High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.

Circa Group, a biotechnology company, has announced a collaboration with formulation science consultancy iFormulate to launch Cyrene, a biosolvent.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

MilliporeSigma, the life-science subsidiary of Merck KGaA, announced an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.

An industry workgroup made up of pharmaceutical companies, toxicologists, and data experts plans to unveil the early results of a data sharing project designed to enhance the safety of drug substances and aid compliance with quality guidelines, such as ICH M7.

FDA’S CDER and ORA have entered into a concept of operations agreement to integrate facility evaluations and inspections for human drugs.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

The KBF 1020 constant climate chamber from Binder offers storage for large quantities of test specimens or large samples.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The private equity funding will enable the startup biotech firm to expand product development as well as sales and marketing capabilities.

Watson-Marlow Fluid Technology Group added platinum-cured silicone gaskets and platinum-cured silicone braided hoses for fluid path validation to its BioPure range.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Sartorius Stedim Biotech presents a new system for laboratories needing low volumes of ultrapure water.

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.