Indian regulator: Drugs may be relabeled with new MRPs | Additional vaccines made mandatory in France | Study of oral biologic tackles peanut allergies
July 13, 2017
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Indian regulator: Drugs may be relabeled with new MRPs
Indian drugmakers may relabel old medicine stocks with revised maximum retail prices resulting from the Goods and Services Tax, according to the country's Central Drugs Standard Control Organization.
The Economic Times (India) (7/10) 
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Additional vaccines made mandatory in France
Eight vaccines were added to France's list of mandatory vaccines: pertussis, pneumonia, meningitis C, hepatitis B, mumps, rubella, influenza and measles. Sanofi, which produces some of the vaccines, is ready for the increased demand, according to the company.
In-Pharma Technologist (7/11) 
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Study of oral biologic tackles peanut allergies
Study of oral biologic tackles peanut allergies
(Saul Loeb/AFP/Getty Images)
Aimmune Therapeutics is testing an oral biologic, AR101, as a peanut protein desensitizing agent. The study, which enrolled its first patient in the UK and plans to include 160 European children and adolescents, builds on midstage trials that successfully desensitized 90% of subjects to the protein equivalent of about two peanuts.
PharmaTimes (U.K.) (7/12) 
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Scottish regulator rejects Actelion's pulmonary arterial hypertension drug
Actelion's Uptravi, or selexipag, was rejected by the Scottish Medicines Consortium for use in adult patients with functional class III pulmonary arterial hypertension, whose condition is not sufficiently controlled with dual oral combination therapy and who are considered for inhaled iloprost treatment. The committee's decision came in part because it could not compare long-term benefits of selexipag and iloprost because of lack of long-term data, Actelion said.
PharmaTimes (U.K.) (7/11) 
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Ipsen's Cabometyx for kidney cancer gains NICE backing
A final guidance document has been issued by the National Institute for Health and Care Excellence recommending the use of Ipsen's Cabometyx, or cabozantinib, as a treatment for patients with kidney cancer, a change in the institute's previous decision to reject the drug. Ipsen addressed the institute's concerns by comparing the drug with other medicines often used in the National Health Service and lowering its cost.
European Pharmaceutical Review (U.K.) (7/10) 
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Asia Pacific
GMP issues at Biocon plant could delay approval of 3 Mylan biosimilars
Regulators from France uncovered 35 Good Manufacturing Practice problems at Biocon's fill/finish plant in Bangalore, India, during inspections related to the manufacturing of three of the company's biosimilars -- Fulphila, or pegfilgrastim; Ogivri, or trastuzumab; and Semglee, or insulin glargine -- which it is developing and commercializing in partnership with Mylan. The inspection was part of the European Medicines Agency's approval process for the drugs; French officials said the treatments should not be approved until the GMP issues have been resolved.
In-Pharma Technologist (7/10) 
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Singapore to launch trial using stem cell therapies to treat liver cirrhosis
Researchers at Singapore's National University Hospital will conduct a study on patients with liver cirrhosis that will utilize stem cell treatments to boost liver function. The four-year trial will recruit 46 patients and is financed by the National Medical Research Council.
The Straits Times (Singapore) (free content) (7/11) 
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North America
Novartis' CAR-T therapy for blood cancers reviewed by FDA
Novartis' CAR-T therapy for blood cancers reviewed by FDA
(Sebastien Bozon/Getty Images)
The FDA was set to decide Wednesday on CTL019, an experimental immunotherapy developed by Novartis as a treatment for hematologic cancers, and it could become the first chimeric antigen receptor T-cell therapy approved by the agency. The treatment has kept 57 pediatric patients with acute lymphoblastic leukemia alive for 17 months in a trial of 68 critically ill patients and has led to some patients becoming cancer free, but safety remains a concern because of the therapy's serious side effects, which vary from patient to patient.
Reuters (7/11),  The Washington Post (tiered subscription model) (7/11) 
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FDA allows Fabry drug submission without additional testing
The FDA has told Amicus it will be allowed to resubmit its Fabry disease candidate migalastat without undergoing additional tests, a move that may signal a change at the FDA. Under the previous administration, Amicus was asked to do additional safety studies that would have caused a delay of several years in potential approval.
FierceBiotech (7/11) 
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List of Class II device types exempt from 510(k) requirements finalized by FDA
A final list of 1,003 Class II medical device types exempted from premarket notification requirements under the 21st Century Cures Act, along with new product codes, has been released by the FDA. Companies that have pending 510(k) submissions for devices included on the list should discuss with the 510(k) lead reviewer if their device falls within the exemption's general limitations or if review needs to continue, the agency said.
Regulatory Focus (7/10) 
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