BioPharm International Editors

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

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

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

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.

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.

Evotec and MaRS launched Fibrocor Therapeutics, a company dedicated to developing novel therapeutics for fibrosis.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.

The company made a new strain of the influenza virus available for use as a challenge agent in clinical trials.

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.

The company was cited by FDA for violations of sterile processing GMPs.

The combined company’s turnover is estimated to reach €8 million ($8.35M) in 2017.

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.

According to a Deloitte report, the industry’s return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

The contract service provider entered into a contract agreement with the US Army to provide services in the development of treatments of malaria.

Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.

Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

A pilot project, beginning in 2017, will support the development of biosimilars.

Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

The agency announces that 81 medicines overall were recommended in 2016.