News

Onset expanded its product line for pharmaceutical cold-chain management with the launch two new products.

The next decade of drug development will depend on better ways of storing, using, and analyzing data, says CPhI advisor Bikash Chatterjee, president and chief science officer of Pharmatech Associates. But each of the following must be optimized: volume, variety, velocity, veracity, and value.

The choice of metrics used to measure the performance of a pharmaceutical operation are crucial, and should be systems oriented.

The most recent PharmSource report says bio/pharma companies have spent more than $150 billion for new plant equipment in the past five years.

The current approach of classifying process parameters and quality attributes as critical or non-critical is too simplistic to adequately reflect current science and risk-based approaches to product quality.

BASF’s new production facility in Shanghai will produce PVP K30 powder, a polymer used as a base for pharma excipients.

Employee empowerment is needed and it begins with senior leaders making adherence to cGMP regulations and compliance with SOPs the normal, easy, and rewarding thing to do.

Pharma’s lack of manufacturing innovation is its biggest shortcoming; but like any other business, investment in this area will need to be justified.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Sharp Packaging Services adds Biotechnology Center of Excellence to its to its Allentown, PA campus.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

The company will add a new clinical services facility at Central Park on Bridgend Industrial Estate.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

PCI will be participating in two Speakers Corner slots at the ICSE Exhibitor Showcase.

West will showcase several drug-delivery systems and packaging component technologies such as its NovaPure plungers and SmartDose technology platform.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.

Dow and Colorcon extend and broaden the scope of the Controlled Release Alliance.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

The company announced that an August 2016 FDA inspection of the company’s facility resulted in no form 483s.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

CRT and SV Life Sciences launched Artios Pharma, a new company formed to develop drugs targeting the DNA damage response to cancer.

Mucodel reported that the study met its objectives, and effectively delivered a dose of naloxone using an oromucosal route.