The U.S. FDA is backing early adopters of continuous manufacturing and other advanced manufacturing technologies through its Emerging Technology Team, and by requesting funding as part of the president's 2019 budget. The FDA has also issued draft

Novavax shares lost no less than 65 percent of their value this week after trial data showed one of its lead vaccines failed to prevent RSV disease, missing the main goal of the late-stage study. RSV, or respiratory syncytial virus, is highly cont

Akorn made public this week that the U.S. FDA had issued a number of observations related to a recent inspection of the company's manufacturing facility in Amityville, New York. Among the observations noted in the associated Form 483 dated Februar

A U.S. Patent Application for an "Electronically Controlled Diaphragm Pump" was published by Stobbe Pharma on February 28th, 2019. The present invention is an electronically controlled diaphragm pump system that i

The Yellowstone Act of  1872 set a precedent and popularized the idea of preserving sections of the public domain for use as public parks. Congress went on to designate dozens of other national parks after.

Tuesday, March 5th, 2019

In this webinar, the benefits of Pall's chromatography process, which features KANEKA KanCapA, Mustang® Q and CMM HyperCel™ sorbents will be presented with a f

The UK company RUNLABS, founded in 2018, plans to open its first facility where biotech companies can hire a package of lab space, lab services, offices, and even technicians in Paris. As of this writing the company has declined to disclose how pa

A federal jury this week upheld the validity of two patents held by Amgen on antibodies that work similarly to its cholesterol drug Repatha, setting back the rival team of Sanofi and Regeneron for the second time in a long-running court fight. Whi

The U.S. FDA this week issued a draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs. The 27-page draft guidance is part of the FDA's effort to encourage the adoption of continuous manufactur

Amicus has made public plans for a 75,000 sq. ft. Global Research and Gene Therapy Center in the heart of Philadelphia, Pennsylvania. The site, which is expected to be home to 200+ biologists, chemists and others, is expected to be available for m

By age 10, Antoine was playing professionally in New Orleans honky-tonks where he earned the nickname "Fats". He went on to become a major international star selling an estimated 65 million records worldwide.

Amid news of the Roche acquisition of Spark Therapeutics comes speculation among analysts of whose most likely to be next. Topping the list are Biogen and BioMarin, with the latter's smaller market cap making the prospect of an acquisition seeming

The Bioprocess Systems Alliance published its first component quality test matrices in 2007. The state purpose of this work was to “help guide users when making their selections and (to) facilitate qualification, validation, and use of single-us

Single-use technology is fast growing in the biopharmaceutical industry.  Often, designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met.

This white paper, The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production:

  • Defines and maps commonalities between bioprocessing and CGT
  • Provides high level documentation to identify informatio

Get an introduction to the white paper and learn about Single Use Technology and the role it may play in the C&G Therapy marketplace.
View Resource: 

As part of its push to increase generic competition, the U.S. FDA has published 74 product-specific guidances, including 22 new and 52 revised guidances. Four of the new draft guidances and 45 of the revised guidances are for complex drug products

A U.S. Patent Application for a "Method for Chromatography Reuse" was published by Genentech on February 21st, 2019. The present invention provides methods for cleaning or regenerating a chromatography material fo

Thursday, February 28th, 2019

Please join us for a one-day seminar by bioprocessing professionals, end users and suppliers alike, discussing the challenges associated with bioprocess opti

One of the foremost playwrights of the 20th-century and member of the American Theater Hall of Fame, he is remembered for his plays including  The Glass Menagerie, A Streetcar Named Desire and Cat on a Hot Tin Roof. 

A great blog written by Aoife Brennan, CEO of Synlogic, has been posted on the Life Sci VC website this week. An excerpt from which reads "It was apparently random, although I secretly suspect it was karmic punishment for my lack of imagination in

Scientist, Cell Line Development - St. Louis, MO.
A technical, lab-based position is available within Pfizer's Cell Line Development (CLD) organization primarily involved in mammalian CLD portfolio advancement, novel technology development a

A U.S. Patent for "Pre-Sterilized Syringe System and Method of Use" was awarded to Paw Bioscience on February 19th, 2019. The present invention is a pre-sterilized fluid sampling syringe is provided which includes