Amgen gets go-ahead from EC to market PCSK9 inhibitor Repatha | Report: Greece spends more on branded drugs than its European neighbors | Japanese companies to collaborate on central nervous system disease treatments
July 23, 2015
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Amgen gets go-ahead from EC to market PCSK9 inhibitor Repatha
The European Commission has granted Amgen approval to market its Repatha anti-cholesterol drug -- the first regulatory win for a PCSK9 inhibitor. Repatha, which is administered in monthly or twice-monthly injections, has been shown to reduce low-density lipoprotein by 50% or more. Los Angeles Times (tiered subscription model) (7/21), Reuters (7/21)
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Report: Greece spends more on branded drugs than its European neighbors
Mandated use of generic drugs could help Greece reduce health care spending, according to an IMS Health Holdings report published in June. About 51% of drugs dispensed in Greece are branded. Further, imported foreign-made drugs account for 88% of the country's pharmaceutical market, IMS says. Bloomberg (7/22)
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Asia Pacific
Japanese companies to collaborate on central nervous system disease treatments
JCR Pharmaceuticals and Eisai have agreed to collaborate on using JCR's blood-brain-barrier penetration technology and Eisai's drug compounds to develop treatments for central nervous system diseases. Pharmaceutical Business Review Online (7/22)
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Report: Neediest in India lack drug access despite government controls
The Indian government's efforts to put price controls on pharmaceuticals have failed to give the neediest patients access to drugs, according to a report by IMS Health. The government controls have also reduced the number of generics introduced and hindered competition, the report says. The Wall Street Journal (tiered subscription model) (7/22)
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North America
FDA grants breakthrough designation to Bristol-Myers' HIV drug
Bristol-Myers Squibb's investigational HIV drug BMS-663068 has been designated a breakthrough therapy by the FDA for use in previously treated patients and those who have developed resistance to other therapies. The designation was granted based on data from a midstage trial. A late-stage trial is underway. The Wall Street Journal (tiered subscription model) (7/21)
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Lilly's solanezumab slows disease in some Alzheimer's patients, study finds
Experimental drug solanezumab helped preserve cognitive and functional ability in patients with mild Alzheimer's, according to clinical trial results released Wednesday by Eli Lilly and Co. The company found that after 18 months of treatment that mental decline in patients with a mild form of the disease was slowed by 34%, and functional ability decline was slowed by 18%. Reuters (7/22)
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Appeals court rules in favor of Novartis in Neupogen patent infringement case
(Joe Raedle/Getty Images)
The U.S. Court of Appeals for the Federal Circuit ruled Tuesday to allow Novartis to market Zarxio, a biosimilar version of Amgen's anti-infection drug Neupogen, starting Sept. 2. The decision stemmed from a case filed by Amgen claiming that Sandoz, the generic drug unit of Novartis, infringed on the patent Amgen holds for the treatment. Novartis obtained FDA approval to sell the biosimilar in the U.S. in March. Reuters (7/21)
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WHO to release new HIV treatment guidelines
New guidelines for HIV treatment are set to be released by the World Health Organization later this year, according to Dr. Meg Doherty of the WHO Department of HIV/AIDS. The new guidelines will recommend treatment for children and pregnant women, as well as for all adult patients regardless of their CD4 cell level, and will endorse preventative treatment for those at high risk of infection. The integration of low-dose efavirenz and the integrase inhibitors for clinical care use will also be considered. Aidsmap (7/20)
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Pharma companies are contributing to UN millennium goals
Pharmaceutical companies are helping poorer countries meet the United Nations Millennium Development Goal 5, which calls for reducing maternal and child deaths, a report from the Access to Medicine Foundation found. Pharma firms are helping not only with research and development, but also with affordability of drugs and building local community capacities. The Guardian (London) (7/22)
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Early-stage trial of Novavax's Ebola vaccine shows promise
An early-stage trial of Novavax's Ebola GP Vaccine generated a substantial immune response in the 230 healthy adults participating. While the company reports being in talks with governments and NGOs to develop the vaccine, analysts say other pharma companies are further ahead in testing their vaccines. Reuters (7/21)
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