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

• U.S. Court Decision to Speed Introduction of Generic Drugs

  The Supreme Court pushed back Monday against a longstanding practise in the U.S. pharmaceuticals industry under which large-scale companies pay producers of generic copies to hold off introducing those low-cost drugs into the marketplace. The practise, known as “reverse payments”, maintains a company’s lucrative monopoly over a drug, often resulting in significant extra income.

  18 June 2013 | Inter Press Service

• AbbVie Says It Can Be First With New Hepatitis C Drugs

  AbbVie Inc. (ABBV) said it can win the race against Gilead Sciences Inc. (GILD) to bring to market a new generation of all-oral hepatitis C drugs.

  14 June 2013 | Bloomberg

• CALIFORNIA: HIV Patients Fight Mail-Order Drug Program

  An anonymous Californian has filed a class action suit against United Healthcare Insurance, mail order pharmacy OptumRx, Pacificare Life and Health Insurance, and UnitedHealth Group for forcing HIV-infected patients to obtain HIV medications through the mail. “John Doe” claimed that receiving HIV drugs via mail violated his privacy since HIV medications that arrived in refrigerated containers would alert co-workers or neighbors to his infection.

  13 June 2013 | Courthouse News Service

• New FDA Guidance for Industry: Developing Antiretroviral Drugs for Treatment

  Significant changes from the 2002 version include: more details on nonclinical development of antiretroviral drugs; a greater emphasis on recommended trial designs for HIV-1-infected heavily treatment-experienced patients (those with multiple-drug resistant virus and few remaining therapeutic options); use of a primary endpoint evaluating early virologic changes for studies in heavily treatment-experienced patients; and use of the traditional approval pathway for initial approval of new antiretrovirals with primary analysis time points dependent on the indication sought.

  11 June 2013 | US Food and Drug Administration

• Shortages of Drugs Threaten TB Fight

  The U.S., India and other nations are facing shortages of tuberculosis drugs—threatening to reverse decades of progress against a deadly disease that is becoming increasingly untreatable.

  06 June 2013 | Wall Street Journal

• India says its drugs 'safe' after US generics fraud

  India, known as the "pharmacy to the world", Monday defended its lucrative generic drug industry as safe and strongly regulated after the nation's biggest drug firm pleaded guilty to US charges of making adulterated medicines. In a bid to defend its generic export sector, the government also charged that "isolated reports" of spurious drugs found in global markets and alleged to be from India were "desperate attempts" by other countries hurt by "the strength of the Indian pharma industry".

  05 June 2013 | France 24

• Drugs Go From Hit to Dud in Two Years in Hepatitis Race

  The pace of innovation, spurred by drugmakers jostling for a slice of a market that may reach $15 billion by 2018, has turned hepatitis C research into one of the fastest-developing areas of medicine. That boosted Gilead’s shares to a record last month, and left others like Vertex facing dwindling sales as their products quickly go from revolutionary to outdated.

  04 June 2013 | Bloomberg

• UNITAID report cites price reductions of up to 80% for HIV/AIDS, tuberculosis and malaria products

  UNITAID’s approach to transform health product markets has delivered price reductions of up to 80% for HIV/AIDS, tuberculosis and malaria medicines and diagnostics for the world’s poor, according to Results Beyond Investment, its 2012 Annual Report just released.

  29 May 2013 | UNITAID

• South African ARV plan bounces back

  The hunt is on for a new private sector partner with the expertise to set up a drug-making plan.

  28 May 2013 | Mail & Guardian

• Rwandan health minister hits back at critics of drug company deal

  Adam Green's piece voiced concerns about Merck's HPV programme serving as "market priming to create the conditions for adoption". From Rwanda's view, the jury is in: with more women dying of cervical cancer than in childbirth worldwide, the market is quite primed and demand readily apparent. Supply of the HPV vaccine and many other tools of modern medicine, on the other hand, remains in doubt for those who need them most.

  23 May 2013 | The Guardian

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