Article Listing - Pharmaceutical
Spiriva closes the gap in patient share with Advair for COPD treatment in USA
24 December 2009
Since a 2008 retrospective analysis of patient-level claims data, Boehringer Ingelheim/Pfizer's Spiriva (tiotropium bromide), has closed the gap in patient share between itself and GlaxoSmithKline's Advair (fluticasone and salmeterol) in newly-diagnosed chronic obstructive pulmonary disease (COPD) patients, according to a report from research and advisory firm Decision Resources.
A New lease of life for Big Pharma, by David Stevenson, writing for MoneyWeek
23 December 2009
Few people – or businesses – were buoyed up by last week’s UK Pre-Budget Report (PBR). But bosses in one sector had big smiles on their faces. The Chancellor’s decision to slash corporation tax on income derived from patents to just 10% was great news for Britain’s big pharma firms
Novartis to buy Corthera for $120 million, plus up to $500 million on success of ADHF drug relaxin
23 December 2009
Novartis will gain exclusive worldwide rights to relaxin, a recombinant version of a naturally occurring human peptide, through the acquisition of the privately held US biopharmaceutical company Corthera. Relaxin is currently in Phase III clinical trials as a potential treatment option for patients with acute decompensated heart failure (ADHF).
Court blocks Roche’s sales of Mircera in USA until 2014, as Amgen prevails in EPO patent dispute
23 December 2009
Ending a five-year patent dispute, the US District Court in Boston has entered final judgment and a permanent injunction against Swiss drug major Roche from infringing US biotechnology firm Amgen's patents on recombinant erythropoietin (EPO).
Shire submits Replagal BLA with the USA’s FDA; recaps velaglucerase status
23 December 2009
Specialty biopharmaceutical company Shire says that it has submitted a Biologics License Application (BLA) with the USA’s Food and Drug Administration for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. The drug first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.
UK NICE draft guidance recommends Zeltia’s trabectedin for advanced soft tissue sarcoma but on a cost sharing basis
23 December 2009
In the final draft of guidance this week reversing a previous decision by the UK’s National Institute for Health and Clinical Excellence (NICE) says that Yondelis (trabectedin) is recommended as a treatment for certain patients with advanced soft tissue sarcoma.
Negative outcome in arbitration with Asahi will cost Actelion $91 million; and bad news emerges with insomnia drug
23 December 2009
Swiss biotoechnology firm Actelion has received a negative ruling in its arbitration proceeding in California, USA, between one of its subsidiaries, CoTherix, and Japan’s Asahi Kasei Pharma regarding a license agreement to develop the latter’s rho kinase inhibitor, fasudil.
Ranbaxy to launch Daiichi Sankyo’s olmesartan in six African markets
23 December 2009
Indian drug major Ranbaxy Laboratories, which is majority owned by Japan’s Daiichi Sankyo, is to launch olmesartan medoxomil, an antihypertensive originally discovered by Daiichi Sankyo, in six African countries; Kenya, Mozambique, Nigeria, Tanzania, Uganda, and Zambia. The companies will market the products under the brand name Olvance, as soon as the necessary measures have been completed in each country.
NicOx files for European approval of naproxcinod in OA indication
23 December 2009
French drug developer NicOx has submitted a Marketing Authorization Application (MAA) naproxcinod to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a New Drug Application (NDA) to the US Food and Drug Administration in September that has recently been accepted for filing, the Sophia Antipolis-headquartered company said.
Lilly gains global rights to Incyte's novel JAK1/JAK2 inhibitor for $90 million upfront and up to $665 million more; deal with PDL
22 December 2009
US firm Incyte saw its shares rise 5% to $8.92 after announcing it had entered into an exclusive worldwide license and collaboration deal with drug major Eli Lilly for the development and commercialization of its oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis.
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- Is failure to adopt business process management putting the pharma industry at risk?
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
- Ignyta acquires Actagene Oncology and entry into cancer personalized medicine
