News

FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.

Construction has started on Novo Nordisk's laboratories for diabetes research in Denmark.

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

MedImmune enters into an agreement to acquire the image analysis and data mining company.

M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.

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.

LabCorp announced it will purchase contract research company Covance Inc. for approximately $6.1 billion in cash and stock.

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

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 company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.

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.

GSK's investigational Ebola vaccine is in Phase I safety trials.

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.

The latest Ebola epidemic sheds light on the delicate processes surrounding the manufacture of genetically modified live cells for biopharmaceutical production.

Unum Therapeutics raised $12 million in Series A funding for its development of antibody-coupled T cell receptors (ACTRs) for the treatment of nonspecific tumor cells.

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