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Pharmaceutical Business Review

FDA approves UCB's anti-epileptic drug Vimpat as monotherapy The US Food and Drug Administration (FDA) has granted approval for UCB's supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy to treat partial-onset seizures in patients with epilepsy. Drug Research > Drug Delivery > News
FDA approves UCB's anti-epileptic drug Vimpat as monotherapy By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for UCB's supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy to treat partial-onset seizures in patients with epilepsy.
Drug Research > Drug Delivery > News BMS and Pfizer report positive results from Phase III AMPLIFY-EXT trial of Eliquis By PBR Staff Writer
Bristol-Myers Squibb (BMS) and Pfizer have reported results of a pre-specified secondary analysis of the Phase III AMPLIFY-EXT trial of Eliquis in patients with venous thromboembolism (VTE).
Contract Research & Services > Clinical Trials > News Boston Scientific reports primary endpoint results of NECTAR-HF trial By PBR Staff Writer
Boston Scientific has released the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial, the first and only randomized sham-controlled clinical trial investigating vagus nerve stimulation (VNS) to treat heart failure patients.
Drug Research > Drug Discovery & Development > News
Takeda completes post-marketing commitment to submit data for pioglitazone containing medicines Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).
Production & Manufacturing > Process & Production > News Roche starts tender offer for InterMune for $74 per share in cash Roche has commenced a cash tender offer for all outstanding shares of common stock of InterMune at a price of $74.00 per share.
Production & Manufacturing > Manufacturing > News Sanofi and Regeneron report positive results from four pivotal alirocumab trials Sanofi and Regeneron Pharmaceuticals have announced detailed positive results from four Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Takeda completes post-marketing commitment to submit data for pioglitazone containing medicines
Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).
Production & Manufacturing > Process & Production > News
Roche starts tender offer for InterMune for $74 per share in cash
Roche has commenced a cash tender offer for all outstanding shares of common stock of InterMune at a price of $74.00 per share.
Production & Manufacturing > Manufacturing > News

Drug Research

FDA approves UCB's anti-epileptic drug Vimpat as monotherapy
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for UCB's supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy to treat partial-onset seizures in patients with epilepsy.
Drug Research > Drug Delivery > News
Boston Scientific reports primary endpoint results of NECTAR-HF trial
By PBR Staff Writer
Boston Scientific has released the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial, the first and only randomized sham-controlled clinical trial investigating vagus nerve stimulation (VNS) to treat heart failure patients.
Drug Research > Drug Discovery & Development > News

Inward Investment

Janssen's Cilag International acquires biopharmaceutical firm Covagen
By PBR Staff Writer
Janssen Pharmaceutical's affiliate Cilag International has completed the acquisition of Covagen, Swiss biopharmaceutical firm specializing in the development of multispecific protein therapeutics through its FynomAb technology platform.
News
Recipharm to buy Corvette Pharmaceutical Services for $160m
By PBR Staff Writer
Swedish contract development and manufacturing organisation Recipharm has agreed to purchase Milan based Corvette Pharmaceutical Services Group (Corvette) from Italian private equity group LBO Italia Investimenti.
Contract Research & Services > Contract Research > 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

BMS and Pfizer report positive results from Phase III AMPLIFY-EXT trial of Eliquis
By PBR Staff Writer
Bristol-Myers Squibb (BMS) and Pfizer have reported results of a pre-specified secondary analysis of the Phase III AMPLIFY-EXT trial of Eliquis in patients with venous thromboembolism (VTE).
Contract Research & Services > Clinical Trials > News
FDA grants QIDP status for Wockhardt anti-infective drug discovery program
Wockhardt Limited has announced a major boost to the New Drug Discovery program in Anti-Infective research when two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from U.S. Food & Drug Administration (FDA).
Contract Research & Services > Contract Research > News

Automation

iBio secures European patent allowances for protein expression technology
iBio, a leader in plant-based biotechnology for developing and manufacturing biological products, received notices of intention to grant for two European patent applications claiming novel protein expression technologies.
Automation > IT & Software > News
Ayasdi introduces care application for healthcare providers to develop precise clinical pathways
Ayasdi has launched Ayasdi Care, a new advanced analytics application designed for healthcare providers to quickly develop and optimize clinical pathways using their own electronic health records (EHRs), financial data and physician best practices
Automation > IT & Software > News

Regulatory Affairs

FDA approves Pfizer and Protalix's Elelyso to treat type 1 Gaucher Disease
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Pfizer and Protalix BioTherapeutics' Elelyso (taliglucerase alfa) for injection to treat adult and pediatric patients with confirmed diagnosis of Type 1 Gaucher disease.
Regulatory Affairs > News
Bristol-Myers's hepatitis C infection combination therapy gets European approval
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has received approval from the European Commission for Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), to treat patients with chronic hepatitis C infection (HCV).
Regulatory Affairs > News

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