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Pharmaceutical Business Review

FDA extends review period for Novartis’ multiple myeloma investigational compound LBH589 The US Food and Drug Administration (FDA) has extended the priority review period by up to three months for Novartis' new drug application (NDA) of LBH589 (panobinostat), a potent pan-deacetylase (pan-DAC) inhibitor, in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma. Regulatory Affairs > News
Lilly's Trulicity solution for injection gets European approval to treat type 2 diabetes By PBR Staff Writer
Eli Lilly and Company has received marketing authorization from the European Commission for Trulicity (dulaglutide) solution for injection to improve glycaemic control in adults with type 2 diabetes.
News Synthon doses first patient in Phase I trial of cancer drug SYD985 By PBR Staff Writer
Synthon Biopharmaceuticals (Synthon) has started dosing patients with its investigational anti-HER2 antibody-drug conjugate (ADC), SYD985, in a Phase I trial to treat metastatic solid tumors.
News Oxford and Menarini begins first-in-human trial of leukemia drug OBT357 By PBR Staff Writer
Oxford BioTherapeutics and Menarini Group have started the first-in-human clinical trial of OBT357 (MEN1112), a new improved antibody to treat acute myeloid leukemia (AML).
News
Alexion's Soliris secures orphan drug designation (ODD) in Japan to treat neuromyelitis optica By PBR Staff Writer
Alexion Pharmaceuticals has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Soliris (eculizumab) to treat patients with neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
News EMA committee grants orphan designation for Apitope's ATX-F8-117 to treat haemophilia A By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to Apitope's ATX-F8-117 to treat patients with haemophilia A.
News Mylan confirms first-to-file patent challenge relating to BREVIBLOC Mylan confirmed that it and several subsidiaries have been sued by Baxter International, Baxter Healthcare Corporation and Baxter Healthcare S.A., in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Esmolol HCl in Sodium Chloride Injection, 10mg/ml (250 ml) and 20 mg/ml (100 ml).
News

Latest News and Insight by Sector

Production & Manufacturing

Mylan confirms first-to-file patent challenge relating to BREVIBLOC
Mylan confirmed that it and several subsidiaries have been sued by Baxter International, Baxter Healthcare Corporation and Baxter Healthcare S.A., in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Esmolol HCl in Sodium Chloride Injection, 10mg/ml (250 ml) and 20 mg/ml (100 ml).
News
Inergetics' advisory board meets to discuss launch preparations for new CBD-Based supplement line
Inergetics, a world-class developer of nutritional supplements, announced that it had held a meeting of its Scientific/Medical Advisory Board to discuss product development and other preparations for the launch of its new CBD-based product line.
News

Drug Research

Lilly's Trulicity solution for injection gets European approval to treat type 2 diabetes
By PBR Staff Writer
Eli Lilly and Company has received marketing authorization from the European Commission for Trulicity (dulaglutide) solution for injection to improve glycaemic control in adults with type 2 diabetes.
News
Oxford and Menarini begins first-in-human trial of leukemia drug OBT357
By PBR Staff Writer
Oxford BioTherapeutics and Menarini Group have started the first-in-human clinical trial of OBT357 (MEN1112), a new improved antibody to treat acute myeloid leukemia (AML).
News

Inward Investment

Endo International to buy Auxilium Pharmaceuticals for $2.6bn
By PBR Staff Writer
Ireland-based Endo International has signed an agreement to acquire Auxilium Pharmaceuticals, in a deal that is worth nearly $2.6bn.
News
Endo offers $2.2bn to acquire Auxilium
By PBR Staff Writer
Irish pain drugmaker Endo International has proposed $2.2bn offer to acquire biopharmaceutical company Auxilium Pharmaceuticals.
News

Packaging

Packaging Coordinators completes acquisition of Biotec
By PBR Staff Writer
Packaging services provider Packaging Coordinators (PCI) has completed the acquisition of UK-based pharmaceutical services provider Biotec for an undisclosed amount.
News
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.
News

Contract Research & Services

Paragon wins NIH contract to design and scale-up manufacturing of rhE-Selectin protein
Paragon Bioservices has been awarded a contract from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke to design and establish a scale-up manufacturing process for the cGMP production of the recombinant human rhE-selectin protein.
News
Amgen terminates all company-sponsored trials of rilotumumab in advanced gastric cancer
By PBR Staff Writer
Amgen has terminated all of the company-sponsored clinical trials of rilotumumab, an investigational fully-human monoclonal antibody, in advanced gastric cancer including the Phase III RILOMET-1 and RILOMET-2 trials.
News

Automation

Synthon doses first patient in Phase I trial of cancer drug SYD985
By PBR Staff Writer
Synthon Biopharmaceuticals (Synthon) has started dosing patients with its investigational anti-HER2 antibody-drug conjugate (ADC), SYD985, in a Phase I trial to treat metastatic solid tumors.
News
Trimel announces issuance of additional patent covering NATESTO
Trimel Pharmaceuticals announced that its technology partner Mattern Pharma AG has been granted an additional United States Patent in respect of NATESTO and its proprietary nasal gel technology.
News

Regulatory Affairs

Alexion's Soliris secures orphan drug designation (ODD) in Japan to treat neuromyelitis optica
By PBR Staff Writer
Alexion Pharmaceuticals has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Soliris (eculizumab) to treat patients with neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
News
EMA committee grants orphan designation for Apitope's ATX-F8-117 to treat haemophilia A
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to Apitope's ATX-F8-117 to treat patients with haemophilia A.
News

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