News

In a statement, Chip Davis, president and CEO of GPhA offers support of a study published in JAMA identifying opportunity for drug savings.

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Pelican BioThermal, a provider of temperature-controlled packaging solutions for the life-sciences industry, announced on May 13, 2016 that it has entered into partnerships with BioThermal Solutions and NatBio, which offer cold chain logistics support in South America. Located in Sao Paulo, Brazil, NatBio was created to meet the demands of specialized clinics. BioThermal Solutions, based in Santiago, Chile, provides cold-chain maintenance solutions throughout Chile.

The Phase I trials will examine AX-1602’s clinical efficacy for the treatment of psoriasis and eczema.

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

Biomedical innovation legislation may stall in 2016.

Drug manufacturing lapses undermine NIH research programs.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

The updated guidelines detail best practices for conducting research with human embryonic stem cells.

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.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

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.

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

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