Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.

Biotage has announced a strategic collaboration with Shandong Yingsheng Biotechnology for the development of clinical MS applications in China.

ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.

Shimadzu’s C2MAP-2030 system can improve operational efficiency for optimizing and controlling the cell culturing process.

Agilent’s updated portfolio of products for immunotherapy researchers provides cell-based tools for translational research and development.

FDA’s annual manufacturing report card shows more quality compliance is needed.

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

Cannuba has announced that it is collaborating with an independent scientific body on drugs from the UK on the launch of a medical cannabis working group.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

ABPI has issued a response to the recent publication of the UK's Migration Advisory Committee’s full review on the shortage occupation list.

Metrohm gains B&W Tek’s line of spectroscopy instruments as well as expertise and facilities.

Knauer has introduced new columns and screening services for the enantioseparation of chiral substances.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.