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Pharmaceutical Business Review

FDA approves new formulation of Eisai’s Fycompa to treat seizure disorders The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures. Regulatory Affairs > News
Biogen looks to spin off hemophilia business to focus on neurology medicines Biogen is looking to spin off its hemophilia business to focus on developing medicines for neurological disorders.
News Veristat acquires UK-based CRO, Spero Oncology Veristat, a full service Clinical Research Organization (CRO), is expanding its clinical research offerings into Europe through the acquisition of UK-based CRO, Spero Oncology.
Drug Research > Drug Delivery > News Protalex receives positive interim review in European phase 1b study of PRTX-100 to treat immune thrombocytopenia Protalex announced that following a planned interim data review by its independent Safety Monitoring Committee (SMC), the Company is continuing enrollment and increasing the dose for subjects in its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study).
Contract Research & Services > Clinical Trials > News
EMD Serono expands biopharmaceutical R&D facility in Billerica, Massachusetts EMD Serono, the biopharmaceutical business of Merck KGaA, in North America, announced a $12m investment for the expansion of its R&D facility in Billerica, Massachusetts.
Production & Manufacturing > Manufacturing > News Seres achieves target enrollment of SER-109 phase 2 study to prevent recurrent clostridium difficile infection Seres Therapeutics announced that the target enrollment of 87 patients has been achieved for its ongoing SER-109 Phase 2 clinical study.
Contract Research & Services > Clinical Trials > News Perrigo receives final FDA approval for generic version of Valeant's BenzaClin Pump Topical Gel Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Valeant Pharmaceutical International's BenzaClin Pump Topical Gel.
Production & Manufacturing > OTC > News

Latest News and Insight by Sector

Production & Manufacturing

EMD Serono expands biopharmaceutical R&D facility in Billerica, Massachusetts
EMD Serono, the biopharmaceutical business of Merck KGaA, in North America, announced a $12m investment for the expansion of its R&D facility in Billerica, Massachusetts.
Production & Manufacturing > Manufacturing > News
Perrigo receives final FDA approval for generic version of Valeant's BenzaClin Pump Topical Gel
Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Valeant Pharmaceutical International's BenzaClin Pump Topical Gel.
Production & Manufacturing > OTC > News

Drug Research

Veristat acquires UK-based CRO, Spero Oncology
Veristat, a full service Clinical Research Organization (CRO), is expanding its clinical research offerings into Europe through the acquisition of UK-based CRO, Spero Oncology.
Drug Research > Drug Delivery > News
Graybug Vision secures $44.5m funding for clinical development activities
By PBR Staff Writer
Venture-stage pharmaceutical firm Graybug Vision has secured $44.5m in funding for clinical development activities.
Drug Research > Drug Discovery & Development > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
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.
Inward Investment > 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.
Production & Manufacturing > OTC > 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.
Packaging > News

Contract Research & Services

Protalex receives positive interim review in European phase 1b study of PRTX-100 to treat immune thrombocytopenia
Protalex announced that following a planned interim data review by its independent Safety Monitoring Committee (SMC), the Company is continuing enrollment and increasing the dose for subjects in its European Phase 1b study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study).
Contract Research & Services > Clinical Trials > News
Seres achieves target enrollment of SER-109 phase 2 study to prevent recurrent clostridium difficile infection
Seres Therapeutics announced that the target enrollment of 87 patients has been achieved for its ongoing SER-109 Phase 2 clinical study.
Contract Research & Services > Clinical Trials > News

Automation

IBC Generium selects Goodwin Biotechnology to optimize process of IgG-based bispecific antibody
International Biotechnology Center "Generium", (LLC IBC Generium), has selected Goodwin Biotechnology for the assay and process technology transfer, process scale-up, and cGMP manufacturing of an IgG-based, bispecific antibody to support early stage clinical trials.
Automation > IT & Software > News
biOasis Technologies signs license deal with Astellas Research Institute of America
biOasis Technologies has entered into a License Agreement to collaborate with Astellas Research Institute of America (Astellas).
Automation > IT & Software > News

Regulatory Affairs

FDA approves new formulation of Eisai’s Fycompa to treat seizure disorders
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures.
Regulatory Affairs > News
FDA approves Acadia's Nuplazid to treat Parkinson’s disease psychosis
By PBR Staff Writer
Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Regulatory Affairs > News



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