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Pharmaceutical Business Review

Boehringer, University of Toronto form alliance for new therapeutic concepts in ubiquitin biology Germany-based Boehringer Ingelheim has entered into a research alliance with the University of Toronto through the Toronto Recombinant Antibody Centre (TRAC), together with Toronto-based University Health Network and Mount Sinai Hospital to investigate new therapeutic targets in the field of ubiquitin signalling biology. Contract Research & Services > Contract Research > News
Puma Biotechnology revises Neratinib licensing deal with Pfizer By PBR Staff Writer
US-based biopharmaceutical firm Puma Biotechnology has revised its licensing agreement with Pfizer for Puma's investigational drug PB272 (neratinib).
Contract Research & Services > Contract Services > News Antares starts dosing in Phase III QuickShot trial evaluating testosterone-deficient adult males By PBR Staff Writer
US-based Antares Pharma has dosed first patient in a Phase III trial designed to evaluate the efficacy and safety of QuickShot Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males.
Contract Research & Services > Clinical Trials > News Iroko Pharmaceuticals, CALOX partner to commercialize Zorvolex in Latin America By PBR Staff Writer
US-based Iroko Pharmaceuticals has signed a licensing agreement with CALOX DE COSTA RICA for exclusive rights to market and sell Zorvolex (diclofenac) capsules in specified countries in Latin America.
Contract Research & Services > Contract Services > News
Galena Biopharma inks licensing deal with MonoSol Rx for US rights of Zuplenz By PBR Staff Writer
US-based biopharmaceutical firm Galena Biopharma has entered into a definitive agreement to license the US rights for Zuplenz (ondansetron) oral soluble film (OSF), from MonoSol Rx, the developer of the oral soluble film technology, PharmFilm, and manufacturer of the product.
Automation > IT & Software > News FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
Regulatory Affairs > News Tute Genomics biomarker discovery platform to support BYU's Alzheimer's disease genetics research Tute Genomics announced that its genome annotation and discovery platform will support Brigham Young University's (BYU) efforts to advance Alzheimer's disease genetics research.
Contract Research & Services > Contract Research > News

Latest News and Insight by Sector

Production & Manufacturing

OPKO granted patent from US Patent & Trademark Office for RAYALDEE
OPKO Health, a multinational biopharmaceutical and diagnostics company, has announced that the United States Patent and Trademark Office granted OPKO a patent covering RAYALDEE, the company’s product to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Production & Manufacturing > Process & Production > News
Galmed gets FDA clearance of IND of Armachol to treat fatty liver disorders
Galmed Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, has announced that the US Food and Drug Administration, or the FDA, cleared its Investigational New Drug (IND) application.
Production & Manufacturing > Manufacturing > News

Drug Research

Regeneron, Bayer release positive Phase III trial results of EYLEA to treat DME
By PBR Staff Writer
Regeneron Pharmaceuticals and Bayer HealthCare have released positive results from the Phase III VIVID-DME trial of EYLEA (aflibercept) Injection indicated to treat diabetic macular edema (DME).
Drug Research > Drug Delivery > News
Durata Therapeutics launches DALVANCE for injection in US
By PBR Staff Writer
Durata Therapeutics has launched DALVANCE (dalbavancin) for injection in the US to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI).
Drug Research > Drug Delivery > News

Inward Investment

Amgen to buy Onyx Pharmaceuticals for $10.4bn
By PBR Staff Writer
Biotechnology company Amgen has reached a deal to buy all outstanding shares of California-based Onyx Pharmaceuticals for $125 per share in cash.
Inward Investment > News
Johnson & Johnson completes purchase of Aragon Pharmaceuticals
By PBR Staff Writer
Johnson & Johnson has completed the acquisition of Aragon Pharmaceuticals, a pharmaceutical discovery and development company focused on drugs to hormonally-driven cancers.
Inward Investment > News

Packaging

Biologics adds frozen storage capabilities to clinical research services
By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
Packaging > News
ATMI, D-Lab launch new Sterile Pyrofree vials
By PBR Staff Writer
US-based technology firm ATMI in partnership with Disposable Lab (D-Lab), a French contract-manufacturing company, has launched a line of pyrogen-free vials in order to meet biopharmaceutical filling and final packaging needs.
Packaging > News

Contract Research & Services

Puma Biotechnology revises Neratinib licensing deal with Pfizer
By PBR Staff Writer
US-based biopharmaceutical firm Puma Biotechnology has revised its licensing agreement with Pfizer for Puma's investigational drug PB272 (neratinib).
Contract Research & Services > Contract Services > News
Antares starts dosing in Phase III QuickShot trial evaluating testosterone-deficient adult males
By PBR Staff Writer
US-based Antares Pharma has dosed first patient in a Phase III trial designed to evaluate the efficacy and safety of QuickShot Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males.
Contract Research & Services > Clinical Trials > News

Automation

Galena Biopharma inks licensing deal with MonoSol Rx for US rights of Zuplenz
By PBR Staff Writer
US-based biopharmaceutical firm Galena Biopharma has entered into a definitive agreement to license the US rights for Zuplenz (ondansetron) oral soluble film (OSF), from MonoSol Rx, the developer of the oral soluble film technology, PharmFilm, and manufacturer of the product.
Automation > IT & Software > News
Alnylam gets notice of allowance from USPTO for new patent broadly covering conjugate-based delivery of RNA Therapeutics
Alnylam Pharmaceuticals, a leading RNAi therapeutics company, has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for claims in the Manoharan et al. patent application 13/693,478.
Automation > IT & Software > News

Regulatory Affairs

FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
Regulatory Affairs > News
Regulus gets FDA orphan drug status for RG-012 to treat Alport Syndrome
By PBR Staff Writer
US-based biopharmaceutical firm Regulus Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for RG-012, a single stranded, chemically modified oligonucleotide.
Regulatory Affairs > News

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