The UK drug regulator has granted volanesorsen a positive scientific opinion under its early access to medicines scheme for use in patients with familial chylomicronemia syndrome. The drug’s sponsor, Akcea Therapeutics, is hoping to get the drug approved in the EU, the US and Canada this year.
Akcea Therapeutics has received permission to make its unlicensed treatment for familial chylomicronemia syndrome (FCS) available to patients in the UK under the government’s early access to medicines scheme (EAMS) while the product undergoes evaluation for marketing throughout the EU.
Volanesorsen, an EU orphan designated drug for treating patients with the rare lipid disorder, was granted a positive scientific opinion under EAMS by the Medicines and Healthcare products Regulatory...
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
