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A-Alpha Bio Wins NSF Grant for Cancer Drug Development
The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.
Waters Acquires Mass Spec Technology
Waters’ acquisition of Prosolia’s DESI technology boosts its mass spectrometry imaging portfolio.
Quartzy to Expand Digital Lab Supplies Catalog with Bioline, Biotium, MP Biomedicals
Quartzy, an online laboratory supply management company, will offer lab products from Bioline, Biotium, and MP Biomedicals.
Fully Integrated Karl Fischer Titrator
The Omnis KF is fully integrated solution for moisture analysis and water content determination with volumetric Karl Fischer titration.
Sangamo Therapeutics to Acquire TxCell
The acquisition would combine Sangamo’s ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.
Gottlieb Reshapes FDA to Elevate Centers
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
Almac to Invest in Analytical Services Capability
The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.
AGC to Expand Chemical and API Capacity
The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.
FDA Opens Door to Importing Drugs
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
Cambrex to Acquire Halo Pharma for $425 Million
The acquisition will place Cambrex into the finished dosage form CDMO market.
FDA Takes Actions to Secure Safety of Compounded Drugs
The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
Novartis Has Production Hiccup for Kymriah CAR-T Therapy
The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
FDA Approves First Drug to Treat Smallpox
The agency has approved Tpoxx (tecovirimat), the first drug with an indication for the treatment of smallpox, to address the impact of a potential outbreak.
FDA Invites Comment on New Exposure Limits for Cadmium
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
FDA Sends Warning Letter to California OTC Manufacturer
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays
In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
Augmenting Labeling for OTC Drugs
New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.
FDA Forms Drug Shortages Task Force
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
AbbVie Signs Patent License with Mylan for Humira Biosimilar
AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.
Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies
CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.
Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification
The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.
EU and Japan Strengthen Collaboration on GMP Inspection
Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
Moderna Opens Manufacturing Site for mRNA Therapeutics
Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.
Drugs Containing Valsartan Recalled
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Otsuka to Acquire Visterra for $430 Million
Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.
Generics Drive Finished Drug Market Growth in Korea
CPhI Korea to feature zone for finished dosage formulation drug products.
FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Catalent Implements Optofluidic Platform for Cell-Line Development
Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.
Teva to Relocate US Headquarters to New Jersey
Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.
