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ThromboGenics' microplasmin positive in second Phase III trial
02 September 2010
ThromboGenic's microplasmin met its primary endpoint – resolution of vitromacular adhesion (VMA) – in patients with the eye disease. The study results, presented at the American Society of Retina Specialists (ASRS) meeting this week, confirm the results of a previous Phase III trial and pave the way for an expected mid-2011 filing. In the latest TG-MV-007 trial, 25.3% of microplasmin-treated patients experienced a resolution of VMA, compared with 6.2% of placebo-treated patients (p=0.001). In ...
 
FDA hands refusal to file letter to EpiCept for lead leukaemia product
25 August 2010
EpiCept has received a rare refusal to file letter from the US FDA for its NDA for its lead product, Ceplene (histamine dihydrochloride), which it was intending to be a maintenance treatment for patients with acute myeloid leukaemia (AML) in their first remission. "We are surprised and obviously ...
US FDA warns of meningitis risk with GSK's Lamictal
13 August 2010
The US FDA has issued a safety warning for GlaxoSmithKline's Lamictal (lamotrigine) over an increased risk of aseptic meningitis associated with its use. The agency is revising the warnings and precautions section of the drug's label and patient medication guide to include information about the ...
 
Deal with Ono the first for Concordia's novel Ras inhibitor
02 September 2010
Ono Pharmaceutical has acquired exclusive development and commercialisation rights in Japan to Concordia Pharmaceuticals' direct Ras inhibitor salirasib, which it will develop initially for pancreatic cancer. The Japanese firm will pay undisclosed upfront and milestone payments to privately held ...
Hope high for "personalised medicine" in melanoma
26 August 2010
Hopes are high that inhibition of the mutated BRAF oncogene, present in about 40-60% of melanomas, will become a strategy for "personalised medicine" in the difficult-to-treat disease, based on the promising results of an early clinical trial of a BRAF kinase inhibitor being developed by Plexxikon ...
 
FDA hands refusal to file letter to EpiCept for lead leukaemia product
25 August 2010
EpiCept has received a rare refusal to file letter from the US FDA for its NDA for its lead product, Ceplene (histamine dihydrochloride), which it was intending to be a maintenance treatment for patients with acute myeloid leukaemia (AML) in their first remission. "We are surprised and obviously ...
Optimer's fidaxomicin filing accepted in EU
26 August 2010
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI. The company, which filed the application earlier this month, is now concentrating on finding a ...
 
Relief for Dendreon on upcoming US Medicare coverage meeting on Provenge
02 September 2010
The US agency that runs Medicare – the Centers for Medicare and Medicaid Services (CMS) - has scheduled a 17 November advisory panel meeting to consider on-label and off-label use of Dendreon's prostate cancer treatment Provenge (sipuleucel-T). Provenge is a first-of-its kind approach, approved by ...
More FDA warnings on GMP: Sun Pharma's NJ plant and Albany Molecular
01 September 2010
The US FDA has issued a warning letter to a wholly owned US unit of India's Sun Pharmaceutical Industries in Cranbury, New Jersey, over good manufacturing practice (GMP) deviations at the plant. FDA inspectors made a number of observations, which included a failure of the firm to investigate ...
 
Glenmark unveils details of its TRPA1 antagonist
31 August 2010
Glenmark Pharmaceuticals is developing a TRPA1 receptor antagonist for pain and respiratory disorders. The Indian company joins at least four other firms including Hydra Biosciences, Abbott and Janssen that are known to be working in the same area. Glenmark said that its compound, GRC 17536, had ...
R&D update: Sun upbeat on gabapentin pro-drug and extended-release baclofen
25 May 2010
Sun Pharma Advanced Research Company (SPARC) is optimistic about the prospects for its pro-drug of gabapentin, SUN-44, and has filed a patent for the composition of matter of the compound internationally. SPARC is the demerged research arm of Sun Pharma of India. "We have not yet been granted ...
 
More FDA warnings on GMP: Sun Pharma's NJ plant and Albany Molecular
01 September 2010
The US FDA has issued a warning letter to a wholly owned US unit of India's Sun Pharmaceutical Industries in Cranbury, New Jersey, over good manufacturing practice (GMP) deviations at the plant. FDA inspectors made a number of observations, which included a failure of the firm to investigate ...
US judge denies Sanofi-Aventis's bid to stop generic rival for Lovenox
31 August 2010
A federal judge has denied Sanofi-Aventis 's request for a preliminary injunction that would have directed the US FDA to suspend and withdraw its approval of a generic version of Lovenox (enoxaparin sodium) from Sandoz (Novartis) and partner Momenta Pharmaceuticals, which has been on the market for ...
 

2010 Scrip 100 - Mixed fortunes on the R&D front
23 August 2010

Continued problems with anti-obesity drugs, more measures designed to improve R&D efficiency, and ...

Liver cancer becomes more preventable and treatable
12 August 2010

New drugs to treat viral hepatitis infection, coupled with renewed interest from companies in ...

2010 Scrip 100 - Changes pharma can believe in?
23 August 2010

Ian Schofield picks some of the most significant developments in the health policy and regulation ...

AstraZeneca makes a narrow escape from UK Seroquel probe
20 August 2010
Elizabeth Sukkar
AstraZeneca's blockbuster atypical antipsychotic Seroquel (quetiapine) has been in the news quite a ...

Calling German and Spanish Physicists: the EMA Needs You
13 July 2010
Maureen Kenny
German or Spanish physicists hoping for a career change involving a move to London at the end of ...

GW high on pipeline of cannabis extracts
23 August 2010
Katie McQue
GW Pharma has enjoyed recent success with its cannabinoid extract product Sativex (nabiximols), ...

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