Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.

The company has extended its presence in the US market to support its growing business in the region.

Piramal Pharma Solutions (PPS), part of Piramal Enterprises, has appointed John Fowler as its COO.

AAPS has announced the five graduate students awarded with a $10,000 fellowship for their research efforts in global health solutions.

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.

HTG, a company that provides molecular profiling services, expects to complete submission of its premarket approval application to FDA for an in vitro gene assay by 2018.

J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.

The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.

The biopharmaceutical company broke ground on what will be a new 3000-ft2 addition to its Kansas biomanufacturing facility.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

Predictive maintenance is one application planned for a new alliance that will bring Internet of Things capability to users of OSI's PI solution.

Alcami has announced the development of a Center of Excellence at its API development and manufacturing facility in Germantown, WI.

As Merck KGaA continues its strategic shift into a science and technology company, it is considering options for its Consumer Health business, including a potential sale.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

With this acquisition, Merck gains a lead anti-tumor drug candidate and a proprietary technology that can potentially induce immediate and long-term anti-tumor immunity.

Roche’s subsidiary, Genentech, issued the voluntary recall of the anti-stroke drug because of compromised vials containing sterile water that were packaged with the drug.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

The VIA Thaw CB1000 from GE Healthcare offers thawing for large volumes of cell therapies cryopreserved in cryo-bags for research laboratories.

The Carlyle Group and GTCR have completed a previously announced acquisition of AMRI, a contract research and manufacturing organization.

Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.

Novartis has appointed Dr. Vasant Narasimhan as CEO.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

Faced with divisive political and social issues, Congress must find a way to reach consensus.

Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.