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hepatitis C

AbbVie's Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients

The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the treatment of previously untreated patients over the age of 12 who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis.

The approval will see the duration of treatment with the drug shortened from 12 to eight weeks.

FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.

The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.

FDA approves AbbVie's Mavyret for children with Hepatitis C (HCV)

The FDA has approved AbbVie’s Mavyret tables (glecaprevir/pibrentasvir) as a treatment for hepatitis C (HCV) in children aged 12 to 17 years old.

AbbVie’s two drug combo tablets have been approved as a treatment for all six genotypes of HCV in children. The combination of glecaprevir and pibrentasvir was approved for adults in 2017.

Reformulated OxyContin led to spike in Hepatitis C infections

Efforts to create an “abuse deterrent” OxyContin pill inadvertently led to an increase in the number of Hepatitis C infections, according to a report from the US think-tank, RAND Corporation.

In 2010, Purdue Pharma reformulated its signature pain drug OxyContin, with the aim of making it harder to crush or ingest nasally. The move was intended to make the opioid drug harder to abuse.

AbbVie's case against the NHS thrown out of court

A judge has thrown US multinational AbbVie’s case against NHS England’s hepatitis C procurement process, out of court.

Mr Justice Choudhury, a judge at the Technology and Construction Court, dismissed AbbVie’s case against the NHS, after the US firm alleged that NHS England’s procurement process for curative drugs for Hepatitis C (HCV) was unfair.

The Judge rejected the arguments of the Illinois-based multinational, after the firm launched a legal challenge against NHS England’s £1 billion procurement of drugs for HCV.

Gilead to release generic versions of hep C meds over a decade before patent expiry

Gilead has announced its intention to undercut itself by releasing generic versions of its blockbuster drugs for the treatment of hepatitis C, Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir), more than a decade before their patents expire.

The company’s hep C portfolio generated $831 million in the second quarter of 2018, and the latter of the pair attracted controversy on its 2014 launch when its $1,150-per-pill price tag was revealed.

US court upholds verdict voiding MSD's claim to $200m from Gilead in patent dispute

MSD has taken a legal hit after a US appeals court upheld a ruling that the pharma giant had illicitly obtained patent rights for the treatment of hepatitis C, voiding its claim to an infringement verdict against Gilead to the tune of $200 million.

Top Ten most popular articles on Pharmafile.com this week

It's Friday the 13th, but that doesn't change a strong showing from the industry this week as it continued to deliver some remarkable news: the pharma M&A train keeps rolling as the year goes on as Novartis announced it is to shell out $8.7 billion to snatch up gene therapy biotech AveXis, while an exciting partnership is promising to transform the hepatitis C market by offering a drug which boasts a 97% cure rate in trials for as little as $300.

New hepatitis C combo boasts 97% cure rate for just $300

Image Credit: BruceBlaus

A partnership of the not-for-profit organisation Drugs for Neglected Diseases initiative (DNDi) and Egyptian drug firm Pharco Pharmaceuticals is working to bring a new, effective and affordable combination therapy to patients with hepatitis C (HCV).

Gilead launches hep C drug Sovaldi in China at one-fifth of US price

Gilead has officially launched its hepatitis C drug Sovaldi (sofosbuvir) in the Chinese market, but with one major caveat: it will cost 58,980 yuan ($8,937) in the region, just one-fifth of its price tag in the US – a price which has fallen rapidly from the $84,000 it originally launched at.

There are around 10 million cases of chronic hepatitis C in China, says Zhang Hong, Director of the Infectious Diseases Department at Shaanxi Provincial People’s Hospital, while the total number of such cases worldwide is 130 million, according to WHO estimates.

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