AveXis touts positive FDA feedback on gene therapy

Rival Biogen has already submitted its competing spinal muscular atrophy drug for approval by the FDA. 

By Judy Packer-Tursman • Nov. 3, 2016

Sanofi, Regeneron hit with CRL for manufacturing

The French pharma and its partner hit a snag in the review of their rheumatoid arthritis drug sarilumab.

By Lisa LaMotta • Oct. 31, 2016

Prescribed Reading: Dealmaking sparse, despite earnings reports

Analysts question Allergan's latest buy, Bristol-Myers shuffles R&D and FDA makes some proclamations about sex. 

By Lisa LaMotta • Oct. 28, 2016

Czech drugmaker hit with FDA warning letter

While the regulator has stepped up its oversight of manufacturers in India and China, CGMP warnings to European firms are less common.

By Ned Pagliarulo • Oct. 27, 2016

FDA taking a closer look at DTC animation

But major players like Eli Lilly, AstraZeneca and Regeneron have some issues with the agency's proposal.

By Jacob Bell • Oct. 26, 2016

Two approvals in two days for Merck

The big pharma's hospital-based infection treatment should hit the market early next year, but will face a lot of competition.  

By Suzanne Elvidge • Oct. 25, 2016

Merck cements advantage in I/O with first-line approval

Keytruda's approval in first-line NSCLC is a major success for Merck, especially in light of Bristol-Myers' earlier trial failure.

By Ned Pagliarulo • Oct. 24, 2016

Aduro hit with partial hold, sending shares spiraling

The FDA halted new patient enrollment in all trials involving Aduro's LADD platform due to concerns over a reported listeria infection in one patient. 

By Ned Pagliarulo • Oct. 24, 2016

Prescribed Reading: Only one FDA approval in October so far

While few deals flowed in this week, there was plenty of clinical data dominating pharma news.

By Lisa LaMotta • Oct. 21, 2016

Teva clears submission hurdle for Huntington's drug

Following an initial rejection, the FDA accepted Teva's application and set a goal date for approval. 

By Jacob Bell • Oct. 21, 2016

Allergan urological drug gets thumbs up from FDA panel

Despite FDA staff concerns, advisory committee members recommended approval for SER-120, a drug designed to treat frequent nighttime urination.

By Suzanne Elvidge • Oct. 21, 2016

Three's a crowd: Tecentriq gets lung cancer nod

Roche hopes to catch rivals Merck and Bristol-Myers Squibb in immuno-oncology. Winning approval in second-line NSCLC is a key step toward that goal. 

By Suzanne Elvidge • Oct. 19, 2016

Lipocine plans new dosing for rejected oral testosterone

The company is looking for a path forward for LPCN 1021 after the FDA rejected the company's initial NDA over the summer. 

By Suzanne Elvidge • Oct. 18, 2016

Regeneron, Teva smacked with clinical hold, again

The pair's NGF inhibitor is put on clinical hold for a second time after safety issues crop up in mid-stage studies. 

By Lisa LaMotta • Oct. 17, 2016

FDA snubs PTC appeal for Duchenne drug

PTC Therapeutics said it would continue its efforts to win a review of ataluren even after the FDA rejected the company's appeal. 

By Ned Pagliarulo • Oct. 17, 2016

NICE says no to Opdivo

The Bristol-Myers Squibb drug hit another setback in lung cancer, but NICE's decision leaves the door open. 

By Suzanne Elvidge • Oct. 17, 2016

Bluebird touts upgrades to gene therapy

A new manufacturing process could boost the effectiveness of its Lentiglobin product. Investors seem to want more.

By Ned Pagliarulo • Oct. 16, 2016

Prescribed Reading: AZ sell-off, Merck wins ESMO, generics dominate

Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

By Lisa LaMotta • Oct. 13, 2016

Chinese drugmaker, 3 others warned in FDA letters

The China-based company was missing an active ingredient in at least one batch of drug product.

By Jacob Bell • Oct. 13, 2016

FDA hits Nicox with CRL on eye drug application

Nicox indicated the FDA's rejection of its new drug application stemmed from issues with an API supplier. 

By Joe Cantlupe • Oct. 11, 2016

Mylan pays to settle EpiPen matter

The specialty pharma is working urgently to put price gouging accusations behind it. 

By Lisa LaMotta • Oct. 10, 2016

Prescribed Reading: Pharma re-focuses, face-off at ESMO, Hep C boxed

Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

By Lisa LaMotta • Oct. 6, 2016

FDA adds boxed warning to hepatitis C drugs

The regulator cited two deaths and 24 adverse events related to hepatitis B reactivations among patients treated with new direct-acting antivirals.

By Joe Cantlupe • Oct. 5, 2016

FDA wants more info from Dynavax over Hep B vaccine

Dynavax Technologies revealed in an SEC filing it is working to resolve questions from the FDA over its previously rejected experimental vaccine.

By Joe Cantlupe • Oct. 5, 2016

Biosimilars emerge in US, but what to call them?

With four biosimilars now approved in the U.S., the competitive threat for biologics is apparent. What's not clear? How to name them. 

By Ned Pagliarulo • Oct. 3, 2016