Industry news

04 March 2016

Tobira Therapeutics Reports Fourth Quarter 2015 Financial and Year-End Business Results

Tobira Therapeutics, Inc.  (NASDAQ : TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the three and 12 months ended  December 31, 2015 .

Generic-Drug Production and Oversight Challenge FDA and Manufacturers

Jill Wechsler / BioPharm International

It’s well known that generic drugs account for 88% of prescription drug sales in the United States and have saved billions for patients and healthcare systems since Congress enacted the Hatch-Waxman Act more than 30 years ago. That growth, though, has created difficulties for FDA in processing the hundreds of resulting abbreviated new drug applications (ANDAs) and in inspecting an expanding number of generic-drug manufacturers and ingredient producers all over the world.

2016: A Biopharma Market in Flux

William Looney / PhamExec.com

M&A activity will continue to dominate in 2016 as biopharma companies respond to a similar wave of restructuring on the insurance and provider side of health care.  Even though the track record for ever-larger combinations is mixed, scaling up remains a compelling proposition for biopharma in an era of growing payer power and the high-cost complexities of drug development.

The Digital Healthcare Evolution

Bruno Villetelle / Pharmaceutical Executive

A lot happens in 60 seconds on the internet. More than 293,000 Facebook statuses are updated, 550,000 tweets are written, and 2.78 million YouTube videos are watched in this small amount of time.

03 March 2016

Syndax Cuts Price But Bags $53M in Second IPO Try

Ben Fidler / Xconomy

Over the past year, Syndax Pharmaceuticals has altered its strategic course and hired new management to implement it. And it looks like that change was big enough to propel Waltham, MA-based Syndax through the IPO queue on its second attempt since late 2014—albeit not on the terms the company had hoped for.

Can Better Modeling Reduce Pharmaceutical Development and Manufacturing Costs?

Agnes Shanley / Biopharm International

In the UK, a new four-year initiative has been launched to streamline drug development and manufacturing by leveraging better computer-based process modeling and simulation. Dubbed Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT), the $29-million program, part of the UK's Advanced Manufacturing Supply Chain Initiative, aims to develop the tools required for an “efficient, knowledge-based, quality by design-oriented [pharmaceutical] supply chain.”

New Strategies Needed to Clarify Off-Label Marketing

Jill Wechsler / Phamaceutical Executive

Litigation, high court decisions and the internet have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies. Despite considerable pressure to address these issues, FDA has yet to issue new guidance or to hold a public meeting on the subject, something that top officials said they would do more than a year ago. The result is inconsistent policies that lead manufacturers to seek clarification in the courts.

Scientists create digital 'magic wand' to improve at-home device cybersecurity

Emily Wasserman / FierceMedicalDevices

Medical device security is at the top of most people's minds lately, especially as products move into the home setting and monitoring becomes more challenging. Now, researchers are tackling the issue by creating a digital "magic wand" that could increase device cybersecurity at home.

U.S. biotech shares enjoy best day since October

Lewis Krauskopf / Reuters

U.S. biotech shares on Tuesday posted their best overall day since October, helped by a big upswing in the broader U.S. stock market.

Why neglected tropical disease and rare disease researchers need each other

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