Bio/Pharma News

Bayer announces that it will pay up to $155 million, plus royalties, for the rights to Isis Pharma’s anti-clotting drug, ISIS-FXI.

Novo Nordisk announces that it will invest DKK1.5 billion (US$224 million) in a haemophilia treatment manufacturing facility in Denmark.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

After rejecting Teva’s unsolicited $40 billion purchase offer, Mylan has increased its own offer to purchase Perrigo from $29 billion to over $32 billion in cash in stocks.

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

The agency has recommended granting marketing authorization for Opdivo.

The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.

FDA grants Pfizer Breakthrough Therapy designation for its treatment of ROS1-positive non-small cell lung cancer.

Endolysin technology targets unwanted bacteria, including resistant strains

Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan.

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.