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FDA to Promote Continuous Manufacturing
The agency is looking for industry input on best practices for continuous manufacturing.
Alexion Restructures, Moves Headquarters, Closes Facilities, Cuts Jobs
Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.
Oxford Genetics Opens First US Office
The company has extended its presence in the US market to support its growing business in the region.
PPS Appoints New COO
Piramal Pharma Solutions (PPS), part of Piramal Enterprises, has appointed John Fowler as its COO.
AAPS Announces 2017 Foundation Fellowship Winners
AAPS has announced the five graduate students awarded with a $10,000 fellowship for their research efforts in global health solutions.
FDA Issues Warning Letter to EpiPen Manufacturer
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.
US Gov’t Partners with Summit Therapeutics on New Antibiotic
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 Molecular Diagnostics to Complete FDA Filing for Gene Assay
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 Terminates Hep C Collaboration with Achillion
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.
Lilly to Cut 3500 Jobs, Aims for $500 Million in Savings
The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.
Scripps Confirms QC Mechanism that Protects Protein Production
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.
Ventria to Double Biomanufacturing Capacity
The biopharmaceutical company broke ground on what will be a new 3000-ft2 addition to its Kansas biomanufacturing facility.
Process Validation: Do We Need Brainwashing?
Six years after the guidance, it’s time to change our quality assurance vocabulary.
PCMM, The Next Generation
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.
OSI and Petasense to Collaborate on IoT Solutions
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 to Establish API Center of Excellence
Alcami has announced the development of a Center of Excellence at its API development and manufacturing facility in Germantown, WI.
Merck KGaA Considers Sale of Consumer Health Business
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 $788-Million Divestment of Biosimilars Business
Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.
Merck & Co. to Buy German Immuno-Oncology Firm in Nearly $560-Million Dea
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 Recalls Three Lots of Activase on Sterility Issues
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.
FDA Clears Pfizer’s ADC for Leukemia
Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.
GE’s Thawing Technology for Delivering Cell Therapies
The VIA Thaw CB1000 from GE Healthcare offers thawing for large volumes of cell therapies cryopreserved in cryo-bags for research laboratories.
AMRI Acquired by The Carlyle Group and GTCR
The Carlyle Group and GTCR have completed a previously announced acquisition of AMRI, a contract research and manufacturing organization.
Catalent Signs Manufacturing Agreement with US WorldMeds
Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.
Novartis Appoints New CEO
Novartis has appointed Dr. Vasant Narasimhan as CEO.
The Role of the Quality Unit
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
The Human Cost of Congressional Stalemates
Faced with divisive political and social issues, Congress must find a way to reach consensus.
Roquette Acquires Itacel
Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.
EMA’s PRAC Recommends Removal of Modified-Release Paracetamol
Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.
FDA Puts Out Alert on Halted Merck & Co. Trials for Keytruda
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.
