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

• London HIV drug prescribing changes – patient satisfaction and clinical outcomes maintained

  Controversial changes to the range of anti-HIV drugs which are most commonly prescribed in London have resulted in a £7.2 million saving over two years, with no sign of reduced patient satisfaction or poorer clinical outcomes, Dr Paul Benn ...

  22 April 2013 | Roger Pebody

• 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

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Pharmaceutical industry news selected from other sources

• The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that made generic ARVs

  The confidential report laid bare systemic fraud in Ranbaxy's worldwide regulatory filings. It found that "the majority of products filed in Brazil, Mexico, Middle East, Russia, Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations, have data submitted which did not exist or data from different products and from different countries ..."

  17 May 2013 | Fortune

• India: Patents and precedents

  Pharmaceutical companies fear that the battle raging in India over patents will inspire other countries to change their laws.

  16 May 2013 | Financial Times

• Analysis: Drugmakers face more scrutiny of discordant U.S. prices

  The world's biggest drug makers have for years enjoyed rich premiums for their medicines in the U.S. market. Those days may be coming to an end.

  13 May 2013 | Reuters

• Stockout Risks of South Africa’s New ARV Programme

  It is South Africa's shaky ARV supply track record that has treatment activists sounding alarm bells over the Apr. 1 introduction of fixed-dose ARVs (FDAs). “With the individual ARV drugs, if there is a shortage of one ARV then people can still take the other two drugs, though it’s not ideal. However, if there’s a stockout of the fixed-dose pill, then patients will have no recourse,” Mark Heywood, executive director of health and social justice advocacy group Section 27, tells IPS.

  07 May 2013 | Inter Press Service

• Patients in Control: Protest action in Russia - the lives of HIV-positive children are not profitable for distributors

  A protest action organized by activists of "Patients in Control" took place in Moscow in front of the office of the largest distributor of ARV medications in Russia ("R-Pharm"). The activists were outraged about the fact that around 20 auctions for antiretrovirals in different regions did not take place because no bids were submitted; half of those tenders were for paediatric formulations.

  03 May 2013 | EATG

• Gilead Sciences Reports Higher Sales, FDA Letter

  Gilead Sciences Inc.'s (GILD) first-quarter sales rose a disappointing 8.4% as increased traction for the newer additions to the company's HIV franchise wasn't enough to offset customers stocking up on its antiviral drugs ahead of price increases implemented earlier this year.

  03 May 2013 | Wall Street Journal

• Gilead profit rises 63 pct, sales of older HIV drugs dip

  Sales of HIV drug Atripla fell 1 percent to $877.1 million, while sales of another older product, Truvada, fell 8 percent to $700.2 million. Sales of newer HIV drug Complera rose 184 percent, and recently launched Stribild had sales of $92.1 million.

  03 May 2013 | Reuters

• Health NGO pushes for more transparency in clinical trials

  The European Commission's proposed revision on the Clinical Trials Directive is an important step forward, but does not go far enough, says the Cochrane Collaboration, a healthcare NGO which advocates more transparency in clinical trials.

  02 May 2013 | EurActiv.com

• Pharmaceutical Industry: The Doctor’s Dilemma

  By law medical professionals must keep up their education — providing plenty of opportunities for wealthy pharmaceutical companies to help out. But do free flights, consultancy fees, free dinners and free conferences put doctors in Big Pharma’s pocket?

  01 May 2013 | The Global Mail

• Johnson & Johnson allies with biotech startup on HIV drug in China

  The biopharma startup Ascletis has snagged exclusive rights from Johnson & Johnson's ($JNJ) Janssen for an experimental HIV protease inhibitor for the China market. Hangzhou, China-based Ascletis aims to develop the candidate, called TMC310911.

  01 May 2013 | FierceBiotech

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