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Pharmaceutical industry news

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New and experimental HIV treatments
European CHMP Adopts Positive Opinion for Stribild®, a Once-Daily, Integrase Inhibitor-Based, Single Tablet Regimen for the Treatment of HIV-1 Infection

Gilead Sciences today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)).

Published
8 hours ago
From
Gilead press release
Side-effects
EU new drug approval studies "have too few patients to evaluate safety"

For medicines intended for chronic use, the number of patients studied before regulatory approval in the European Union (EU) is insufficient to properly evaluate safety and long-term efficacy, and this points to a need for new EU legislation, say researchers writing in this week's PLOS Medicine.

Published
12 hours ago
From
Pharma Times
Hepatitis C treatment
Roche’s Pegasys receives EU approval for the treatment of chronic hepatitis C in children five years of age and older

Roche announced today that the European Medicines Agency (EMA) has expanded the approval of Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic hepatitis C virus (HCV). The new label includes children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus.

Published
19 March 2013
From
Roche press release
Access to medicines and treatment
Athens urged to import generic drugs

Public health advocates are petitioning the Greek government to overturn patent protection on costly medicines and import them from low-cost generic producers to ease the burden on the country’s medical system.

Published
18 March 2013
From
Financial Times
Pharmaceutical industry
GlaxoSmithKline boss says new drugs can be cheaper

The pharmaceutical industry should be able to charge less for new drugs in future by passing on efficiencies in research and development to its customers, according to the chief executive of GlaxoSmithKline Plc.

Published
18 March 2013
From
Reuters
Lipodystrophy
Health Canada rejects tesamorelin for lipodystrophy

After consideration of the NDS, Health Canada decided that the risks of tesamorelin outweighed its benefits under the proposed conditions of use.

Published
13 March 2013
From
Theratechnologies press release
Pharmaceutical industry
Pfizer stops developing hepatitis C drug

Pfizer Inc. has stopped development of an experimental hepatitis C drug, bowing out of a hotly contested industry race to introduce the next generation of treatments for the infectious liver disease.

Published
10 March 2013
From
EATG
Access to medicines and treatment
U.S. “Stalling” Could Force Acceptance of Onerous TPP

Civil society opposition here has strengthened against a U.S.-proposed free trade zone that would include some dozen countries around the Pacific Rim. As negotiators head into a 16th round of talks this week in Singapore, around 400 organisations are urging the U.S. Congress to demand greater transparency in the proceedings.

Published
05 March 2013
From
Inter Press Service
Access to medicines and treatment
India board rules against Bayer in cancer drug patent case

An Indian patent appeals board upheld on Monday a decision to allow a domestic company to sell a generic version of Bayer AG's cancer drug Nexavar, in a blow for global drugmakers' efforts to hold on to monopolies on high-price medicines.

Published
05 March 2013
From
Chicago Tribune
Health monitoring in resource-limited settings
Alere to Develop Simple, Affordable Point-of-Care Nucleic Acid Test for Tuberculosis & Expand Manufacturing for POC HIV Viral Load Platform

Alere Inc. announced that it has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation to support development of a point-of-care nucleic acid test for tuberculosis and to expand production facilities for this test and for a point-of-care viral load test.

Published
02 March 2013
From
Alere
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