News

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.

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

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

Boehringer Ingelheim's OFEV was approved by FDA as the first treatment for idiopathic pulmonary fibrosis, a fatal lung disease.

Genentech announced FDA-approved Esbriet for the treatment of Idiopathic Pulmonary Fibrosis.

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.

The company submits an orphan drug application to FDA for its Cell-in-a-Box treatment for pancreatic cancer.

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

BioReliance has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services its service offering. The company#&39;s range of predictive assays use a novel suite of genetically modified cell lines created with CompoZr zinc finger nuclease (ZFN), a Sigma-Aldrich proprietary technology.

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

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.