
An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

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.

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

Spectranetics announced that it acquired Covidien's drug-coated balloon platform, Stellarex, for $30 million.

Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.

The authors take a look at some of the recent developments in the German pharmaceutical market.

Industry veteran Peter Bigelow to guide PBOA Board.

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.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

SGS Life Science Services announced the completion of its Glasgow, UK testing facility for cell banks in biological medicines.

CDMO DPT Laboratories, a specialist in semi-solid and liquid dosage forms, announced that it has implemented a high-speed bottle-filling center at its San Antonio location.

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

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 board of directors at Sanofi unanimously agree to remove Sanofi's CEO.

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

FUJIFILM announced an agreement to acquire Kalon Biotherapeutics, a biopharmaceutical contract manufacturing organization specializing in vaccine manufacturing.

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

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

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

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.

A customer complaint prompts the recall of a lot of anticoagulants from a plant in Puerto Rico.

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

Contract Packaging Resources issued a voluntary recall of naproxen sodium tablets because some cartons contain bottles of ibuprofen.

Ashland Specialty Ingredients opened a drug development and bioavailability enhancement facility in Wilmington, Delaware.

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

FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.

AbbVie to pay Shire $1.635 billion break fee for terminating purchase agreement.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.