EMA frets drug shortages ahead of Brexit

The European regulatory agency is surveying U.K. manufacturers to prepare for drug shortages after the U.K.'s departure from the EU. 

By Lisa LaMotta • Jan. 24, 2018

FDA debuts paper on quality standards, aiming to decrease review times

The Office of Pharmaceutical Quality is aiming to give manufacturers clarity on standards, in line with other FDA initiatives to increase efficiency. 

By David Lim • Jan. 24, 2018

UPDATED: Shutdown ends after half of HHS furloughed

With government agencies operating at a diminished capacity, the FDA had been set to stop routine establishment inspections, as well as certain compliance and enforcement activities.

By David Lim • Jan. 22, 2018

Braeburn hits setback with CRL for opioid disorder

One analyst says the delay could push back approval by four to eight months.

By Suzanne Elvidge • Jan. 22, 2018

FDA to speed public notification of product recalls

The move is part of the FDA's efforts to strengthen its enforcement of potentially unsafe food and medical products.

By Ned Pagliarulo • Jan. 19, 2018

Prescribed Reading: Murmurs of M&A, backlash over CRLs

Celgene may make another acquisition, while the FDA Commissioner gets his first negative marks for reneging on a promise. 

By Lisa LaMotta • Jan. 19, 2018

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

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