China denies approval for 11 generics over trial data | Biomedical groups call for antibiotic research funding | Combined treatment from MSD promising for HCV patients with cirrhosis
November 17, 2015
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China denies approval for 11 generics over trial data
The China Food and Drug Administration has not allowed eight Chinese firms to market 11 generic drugs for infections, schizophrenia and other conditions because of incomplete or incorrect clinical trial data. The agency carried out a series of inspections of the companies' facilities from Oct. 26 to Oct. 31. Hebei Pharmaceutical, Hainan Pharmaceutical and Zhejiang Huahai Pharmaceutical are among the firms that submitted the applications. Reuters (11/12)
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Biomedical groups call for antibiotic research funding
Representatives of the BioIndustry Association, Antibiotic Research UK, the Royal Pharmaceutical Society and AstraZeneca called for a new comprehensive approach to funding antibiotic research, warning that without new antibiotics, routine surgeries and other procedures "will become increasingly dangerous." Their open letter appeared in the Financial Times. BBC (11/16)
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Combined treatment from MSD promising for HCV patients with cirrhosis
An analysis of data from six mid- and late-stage trials found that MSD's fixed-combination therapy of elbasvir and grazoprevir without ribavirin achieved virologic response rates of 98% among treatment-naive hepatitis C patients with related cirrhosis. Administration of the treatment with ribavirin was associated with virologic response rate of 90%. PharmaTimes (U.K.) (11/16)
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Asia Pacific
Medtech reporting, labeling guidance released in Malaysia
Guidance clarifying labeling and mandatory postmarket incident reporting of medtech products has been released by Malaysia's Medical Device Authority. The guidance, which would benefit regulators, manufacturers and patients, is based primarily on labeling and reporting requirements in Europe. (Boston)/Emergo Group blog (11/12)
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Gates Foundation grants $2M for malaria vaccine development
The Bill and Melinda Gates Foundation has awarded researchers with James Cook University's Australian Institute of Tropical Health and Medicine a grant worth $2 million to aid the development of malaria vaccine. The team will work with other scientists in the US and in Melbourne to create the vaccine. Vaccine News Daily (11/13), NineMSN (Australia)/Australian Associated Press (11/10)
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IPO brings in $60M for Mesoblast
Mesoblast has secured $60 million in an initial public offering of 7.5 million shares. The Australia-based firm will use the money to support the development of five mesenchymal lineage adult stem cell-based candidates. FierceBiotech (11/13)
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North America
Pharmacies' ties to drugmakers scrutinized
Express Scripts, OptumRx and CVS Health are reviewing or have terminated contracts with certain mail-order pharmacies. "What we had not been aware of, until really the last year, was these type of pharmacies that have a really high proportion of sales from a drugmaker and it was not out in the open," said Everett Neville of Express Scripts. Reuters (11/15)
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Report: Generics saved US $254B last year
The US saved an estimated $254 billion through the use of generic drugs in 2014, according to a report by the IMS Institute for Healthcare Informatics for the Generic Pharmaceutical Association. Last year's savings were almost $8 billion greater than in 2013. Savings were greatest in the areas of mental health, hypertension and cholesterol treatment. The American Journal of Managed Care online (11/16)
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Africa backs India's ability to produce cheaper generics
African nations have endorsed India's efforts to retain aspects of its Patents Act enabling production of low-cost generics in spite of drugmakers' patent rights. The US plans to push for stricter enforcement of drug patents at a December trade summit in Nairobi, Kenya, according to a World Trade Organization official. AllAfrica Global Media (11/14)
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