FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The company will be exhibiting at the 2016 International Fuel Ethanol Workshop and Expo.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.

The company showcased new technologies at ASMS for biopharmaceutical characterization.

The company opened a 200,000-square-foot facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.

MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.

The new company is the product of a merger with Formex.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

Amyris will use its platform technology to develop a library of natural and natural-like compounds to test against Janssen’s therapeutic target.

The agency published a report on fostering the development of advanced therapy medicinal products.