News

On April 20, 2017 UniQure announced that it will not pursue marketing authorization renewal in the European Union for Glybera (alipogene tiparvovec), the first gene-therapy approved by EMA. Glybera’s marketing authorization is set to expire on Oct. 25, 2017.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Bosch’s new system for the production of water for injection uses membrane processing and ultrafiltration.

UC Berkeley appealed the February 2017 decision that determined Harvard and MIT’s Broad Institute and Berkeley’s CRISPR-Cas9 technologies were separately patentable.

BMS is licensing two investigational compounds in separate deals with Roche and Biogen for a total of $470 million in upfront payments.

This platform is designed to give pharmaceutical professionals a deeper knowledge of excipient functionality, core formulation, film coating, and controlled release of oral solid dosage forms, along with regulatory insights.

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

The agency cited the company’s India facility for batch failures and data integrity problems.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The company announced the expansion of its global shipping program, which now allows companies to ship dangerous goods between 36 countries.

Sharp acquired the pharmaceutical packaging facility in Bethlehem, PA.

Uhlmann Packaging Systems joined the OPC Foundation’s Open Serialization Communication Standard (OPEN-SCS) Working Group.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

The conference has partnered with Mercy Ships, a non-profit organization using hospital ships to deliver health care to developing nations.

Pharmaceutical Technology spoke with CPhI North America presenters Ben Locwin, PhD, MBA, MBB, president at Healthcare Science Advisors, and Tom Fox, principal at Advanced Compliance Solutions, to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

The recall was issued because of a defective delivery system; the units affected had possible package leakage.

MilliporeSigma’s new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.