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FDA Releases Draft Guidance on Gluten in Drug Products
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein
Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.
Abzena Secures ADC Manufacturing Contract with US Biotech Firm
Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.
FDA Approves Sanofi’s Follow-On Insulin
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
Novo Nordisk Expands Insulin Manufacturing Facility in India
In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders
The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.
EMA Approves mAb Production at Samsung BioLogics Facility
The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
Almirall and Athena Partner on Skin-Care Drug
The partnership aims to develop and commercialize a skin-care drug candidate being developed to treat actinic keratosis, which, left untreated, can progress to cancer.
FDA Warns Companies for Promoting Street Drug Substitutes
The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.
FDA Approves First Drug for EGPA
The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.
SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility
SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.
FDA Accepts Lilly’s Application for Migraine Biologic
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility
The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.
Gilead Sciences and Kite to Acquire Cell Design Labs
Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.
Phillips-Medisize Invests in Manufacturing Center of Excellence for Connected Health and Drug-Delivery Devices
The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.
Bluetooth-Enabled Temperature Data Loggers for Cold Chain Management
Oceasoft has updated its line of Bluetooth-enabled temperature data loggers for shipping and logistics applications.
AMRI Expands Bulk API Aseptic Manufacturing Capacity
The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.
Honeywell Survey Shows Low Adoption of Industrial Cyber Security Measures
A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.
PharmaForce to Invest $145 Million in Facilities Expansion
The company will expand two of its Ohio facilities, investing approximately $145 million to support manufacturing and warehouse operations.
EMA Updates Brexit Guidance
The agency and the European Commission published updated guidance to answer questions about Brexit.
EMA Issues Drug Warnings and Review
During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.
Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Ophthalmic Drug-Delivery Device Improves Patient Experience
Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.
FDA Approves First Biosimilar to Roche’s Herceptin
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.
Astellas Acquires Mitobridge in $450-Million Deal
The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
Wanted: A Highly Skilled Bio/Pharma Workforce
Is pharma up to the task of developing knowledgeable, motivated employees?
What are the Ingredients for Bio/Pharma Career Advancement?
Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.
Orchard Therapeutics Opens Gene Therapy Laboratory Facility
The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.
