News

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.

Biomedical innovation legislation may stall in 2016.

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

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.

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.

*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.

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.

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

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.

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

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

Typical single-use bags and materials cannot withstand a large range of temperatures. Many of the items on the market are associated with extractables that can leach into bioprocessing fluids-an issue that has recently been a topic of conversation among groups that seek to standardize single-use systems, such as the BioPhorum Operations Group (BPOG) and the Bio-Process Systems Alliance (BPSA).

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

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

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

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

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

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.

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

The agency holds a workshop to strengthen collaboration with healthcare providers.

MSD joined the WHO campaign in Africa, which is focused on staying polio free.

AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.