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Brexit spells upheaval for EU and UK drug regulation

Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based European Medicines Agency (EMA), which approves treatments for all EU countries, expected to have to relocate. Britain's biggest drugmaker, GlaxoSmithKline, said the exit vote "creates uncertainty and potentially complexity for us in the future".

Published
30 June 2016
From
Reuters
Gilead’s single tablet regimen Odefsey receives European marketing approval for HIV treatment

The European Commission has granted marketing authorization for Gilead Sciences' once-daily single tablet regimen (STR) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.

Published
27 June 2016
From
PharmaBiz
What Do Gilead And Martin Shkreli Have In Common?

The U.S. Attorney for Massachusetts issued Gilead a subpoena pursuant to donations to charities that help patients pay for drugs. Medicare prohibits drug makers from helping patients afford their copays. The investigation could result in a ban on donations to copay charities, a decline in Gilead's customer retention and/or a fall in revenue.

Published
22 June 2016
From
Seeking Alpha
Cipla in pact with Russian firm for HIV, Hepatitis C drugs

Drug major Cipla has inked a pact with Russia's National Immunobiological Company to collaborate on HIV and Hepatitis C drugs, entailing an investment of 2.8 billion roubles (around Rs 289 crore).

Published
20 June 2016
From
Moneycontrol
HLM 2016 AIDS: Universal treatment access panel looks at issues in generic antiretroviral medicines

Manufacturing generic antiretroviral drugs has become a losing financial proposition for the few companies involved, according to Dr. Ren Minghui, the Assistant Director General for HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases at the World Health Organization.

Published
12 June 2016
From
Science Speaks
Gilead escapes liability in hepatitis C patent fight with Merck

A U.S. judge on Monday found a pattern of misconduct by Merck & Co including lying under oath and other unethical practices, freeing Gilead Sciences Inc from paying any damages for infringing Merck's patents with its lucrative treatments for hepatitis C, Sovaldi and Harvoni.

Published
07 June 2016
From
Reuters
Patients who pay £1,000 for life-saving drugs online that would cost NHS £35,000: More and more are doing it - but doctors warn it's a big risk

Doctors predict that internet drug buyers' clubs are the shape of things to come. Graham Cooke, a consultant in infectious diseases at Imperial College London, says he is supervising NHS patients who have received hep C treatments via fixhepc.com. 'This is a growing trend, as the prices for cancer drugs and other treatments mean they are increasingly unavailable on the NHS,' he adds.

Published
01 June 2016
From
Daily Mail
A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner

More than a decade ago, researchers at Gilead Sciences thought they had a breakthrough: a new version of the company’s key HIV medicine that was less toxic to kidneys and bones. But in 2004 Gilead executives stopped the research, only to restart it as the expiration of tenofovir’s patent in 2018 neared.

Published
30 May 2016
From
Los Angeles Times
European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection.

Published
27 May 2016
From
Gilled press relase
Gilead's $1000 hepatitis C pill gets patent in India

In what could be a major setback to access to treatment in high-burden countries, the Indian Patent Office on Monday granted a patent to Gilead Pharmasset on Sovaldi (sofosbuvir), its blockbuster drug for hepatitis C, for which the company charges $1,000 per pill in the US.

Published
10 May 2016
From
Times of India
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