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FDA Approves Novartis’ Cosentyx for Plaque Psoriasis
Cosentyx (secukinumab) is the first IL-17A inhibitor for moderate-to-severe plaque psoriasis patients.
Catalent and MGC Pharma Partner for Production of High-Yield Cell Lines
Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.
The Quest Continues for Quality Metrics
FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
Europe Collaborates on Generic Drugs
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
Eli Lilly Announces Collaborations for Cancer Treatments
Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.
Boehringer Ingelheim Announces Partnership with Vanderbilt University to Develop Ras Inhibitors
Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.
Sanofi and Boehringer Ingelheim Enter into Monoclonal Antibody Alliance
Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.
USP Elemental Impurities Implementation Set for January 2018
USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.
Catalent and Sanofi to Collaborate on ADC Development
Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.
Hospira Submits Application for Epoetin Alfa Biosimilar to FDA
The move represents Hospira’s first biosimilar submission in the United States.
Commercial-Scale Cell Therapy Manufacturing Partnership Announced
The new partnership between NeoStem and Invetech focuses on the development of a closed processing system for cell-based therapy manufacturing.
Shire Announces NPS Pharma Acquisition for $5.2 billion
Shire adds rare-disease portfolio with acquisition of NPS Pharma.
BMS Celebrates Superior Overall Survival for Opdivo
Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.
Pfizer will Forgo Advisory Panel for Breast Cancer Drug Palbociclib
The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.
Argos Partners With Saint-Gobain on Single-Use Components for Immunotherapy Manufacturing
Single-use components aid efficiency in automated personalized therapy manufacturing.
FDA Extends Track and Trace Enforcement Deadline
A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
Mixed Results for Biogen Idec’s Neuroprotective Drug
Biogen Idec’s investigational monoclonal antibody met its primary endpoints in a recent Phase II for the treatment of acute optic neuritis.
FDA Recommends Approval of First Biosimilar Application
An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.
CDER Announces 2015 Guidance Plan
The FDA center released a list of the guidance documents it plans to publish in 2015.
CVS Health Strikes Hepatitis C Drug Exclusivity Deal with Gilead
The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.
Janssen May Pay Up to $835 Million for Antisense Therapy
Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.
Drug Approvals Highest Since 1996
In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.
PDA Publishes Drug Shortage Technical Report
The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.
Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.
FDA Guidance Delays Enforcement of Product Tracing Requirements
FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.
Roivant Neurosciences Acquires GSK’s Novel Neurological Disorder Treatment
Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.
Anti-PD-1 Therapies: Immune to Pricing Wars?
Although competing therapies will continue to be released in the immune-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.
Hospira Announces Voluntary Recall Due to Subpotency and Impurity Levels
Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.
FDA Approves First Ebola Test for Emergency Use
Roche’s LightMix Ebola test can give results in around three hours.
FDA Approves Genentech’s Combination Leukemia Treatment
When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.
