News

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

The transaction provides Allergan stockholders with immediate value and enhanced commercial opportunities, according to a company statement.

The new location will increase Bristol-Myers Squibb's biologics manufacturing capacity.

ValiRx entered into a collaboration agreement with the Deutsches Krebsforschungzentrum cancer research center.

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.

Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.

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.