Bristol-Myers Squibb took an intriguing approach to developing its hepatitis C drug, daclatasvir. Rather than focus its trials on the United States, the globe's biggest market for spending on medicine, it concentrated trials on Japan. That move allowed daclatasvir to carve out an early lead in Japan, but it also left investors wondering what the company's strategy for the drug in the United States would be -- particularly after the FDA balked at an initial application to approve the drug last fall. This week, Bristol-Myers shed some light on its strategy by announcing that it's resubmitting daclatasvir for approval in the U.S. as an adjunct treatment to be used alongside Gilead Sciences' (NASDAQ: GILD ) top-selling HCV drug Sovaldi in genotype 3 patients.
18 March 2015 | Motley Fool
Sangamo's purportedly ground-breaking results in HIV with SB-728 do not stand up under close examination. SB-728 has not shown any indication that it can provide a "functional cure" for HIV, does not compare well to today's standard of care, and cannot find a partner. Sangamo refuses to conduct studies that rigorously assess whether their drugs work. This includes the inclusion of a control arm so assiduously avoided by Sangamo's management.
10 March 2015 | Seeking Alpha
Based on the prescription data released by Symphony Health, the latest Bloomberg Intelligence (BI) analysis suggests that 95% of hepatitis C patients in the US are being administered with Gilead’s drugs, Harvoni and Sovaldi. On the other hand, AbbVie’s competing drug, Viekira Pak is only covering the remaining 4%.
10 March 2015 | Bidness
Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.
09 March 2015 | Bloomberg
EECA CAB (Community Advisory Board in Eastern Europe and Central Asia) has published its positions in regards to Janssen, BMS, ViiV and Gilead policy. The positions were developed on the results of the meetings with the companies during last year.
09 March 2015 | EATG
Natco, a mid-sized player in India's crowded pharmaceutical industry, is the latest generic drugmaker to team up with Gilead on Sovaldi, having previously attempted to block the U.S. firm from getting a patent for the breakthrough drug in India in the hope of producing a cheaper version on its own. In September, Gilead announced similar licensing deals with seven other generic drugmakers.
04 March 2015 | Reuters
US pharmaceutical giant Gilead Sciences has begun the application process to have Truvada approved for PrEP in Australia, removing one of the most significant hurdles currently preventing access to the HIV-prevention drug and opening the door to affordable access.
03 March 2015 | Star Observer
Gilead Sciences Inc., whose $1,000-a-pill hepatitis C treatment is one of the world's most expensive drugs, is avoiding billions of dollars in U.S. taxes by booking profits overseas.
27 February 2015 | Chicago Tribune
The European AIDS Treatment Group (EATG), Europe’s network of HIV activists, and AIDES, a leading French NGO in the fight against AIDS and viral hepatitis, backed by 81 European HIV LGBT civil society organisations and concerned actors, issued an urgent HIV Prevention Manifesto today. We demand that pre-exposure prophylaxis for HIV (PrEP) is made available as soon as possible within the European Union, and that Gilead, the company that makes the PrEP medicine Truvada®, submits an application to the European Medicines Agency (EMA) for a change of indication so that its use to prevent HIV can be approved.
25 February 2015 | EATG
U.S. drugmaker Merck & Co has contributed an HIV medicine for children to an international shared patent pool in a move that should speed the development of cheap pediatric formulations for use in poor countries.
24 February 2015 | Reuters