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Access to medicines and treatment
India May Drop Compulsory Licenses Based On Price

India’s Department of Pharmaceuticals this week issued a new draft guidance that says once patented drugs come under proposed price controls, the cost of these medicines should be considered reasonable and compulsory license should not be issued based on affordability.

Published
02 March 2013
From
Pharmalot
Access to medicines and treatment
Detailed analysis of the Medicines Patent Pool-ViiV pediatric ARV license and memorandum of understanding

This License Agreement and its subsidiary Sublicense Agreement will be a presumptive template for pediatric access to all of ViiV's current pipeline ARVs once they are approved by for use by the US Food and Drug Administration (FDA) or by the European Medicines Authority (EMA).   On February 27, the Medicines Patent Pool (MPP) and ViiV Healthcare UK Limited (ViiV) announced their License Agreement on an older antiretroviral (ARV), abacavir (ABC), for pediatric treatment only, in 118 countries where 98.7% of child living with HIV live.  They also entered into a separate, non-binding Memorandum of Agreement (MoU),...

Published
01 March 2013
From
EATG
Finance and funding
HIV drugs to be uniquely shielded from generic pricing pressure in public payer scheme

HIV drug makers in the US are expected to be somewhat protected from generic drug pricing pressure given the emphasis on single-tablet regimens (STRs) and the large role of public payers, experts told BioPharm Insight. The role of private payers is more uncertain, they added.

Published
01 March 2013
From
Financial Times
GlaxoSmithKline unit joins patent pool for AIDS drugs

GlaxoSmithKline's HIV/AIDS drugs business is to share intellectual property rights on children's medicine in a patent pool designed to make treatments more widely available in poor countries. ViiV and the patent pool have also agreed to negotiate further licenses that will allow generics firms to manufacture low-cost versions of an experimental drug, dolutegravir, that is currently awaiting regulatory approval in Western markets.

Published
27 February 2013
From
Reuters
New and experimental hepatitis C treatment
Regulators Await Gilead's Hep C Candidate

Gilead Sciences’ (GILD) sofosbuvir has passed all its preliminary examinations, and now is looking like a good bet for regulatory submissions in the coming months.

Published
22 February 2013
From
Seeking Alpha
Pharmaceutical industry
Gilead Settles Teva HIV Drug Patent Suit to Avoid Trial

Teva will be permitted to begin sales of a generic version of Viread on Dec. 15, 2017, Gilead said in a statement distributed by Business Wire.

Published
20 February 2013
From
Bloomberg
New and experimental hepatitis C treatment
Gilead's Sofosbuvir for Hepatitis C Meets Primary Endpoint in Fourth Pivotal Phase 3 Study

Initial Regulatory Filings Planned for Q2 2013. Gilead Sciences (Nasdaq:GILD) today announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.

Published
19 February 2013
From
Gilead press release
Pharmaceutical industry
GSK wins priority status for new HIV drug in US

U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.

Published
18 February 2013
From
Reuters
Access to medicines and treatment
Have a heart, save my liver!

Today, on the occasion of Valentine’s Day, Médecins du Monde and Treatment Action Group (TAG) launch an action urging pharmaceutical giants Merck and Roche to drop their exorbitant prices for pegylated interferon, an effective hepatitis C (HCV) treatment.

Published
14 February 2013
From
HepCoalition.org
Pharmaceutical industry
EMA: Viracept: Non-renewal of the marketing authorisation in the European Union

Before the expiry of the last 5-year period of validity the Marketing Authorisation Holder did not apply to renew the marketing authorisation. Consequently, the marketing authorisation for Viracept expired on 23 January 2013.

Published
07 February 2013
From
European Medicines Agency
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