Pharmaceutical industry

Pharmaceutical industry features

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  The generic generation

  In the next few years, some of the most widely used HIV drugs will come off patent in the UK. Gus Cairns asks: what are the...

  From:  HIV treatment update

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  WHO issues guidance for doctors, governments, patients on what to do about delisted ARVs

  WHO advice after delisting of a number of generic antiretroviral products....

  From:  HIV & AIDS treatment in practice

Pharmaceutical industry news from aidsmap

• FDA Advisory Committee recommends accelerated approval of bedaquiline for drug-resistant TB

  Bedaquiline, the first agent in a new class of TB drug, has been recommended for accelerated approval by the Anti-Infective Drugs Advisory Committee of the United States Food and Drug Administration (FDA). The committee voted unanimously (18 to 0) ...

  03 December 2012 | Lesley Odendal

• Telaprevir and VX-222 pair well in interferon-free regimen, VX-135 on the horizon

  An all-oral regimen of telaprevir, VX-222 and ribavirin for 12 weeks was generally well-tolerated and produced sustained virological response in approximately 70% of previously untreated chronic hepatitis C patients, according to findings from the ZENITH study presented at The Liver ...

  03 December 2012 | Liz Highleyman

• New fixed-dose combination pills measure up to Atripla - corrected version*

  Several studies, or updates of studies, comparing newer against older drug regimens were presented at the Eleventh International Congress on Drug Therapy in HIV Infection last week. Amongst them were the 48-week results from the STAR study, an open-label ...

  20 November 2012 | Gus Cairns

• Are antiretroviral switch or simplification studies of benefit for patients?

  The attitude of physicians, ethics committees and medical journals to antiretroviral switch and simplification studies needs to be radically reappraised, according to an article published in PLoS Medicine. Before approval, studies of this type must show a clear potential advantage ...

  15 August 2012 | Michael Carter

• First generic HIV drugs could save US at least $920 million a year

  Even using very conservative estimates of efficacy, using two generic HIV drugs plus one branded one in the most popular first-line regimen instead of using all three in a single-pill fixed-dose combination would save $4000 per quality-adjusted year of ...

  27 July 2012 | Gus Cairns

• The road to PrEP: trials, regulation and roll-out

  Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence summit, Controlling the HIV epidemic ...

  25 June 2012 | Gus Cairns

• Tenofovir pro-drug GS-7340 shows good safety and efficacy in short study

  GS-7340, a pro-drug of tenofovir that reaches higher concentrations in cells, had superior efficacy and may be more suitable for inclusion in co-formulations, researchers reported on 7 March at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle. Gilead ...

  08 March 2012 | Liz Highleyman

• US approval for new three-drug combination pill

  The US Food and Drug Administration has approved Complera, a combination pill containing three drugs, including the new non-nucleoside reverse transcriptase inhibitor rilpivirine. Complera combines tenofovir and emtricitabine (FTC) (also available as the combination pill Truvada) with rilpivirine (recently approved in ...

  11 August 2011 | Keith Alcorn

• US approval for hepatitis C drug telaprevir

  The US Food and Drug Administration has approved a new hepatitis C drug telaprevir (Incivek), the agency announced today. Telaprevir is a direct-acting antiviral drug (an HCV protease inhibitor), licensed for use in combination with the current standard treatment, pegylated interferon ...

  23 May 2011 | Keith Alcorn

• European approval recommended for hepatitis C drug boceprevir

  The European Medicines Agency has recommended marketing approval for Merck’s hepatitis C protease inhibitor boceprevir (Victrelis), the agency announced on May 20th. Boceprevir is the first direct-acting antiviral agent for hepatitis C to be approved in Europe. It has been approved ...

  23 May 2011 | Keith Alcorn

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Pharmaceutical industry news selected from other sources

• 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.

  19 March 2013 | Roche press release

• 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.

  18 March 2013 | Financial Times

• 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.

  18 March 2013 | Reuters

• 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.

  13 March 2013 | Theratechnologies press release

• 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.

  10 March 2013 | EATG

• Panic in Greek pharmacies as hundreds of medicines run short

  Greece is facing a serious shortage of medicines amid claims that pharmaceutical multinationals have halted shipments to the country because of the economic crisis and concerns that the drugs will be exported by middlemen because prices are higher in other European countries.

  05 March 2013 | The Guardian

• 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.

  05 March 2013 | Inter Press Service

• 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.

  05 March 2013 | Chicago Tribune

• 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.

  02 March 2013 | Alere

• 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.

  02 March 2013 | Pharmalot

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