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European Medicines Agency recommends Opdivo for treatment of advanced melanoma Bristol-Myers Squibb's Opdivo has been recommended by the European Medicines Agency (EMA) for use in the treatment of adult patients with advanced melanoma in the European Union (EU). Production & Manufacturing > Process & Production > News
Synchrogenix teams up with CISCRP to improve global medical writing capabilities By PBR Staff Writer
Synchrogenix, the regulatory writing unit of US-based pharmaceutical firm Certara, has formed a partnership with Center for Information and Study of Clinical Research Participation (CISCRP) to offer clinical trial results to the volunteers in lay language.
News Researchers develop new model to investigate cancer’s earliest stages By PBR Staff Writer
Researchers at the Northwestern University have developed a computational model that enables to examine how emerging metastatic tumors interact with the immune system.
News Actavis' DUR001-303 phase 3 study of single-dose Dalvance for ABSSSI meets end points By PBR Staff Writer
Ireland based pharmaceutical firm Actavis has announced the top-line results for DUR001-303 which is a phase 3 study comparing a single 1500 mg dose of Dalvance with the same total dose given as two-doses one week apart.
News
Merck releases phase III data of grazoprevir/elbasvir to treat chronic hepatitis C virus By PBR Staff Writer
Merck has released first presentations of data from C-EDGE phase III clinical trial of grazoprevir/elbasvir in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).
News European Medicines Agency recommends Opdivo for treatment of advanced melanoma By PBR Staff Writer
Bristol-Myers Squibb's Opdivo has been recommended by the European Medicines Agency (EMA) for use in the treatment of adult patients with advanced melanoma in the European Union (EU).
News Cardiff University scientists find potential root cause for asthma By PBR Staff Writer
Scientists from the Cardiff University have discovered the potential root cause and a novel treatment for asthma, a chronic lung disease affecting 300 million people worldwide.
News

Latest News and Insight by Sector

Production & Manufacturing

European Medicines Agency recommends Opdivo for treatment of advanced melanoma
By PBR Staff Writer
Bristol-Myers Squibb's Opdivo has been recommended by the European Medicines Agency (EMA) for use in the treatment of adult patients with advanced melanoma in the European Union (EU).
News
Boehringer's BLA for idarucizumab gets FDA priority review
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for Boehringer Ingelheim Pharmaceuticals' biologics license application (BLA) for idarucizumab.
News

Drug Research

Cardiff University scientists find potential root cause for asthma
By PBR Staff Writer
Scientists from the Cardiff University have discovered the potential root cause and a novel treatment for asthma, a chronic lung disease affecting 300 million people worldwide.
News
ThromboGenics begins evaluation of Jetrea to treat retinal vein occlusion
By PBR Staff Writer
Belgium-based biopharmaceutical firm ThromboGenics has started evaluating Jetrea (ocriplasmin) as a potential treatment for retinal vein occlusion (RVO).
News

Inward Investment

PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
News
Merck in talks to acquire Cubist Pharmaceuticals for nearly $8bn
By PBR Staff Writer
New Jersey-based drug giant Merck & Co is, reportedly, in talks over a potential acquisition of antibiotics maker Cubist Pharmaceuticals for more than $8bn.
News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
News

Contract Research & Services

Actavis' DUR001-303 phase 3 study of single-dose Dalvance for ABSSSI meets end points
By PBR Staff Writer
Ireland based pharmaceutical firm Actavis has announced the top-line results for DUR001-303 which is a phase 3 study comparing a single 1500 mg dose of Dalvance with the same total dose given as two-doses one week apart.
News
Merck releases phase III data of grazoprevir/elbasvir to treat chronic hepatitis C virus
By PBR Staff Writer
Merck has released first presentations of data from C-EDGE phase III clinical trial of grazoprevir/elbasvir in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).
News

Automation

Dicerna gets FDA orphan drug status for DCR-PH1 to treat primary hyperoxaluria type 1
By PBR Staff Writer
Dicerna Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its therapeutic candidate, DCR-PH1, to treat primary hyperoxaluria type 1 (PH1), a severe, rare, inherited disorder of the liver.
News
Oasmia's Paclical cancer drug gets Russian marketing approval
By PBR Staff Writer
Sweden-based Oasmia Pharmaceutical has received market authorization from the Russian Ministry of Health for its lead cancer product Paclical in Russia.
News

Regulatory Affairs

CanTx gets FDA orphan drug designation for Cantrixil to treat ovarian cancer
By PBR Staff Writer
CanTx, the Novogen-Yale joint venture, has received orphan drug designation from the US Food and Drug Administration (FDA) for its chemotherapy candidate drug, Cantrixil, to treat ovarian cancer.
News
CymaBay gets FDA orphan drug status for MBX-8025 to treat hypertriglyceridemia
By PBR Staff Writer
US-based biopharmaceutical firm CymaBay Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for MBX-8025 to treat patients with hyperlipoproteinemia types I or V (Fredrickson classification).
News



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