News

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

The Alios Biopharma acquisition strengthens J&J's infectious disease pipeline.

USP releases compendium of quality standards for compounded medicines.

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.

GE Healthcare and Takeda Pharmaceutical Company announced an alliance to develop therapeutic drugs in the field of hepatic fibrosis to treat various liver diseases.

The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.

ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.

SGS Life Science Services has been awarded cGMP accreditation from AIFA for its analytical laboratory in Livorno, Italy.

The deal between the two companies will strengthen Perrigo's presence in Europe.

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.

Sartorius opened a new application center at its offices in Shanghai for product demonstrations, trial runs, and training sessions.

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.