Industry news

Volatile valuations make biotech a haven for short sellers

Damian Garde / Fierce Biotech

The years-long glut of biotech IPOs has flooded the public markets with high-risk life sciences companies, and shorts have taken a particular interest in those newly public drug developers, according to a report, betting the industry's recent boom will see its shadow.

Pharma's new patent worry by the numbers: No 'IP death squad' here, analyst says

Carly Helfand / FiercePharma

According to an analysis of past IPR challenges, not a lot, Bernstein analyst Ronny Gal wrote in a Thursday note to clients. In 165 pharma cases so far, only 88 have gone through a decision on whether to institute review proceedings. Of those 88, the U.S. Patent and Trademark Office (PTO) has only chosen to fully institute proceedings 41 times, or in 47% of cases. That rate is "remarkably lower" than the 75%-plus rate across all sectors, which includes tech, he pointed out.

Pharma market bets on ASEAN in focus ahead of economic pact

EJ Lane / FeircePharmaAsia

At the end of 2015, the Association of Southeast Asian Nations (ASEAN) will launch an economic union in a region that has already seen a slew of device and drug companies contemplate, start or expand hubs in Singapore to sell into nearby markets.

Pharma Faces More Comparisons of Drug Costs and Effectiveness

Jill Wechsler / Phamaceutical Executive

Will emerging drug cost assessment initiatives provide useful, valid information on total drug value? Or will new “scores” on drug cost-effectiveness merely justify more no-coverage decisions by insurers and health plans? These are troubling prospects for biopharma companies, as well as for patients and prescribers, as medical authorities and health care analysts look to more broadly incorporate drug costs into treatment evaluations and recommendations.

08 September 2015

Neothetics Announces Last Patient Enrolled in LIPO-202 Pivotal Phase 3 Clinical Trials for Reduction of Subcutaneous Abdominal Fat

Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2. The trials are evaluating LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. The Company expects to report top-line data by year-end.

The Biotech sector still remains solid after meltdown of general markets

Peter Winter / BioWorld

The fears that the downward spiral of the capital markets during the financial crisis that occurred in 2008 would be repeated in the wake of last week's "Black Monday" are, for the time being, in the rearview mirror. In fact, the markets have rebounded strongly and now seem poised to remain positive for the final months of the year, although it is predicted there will be some turbulence along the way.

Financial Snapshots: Research and Development in High Gear

Peter Winter / Thomson Reuters BioWorld

Although overall the second quarter financial report filings of biotech companies received a modest passing grade, investors were lukewarm to those less than stellar performances. That general angst was one of the contributing factors for the pullback in biotech during August.

Manufacturing’s True North: The Quality Compass

By Ian Wilcox, Conrad J. Heilman, Jr., PhD / Pharmaceutical Executive

In pharmaceutical manufacturing, tales of quality failure follow a familiar pattern. A manufacturing site—often offshore—finds itself on the receiving end of regulatory action for such violations ranging from missing or manipulated test data and failure to submit field alert reports, to lack of compliance with current good manufacturing practices (cGMP). 

U.K. starts enrolling cancer patients into the 100,000 Genomes Project

Nick Paul Taylor / Fierce Biotech IT

The United Kingdom has opened up another front of its 100,000 Genomes Project. Having started off sequencing the genomes of people with rare diseases, the team behind the initiative are now ready to take aim at their other big target: cancer.

Industry Responds to FDA Metrics Program

Jill Wechsler / BioPharm International

After nearly three years of workshops, white papers, and pilot tests, one might expect some agreement between FDA and manufacturers of drugs and biologics on how to measure the quality and reliability of production systems and resulting products.