter.
By Lisa LaMotta • Sept. 12, 2017 -
Elizabeth Regan/BioPharma Dive
ESMO: Clovis seeking new indication on positive ARIEL3 data
Strong results in all types of advanced ovarian cancer patients has the biotech looking to expand the market for its PARP inhibitor.
By Lisa LaMotta • Sept. 8, 2017 -
Pfizer's EpiPen manufacturer warned by FDA
The agency found glaring issues with how the site handled quality control, complaints and defective auto-injectors.
By Jacob Bell • Sept. 8, 2017 -
Prescribed Reading: PD-1, CAR-T threatened by clinical holds
Highly innovative oncology technologies may be life-saving, but they have also raised major safety concerns.
By Lisa LaMotta • Sept. 8, 2017 -
FDA
Integration a key focus of FDA's new drug review model
Agency head Scott Gottlieb plans to create more integrated teams to boost information sharing between staff scrutinizing new drugs and those reviewing manufacturing facilities.
By Jacob Bell • Sept. 7, 2017
Previous
