New Medi-Cal budget expands hepatitis C drug access

New Medi-Cal budget expands hepatitis C drug access

In 2013, the U.S. Food and Drug Administration approved Sovaldi, a hepatitis C drug known as a “direct-acting antiviral.” At that time, its list price was $84,000 for a 12-week course of treatment. Public health programs such as Medi-Cal often negotiate prices down. Fair use. California’s 2018 budget sets aside $70 million so more Medi-Cal […]

Ireland urgently needs access to new drugs, says pharma body

Ireland urgently needs access to new drugs, says pharma body

Patients in Ireland have not been getting access to new top-class drugs because of delays in getting approval and agreements on price, the body representing Ireland’s pharmaceutical industry body has said. The warning came as Minister for Health Simon Harris signed a deal with Austria, Belgium, the Netherlands and Luxembourg to secure affordable and timely […]

Global CNS Therapeutics Markets, 2016-2018 & 2024: Patent Expiries of Major Drugs Exert Downward Pressure on …

Global CNS Therapeutics Markets, 2016-2018 & 2024: Patent Expiries of Major Drugs Exert Downward Pressure on …

Dublin, June 22, 2018 (GLOBE NEWSWIRE) — The “CNS Therapeutics – Global Strategic Business Report” report has been added to ResearchAndMarkets.com’s offering. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2016 through 2024. Also, a […]

Key drug approval looms as cannabis goes mainstream

Key drug approval looms as cannabis goes mainstream

By Ben Hirschler LONDON (Reuters) – Evidence that cannabis can ease epilepsy and other conditions is building as a British company counts down to what would be the first U.S. government approval for a prescription drug derived from the marijuana plant. GW Pharmaceuticals, which has spent 20 years developing medicines from cannabis, is hoping for […]

Recon: White House Proposes Taking the Food out of FDA

Recon: White House Proposes Taking the Food out of FDA

Posted 22 June 2018 | By Ana Mulero  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US In Focus: International Pharmaceuticals & Biotechnology What Is Ailing the Drug Industry? (The Wall Street Journal) Tesaro stock rockets as rumours of Roche takeover abound (pharmaphorum) Opioids don’t have […]

FDA slaps new bladder cancer limits on Merck's Keytruda, Roche's Tecentriq

FDA slaps new bladder cancer limits on Merck's Keytruda, Roche's Tecentriq

Last month, the FDA warned that immuno-oncology stars from Merck and Roche might actually be hurting some previously untreated bladder cancer patients’ survival chances. And now, it’s followed up by narrowing the drugs’ labels. The agency has restricted use of Merck’s Keytruda and Roche’s Tecentriq among patients with locally advanced or metastatic bladder cancer who […]

FiercePharmaAsia—China's first IO nod, Dr. Reddy's Suboxone generic, MNC-to-biotech shifts

FiercePharmaAsia—China's first IO nod, Dr. Reddy's Suboxone generic, MNC-to-biotech shifts

China green-lighted Bristol-Myers Squibb’s Opdivo as a second-line non-small cell lung cancer treatment, making it the country’s first immuno-oncology approval. Indivior seeks a U.S. court injunction to Dr. Reddy’s just-approved Suboxone Film generic. Offering higher pay and an less-layered entrepreneurial environment, Chinese biopharma startups have recently attracted many Big Pharma executives. And more. 1. Bristol-Myers’ Opdivo ushers in […]