News

In replacing the retiring Paul Hegwood, Ricci Whitlow will oversee global clinical trial operations.

Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

Amid the rapidly rising cases of a novel coronavirus, concerns are being raised over preparedness and potential disruptions to the pharma supply chain.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.

The UK BioIndustry Association (BIA) has issued a statement welcoming the publication of the Life Sciences 2030 Skills Strategy, a report setting out how the life sciences sector in the United Kingdom will develop future talent.

Abcam has purchased Applied StemCell’s (ASC’s) gene editing platform and oncology product portfolio, adding comprehensive cell editing capabilities and engine to support expansion of existing “off-the-shelf” cell lines.

The partners will collaborate on developing scale-up chip-based technology to enable commercial-scale production of a third-generation DNA synthesis platform.

The license gives Daiichi Sankyo access to ERS Genomics’ genome-editing technology for internal R&D initiatives.

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

Otsuka will use PhoreMost’s phenotypic screening platform to identify new targets for drug development, with a focus on gene therapy.

WuXi’s R&D team will be developing and manufacturing 2019-nCoV-neutralizing antibodies at the company's four GMP facilities.

The company announced it will be unveiling a new name, Jones Healthcare Group, and a new corporate logo as it celebrates 100 years in the health and wellness markets.

J&J’s Janssen Pharmaceutical Companies seeks to develop a vaccine candidate against the novel coronavirus.

Clinical manufacturing of the therapy will take place at Lonza's Houston, TX, and Netherlands cGMP manufacturing sites.

The new 1800-m2 building houses more than 50 employees and features non-GMP laboratory space and a GMP analytical laboratory.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

Tina Morris will be taking on the role of executive director for AAPS.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

Drug development contract services company PPD announces initial public offering.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.

The amount was the third highest year recorded and investment has increased more than 400% since 2012.

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

Fios Genomics, a spin-out bioinformatics company from Edinburgh University, has entered into a strategic partnership with Charles River Laboratories.

The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise.