Article Listing
Brazil’s final list of tariff increases in retaliation against USA less onerous than expected
12 March 2010
Brazil’s long-running battle with the USA over cotton subsidies, after the former won its argument through a World Trade Organization arbitration panel last year, took another step forward this week after the government finally announced the list of American product - which were expected to include pharmaceuticals - on which it would raise tariffs in retaliation.
Pfizer ditches figitumumab in study with erlotinib and gets poor results from Sutent
12 March 2010
It was a bad news day for global behemoth Pfizer yesterday, as the company announced that it is discontinuing its A4021018 study (also known as ADVIGO 1018), a Phase III trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). It also revealed that two Phase III studies of Sutent (sunitinib malate) in advanced breast cancer did not meet their primary endpoints.
Johnson & Johnson unit calls for re-examination of ceftobiprole, licensed from Basilea, submitted to CHMP
12 March 2010
Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson, has submitted a request for re-examination of the negative opinion issued on February 18 by the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Application (MAA) for Zeftera (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI).
Increase in UK R&D spend led by pharma and biotech
12 March 2010
The top one thousand UK companies invested more than £26 billion ($39.26 billion) on developing new products, services and improving productivity in 2008, according to the latest R&D scoreboard published this month. The R&D Scoreboard is an annual investigation of the top 1,000 UK and top 1,000 global corporate investors in research and development.
BioSante reveals positive leukemia vaccine results, sending the stock soaring
12 March 2010
USA-based BioSante Pharmaceuticals saw its shares leap 17% to $2.00 in early trading yesterday, after the company announced positive results of a human clinical study that show that its GVAX Leukemia vaccine may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the cancer drug Gleevec (imatinib mesylate), which earned Swiss drug major Novartis $3.9 billion in sales last year (The Pharma Letter January 29).
US FDA to review safety of long term use of common bisphosphonate osteoporosis drugs
12 March 2010
The US Food and Drug Administration says that it will investigate whether a link exists between the long-term use of certain osteoporosis drugs used to treat post-menopausal women and a particular type of leg fracture, following reports by the ABC News of the possible connection, but says that no such problems have been confirmed to date.
FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis
12 March 2010
German drug major Bayer HealthCare has received an orphan drug designation from the US Food and Drug Administration for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMEA), the company noted.
Merck KGaA’s Stimuvax set to become “gold standard” for locally-advanced non-small-cell lung cancer
12 March 2010
Merck KGaA/Oncothyreon's Stimuvax vaccine has earned advisory firm Decision Resources' proprietary clinical “gold standard” status in 2013 and 2018 for the treatment of locally-advanced non-small-cell lung cancer. Available data from Phase II clinical trials of Stimuvax have shown promising median overall survival and tumor response rates in patients when the drug is used as a maintenance therapy following chemo-radiotherapy.
Regulatory affairs workload at drug development firms has increased dramatically, according to Tufts study
12 March 2010
A growing volume of global drug development and commercialization activity during the past decade has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies, according to a study recently completed by the USA’s Tufts Center for the Study of Drug Development.
Diapharm pushes for a paradigm shift in the legislation for OTC products at DIA Annual EuroMeeting
12 March 2010
Due to the undifferentiated regulations in the European market for over-the-counter (OTC) medicinal products, a paradigm shift in the legislation is overdue. This point was emphasised by Annemarie Jasper, manager of business development services for the Germany-based pharmaceutical service provider Diapharm, at the DIA 22nd Annual EuroMeeting in Monaco.
- Transgene signs billion dollar deal with Novartis for TG4010 cancer vaccine option, but still disappoints investors
- US FDA issues complete response on Amgen’s Prolia with July action date
- FDA and European Medicines Agency agree to accept a single orphan drug designation annual report
- Abbott Labs bids $722 for Facet to enhances its biotech R&D pipeline, including daclizumab
- Japanese Pharma market seeing more foreign entrants
