Industry News
China Facility Limits FDA Inspection
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
NICE Recommends Eribulin
NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.
CPhI India Marks 10th Anniversary
Pharma industry event in Mumbai will host 40,000 visitors on Nov. 17-23.
FDA Advises Limited Clinical Testing for Biosimilars
The biosimilar pathway permits licensure based on less than full clinical data.
USP and Chinese Pharmacopeia Extend Partnership
US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.
Interpharm Praha A.S Receives FDA Warning Letter
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
FDA Tackles Cellular, Gene Therapies
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
Researchers Propose a Flexible Method for Gene Therapy Manufacture
Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.
FDA Highlights Flexibility in Approving Rare Disease Therapies
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
ICH Introduces Two New Guidelines
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
FDA Awards Grants for Treatments of Rare Diseases
The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.
US and Europe Collaborate on Patient Treatments
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
Scottish Company Receives USFDA Warning Letter
Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
FDA Warns Swiss Company
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Study Demonstrates Potential Method for Treating Congenital Diseases In Utero
A new study proposes a new way to potentially treat congenital diseases in utero.
HHS Sponsors Commercial Manufacturing Tests for Ebola Vaccine
HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
FDA Completes 20 Meetings on Patient Involvement in Drug Development
The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.
EUIPO Report Says Counterfeit Medicines Cost EU €10.2 Billion a Year
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
PDA’s First Aging Facilities Survey Sees Regulatory Obstacles to Modernization
The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
Drug Value Assessment Here to Stay
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
Children’s Hospital of Pittsburgh of UPMC Receives Grant to Join Vaccine Surveillance Network
The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.
CDER Publishes Drug Safety Priorities
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.
Europe Strengthens Collaborations with Japanese Pharmacopoeia
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
Baxter Recalls Micron Filters
The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.
FDA Releases Q7 GMP for API Guidance
he guidance addresses the good manufacturing practice for managing quality in APIs.
Outlook for Biosimilars in 2020
Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.
PharmSource Report Says Bio/Pharma Companies Prefer In-House Manufacturing
The most recent PharmSource report says bio/pharma companies have spent more than $150 billion for new plant equipment in the past five years.
US and Europe Collaborate on Treatment of Rare Diseases
FDA and EMA set up new working group on the development of treatments for rare diseases.
HHS Contracts Sanofi Pasteur for Zika Vaccine Development
HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.
China Facility Receives FDA Warning Letter
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
