Industry News
Compounding Pharmacy Issues Recall
US Compounding, Inc. issues voluntary recall of all sterile products.
CPhI Worldwide Reveals Pharma Awards Finalists
Winners from the seven categories will be announced live at the event in Madrid.
NIH Awards Grants for Genomics Research
Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.
EMA CHMP Chair Re-elected
Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
Indian Pharma Sees Surge in M&As
Exports and domestic market have each been valued at more than US$15 billion.
Pharma Urged to Embrace Green Chemistry
Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.
FDA Cites India API Facility For CGMP Violations
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
Impurities Guidelines Clarified for Veterinary Products
EDQM clarifies elemental impurities guidelines for veterinary and other products.
Confirmation for Califf?
The White House nominates Robert Califf to head FDA, but will he be confirmed?
FDA Issues Import Ban for Indian Drug Manufacturer
Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
New Zealand Manufacturer Cited for CGMP Violations
FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.
Rob Califf Named to Fill FDA Commissioner Post
President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.
CMO Industry Growth Unsustainable According to Report
PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.
MGB Biopharma Wins Scottish Business Award
MGB Biopharma, a biopharmaceutical company specializing in the development of novel anti-infectives to antibiotic resistance, has been named a winner in the 2015 Scottish Business Insider Deals & Dealmakers Awards.
FDA Expands Warning on BD Syringes
FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.
FDA Issues Final Elemental Impurities Guidance
FDA publishes the final Q3D Elemental Impurities guidance.
FDA Issues Guidance on Evaluation of Drug Toxicity
The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.
FDA Releases Guidance on Formal Disputes
The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.
EMA Sets Up Workshop on Orphan Drugs
The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
USP Partners with USAID to Secure Supply Chain
UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.
EMA’s Medical Literature Monitoring Begins
The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.
AAPS Announces New Slate of Leaders
Pharma scientists announced for AAPS executive council and section leadership positions.
Knowledge-Sharing and Networking at the CPhI Pre-Connect Congress
The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.
Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020
Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
BIOTECHNICA 2015
Set to take place in Hannover, Germany from October 6–8, 2015, BIOTECHNICA is one the major events in Europe that brings together players in the biotechnology, life sciences, and lab technology sectors.
Cracked Caps Spark Recall of Merck's Cancer Drug Bottles
Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.
Novartis Licenses AVEO Oncology’s Antibody to Treat Metabolic Syndrome
Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.
FDA Guidance on Treatments for Rare Diseases
The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.
FDA Releases Guidance on Developing Botanical Drugs
FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.
