Industry news

Tougher regulations force Indian drugmakers to invest or divest

Eric Palmer / FeircePharmaManufactoring

After more than 5 years of FDA regulatory issues kept Ranbaxy Laboratories from generating the kind of cash it once had, owner Daiichi Sankyo threw in the towel. It recently sold the Indian generics maker at a loss to Sun Pharmaceutical and moved on down the road. Analysts say a tougher regulatory world is, in fact, remaking India's vast drugmaking industry.

30 June 2015

Neothetics Initiates Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 for Body Contouring

Neothetics, Inc.  (Nasdaq:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of the post-treatment safety and duration of effect study, LIPO-202-CL-23, of LIPO-202, the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that  Neothetics  expects to submit to the  U.S. Food and Drug Administration  ( FDA ) as part of the company's New Drug Application (NDA) package for LIPO-202, which the Company anticipates filing in the second half of 2016.

Rumors of mass exodus from China were just that

Cornelia Zou / BioWorld

Claims last year that the Chinese market was due for a massive exodus, particularly in the biotech space, may have been somewhat premature. Both international and domestic investors are actively betting on the country’s pharmaceutical sector.

India's drug watchdog calls all hands on deck in largest ever inspection effort

EJ Lane / FeircePharmaAsia

India's Central Drugs and Standards Control Organisation (CDSCO) has told staff to forget holidays and weekends as it undertakes a massive drug inspection exercise it intends to complete by the end of the year.

FDA slaps U.S. drugmaker over drug testing issues

Eric Palmer / FeircePharmaManufactoring

Quality control is really important for drug manufacturing as far as the FDA is concerned, and when a company isn't even familiar with common QC language it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.

5 drug categories having the biggest impact on pharma spending

Tracey Walker / ModernMedicine Network

The transformations taking place throughout all healthcare sectors will have repercussions for the pharmaceutical industry. How will they affect industry prospects, and what are the implications for drug manufacturers be affected?

European researchers develop thought-controlled robot

Varun Saxena / FierceMedicalDevices

A team of engineers from Switzerland's Defitech Foundation Chair in Brain-Machine Interface have developed a robot that is controlled from afar via mental commands.

BlackBerry unveils plans for bacteria-free smartphone device

Emily Wasserman / FierceMedicalDevices

BlackBerry has been working hard to expand its presence in healthcare since losing its share of the smartphone market, scouting out opportunities to diversify its offerings as it makes a name for itself in the industry. Now, the company is taking its healthcare aspirations one step forward, planning to design a bacteria-free smartphone device geared toward hospitals.

Panel: Activist success begets more activism by biotech shareholders

Jennifer Boggs / BioWorld

With biotech enjoying a spurt of tremendous growth – increasing market caps and widening profit margins – another trend has emerged, one that’s not quite so enjoyable, at least for company execs: increasingly confrontational shareholder activity.

There's a great future in biotech: Scenes from BIO 2015

Jennifer Boggs and Karen Pihl-Carey / BioWorld

Kicking off the last panel of this year's BIO International Convention, radio and television host David Brancaccio referenced the scene from The Graduate, when a family friend tells Dustin Hoffman's character, "There's a great future in plastics." Brancaccio asked a group of panelists during the Scientific American Worldview session what word or phrase signifies to each of them a great future in today's world.