Bio/Pharma News
Novartis Sells Influenza Vaccine Business to CSL for $275 Million
The divestment will create the number two player in the global influenza vaccine industry.
Lilly to Close Manufacturing Facility in Puerto Rico
Lilly announces the closure of its Guayama, Puerto Rico manufacturing facility amid continued investments at other plants.
FDA Approves OFEV for the Treatment of Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim's OFEV was approved by FDA as the first treatment for idiopathic pulmonary fibrosis, a fatal lung disease.
Genentech Announces FDA Approval of Idiopathic Pulmonary Fibrosis Treatment
Genentech announced FDA-approved Esbriet for the treatment of Idiopathic Pulmonary Fibrosis.
Nuvilex Applies for Orphan Drug Designation for Pancreatic Cancer Treatment
The company submits an orphan drug application to FDA for its Cell-in-a-Box treatment for pancreatic cancer.
Sanofi Pasteur and Immune Design Collaborate to Develop Herpes Simplex Virus Therapy
Sanofi Pasteur and Immune Design agree to jointly develop therapies through Phase II clinical trials.
FDA Grants Priority Review for Pfizer's HER2- Advanced Breast Cancer Treatment
Pfizer announced that it has received FDA Priority Review for palbociclib, in combination with letrozole, as a treatment for HER2- advanced breast cancer.
Endo to Acquire Auxilium Pharmaceuticals
Endo will acquire Auxilium Pharmaceuticals in a cash and stock transaction for approximately $2.6 billion.
Genentech Receives FDA Priority Review for Diabetic Retinopathy Treatment
FDA granted Genentech priority review for its diabetic retinopathy treatment, Lucentis.
Ebola Outbreak Sparks EMA Review of Experimental Ebola Treatments
In response to the Ebola outbreak, EMA has started reviewing Ebola treatments in the development pipeline.
MedImmune Receives Fast Track Designation for Development of Nosocomial Pneumonia Prevention
AstraZeneca's global biologics research group, MedImmune, received FDA Fast Track designation for MEDI3902, for the prevention of nosocomial pneumonia.
Avalon Ventures Announces the Launch of Two New Companies: Silarus Therapeutics and Thyritope Biosciences
Avalon Ventures and GSK add two more companies to their launch list of early-stage life-science companies.
Alchem International Commits to Tropane Alkaloid APIs
Alchem International announced that it will continue to market and support Tropane Alkaloid APIs despite earlier reports.
Merck KGaA Acquires Sigma-Aldrich for $17 Billion
Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich.
GSK Fined in China Bribery Scandal
GSK is found guilty of offering bribes to doctors and is fined $489 million.
Bayer Plans to Separate to Benefit Company Growth
Bayer separates into two entities to benefit the growth and development of Bayer Life Science and MaterialScience.
EMD Serono Collaborates with Sutro Biopharma to Develop ADCs
EMD Serono announces a collaboration with Sutro Biopharma to develop antibody drug conjugates for multiple undisclosed targets.
Baxter Names New Biopharmaceutical Company Baxalta
Baxter announced that its new biopharmaceutical company will be named Baxalta when the company separates into two publicly traded companies in mid-2015.
FDA Approves Treatment for Children with Hemophilia B
FDA approved Baxter International's treatment, RIXUBIS, for the treatment of children with hemophilia B.
EYLEA Receives FDA Breakthrough Therapy Designation
Regeneron Pharmaceuticals' injection for diabetic retinopathy in patients with diabetic macular edema received FDA breakthrough therapy designation on Sept. 16, 2014.
European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing in EU
European Commission granted the first biosimilar insulin to receive regulatory approval in Europe.
FDA Approves XTANDI Capsules for Prostate Cancer
FDA approved XTANDI for the treatment of metastatic castration-resistant prostate cancer.
Merck Receives Accelerated Approval of the First FDA-Approved Anti-PD-1 Therapy
KEYTRUDA was approved for the treatment of unresectable or metastatic melanoma and disease progression.
AbbVie Announces Collaboration with Calico to Develop New R&D Facility
AbbVie and Calico announce a novel collaboration to accelerate the discovery, development, and commercialization of new therapies.
Pfizer to Acquire Vaccines from Baxter
Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.
Redbiotec Collaborates with GE Healthcare Life Sciences on Vaccine Development and Manufacturing
Redbiotec and GE Healthcare Life Sciences develop a novel manufacturing process for virus-like particles.
CPI Announce Investment into Biologics Factory of the Future
CPI invests $34 million to develop a Biologics Factory of the Future due to open in 2017.
Novasep Passes FDA Inspections on Two Sites
Novasep gains approval from FDA to produce new molecular entity for US market.
MedImmune Collaborates With Advaxis on Immunotherapies
MedImmune and Advaxis partner on immuno-oncology combination clinical trial.
West Dedicates Manufacturing Plant in India
West's new plant in India will manufacture primary packaging for injectable drugs.
