News

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The SCIEX PA 800 Plus Pharmaceutical Analysis system is used to identify and quantify glycans to ensure therapeutic efficacy.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

After a positive Phase II trial, the company said its C. difficile vaccine candidate will advance to Phase III trials during the first half of 2017.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

In a recent deal with the Federal Trade Commission, Endo agreed to refrain from entering into future pay-for-delay patent settlements for ten years.

The medical cannabis producer has become compliant with EMA’s GMP standards.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

The organization launched its GOBOLDLY campaign to highlight the work of US biopharmaceutical companies.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

The company released the Biopharma Compass 2.0 software, which automates workflows for high-resolution mass spectrometry.

A new report says that failure to account for rebates, discounts, and price concessions leads to an “overstatement of payments realized by manufacturers” in most annual industry drug spend reports.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

The Reproducibility Project: Cancer Biology has been working to confirm the results in five prominent cancer biology experiments, and just released the results of its preliminary findings on Jan. 19, 2017. The researchers were only able to validate the findings in two of the five initial studies. The researchers could not replicate the findings in one study, and deemed another two studies “uninterpretable” because the tumor cells under investigation either grew too quickly or too slowly to measure whether the cancer drug had the predicted effect.

The agency published an overview of marketing authorizations made in 2016.

Luke Miels will replace Abbas Mussain as president of GSK’s Global Pharmaceutical division later this year.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

The company opened a facility in Spain dedicated to the production of meglumine.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.