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Pharmaceutical Business Review

EMA committee recommends full approval of Imbruvica to treat two blood cancers The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of full marketing approval for Pharmacyclics' Imbruvica (ibrutinib) in the European Union (EU). Regulatory Affairs > News
Lion, Moffitt Cancer Center partner to improve tumor infiltrating lymphocyte production By PBR Staff Writer
Lion Biotechnologies that develops new cancer immunotherapies based on tumor infiltrating lymphocytes (TILs) has entered into an exclusive, worldwide license agreement with Moffitt Cancer Center.
Automation > IT & Software > News CHMP recommends Allergan's OZURDEX to treat diabetic macular edema By PBR Staff Writer
Allergan has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending extension of the marketing authorization for OZURDEX to treat adult patients with vision loss due to diabetic macular edema (DME).
Regulatory Affairs > News First patient enrolled in Reata's Phase II trial of RTA 408 to treat radiation dermatitis By PBR Staff Writer
Reata Pharmaceuticals has enrolled the first patient in a Phase II dose-ranging trial of RTA 408 Lotion in breast cancer patients at risk for radiation dermatitis.
Contract Research & Services > Clinical Trials > News
Bayer, Onyx report results from Phase III breast cancer trial of sorafenib By PBR Staff Writer
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have released results from an investigational Phase III trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer.
Contract Research & Services > Clinical Trials > News Shire Takeover Could Save AbbVie $8 Billion Tax on Humira over Next 15 Years, say GlobalData Analysts AbbVie's recent $54 billion acquisition of Shire and subsequent relocation to Ireland will mean substantial tax savings for the US pharmaceutical giant, say analysts with research and consulting firm GlobalData.
Production & Manufacturing > Manufacturing > News biOasis releases quantitative results: siRNA-Transcendpep reduces target gene expression in the brain BIOASIS TECHNOLOGIES, a pioneering biopharmaceutical company focused on overcoming the limitations of therapeutic drug delivery across the blood-brain barrier (BBB), has announced on May 6th, 2014, that its newly discovered carrier peptide-Transcendpep-effectively delivered siRNA across the BBB and into brain cells.
Automation > IT & Software > News

Latest News and Insight by Sector

Production & Manufacturing

Shire Takeover Could Save AbbVie $8 Billion Tax on Humira over Next 15 Years, say GlobalData Analysts
AbbVie's recent $54 billion acquisition of Shire and subsequent relocation to Ireland will mean substantial tax savings for the US pharmaceutical giant, say analysts with research and consulting firm GlobalData.
Production & Manufacturing > Manufacturing > News
MYOS extends manufacturing, supply agreement for Fortetropin
MYOS Corporation, an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, has signed an extension of its supply agreement with Deutsches Institut fuer Lebensmitteltechnik e.V, the German Institute for Food Technologies, for the continued manufacturing and supply of Fortetropin, the first clinically proven natural myostatin inhibitor.
Production & Manufacturing > OTC > News

Drug Research

Prometic Biosciences enters into new product development program
By PBR Staff Writer
ProMetic Life Sciences' UK subsidiary has signed an agreement with one of its existing multinational clients, a global leader in the biotherapeutics industry.
Drug Research > Drug Discovery & Development > News
National Institute of Allergy and Infectious Diseases awards SRI International Contract to study new therapies for HIV and AIDS
SRI International has been awarded a new $49 million, seven-year contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to conduct preclinical development of potential therapies for HIV infection and AIDS.
Drug Research > Drug Discovery & Development > 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

First patient enrolled in Reata's Phase II trial of RTA 408 to treat radiation dermatitis
By PBR Staff Writer
Reata Pharmaceuticals has enrolled the first patient in a Phase II dose-ranging trial of RTA 408 Lotion in breast cancer patients at risk for radiation dermatitis.
Contract Research & Services > Clinical Trials > News
Bayer, Onyx report results from Phase III breast cancer trial of sorafenib
By PBR Staff Writer
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have released results from an investigational Phase III trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer.
Contract Research & Services > Clinical Trials > News

Automation

Lion, Moffitt Cancer Center partner to improve tumor infiltrating lymphocyte production
By PBR Staff Writer
Lion Biotechnologies that develops new cancer immunotherapies based on tumor infiltrating lymphocytes (TILs) has entered into an exclusive, worldwide license agreement with Moffitt Cancer Center.
Automation > IT & Software > News
biOasis releases quantitative results: siRNA-Transcendpep reduces target gene expression in the brain
BIOASIS TECHNOLOGIES, a pioneering biopharmaceutical company focused on overcoming the limitations of therapeutic drug delivery across the blood-brain barrier (BBB), has announced on May 6th, 2014, that its newly discovered carrier peptide-Transcendpep-effectively delivered siRNA across the BBB and into brain cells.
Automation > IT & Software > News

Regulatory Affairs

CHMP recommends Allergan's OZURDEX to treat diabetic macular edema
By PBR Staff Writer
Allergan has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending extension of the marketing authorization for OZURDEX to treat adult patients with vision loss due to diabetic macular edema (DME).
Regulatory Affairs > News
European CHMP adopts positive opinion for Gilead’s Zydelig to treat chronic lymphocytic leukemia and follicular lymphoma
Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL).
Regulatory Affairs > News

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