Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

*Updated May 11, 2016Following JHL Biotech’s opening of a FlexFactory flexible manufacturing facility in Hsinchu, Taiwan in 2014, the company opened a second manufacturing location in Wuhan, China on May 10, 2016. According to the company, with the addition of the new Wuhan facility, JHL Biotech will now hold the largest volume of single-use cell-culture capacity in all of Asia.

Takeda received a $38 million grant from the Bill & Melinda Gates Foundation to develop, license, and supply Sabin-strain inactivated poliovirus to more than 70 developing countries.

The new facility will produce GMP film coating productions for the pharmaceutical and nutritional markets in South America.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

FUJIFILM Diosynth Biotechnologies Opens New Laboratory Facility in Research Triangle Park, NC.

CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.

Under the terms of an agreement with Pfizer, WAVE will advance up to five programs from discovery through the selection of clinical candidates.

ANSM lifted the suspension on Catalent’s Beinheim, France facility, allowing the company to resume pharmaceutical operations.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

The company’s Aramus bags are made of an innovative material that is unlike that of the material currently used in commercial single-use bags.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

The companies have agreed to an all-stock merger of equals transaction anticipated to close in the second half of 2016.

The collaborations have the goal of creating new tools that will help predict how people with Type 2 diabetes adhere to their medication.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

MilliporeSigma, the North American life-sciences business of Germany’s Merck KGaA, added a 2000-L single-use bioreactor to its facility in Massachusetts.

EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.

Pharma understands the importance of patient centricity, but the problem is the gap between intent and action.

The agency found no differences in risk of pneumonia for different products.

The agency extends the indication of the drug in combination with bendamustine.

The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.

Hacene Mekerri will serve as vice-president of PPD’s central laboratory organization.