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FDA Grants Approval of Treatment for Hepatitis C
FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).
FDA Grants Approval of Treatment for cGVHD
FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.
Horizon Discovery Releases CHO Genome Sequence for Bioproduction
Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.
EMA Looks at Drug Development for Senior Population
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
ISPE Bio Event Examines Approaches for Optimizing Operational Agility and Time-to-Launch Readiness
The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.
EMA Unveils Brexit Plan
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
FDA Accepts Application for Teva’s Herceptin Biosimilar
FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Predictions from CPhI Annual Reports—How Accurate Were They?
The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.
FDA advances biosimilars progress with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Janssen, Bavarian Nordic Partner on Hep B and HIV Vaccines
Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.
ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
Manufacturers Struggle to Track Controversial 340B Drug Discounts
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
AstraZeneca, Merck & Co. in $8.5-Billion Oncology Collaboration
Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.
Cesca Receives Cellular Processing Patent for CAR-T Manufacturing
New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.
GSK Plans Major R&D Overhaul
Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.
Takeda in Anti-Cancer Pact Worth Up to $340 Million
Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.
Lonza Launches New Biomanufacturing Complex
Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.
Corning and Gerresheimer Collaborate on Valor Glass
Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.
FDA Launches Expanded Access Tool
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
Eli Lilly, Incyte RA Drug Delayed to Beyond 2017
Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.
Recipharm and LIDDS Establish Industrial Manufacturing Capabilities for Prostate Cancer Drug
Recipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.
Testing and Sterility Deficiencies Found at Illinois Facility
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Boehringer Ingelheim Expands Fremont Manufacturing Facility with $217 Million Investment
Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.
GE, Oritain Partner on Bovine Serum Traceability
GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.
BioPhorum Launches Biomanufacturing Technology Roadmap
Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.
FDA to Lead International Effort to Secure the Supply Chain
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Catalent and Rutgers University to Study Pediatric Drug Challenges
Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.
Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging
A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.
Report: Dose CMOs Stuck in Idle
Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.
New Guide Outlines Risks for Cross Contamination
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
