Monthly Archives: September 2008

Statins does not increase Lou Gehrig’s disease risk

September 30th, 2008|

An analysis of dozens of studies found the widely used statin cholesterol drugs do not increase the risk of Lou Gehrig's disease, U.S. health officials said.

Sanofi gets approval for sweetened Zentiva bid

September 30th, 2008|

The Czech central bank said that Sanofi-Aventis can go ahead with its improved bid for generic drugs producer Zentiva .Sanofi, which is Zentiva's largest shareholder with 24.9 percent, said on Sept. 22 that it had raised its offer for Zentiva to 1,150 Czech crowns per share from 1,050 crowns, valuing Zentiva at around 1.8 billion euros ($2.58 billion).

Piramal gets Canadian nod for phase-I trial of new cancer molecule P-1446A-05

September 30th, 2008|

Piramal Life Sciences Limited, part of the Piramal Group of companies, has received regulatory approval for the initiation of a phase-I study of a new cancer compound, P-1446A-05, in Canada.

Nuvelo & ARCA to merge to create biotech company

September 30th, 2008|

Nuvelo, Inc and ARCA Biopharma Inc, a privately-held biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases Inc have entered into a definitive merger agreement, expected to create a biotechnology company with a near-term commercial opportunity Gencaro (bucindolol hydrochloride), as well as a mid-stage pipeline asset, novel short-acting anticoagulant NU172, to drive long-term growth.

ITGI Medical Received a CE Mark for its Second Pericardium Covered Stent – AneuGraft(R)

September 30th, 2008|

ITGI Medical Ltd, a company engaged with research, development, manufacturing and marketing of heterologous tissue covered stents, announced that its second heterologous tissue covered stent – AneuGraft® received CE Mark approval.

US FDA’s First-Cycle Review of Dysport(R) to Be Completed by Year-End

September 30th, 2008|

Ipsen announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport® (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008.

Delta Lloyd acquires 5.4% of Galapagos

September 30th, 2008|

Galapagos NV announced that it has received a transparency notification from Delta Lloyd, disclosing that they hold a 5.4% interest in the share capital of Galapagos.

SAFC Pharma Completes Large-Scale API Manufacturing Expansion in Ireland

September 29th, 2008|

SAFC Pharma(TM), a focus area within SAFC(R), a member of the Sigma-Aldrich Group announced that a new reactor at its Arklow (Ireland) manufacturing site has begun operation, expanding the facility's capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%. 

Orchid & Merck collaborate to develop novel anti-infective drugs

September 29th, 2008|

Orchid Chemicals & Pharmaceuticals Ltd (Orchid) and Merck & Co., Inc. (Merck owns an affiliate, MSD Pharmaceuticals Pvt. Ltd., a marketer and distributor of Merck pharmaceutical products in India) announced that they have established a strategic Research Collaboration and License Agreement (the “Agreement”) focused on the discovery, development and commercialization of novel agents for the treatment of bacterial and fungal infections.

Ligand to acquire Pharmacopeia for $70 million

September 29th, 2008|

Ligand Pharmaceuticals Incorporated has entered into a definitive merger agreement to acquire Pharmacopeia, in a deal valued up to $70 million.

Dr Reddy’s gets USFDA nod for nabumetone

September 29th, 2008|

Drugmaker Dr. Reddy's Laboratories Ltd has received final approval from the US Food and Drug Administration for nabumetone tablets.

Cepheid Receives USFDA Clearance for First Rapid On-Demand Molecular Diagnostic Test

September 29th, 2008|

Cepheid announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert® System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections.

Cathay Pacific launches cargo product “Pharma LIFT ”

September 29th, 2008|

Cathay Pacific Airways has launched its latest cargo product targeted specifically at the needs of the pharmaceutical industry. It has been developed to cater for pharmaceutical shipments that need careful temperature management throughout their journey to ensure the products arrive in perfect condition.

New Xcelohood Containment System launched by Capsugel

September 29th, 2008|

Capsugel, the world’s leading provider of oral dosage form solutions to the pharmaceutical and related healthcare industries and a division of Pfizer announced the release of its new Xcelohood Containment System. 

Aurobindo gets USFDA nod for Cyclobenzaprine hydrochloride

September 29th, 2008|

Drug firm Aurobindo Pharma has received US Food and Drug Administration (USFDA) approval for marketing Cyclobenzaprine hydrochloride tablets, most widely prescribed as a muscle relaxant.   

Roche sues Cipla over Valcyte patent breach

September 27th, 2008|

Swiss major Roche has moved the Bombay High Court (HC) against domestic major Cipla for allegedly infringing both the patent and trademark of its patented drug Valcyte in India. Cipla had recently launched the low-cost version of the drug under the brand name Valcept. 

Pulse CO-Oximeter – Innovative Medical Technology

September 27th, 2008|

A non-invasive blood monitoring device that removes the need to draw blood to monitor patients has won the 2008 Kerrin Rennie Award for Excellence in Medical Technology. The award was presented to Masimo Corporation on 24 September at the Medical Technology Association of Australia (MTAA) dinner in Sydney.

Gardasil, Cervarix and Exjade bag UK Prix Galien medals

September 27th, 2008|

GlaxoSmithKline’s Cervarix and Sanofi Pasteur MSD’s Gardasil, both vaccines against human papillomavirus, were jointly awarded the 2008 UK Prix Galien medal for innovation at a ceremony held in the House of Commons.

More deaths in patients given Epoetin-alpha versus Placebo – Study

September 27th, 2008|

US FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.

Dyax seeks US FDA approval for angioedema drug

September 27th, 2008|

Dyax Corp has completed its Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE).