Industry News
Experts Propose Licensing Deal to Expand Access to Hep C Therapies
A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
Regulators and Industry Seek Agreement on ICH Lifecycle Management Standard
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
EMA Recommends Three Orphan Drugs for Approval
The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.
EMA Suspends Drugs Associated with Micro Therapeutic Research Labs
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
EMA Creates Taskforce on Big Data
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
More Generic Drug Approvals Not Enough
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
Regenerative Medicine Advanced Therapy Designation Launches
In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.
Another Company Receives FDA Warning Letter Citing Repeat Violations
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
US and Indian Pharmacopeias Collaborate on Drug Quality
The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.
Researchers Discover Structure and Mechanism of Human Antibody for Zika Virus
Human antibody for Zika virus could help in the treatment and prevention of the infection.
FDA Warns API Manufacturer about Quality and Data Integrity Issues
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
Global Regulators Collaborate to Improve Access to Safe Drugs
The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
Trump Nominates Scott Gottlieb to Lead FDA
The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.
FDA Sends Warning Letter to Illinois Manufacturer
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
China API Facility Receives FDA Warning Letter
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
CDER Director Details Priorities for 2017
Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.
Study Dismantles PhRMA’s Long-Standing Argument on Drug Pricing
A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.
CPhI North America Releases Conference Program Lineup
The conference will include 55 speakers at more than 44 sessions.
Study: Software Technology for CRISPR Deletion Experiments
A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.
UKSCB Releases Stem Cell Lines for Development
The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.
Trump Blasts FDA “Restraints,” High Drug Prices
President Trump calls for faster FDA approvals and lower drug prices.
Hospira Receives FDA Warning Letter for Repeated Violations
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
FDA Readies Launch of Quality Metrics
FDA plans to initiate its quality metrics program as industry continues to push back.
Avella Specialty Pharmacy Recalls Sterile Products
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Endo Pharmaceuticals Recalls Alprostadil
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
FDA’s Office of Generic Drugs Releases Annual Report
In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
Microsoft and Adents Develop Traceability Solution for Track and Trace
The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.
FDA Posts ICH Q11 Q&A Guideline
The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
PhRMA Urges USTR to Ramp Up Patent Enforcement Activities Overseas
PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.
FDA Approves Brodalumab for Psoriasis
FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.
