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Pharmaceutical Business Review

Mylan gets tentative FDA nod for generic Lipitor Mylan Laboratories (formerly Matrix Laboratories) has received tentative FDA approval for abbreviated new drug application (ANDA) for Atorvastatin Calcium Tablets, 10mg (base), 20mg (base), 40mg (base) and 80mg (base). Regulatory Affairs > News
OptiNose to begin Phase III trials with intranasal technology By PBR Staff Writer
OptiNose, a drug delivery company, has filed an investigational new drug (IND) with the FDA to use sumatriptan delivered with its novel drug delivery technology, in December 2011.
Drug Research > Drug Delivery > News Sucampo, Takeda Phase III OBD trial meets primary endpoint By PBR Staff Writer
Sucampo Pharmaceuticals (SPI) and Takeda Pharmaceuticals have reported that lubiprostone met the primary endpoint in a Phase III clinical trial for the treatment of opioid-induced bowel dysfunction (OBD).
Contract Research & Services > Clinical Trials > News Nuvo launches Synera in US By PBR Staff Writer
Nuvo Research, a specialty pharmaceutical company, has launched Synera (70mg lidocaine/ 70mg tetracaine/ heated topical patch) in the US.
Drug Research > Drug Discovery & Development > News
DelMar VAL-083 drug gets FDA orphan drug status By PBR Staff Writer
The US Food and Drug Administrations' Office of Orphan Products Development has granted orphan drug designation for DelMar Pharma's VAL-083, used to treat glioma, including glioblastoma multiforme (GBM).
Regulatory Affairs > News COTI develops COTI-2 Phase 1 oral formulation By PBR Staff Writer
Critical Outcome Technologies (COTI) has developed Phase 1 oral formulation candidates for COTI-2, a potentially first-in-class non-ATP competitive modulator/inhibitor of AKT/AKT2.
Drug Research > Drug Discovery & Development > News Geron concludes patient enrollment in cancer drug trial By PBR Staff Writer
Geron has completed patient enrollment in the randomized Phase 2 clinical trial of Imetelstat, in combination with paclitaxel, in patients with locally recurrent or metastatic breast cancer (MBC).
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

Hybrid Fuels selects FDA approved lab for Azul Instan
03 February 2012 | By PBR Staff Writer
Hybrid Fuels has selected a FDA approved laboratory to manufacture all new orders of Azul Instan, developed by Nouveau Life Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
Insero enters licensing deals to produce Huperzine
03 February 2012 | By PBR Staff Writer
Insero Health, a developer of novel therapies derived from natural products, has signed an exclusive license agreement with Yale University for an efficient synthetic manufacturing process of Insero's Huperzine.
Production & Manufacturing > Process & Production > News

Drug Research

COTI develops COTI-2 Phase 1 oral formulation
03 February 2012 | By PBR Staff Writer
Critical Outcome Technologies (COTI) has developed Phase 1 oral formulation candidates for COTI-2, a potentially first-in-class non-ATP competitive modulator/inhibitor of AKT/AKT2.
Drug Research > Drug Discovery & Development > News
Nuvo launches Synera in US
03 February 2012 | By PBR Staff Writer
Nuvo Research, a specialty pharmaceutical company, has launched Synera (70mg lidocaine/ 70mg tetracaine/ heated topical patch) in the US.
Drug Research > Drug Discovery & Development > News

Inward Investment

Sigma-Aldrich takes over BioReliance for $350m
31 January 2012 | By PBR Staff Writer
Sigma-Aldrich, a life science and high technology company, has completed its purchase of BioReliance from Avista Capital Partners for $350m in cash.
Inward Investment > News
Mission Pharmacal launches new subsidiary
27 January 2012 | By PBR Staff Writer
Mission Pharmacal Company has launched a new Doylestown, Pennsylvania, based subsidiary, Alamo Pharma Services.
Inward Investment > News

Packaging

Pfizer recalls oral contraceptives due to packaging error
02 February 2012 | By PBR Staff Writer
Pfizer has voluntarily recalled 14 lots of Lo/Ovral-28 and 14 lots of Norgestrel and Ethinyl Estradiol tablets in the US due to possibility of inexact tablet counts or out of sequence tablets.
Packaging > News
Novartis receives FDA nod for Gleevec drug label change
02 February 2012 | By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Novartis Gleevec (imatinib mesylate) tablets label recommending 36 months of treatment for KIT (CD117)-positive gastrointestinal stromal tumors (GIST) patients after surgery.
Packaging > News

Contract Research & Services

Geron concludes patient enrollment in cancer drug trial
03 February 2012 | By PBR Staff Writer
Geron has completed patient enrollment in the randomized Phase 2 clinical trial of Imetelstat, in combination with paclitaxel, in patients with locally recurrent or metastatic breast cancer (MBC).
Contract Research & Services > Clinical Trials > News
FDA approves Bayer radium-223 chloride expanded access program
03 February 2012 | By PBR Staff Writer
Bayer HealthCare has received the US Food and Drug Administration approval to proceed with its expanded access program for the investigational drug radium-223 chloride.
Contract Research & Services > Clinical Trials > News

Automation

Celerion selects Verified participant verification system
03 February 2012 | By PBR Staff Writer
Celerion, a provider of innovative early stage drug development solutions, has deployed Verified Clinical Trials' VCT Verify to ensure accurate participant identification and qualification for clinical research.
Automation > IT & Software > News
BDI Pharma deploys Zensar SAP ERP and CRM solutions
02 February 2012 | By PBR Staff Writer
BDI Pharma, a distributor of plasma derived pharmaceuticals and infusion therapy products, and Zensar Technologies have entered into an agreement for SAP ERP and CRM solutions.
Automation > IT & Software > News

Regulatory Affairs

Merck receives FDA approval for type 2 diabetes therapy
03 February 2012 | By PBR Staff Writer
Merck, known as MSD outside the US and Canada, has received FDA approval for JANUMET XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets for type 2 diabetes.
Regulatory Affairs > News
DelMar VAL-083 drug gets FDA orphan drug status
03 February 2012 | By PBR Staff Writer
The US Food and Drug Administrations' Office of Orphan Products Development has granted orphan drug designation for DelMar Pharma's VAL-083, used to treat glioma, including glioblastoma multiforme (GBM).
Regulatory Affairs > News

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