News

Lonza and Portola Pharmaceuticals have entered into a supply agreement for AndexXa (andexanet alfa), a recombinant protein used in patients on FXa inhibitors who experience a major bleed or need urgent surgery.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

Shingrix represents a new, possibly better alternative to existing treatments.

The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.

The German biotech company can now supply its proprietary ligand on a GMP industrial-scale for clinical applications in immune-oncology.

The agency is looking for industry input on best practices for continuous manufacturing.

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.

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.