Armed with positive data, Biogen accelerates launch prep for SMA drug

Infrastructure and logistics must be adjusted to prepare for greater patient demand, the firm said at a conference

By Judy Packer-Tursman • Nov. 8, 2016

Cempra drug narrowly wins support of FDA panel

Members of the committee raised concerns about safety risks seen in testing of the bacterial pneumonia drug but were convinced by strong efficacy data. 

By Jacob Bell • Nov. 7, 2016

DOJ may file charges soon in sweeping generic-pricing probe

Reports indicate more than a dozen drugmakers and 24-odd drugs are being investigated, with charges coming shortly. 

By Judy Packer-Tursman • Nov. 7, 2016

Prescribed Reading: ASH abstracts hit biotech hard

Companies refocus their M&A strategies, while abstracts from the upcoming ASH meeting disappoint investors and new discoveries could help treat a rare disease. 

By Lisa LaMotta • Nov. 4, 2016

Prop 61: What does it mean for drug prices?

California has a controversial initiative on the ballot today that pharma has spent millions to defeat. 

By Jacob Bell • Nov. 4, 2016

Cempra stock plummets after FDA raises safety concerns

Briefing documents issued ahead of an advisory panel meeting Friday flagged safety concerns with Cempra's lead product, a drug for pneumonia. 

By Jacob Bell • Nov. 3, 2016

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