All
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.
New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Stelis Biopharma Builds Facility in Malaysia
The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.
Dormant Therapies Act Establishes New Class of Pharmaceuticals
The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.
Compassionate Use Debate Heats Up
Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.
NICE Reverses Decision on Biologics for Patients with Ulcerative Colitis
NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.
Baxter Enters Agreement to Divest Vero Cell Vaccines Platform
Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.
FDA Approves Gardasil 9 for Prevention of Cancers Associated with HPV
FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.
Industry Players Reach Compromise on Biosimilar Substitution
Reference product manufacturers and trade groups support automatic medication switches in new biosimilar “compromise” terms.
Legal Immunity Offered to Makers of Ebola Vaccines in the US
US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.
Pfizer to Intensify AAV Vector Research in Gene Therapy for Hemophilia
On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.
Paragon Bioservices to Scale Up Protein Manufacturing
Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.
