Industry News
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.
Sterility Concerns Cause Recall
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
FDA Releases Guidance on GDUFA Self-Identification
The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.
Researchers Propose a Portable Biomolecular Manufacturing Method
Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.
EMA Determines Certain Drugs Safe from Zika Contamination
The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.
Trends Released from the CPhI Korea Conference
CPhI outlines trends from the conference in Seoul.
EMA Stops Import of Products from US Company
EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.
FDA Director Responds to Drug Pricing Concerns
In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.
Combination Products Challenge Regulators and Manufacturers
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
PhRMA Announces Research & Hope Award Winners
The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.
FDA Issues Guidance on the Use of Plasma Fibrinogen Biomarker
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
Compounder Cited for Sterile Manufacturing Violations
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
Biosimilars Face Repercussions of Drug Pricing Debate
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
Pan Drugs Limited Receives FDA Warning Letter
The Indian facility was cited for a range of quality and data integrity violations.
EDQM Publishes Elemental Impurities Guideline
The agency published a guideline for the implementation of ICH Q3D.
Quality Issues Found at Brazil Drug Manufacturing Facility
FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.
