Industry News
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.
The Broad Institute Triumphs in CRISPR Patent Battle
The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the company to keep patents for their CRISPR-Cas9 gene-editing technology.
Sterile Manufacturing Deviations Found at Japan Facility
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
CPhI South East Asia Gathers March 22–24 in Jakarta
South East Asian pharma manufacturers seeking region growth expected to attend CPhi South East Asia.
EDQM Clarifies the Role of Monographs in Determining Biosimilarity
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
Synergy Rx Pharmacy Issues Recall Due to Lack of Sterility
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
FDA Warns India API Manufacturer Over Contamination Issues
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
GPhA Rebrands as AAM
The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.
EU’s Post-Authorization Study Register Reaches One Thousand Entries
EMA announces that the European Union’s PAS Register has received its 1000th upload.
Biotech Executives Express Concern Over Immigration Order
A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.
Exela Pharma Sciences Recalls Ibuprofen Lysine Injection
The company is voluntarily recalling product due to particulate matter.
