NICE proposes fast-track options for cost-effective new drugs | New adjunctive treatment for Parkinson's launched in UK | Roche, AbbVie's leukemia drug wins EMA panel backing
October 18, 2016
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NICE proposes fast-track options for cost-effective new drugs
The National Institute of Health and Care Excellence proposed a plan to fast-track its recommendations for the most cost-effective new drugs that would clear them as much as three months faster than the current system. The new process will apply to drugs with a likely cost per quality adjusted life year of up to $12,500.
Reuters (10/13) 
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New adjunctive treatment for Parkinson's launched in UK
Bial launched Ongentys, or opicapone, in the UK for Parkinson's patients taking levodopa/DOPA decarboxylase inhibitors who are experiencing end-of-dose motor difficulties. Opicapoone can improve motor symptoms as levodopa wears off, noted neurologist Andrew Lees of London's National Hospital for Neurology and Neurosurgery.
PharmaTimes (U.K.) (10/17) 
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Roche, AbbVie's leukemia drug wins EMA panel backing
Roche Holding and AbbVie's Venclyxto, or venetoclax, has been endorsed for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for chronic lymphocytic leukemia in patients with 17p or TP53 genetic mutations who did not respond to or are not eligible for treatment with a B-cell receptor pathway inhibitor.
Seeking Alpha (free registration) (10/14),  Reuters (10/14) 
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BMS' Opdivo gains positive opinion from EU committee for Hodgkin lymphoma
Bristol-Myers Squibb's Opdivo, or nivolumab, has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for relapsed or refractory classical Hodgkin lymphoma following autologous stem cell transplant and for treatment with Adcetris, or brentuximab vedotin. The drug's submission was partly based on midstage trial data showing 66% of patients responded to the treatment.
OncLive (10/14) 
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Asia Pacific
India to speed up drug regulatory process
Indian authorities are exploring options for fast-tracking clinical trials, which would cut some approval times to four to six months from the current six- to eight-month time frame. The government says it also plans to ensure that contract research organizations comply with tighter quality measures.
The Economic Times (India) (10/14) 
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North America
FDA seeks comments for guidance on software as a medical device
The FDA is asking for public feedback on a guidance produced by the International Medical Device Regulators Forum, which discusses the clinical evaluation of software as a medical device and the principles for establishing the effectiveness, safety and performance of SaMD. According to the guidance, the recommendations it provides are not intended to be at odds with or take the place of applicable premarket or postmarket regulatory requirements.
Regulatory Focus (10/13) 
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Blood clot risk prompts recall of some Medtronic neurovascular products
A recall has been initiated by Medtronic involving some lots of its neurovascular products, namely the Alligator retrieval device, the Pipeline embolization device, the X-Celerator hydrophilic guidewire and the stylet containing UltraFlow and Marathon flow directed micro catheters. The recall was issued over concerns about the risk of blood clots, which can happen if the polytetrafluoroethylene coating separates from parts of the devices and enters the bloodstream.
The Wall Street Journal (tiered subscription model) (10/14) 
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US amends regulations to clear Cuban transactions with FDA, US researchers
US amends regulations to clear Cuban transactions with FDA, US researchers
(Yuri Cortez/AFP/Getty Images)
The Treasury and Commerce departments are making it possible for pharmaceuticals developed in Cuba to seek approval from the FDA through two amendments to the Cuban Assets Control Regulations, which are intended to promote greater interaction between the US and Cuba. The amendments also allow Americans to freely collaborate with Cubans on joint medical research projects and authorize Cuban scientists to conduct studies in the US.
Regulatory Focus (10/14) 
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Cipla to build biosimilars facility in South Africa
Indian drugmaker Cipla has signed an agreement to build a biosimilars manufacturing plant in South Africa, with construction beginning in 2017 and operations projected to begin in the third quarter of 2018.
The Economic Times (India) (10/16) 
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