BioPharm International Editors

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

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.

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.

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.

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

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

Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.

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Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.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

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

A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.

Bristol-Myers Squibb (BMS) and Daiichi Sankyo announced a collaboration to evaluate the combination of Opdivo (nivolumab) and antibody drug conjugate (ADC) DS-8201 for treating breast and bladder cancers.

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.

With this acquisition, Oncurious, a Belgium-based biotechnology company, will gain a pipeline of immune-oncology drug candidates.

Cambridge Research Biochemicals (CRB), a supplier of peptide and antibody research reagents, has licensed new fluorescent dyes from the University of Edinburgh that enhance live-cell imaging.

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

Avista Pharma has appointed Eric Evans as CFO.

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.

FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.

Lonza is expanding parenteral dosage development capability and capacity in its Drug Product Services (DPS) sector at the company’s Basel, Switzerland facility.