Industry news

China drug approval backlog jumped by a third last year

Reuters

China had more than 18,500 drugs waiting for approval at the end of 2014, up by a third from a year before, the official Center for Drug Evaluation said on Friday, reflecting industry concern that it is getting harder to get medicines approved in the China market.

New market for liver disease spawns race for better testing

Bill Berkrot / Reuters

As drugmakers develop new medicines to battle a liver disease epidemic, they have created an urgent need for better diagnostics to select patients for treatment and assess their drugs' effectiveness.

GAO report blames DEA for many drug shortages

Eric Palmer / FeircePharmaManufactoring

Secondary trading environment critical for small businesses

Peter Winter / BioWorld

Emerging companies are considered to be the drivers of U.S. economic activity, innovation and job creation. Their ability to survive and prosper depends on ready access to capital, particularly in the private markets

Watchdog groups decry FDA's move to let reps hand out journal articles

Tracy Staton / Fierce Pharma

Little did the FDA know that allowing drugmakers to hand out medical-journal articles to doctors would be so controversial. After talking about the idea for years--since 2007, at least--the agency rolled out some guidelines last June that would govern the practice. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.

Don’t edit the human germ line

Edward Lanphier, Fyodor Urnov, Sarah Ehlen Haecker, Michael Werner& Joanna Smolenski / Nature

It is thought that studies involving the use of genome-editing tools to modify the DNA of human embryos will be published shortly.

Return to pre-antibiotic era? AMR hits developing countries hardest

John Fox / BioWorld

New antibiotic agents are urgently needed to overcome the burgeoning problem of antimicrobial resistance (AMR) in infectious bacteria, but novel agents alone may not be sufficient to prevent a return to the dark days of the pre-antimicrobial era, an infectious disease specialist has warned.

Building a viable U.S. market is the next big quest for biosimilars

Mari Serebrov / BioWorld

While the FDA may have opened the biosimilar pipeline with its approval of Sandoz Inc.'s Zarxio Friday, a lot of heavy lifting has to be done before biosimilars are a viable market in the U.S.

12 March 2015

Marinus Pharmaceuticals Provides Business Update and Reports Year End 2014 Financial Results

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative epilepsy and other neuropsychiatric therapeutics, today provided a business update and announced its financial results for the year ended December 31, 2014.

Mitigating Risk for Single-Use Assemblies in Sterile Filling

Sue Walker / BioPharm International

Single-use technologies can offer significant benefits compared with traditional stainless-steel systems. The key driver is overall time savings. There are risks associated with single-use technologies, however, that can include product loss and questions around sterility assurance and product safety.