
Amgen wants the regulatory agency to ensure biosimilar applicants follow the rules of the patent dispute resolution process delineated by the BPCIA.

Amgen wants the regulatory agency to ensure biosimilar applicants follow the rules of the patent dispute resolution process delineated by the BPCIA.

AstraZeneca announced a partnership with Pharmacyclics and Janssen for combination trials of MEDI4736 (AstraZeneca) with Imbruvica (Pharmacyclics and Janssen) for the treatment of hematologic cancers.

Bristol-Myers Squibb entered into an agreement with Galecto Biotech AB to gain exclusive rights to TD139, a novel inhaled inhibitor of galectin-3 for the treatment of idiopathic pulmonary fibrosis.

Bristol-Myers Squibb announced a multi-year expansion of its biologics manufacturing agreement with Lonza.

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

The new Argos biomanufacturing facility in North Carolina will include automated production using the company's Arcelis technology.

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

New research will focus on a superfamily of protein receptors linked to various diseases.

The divestment will create the number two player in the global influenza vaccine industry.

Two lots of empty intravenous fluid bags were voluntarily recalled because of the presence of particulates.

Shire announces it will expand its orphan drug portfolio and is ready for future M&A discussions.

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an ebola vaccine.

Celgene expands its oncology drug discovery and development portfolio through a new partnership with Sutro.

Secukinumab is the first IL-17A inhibitor to meet its primary endpoint in two Phase III trials for patients with ankylosing spondylitis.

The renovation to Roche's historic office building in Basel, Switzerland will feature sustainable workplaces and a state-of-the-art research center.

AbbVie to pay Shire $1.636 billion break fee for terminating purchase agreement.

A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen's in the market.

Lilly announces the closure of its Guayama, Puerto Rico manufacturing facility amid continued investments at other plants.

Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.

Sanofi Pasteur and Immune Design agree to jointly develop therapies through Phase II clinical trials.

AbbVie sends Shire notice that it is reconsidering its offer recommendation.

FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.

GSK is found guilty of offering bribes to doctors and is fined $489 million.

Baxter announced that its new biopharmaceutical company will be named Baxalta when the company separates into two publicly traded companies in mid-2015.

ProBioGen, a biopharmaceutical drug manufacturer in Berlin, spends ?20 million to double its workforce.

Pfizer announced that FDA approved ELELYSO for treatment of Type 1 Gaucher disease in adult and pediatric patients.

PSC Investments announces the acquisition of a high potency, sterile fill/finish pharmaceutical manufacturing facility.

CPhI 2014 panel additions to provide global insights from the contract services sector.

After rejecting several bids, Shire has agreed to a merger with AbbVie valued at almost $55 billion.

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.