Industry News
FDA Releases Supply Chain Guidance
The agency published guidance on identifying trading partners under DSCSA.
Amneal Pharmaceuticals Recalls Lorazepam Oral Concentrate
The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
ICH Announces Training Program
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Canadian Manufacturer Receives FDA Warning Letter
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Drug Supply Chain Tracking Challenges FDA and Manufacturers
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
China Joins ICH Global Harmonization Efforts
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
Congress Meets Deadline for Reauthorizing FDA User Fees
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
BMS Acquires Biotech Company in Billion-Dollar Deal
On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.
Congress Passes FDA User-Fee Reauthorization Bill
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
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).
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.
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.
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.
FDA Launches Expanded Access Tool
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
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.
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.
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.
EMA Recommends Five Orphan Drugs
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
Avantor Opens New Collaborative Research Center in New Jersey
The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.
NIH Study May Lead to New Therapies for Neurodegenerative Diseases
Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.
Tubilux Pharma S.p.A. Receives FDA Warning Letter
The agency cited the Italian company for aseptic processing failures.
Opioid Report Recommends Coordinated Effort to Fight Epidemic
The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.
Industry Groups Applaud House Passage of FDARA
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
