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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.
Janssen Beefs Up Antibody Discovery Capabilities through Agreement with Sevion
The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.
More New Drugs and Faster Approvals
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
Express Scripts and AbbVie Ink Landmark Formulary Exclusivity Deal
Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.
Cell Therapy Manufacturing Center to be Built in UK
The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.
Biosimilar Development Moves Forward at FDA
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
Merck Acquires Biotechnology Company, OncoEthix
Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.
EMA Recommends Approval of First Stem-Cell Therapy
The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.
Roche Acquires Bispecific Antibody Developer Dutalys
Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.
Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys
Fujifilm Acquires Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.
Novo Nordisk to Partner with Xencor in the Development of Engineered mAbs
Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.
Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity
Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.
Janssen and Halozyme Therapeutics Ink Licensing Deal for Drug Delivery Platform
Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.
FDA Releases Guidance on Electronic Regulatory Submissions
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
GPhA Supports FDA Proposed Rule on E-labeling
A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.
