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EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. Regulatory Affairs > News
Boehringer starts Phase III colorectal cancer trial of nintedanib By PBR Staff Writer
Germany-based Boehringer Ingelheim has initiated patient enrollment in a new global Phase III trial called LUME-COLON 1 of nintedanib to treat advanced colorectal cancer (CRC).
News EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
News FDA clears Tonix's IND for TNX-201 to treat episodic tension-type headache By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Tonix Pharmaceuticals' investigational new drug (IND) application to evaluate TNX-201, a single isomer of isometheptene (IMH), to treat episodic tension-type headache.
News
iBio expands exclusive product collaboration with Novici Biotech iBio, a provider of plant-based biotechnology for developing and manufacturing biological products, and Novici Biotech (Novici) have agreed to broaden their commercial collaboration, currently focused on antibodies and certain vaccine products, to include iBio's proprietary IBIO-CFB03 product for idiopathic pulmonary fibrosis, systemic sclerosis and other fibrotic diseases.
News Iroko inks new licensing deal with Landsteiner Scientific to market Zorvolex in Mexico By PBR Staff Writer
Iroko Pharmaceuticals has signed a licensing agreement with Landsteiner Scientific for the exclusive rights to market and sell Zorvolex (diclofenac) capsules in Mexico.
News Johnson & Johnson announces major commitment to expedite ebola vaccine development Johnson & Johnson (JNJ) has made a commitment of up to $200m to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies.
News

Latest News and Insight by Sector

Production & Manufacturing

FDA clears Tonix's IND for TNX-201 to treat episodic tension-type headache
By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared Tonix Pharmaceuticals' investigational new drug (IND) application to evaluate TNX-201, a single isomer of isometheptene (IMH), to treat episodic tension-type headache.
News
TWi Biotechnology's AC-201 secures FDA orphan drug status for epidermolysis bullosa
By PBR Staff Writer
TWi Biotechnology has received the Orphan Drug designation from the US food and Drug Administration (FDA) for AC-201, a first-in-class, small molecule, to treat epidermolysis bullosa (EB).
News

Drug Research

Johnson & Johnson announces major commitment to expedite ebola vaccine development
Johnson & Johnson (JNJ) has made a commitment of up to $200m to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies.
News
Oramed releases positive Phase IIa trial results with oral insulin in type 1 diabetes
By PBR Staff Writer
Oramed Pharmaceuticals has reported positive top-line clinical results from a Phase IIa clinical trial of its proprietary oral insulin capsules ORMD-0801, to treat type 1 diabetes.
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

Boehringer starts Phase III colorectal cancer trial of nintedanib
By PBR Staff Writer
Germany-based Boehringer Ingelheim has initiated patient enrollment in a new global Phase III trial called LUME-COLON 1 of nintedanib to treat advanced colorectal cancer (CRC).
News
Iroko inks new licensing deal with Landsteiner Scientific to market Zorvolex in Mexico
By PBR Staff Writer
Iroko Pharmaceuticals has signed a licensing agreement with Landsteiner Scientific for the exclusive rights to market and sell Zorvolex (diclofenac) capsules in Mexico.
News

Automation

iBio expands exclusive product collaboration with Novici Biotech
iBio, a provider of plant-based biotechnology for developing and manufacturing biological products, and Novici Biotech (Novici) have agreed to broaden their commercial collaboration, currently focused on antibodies and certain vaccine products, to include iBio's proprietary IBIO-CFB03 product for idiopathic pulmonary fibrosis, systemic sclerosis and other fibrotic diseases.
News
Plandai Biotechnology's technology could prove potent in battling alzheimers disease
In the recently released preliminary results from Plandaí Biotechnology's human clinical trial that compared its green tea extract to a commercially available extract, Professor Anne Grobler and her team at North West University in South Africa proved that all 8 catechins found in the green tea plant were absorbed into the bloodstream of those using Phytofare Catechin Complex, including, the most potent catechin of the eight, epigallocatechin-3-gallate or EGCG.
News

Regulatory Affairs

EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
News
NICE recommends GSK's skin cancer drug Tafinlar
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending GlaxoSmithKline's (GSK) Tafinlar (dabrafenib) to treat certain NHS patients with melanoma, a type of skin cancer.
News

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