US FDA issues complete response letter to GSK for Eurand’s EUR-1048

December 30th, 2008|

Eurand NV, a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, has been advised by GlaxoSmithKline (GSK) that the US Food and Drug Administration (FDA) has issued a Complete Response letter for the New Drug Application (NDA) for EUR-1048. EUR-1048 is an orally disintegrating tablet (ODT) formulation with an undisclosed active compound co-developed by Eurand and GSK.

SBF Healthcare plans to raise $5 mn for expansion

December 30th, 2008|

Science Beyond Frontiers (SBF) Healthcare, a well-known provider of Rotational Field Quantum Magnetic Resonance (RFQMR) therapy to treat osteoarthritis and cancer patients is now looking to raise funds to the tune of $5 million for expansion of operations.

Claris Lifesciences bags ‘Frost and Sullivan’ Gold award for Manufacturing Excellence in Healthcare

December 30th, 2008|

Claris Lifesciences, a global lifesciences company has received the 'Frost and Sullivan' Gold award for Manufacturing Excellence in Healthcare – Large Enterprise for 'Clarion'. Clarion is the state of the art manufacturing facility of Claris Lifesciences Ltd. This is the second consecutive year that Clarion has received this award.

Novo Nordisk and VLST Corporation announce collaboration agreement

December 30th, 2008|

Novo Nordisk and VLST Corporation, a Seattle-based biotechnology company focused on the development of therapeutics for autoimmune and inflammatory disorders, have entered into an exclusive, worldwide collaboration agreement to develop therapeutic targets utilising VLST's technology platform in the fields of autoimmune and inflammatory disorders.

Breckenridge Pharma inks pact with Helm AG to develop asthma drug

December 30th, 2008|

Breckenridge has entered into another separate agreement with Helm AG to develop and manufacture an ANDA for an asthma drug product. Under terms of this new agreement, Breckenridge will submit an ANDA to the US Food and Drug Administration (FDA) in 2009 for the product which is in development by Helm AG. The product currently shows US sales of approximately $4 Billion Dollars, and is patent protected until 2012.

Intercell begins phase II trial for Pseudomonas aeruginosa vaccine

December 30th, 2008|

Intercell AG announced that the phase-II clinical trial with the company's vaccine candidate to prevent infections with the bacterium Pseudomonas aeruginosa is starting. Intercell's vaccine (IC43) is a recombinant subunit vaccine consisting of two outer membrane proteins of Pseudomonas aeruginosa.

Can-Fite completes patient enrolment in confirmatory phase-IIb RA trial

December 30th, 2008|

Can-Fite BioPharma has achieved yet another goal by completion of enrolment of 230 patients in its confirmatory phase-IIb RA trial. Approximately 230 patients were enrolled to this study, randomized into three groups treated with 0.1 mg and 4 mg of CF101, and placebo. Patients are taking the drug for 12 weeks plus two weeks of follow-up. The trial is being conducted in 30 sites in Europe and Israel. The company estimate to release study data on H1 2009.

Array BioPharma gets $40 mn from Deerfield

December 29th, 2008|

Array BioPharma Inc has received its second draw of $40 million from Deerfield Management, a leading healthcare investment organization and one of Array's largest shareholders. Deerfield committed $80 million to Array in May 2008 and provided the first $40 million draw to Array in June 2008. Together with existing capital, these funds are being use to advance Array's seven wholly-owned small molecule drug programmes in development.

SemBioSys bags US$2.5 mn in option pact with MannKind for plant-produced insulin

December 29th, 2008|

SemBioSys Genetics Inc, announced that MannKind Corporation has purchased an option to license rights to SemBioSys' proprietary plant-produced recombinant human insulin. The option period ends on March 31, 2009. Terms of the option stipulate that the primary use of SemBioSys' plant-produced insulin would be for Afresa, MannKind's ultra-rapid acting insulin, which recently completed phase-3 studies.

Indian authority asks pharma companies to reduce prices by 2.84%

December 28th, 2008|

Consequent upon the reduction in the rate of Excise duty on medicines from 8% to 4% notified by the Ministry of Finance, Department of Revenue, all manufacturers and marketing companies of formulations packs are advised to ensure that the benefit of this excise duty reduction and the reduced rate of abatement is passed on to the consumers through reduced Maximum Retail Price (MRP).  The National Pharmaceutical Pricing Authority (NPPA) in India has asked the pharmaceutical companies to reduce the MRP. 

Tibotec, Emcure launch HIV therapy in India

December 8th, 2008|

Ireland-based Tibotec, which is the subsidiary of Johnson & Johnson, has signed a royalty-free, non-exclusive license agreement with India’s Emcure Pharmaceuticals to distribute the protease inhibitor darunavir (DRV) in India.

Plethico acquires 20% stake in CIS retail chain

December 8th, 2008|

Plethico Pharmaceuticals of India has acquired a 20% stake in a retail pharmacy chain in the CIS from Tricon Holdings of Hong Kong for $20 million. Tricon deals in the pharmaceutical retail business with a sourcing base in the UAE.

ISSCR releases new guidelines for stem cell research

December 8th, 2008|

The International Society for Stem Cell Research (ISSCR), the world's leading professional organization of stem cell researchers, released new guidelines for the responsible development of safe and effective stem cell therapies for patients.

Asuragen Launches of CE-Marked -the Signature LTx v2.0

December 8th, 2008|

Asuragen, Inc.’s Signature® LTx v2.0 Leukemia Translocation Panel was released as a "Conformité Européenne" or "European Conformity" CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

Wockhardt receives US FDA approval for Augmentin* Suspension

December 4th, 2008|

Pharmaceutical and biotechnology major Wockhardt has received United States FDA approval for marketing an oral suspension of a combination of Amoxycillin and Clavulanate Potassium.

Svanen is gets Nordic Ecolabelling grant for Peritoneal Dialysis Products

December 4th, 2008|

The first Ecolabelled peritoneal dialysis bags are now certified by Nordic Ecolabel. It is Fresenius Medical Care, who has been granted the world’s first license.

Antidepressants prescribed to children, babies

December 4th, 2008|

In Australia, almost 4,000 Australian children under the age of 10 received a prescription for antidepressant drugs in the last year, despite the fact that Australia has not approved the use of antidepressants in children or adolescents.

Vical licenses cancer drug to Turkey’s Eczacibasi

December 3rd, 2008|

Biotechnology company Vical Inc signed a letter of intent with Turkey's Eczacibasi Ilac Pazarlama A.S. to market and sell its experimental cancer drug, Allovectin-7, in Turkey and the Turkish Republic of Northern Cyprus

Study examines clinical equivalence between brand-name and generic cardiovascular drugs

December 3rd, 2008|

Data from a study published in JAMA concluded that evidence "does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs," despite numerous editorials that "counsel against the interchangeability of generic drugs," according to the study authors.

DCGI approves Ranbaxy’s Gliadel Wafer

December 3rd, 2008|

Ranbaxy Laboratories Limited has received import permission for marketing the US FDA approved product Gliadel (polifeprosan 20 with carmustine implant) Wafer for the treatment of newly diagnosed high-grade malignant gliomas & recurrent glioblastoma multiforme.

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