Industry news

An inside look at the FDA's approach to speeding new drug approvals

John Carroll, FierceBiotech

The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.

The JP Morgan mood: Damn the biotech valuations and full speed ahead in 2015

John Carroll, FierceBiotech

Every year JP Morgan gives execs a stage to sound convincing about their confidence in the year ahead. So it's no surprise to hear an upbeat tone at the conference. Nevertheless, the mood of the industry this year was exceptional. Even some of the most grizzled veterans who have been making the annual trek to San Francisco for years noted they've never seen anything like this before.

Dealmaking 2014 boom was fueled by a strong market and a renewed pharma focus

Staff Writer / BioWorld

Dealmaking in "really robust" 2014 easily outstripped the previous year, with 3,141 agreements nailed down that year, valued at about $382.7 billion, as compared to 2013's total of just over 2,100, worth about $158 billion, said Vinay Singh, senior deals analyst with Thomson Reuters Recap – "a third as many total deals, [with] well over twice as much" money involved.

Regenerative medicine: A growing global industry, ARM reports

Peter Winter / BioWorld

Last year at this time the regenerative medicine and advanced therapies industry had begun its coming-out party riding a wave of promising clinical data readouts that ignited strong investor interest and catalyzed involvement and interest from big pharma companies. This momentum has continued to increase during the past year, said Edward Lanphier, chair of the Alliance for Regenerative Medicine (ARM) at their state of the industry briefing delivered at the Biotech Showcase meeting here.

'Pharmageddon' Ends as Floodgates Open for Drug Ads

Alexandra Bruell / AdAge

Some called it pharmageddon. In 2012, health-care ad agencies were coming off a billion-dollar drop in annual drug advertising over five years with little hope in sight: A host of blockbuster medications were about to lose patent protection and there were pessimistic projections for the pipeline ahead.

Some ad types are calling it: 'Pharmageddon' is over. DTC is back.

Tracy Staton, FeircePharmaMarketing

As the pharma pipeline flows, so does pharma marketing. That's the moral of a new surge in direct-to-consumer ad spending. Last year, the FDA approved 41 brand-new drugs, a record-breaking figure. And as Advertising Age reports, after some long, dry years when DTC spending sunk to new lows, the pharma category is coming back on tap.

Biotech’s Hot IPO Market Creates Next Takeover Targets: Real M&A

Tara Lachapelle / Bloomberg

After being overshadowed last year by the boom in big pharmaceutical mergers, biotechnology deals are kicking off 2015.

15 January 2015

Regado Biosciences and Tobira Therapeutics Announce Merger Agreement to Create Leading NASH Company

Regado Biosciences, Inc. and Tobira Therapeutics, Inc. today announced that they have entered into a definitive agreement under which privately-held Tobira will merge with a wholly-owned subsidiary of Regado in an all-stock transaction. The merger will create a company focused on the development of novel treatments for liver and inflammatory diseases. 

Limited attention span? Focus on these market shake-ups in 2015

Emily Wasserman, FiercePharma

It has been a whirlwind of a year for pharma, with pricing battles, regulatory showdowns and all-but-legendary M&A. And on the ground, it's Rock-em-Sock-em Robots in some of the industry's biggest markets. A steady flow of new drugs in 2014--and a slate of anticipated launches in 2015--have established brands defending their titles and newcomers looking to land a gut-punch or two, if not a knockout. Here are the match-ups to watch in the coming year. 

FDA launches project to cut quality control lapses at drugmakers

Toni Clarke / Reuters

The U.S. Food and Drug Administration launched an initiative on Monday aimed at reducing lapses in quality control at pharmaceutical manufacturing facilities.