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India: Rules eased for HIV, Hep B & C combo drugs

India's top drug regulator has said in a new order that companies manufacturing combination drugs for HIV and Hepatitis B & C can seek early approval with a WHO recommendation even if internationally the medicines are not approved as a combination but only individually. However, the drugs have to be relevant for India.

Published
23 March 2017
From
Times of India
Drugs costing 8p a day could be hit by 'devastating' NHS rationing plan

At present, the NHS has 90 days to make drugs available to patients, once they have been given the green light by the National Institute of Health and Care Excellence (Nice). The new system will allow health officials an extra three years to introduce drugs, during which time they will try to negotiate cost reductions.

Published
16 March 2017
From
Telegraph
Trump chooses Gottlieb to run FDA; Pharma breathes sigh of relief

U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

Published
13 March 2017
From
Reuters
Regulator defends hepatitis charity criticised on BBC show

The Charity Commission has defended a health charity that attempted to force the NHS to buy more of a treatment for hepatitis C, having accepted funding from the US company that makes it.

Published
02 March 2017
From
Third Sector
Hepatitis C drugs re-energize global fight over patents

The liver disease hepatitis C is the new battleground for lawsuits intended to slash the cost of life-saving medicines. In February alone, five suits were filed in India and Argentina claiming that the latest class of antiviral drugs does not warrant the 20-year patent monopoly that manufacturers have sought in those countries.

Published
01 March 2017
From
Nature
The Medicines Patents Pool Publishes 2017 Prioritization Report Targeting New HIV and Hepatitis C Medicines for In-licensing

The Medicines Patent Pool released its 2017 prioritization report today selecting five HIV and two hepatitis C compounds for potential licensing agreements. The annual medicines priority report, traditionally reviewing MPP’s target list for HIV, this year expands to important treatments for the hepatitis C virus (HCV).

Published
28 February 2017
From
Medicines Patent Pool
Merck's lead HIV play hits the mark in first phase 3 challenge

Merck has taken a big step toward getting its lead HIV candidate doravirine to market, setting up a showdown with Johnson & Johnson's big-selling Prezista.

Published
19 February 2017
From
FierceBiotech
Pharma industry shuns Trump push for radical shift at FDA

President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.

Published
15 February 2017
From
Reuters
Could Trump’s Plan To Deregulate The FDA Benefit HIV Treatment?

Matthew Kavanagh of Health GAP, which advocates for affordable HIV/AIDS drugs, says Trump was right about one thing: “The way to drive down drug prices is to import generic versions of these drugs to allow for competition."

Published
13 February 2017
From
New Now Next
Gilead to use dating sites, Tumblr, and Snapchat in Truvada strategy

Using platforms like Tumblr and Snapchat may help the company raise awareness about the preventative HIV drug Truvada among a population of people who don't engage with the healthcare system in traditional ways, Gilead said during a call with investors on Tuesday.

Published
13 February 2017
From
Medical Marketing & Media
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.