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Pharmaceutical Business Review

Novartis’ BAF312 meets main goal in secondary progressive multiple sclerosis trial A phase III study, assessing the efficacy and safety of Novartis’ BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS), met its primary endpoint of a reduction in the risk of disability progression, versus placebo. Contract Research & Services > Clinical Trials > News
AstraZeneca to sell part of antibiotics business to Pfizer in $1.6bn deal By PBR Staff Writer
AstraZeneca has agreed to sell part of its antibiotics business to Pfizer in a deal worth about $1.6bn.
Production & Manufacturing > Manufacturing > News Insys reports phase 3 trial of Sublingual Buprenorphine spray meets primary endpoint Insys Therapeutics reported that the Phase 3 trial for the Buprenorphine Sublingual Spray met its primary endpoint.
Contract Research & Services > Clinical Trials > News Biothera collaborates with Merck for combination cancer immunotherapy trials in multiple indications Biothera Pharmaceuticals announced a collaboration with Merck to expand the companies’ ongoing clinical program evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 inhibitor, in combination with Biothera’s Imprime PGG, a Pathogen Associated Molecular Patterning molecule, or PAMP.
Contract Research & Services > Contract Research > News
Evgen Pharma gets FDA orphan drug designation for stabilised sulforaphane The US Food & Drug Administration (FDA) has granted Evgen Pharma orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage (SAH).
Production & Manufacturing > Process & Production > News Novartis’ BAF312 meets main goal in secondary progressive multiple sclerosis trial By PBR Staff Writer
A phase III study, assessing the efficacy and safety of Novartis’ BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS), met its primary endpoint of a reduction in the risk of disability progression, versus placebo.
Contract Research & Services > Clinical Trials > News FDA grants priority review to Clovis’ rucaparib for advanced BRCA-mutated ovarian cancer By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review status to Clovis Oncology’s new drug application (NDA) for rucaparib as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least two or more prior lines of chemotherapy.
Production & Manufacturing > Process & Production > News

Latest News and Insight by Sector

Production & Manufacturing

AstraZeneca to sell part of antibiotics business to Pfizer in $1.6bn deal
By PBR Staff Writer
AstraZeneca has agreed to sell part of its antibiotics business to Pfizer in a deal worth about $1.6bn.
Production & Manufacturing > Manufacturing > News
Evgen Pharma gets FDA orphan drug designation for stabilised sulforaphane
The US Food & Drug Administration (FDA) has granted Evgen Pharma orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage (SAH).
Production & Manufacturing > Process & Production > News

Drug Research

Marken secures new pharmaceutical license for Moscow depot
Marken has secured a new pharmaceutical license from the Russian Federation for its Moscow depot.
Drug Research > Drug Delivery > News
Pfizer to acquire Medivation for $14bn
By PBR Staff Writer
Pfizer has agreed to acquire US biopharmaceutical firm Medivation in a transaction valued at about $14bn.
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

Insys reports phase 3 trial of Sublingual Buprenorphine spray meets primary endpoint
Insys Therapeutics reported that the Phase 3 trial for the Buprenorphine Sublingual Spray met its primary endpoint.
Contract Research & Services > Clinical Trials > News
Biothera collaborates with Merck for combination cancer immunotherapy trials in multiple indications
Biothera Pharmaceuticals announced a collaboration with Merck to expand the companies’ ongoing clinical program evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 inhibitor, in combination with Biothera’s Imprime PGG, a Pathogen Associated Molecular Patterning molecule, or PAMP.
Contract Research & Services > Contract Research > News

Automation

Daiichi Sankyo chooses Veeva Vault to streamline submissions, eTMF, and quality management
Daiichi Sankyo has selected Veeva Systems' Veeva Vault eTMF, Veeva Vault QualityDocs, and Veeva Vault Submissions to unify content management throughout its research and development (R&D) operations worldwide.
Automation > IT & Software > News
Eleven Biotherapeutics completes exclusive licensing deal for IL-6 antagonist antibody technology
Eleven Biotherapeutics, a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, announced the effectiveness of the exclusive licensing deal with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche).
Automation > IT & Software > News

Regulatory Affairs

Perrigo secures tentative FDA approval for generic version of Suprep oral solution
Perrigo has received tentative approval from the U.S. Food and Drug Administration (FDA) for the generic version of Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution.
Regulatory Affairs > News
AstraZeneca and Eli Lilly secure FDA fast-track status for Alzheimer’s drug
By PBR Staff Writer
AstraZeneca and Eli Lilly and Company have secured fast track designation from the US Food and Drug Administration (FDA) for AZD3293, an investigational treatment for early Alzheimer’s disease (AD).
Regulatory Affairs > News



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