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Pharmaceutical Business Review

AstraZeneca's Lynparza gets European approval to treat BRCA-mutated ovarian cancer AstraZeneca has received approval from the European Commission (EC) for Lynparza (olaparib) capsules 400mg twice daily as the first therapy to treat adults with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. Regulatory Affairs > News
Merck to acquire Swiss biotechnology firm OncoEthix By PBR Staff Writer
US-based Merck, through its subsidiary, has acquired Swiss biotechnology company OncoEthix that is specialised in oncology drug development.
News Aldeyra Therapeutics submits FDA IND filing for noninfectious anterior uveitis Aldeyra Therapeutics, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United States Food and Drug Administration (FDA) on December 16, 2014.
News Enumeral, Merck to predict clinical drug response with human-driven immune profiling platform Enumeral Biomedical Holdings has signed an oncology-focused collaborative study agreement with Merck, known as MSD outside the United States and Canada, through a subsidiary.
News
BioCryst begins OPuS-2 clinical trial of BCX4161 to treat patients with Hereditary Angioedema BioCryst Pharmaceuticals has dosed the first patient in OPuS-2 (Oral ProphylaxiS-2), a blinded, randomized, placebo-controlled clinical trial of orally-administered BCX4161 in patients with hereditary angioedema (HAE).
News Pfizer reports positive results from phase III trial of Pregabalin Pfizer announced top-line results from a double-blind Phase III study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (pain after shingles or PHN).
News Bayer files BLA for BAY 81-8973 to treat Hemophilia A in adults and children By PBR Staff Writer
Bayer HealthCare has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, to treat hemophilia A in children and adults.
News

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Production & Manufacturing

Aldeyra Therapeutics submits FDA IND filing for noninfectious anterior uveitis
Aldeyra Therapeutics, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United States Food and Drug Administration (FDA) on December 16, 2014.
News
Bayer files BLA for BAY 81-8973 to treat Hemophilia A in adults and children
By PBR Staff Writer
Bayer HealthCare has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, to treat hemophilia A in children and adults.
News

Drug Research

BioCryst begins OPuS-2 clinical trial of BCX4161 to treat patients with Hereditary Angioedema
BioCryst Pharmaceuticals has dosed the first patient in OPuS-2 (Oral ProphylaxiS-2), a blinded, randomized, placebo-controlled clinical trial of orally-administered BCX4161 in patients with hereditary angioedema (HAE).
News
iCardiac Technologies IQ-CSRC study shows potential for faster drug development
The Food and Drug Administration hosted the Cardiac Safety Research Consortium (CSRC) meeting to release the results of the IQ-CSRC Study demonstrating the ability to conduct robust cardiac safety characterization several years earlier in clinical development.
News

Inward Investment

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
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

Packaging

Eisai opens new packaging facility at UK's Hatfield production plant
By PBR Staff Writer
Eisai has opened a new packaging facility at its Hatfield, Hertfordshire production plant in the UK, ahead of plans to launch new products.
News
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

Contract Research & Services

Pfizer reports positive results from phase III trial of Pregabalin
Pfizer announced top-line results from a double-blind Phase III study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (pain after shingles or PHN).
News
GlaxoSmithKline reports positive results from Phase III trial of shingles candidate vaccine
By PBR Staff Writer
GlaxoSmithKline (GSK) has reported positive results from a Phase III trial designed to evaluate the efficacy of HZ/su, an investigational vaccine for the prevention of shingles.
News

Automation

Enumeral, Merck to predict clinical drug response with human-driven immune profiling platform
Enumeral Biomedical Holdings has signed an oncology-focused collaborative study agreement with Merck, known as MSD outside the United States and Canada, through a subsidiary.
News
Cerulean doses first patient in Phase I/IIa trial of CRLX301 to treat advanced solid tumors
By PBR Staff Writer
Cerulean Pharma has dosed first patient in its Phase I/IIa trial of CRLX301 for the treatment of advanced solid tumor malignancies.
News

Regulatory Affairs

AstraZeneca's Lynparza gets European approval to treat BRCA-mutated ovarian cancer
By PBR Staff Writer
AstraZeneca has received approval from the European Commission (EC) for Lynparza (olaparib) capsules 400mg twice daily as the first therapy to treat adults with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
News
FDA accepts filing Apotex's biosimilar application for pegfilgrastim
By PBR Staff Writer
The US Food and Drug Administration has accepted for filing Canadian pharmaceutical firm Apotex's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta.
News

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