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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.
Ignyta’s Neuroblastoma Treatment Receives Orphan Drug Designation
Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.
Teva Announces FDA Approval of Granix for Self-Administration
Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.
FDA Approves Opdivo for the Treatment of Melanoma
Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.
Protein Sciences Considers Sourcing Flublok From Japan
Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.
