Biopharma News

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.

The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.

Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.

On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).

FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

FDA advances biosimilars progress with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.