India's medtech FDI fell in first 9 months of 2017, data show | FDA, EMA fast-track review of Novartis' blood cancer drug | Norgine's bowel cleansing drug gains marketing approval in 5 European countries
January 18, 2018
News on diagnostic and therapeutic innovations and regulatory science
Data from India's Department of Industrial Policy and Promotion showed the medtech sector saw a drop in foreign direct investment during the first nine months of last year to $173 million, compared with $416.7 million in the same period last year. The decrease was attributed to the government's order to cap prices of certain medical devices, as well as to changes in the country's regulatory environment.
The FDA granted priority review status to Novartis' Kymriah to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma. The drug also received an accelerated assessment from the European Medicines Agency for treating acute lymphoblastic leukemia in children and young adults.
Norgine's bowel cleanser Plenvu gained marketing approval from regulatory authorities in Austria, Ireland, France, Italy and Portugal, and the company expects to launch the drug in those countries this year. The approval, which was supported by data from a late-stage trial, mean Plenvu is now approved in 10 European countries, plus Iceland and Australia.
Shire's Adynovi, or rurioctocog alfa pegol, was approved by the European Commission as an on-demand and prophylactic treatment for patients at least 12 years old who have hemophilia A. The drug was modified to last longer in the blood, requiring less frequent injections -- from daily to just twice weekly.
Over-the-counter sales of codeine will be banned in Australia effective Feb. 1, and products containing the drug must be obtained only through prescription after that date. The move is aimed at reducing opioid addiction, poisoning, tolerance and dependence.
Singapore's Health Sciences Authority gave Histoindex a Class A license for its stain-free Laennec digital pathology imaging system, which is intended to facilitate clinical diagnosis of chronic liver diseases, including liver fibrosis. The technology enables tissue scanning and generation of digital images showing affected cells and collagen fibers using a novel Second Harmonics Generation and Two-Photon Excitation technology.
A new review program will be launched jointly by the FDA and the Department of Defense to expedite safety and efficacy review of medical products and devices judged to be essential for lifesaving treatments of US military personnel, with high-priority products for review to include cold-stored platelets, cryopreserved platelets and freeze-dried plasma. At least one workshop will be held by the agency and the department this year to inform FDA guidance on determining "unmet medical needs for battlefield settings," according to an initial blueprint for the initiative.
A Credence Research report predicts the worldwide market for spinal implants and surgical devices will see a 6.1% compound annual growth rate through 2025, hitting $21 billion. The market is led by North America in revenue share, although the Asia-Pacific region has seen an increase in product demand.
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