Pharmaceutical industry

Pharmaceutical industry features

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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

• 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

• Further cuts in drug prices make tenofovir more affordable for low-income countries

  UNITAID, the international drug purchase fund, and the Clinton Health Access Initiative have announced further price reductions for key antiretroviral drug regimens, including a 14% reduction in the price of tenofovir-based triple combination therapy, to $159 a year. The reduced ...

  17 May 2011 | Keith Alcorn

• Janssen issues warning on potential non-toxic contamination of Prezista 400mg or 600mg tablets

  Janssen, the manufacturer of the HIV protease inhibitor Prezista (darunavir), has issued a warning to pharmacists and patients regarding the potential contamination with wood preservative of approximately 2000 bottles of Prezista 400mg or 600mg tablets supplied to five ...

  11 May 2011 | Keith Alcorn

• New hepatitis C drugs pose many questions

  Even before new hepatitis C drugs come to market later this year, the vast array of hepatitis C antivirals currently in clinical trials is opening up new horizons for treatment of hepatitis C, in a situation strongly reminiscent of ...

  08 April 2011 | Keith Alcorn

• Once-daily nevirapine approved in United States

  The US Food and Drug Administration has approved a new once-daily extended release formulation of nevirapine, known as Viramune XR. The new 400mg tablet will provide an alternative to the current twice-daily dosing schedule, and can be taken without ...

  29 March 2011 | Keith Alcorn

• Attachment inhibitor BMS-663068 potent and well-tolerated in early study

  A novel type of drug that targets the first step of HIV entry into cells appeared safe and demonstrated good antiviral activity in a phase 2a study presented on Monday at the 18th Conference on Retroviruses and Opportunistic Infections (CROI), taking ...

  01 March 2011 | Liz Highleyman

• GSK and Pfizer HIV divisions to form new company

  GlaxoSmithKline (GSK) and Pfizer have merged the HIV sections of their business to form a new company. In a statement issued on April 16th, they said the new company “would be more sustainable and broader in ...

  17 April 2009 | Michael Carter

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Pharmaceutical industry news selected from other sources

• Who is really helping the WHO?

  The World Health Organization (WHO) holds its General Assembly in Geneva this week. The organization faces criticism for its growing dependence on the pharmaceutical industry.

  23 May 2012 | Deutsche Welle

• How CDC's hep.-C testing advice is already benefiting drugmakers

  The CDC's proposal that all US baby boomers get a one-time test for the hepatitis C virus has already given a boost to drugmakers in the antiviral space. If the agency finalizes the draft guidance later this year, potentially impacting screening rates, current and future players stand to gain even more.

  23 May 2012 | Medical Marketing and Media

• Prizes, Not Patents, For Drug Discovery?

  Once again, Bernie Sanders, the independent Senator from Vermont, is proposing legislation that would eliminate market exclusivity for new AIDS drugs and, instead, would give a drug developer a prize from a $3 billion annual fund that would be supported by insurers and the federal government. Whether the legislation will get anywhere is uncertain.

  22 May 2012 | Pharmalot

• EU drugs regulator accused of being too cozy with Big Pharma - Euro Parliament refuses to approve EMA accounts

  By a large majority, the European Parliament has refused to sign off on the accounts of the EU agency responsible for making sure all medicines in Europe are safe and effective for its citizens to use, accusing the body of being too close to Big Pharma.

  16 May 2012 | EU Observer

• Achillion's hepatitis C drug gets FDA fast track

  The U.S. Food and Drug Administration granted a fast track designation to Achillion Pharmaceuticals Inc's experimental hepatitis C drug ACH-3102, currently in an early-stage trial.

  16 May 2012 | Reuters

• Bernie Sanders floats plan to make HIV drugs less costly

  Why do American patients pay tens of thousands of dollars each year for HIV drugs that cost just hundreds in Africa? Drugmakers wave their patent rights in developing countries as part of the President's Emergency Fund for AIDS Relief.

  15 May 2012 | Politico

• Debate rages over HIV drug

  As the US Food and Drug Administration moves closer to approving a drug that would reduce the likelihood of contracting HIV, critics and some health campaigners have raised fears that the pre-emptive treatment might actually lead to higher infection rates.

  14 May 2012 | Financial Times

• FDA Panel Endorses 'Quad' Pill for HIV

  The FDA's Antiviral Drugs Advisory Committee has voted 13 to 1 to recommend approval of Gilead Sciences' new single-pill, once-daily regimen for HIV treatment.

  14 May 2012 | MedPage Today HIV/AIDS

• Pill to prevent HIV gets an FDA endorsement

  The first drug shown to prevent HIV infection won the endorsement of an FDA advisory panel Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

  11 May 2012 | Los Angeles Times

• Drug Labels Often Lack Pediatric Information

  Next time you examine prescription drug information for a child, chances are that suitable safety or dosing data will be lacking. Why?

  11 May 2012 | Pharmalot

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