FDA: Page 57
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FDA issues PRV guidance for medical countermeasures
A new PRV program looks to reward drugmakers for developing products that address diseases tied to biological, nuclear and other threats, as well as emerging infectious diseases.
By Suzanne Elvidge • Jan. 19, 2018 -
Pharma, payers clash over CMS Part D drug rebate plan
The drug, PBM and insurance industries differ on a CMS proposal to require Part D sponsors to pass on a percentage of rebates to consumers.
By David Lim • Jan. 18, 2018 -
Shire's latest approval won't save it from Hemlibra
The EC thumbs up for Adynovi should bolster Shire's hemophilia business, yet Roche's new drug still threatens bottom lines.
By Jacob Bell • Jan. 17, 2018 -
FDA, Pentagon work to speed review of products for military use
The two government agencies reached an agreement to maintain FDA oversight, while accelerating approval of certain medical products for military use.
By Lisa LaMotta • Jan. 17, 2018 -
FDA roadmap highlights opioids, gene therapy, biosimilars
On the agency's to-do list is broadening access to biologics and calling out pharma for impeding generics.
By Suzanne Elvidge • Jan. 12, 2018 -
Biotech CEOs unfazed by Brexit
During a panel moderated by BioPharma Dive, biotech executives sounded off about the upcoming Brexit and what it means for them.
By Lisa LaMotta • Jan. 11, 2018 -
FDA slaps down Amneal bid to stop Forteo generics
The agency has rejected a citizen petition from the copycat drugmaker.
By Jacob Bell • Jan. 10, 2018 -
Azar talks list prices, mandatory Medicare pilots
The HHS nominee identified high drug prices and shifting payment models to reward health outcomes as top priorities.
By David Lim • Jan. 9, 2018 -
FDA rejects Allergan's latest bid to block Restasis copies
Allergan could face generic competition to Restasis as soon as this year, bringing with it a potential blow to the company's bottom line.
By Ned Pagliarulo • Jan. 5, 2018 -
FDA aims to strengthen oversight of compounded drug manufacturing
While changes have been made since a 2012 meningitis outbreak, large-scale drug compounding still poses risks, an update from the FDA cautions.
By Ned Pagliarulo • Jan. 4, 2018 -
Fresnius Kabi's investigations aren't up to snuff, says FDA
The German drugmaker has repeatedly failed to identify what's causing sterility issues at its plants, pushing the FDA to issue two warning letters last month.
By Jacob Bell • Jan. 4, 2018 -
Deep Dive
Drug approvals surged in 2017. What does that mean for pharma?
The FDA approved more novel medicines in 2017 than in any year since 1996.
By Ned Pagliarulo • Jan. 3, 2018 -
FDA seeks better communication with pharma in new guidance
The FDA sets out its plans for timely, efficient and effective discussions with drug developers.
By Suzanne Elvidge • Jan. 2, 2018 -
Prescribed Reading: FDA approval spree, tax reform, deals pick up
The agency under Scott Gottlieb has hit a new record for approvals, and the new tax bill has already prompted M&A.
By Lisa LaMotta • Dec. 22, 2017 -
Biopharma trends to watch in 2018
Several macro trends will continue to shape the industry in the new year.
By Ned Pagliarulo , Lisa LaMotta , Jacob Bell • Dec. 22, 2017 -
FDA drops boxed warning for combo asthma drugs
A review of four safety studies found pairing long-acting beta agonists and inhaled corticosteroids did not present a greater safety risk.
By Suzanne Elvidge • Dec. 22, 2017 -
Merck, Pfizer face uphill battle for new diabetes med
The big pharma partners got an FDA nod for their SGLT-2 inhibitor, but will struggle as a late-entry to a crowded market.
By Lisa LaMotta • Dec. 21, 2017 -
FDA plans tougher enforcement of homeopathic medicines
Under a proposed risk-based approach, the regulator would target products claiming to treat serious diseases or that contravene manufacturing standards.
By Suzanne Elvidge • Dec. 20, 2017 -
FDA approves Spark blindness drug in gene therapy first
Luxturna is the first gene therapy for an inherited disorder approved in the U.S., marking a major milestone for the field.
By Ned Pagliarulo • Dec. 19, 2017 -
Aerie eyes glaucoma market after early FDA win
Approval of Rhopressa could make Aerie a more attractive takeout option for ophthalmology-focused biopharmas.
By Ned Pagliarulo • Dec. 19, 2017 -
Getty / Edited by Industry Dive
Biopharma scores big win in tax overhaul
Congress passed a tax code rewrite this week. Here's a cheat sheet for what it means for biopharma.
By Lisa LaMotta • Dec. 18, 2017 -
New Year's resolution time: FDA reveals goals for 2018
The regulatory agency looks forward to continued streamlining of regulations and improving access to therapeutics.
By Suzanne Elvidge • Dec. 18, 2017 -
Prescribed Reading: Year-end M&A, Showdown at ASH
New data from the American Society of Hematology conference has the industry buzzing.
By Lisa LaMotta • Dec. 15, 2017 -
Alnylam, Sanofi given the all-clear to resume fitusiran trials
The FDA's decision allows a Phase 2 open-label study and the Phase 3 ATLAS program to re-commence.
By Jacob Bell • Dec. 15, 2017 -
FDA warns Korean OTC manufacturer for GMP violations
A recent warning letter from the regulator flagged labeling concerns and lax quality control on the part of the Seoul-based drugmaker.
By Ned Pagliarulo • Dec. 14, 2017
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