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PharmAsia News
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     ISSN (Print) 1875-7774
     Published by Informa plc Homepage  [13 journals]
  • Xtandi Japan Label Change Worth $45m To Medivation
    • Abstract: What’s the worth of words? Forty-five million dollars if you are Medivation, which will benefit from a milestone payment of that amount from partner Astellas Pharma in relation to a Japanese labeling change for prostate cancer drug Xtandi (enzalutamide).
      PubDate: Wed, 22 Oct 2014 23:40:03 -040
  • India Brandishes Study Discrediting U.S. IP Index
    • Abstract: A new study by academia, at the behest of leading Indian firms, has, among other observations, found flaws in the United States Chamber of Commerce's Global Intellectual Property Center (GIPC) International IP index.
      PubDate: Wed, 22 Oct 2014 20:05:05 -040
  • Conformity Assessment On Way Out For Many Australian Devices
    • Abstract: The Australian government will soon amend its regulations to allow most local medical device manufacturers to rely on conformity assessments by European notified bodies. The change is welcome news for the industry, which has long been pushing for a change to the current scenario under which it is mandatory for products to undergo conformity assessment by the Therapeutic Goods Administration.
      PubDate: Wed, 22 Oct 2014 20:05:00 -040
  • Emerging Markets Regulatory Tracker: India (Vol. 4 No. 66)
    • Abstract: India’s drug control organization has set up a group to reform systems to make these more user friendly, and is asking for industry representatives for the Task Force.
      PubDate: Wed, 22 Oct 2014 19:55:02 -040
  • First Filing For Taisho/Tokuhon’s S-flurbiprofen
    • Abstract: Taisho Pharmaceutical’s marketing authorization application in Japan for TT-063 is the first globally for a transdermal formulation of S-flurbiprofen for osteoarthritis.
      PubDate: Tue, 21 Oct 2014 23:15:01 -040
  • FDA’s Arista To India: What’s Your Everest'
    • Abstract: For the quality-hit Indian drug industry, a senior investigator from the U.S. FDA has driven home a few candid messages – lead by example and clean up.
      PubDate: Tue, 21 Oct 2014 23:10:01 -040
  • FDA Sees American Dream For Chinese Class 3 Devices
    • Abstract: As China steps up to substitute imported medical devices with domestic products, the U.S. FDA says that it is also likely to see market entry of made in China high-risk medical devices into the United States, according to the agency’s device representative to Beijing.
      PubDate: Tue, 21 Oct 2014 22:55:03 -040
  • Southeast Asia Roundup: Thailand, Vietnam, TPP And Infectious Disease
    • Abstract: A key drug firm in Thailand has pushed the government to upgrade regulatory standards, while Vietnam sees a surge cardiovascular disease, nations in the region that are part of the Trans-Pacific Partnership talks reportedly zero in on compulsory licensing and several countries have joined together to develop faster diagnosis of infectious diseases.
      PubDate: Mon, 20 Oct 2014 19:30:03 -040
  • Cipla’s Hamied Voices Continued Support For Indian Compulsory
    • Abstract: In the last few months Cipla has made moves to co-operate with global drug makers through product licensing deals, in a clear switch in the way the Indian firm wants to do business. But outspoken chairman Yusuf Hamied, the man who demolished the patent barriers of global drug makers, continues to see reasons for India to use interventions like compulsory licenses to facilitate drug access.
      PubDate: Mon, 20 Oct 2014 19:30:00 -040
  • Emerging Markets Earnings Roundup: Roche (Part 2)
    • Abstract: Roche feels the heat still from Tarceva competition in China, but Japan regains luster as sales tax hit dims and diagnostics benefit as governments in emerging markets ramp up health care spending.
      PubDate: Mon, 20 Oct 2014 19:00:03 -040
  • New Thinking Needed To Invigorate Japan Pharma Innovation
    • Abstract: If Japan is to invigorate pharma and biotech innovation there will need to be changes to ways of thinking by both investors and research-based ventures, along with closer co-ordination between academia, industry and the government, suggested participants in a panel discussion at the BioJapan meeting in Yokohama.
      PubDate: Mon, 20 Oct 2014 03:35:02 -040
  • China Biosimilar Discount Expectations May Deter MNCs
    • Abstract: Payers and physicians in China are eager to embrace biosimilars despite a lack of regulatory and reimbursement avenues, notes a recent study by global contact research organization ICON PLC.
      PubDate: Sun, 19 Oct 2014 19:30:03 -040
  • Why Novo May Need To Watch Sanofi’s Indian Sugar Clinics Play
    • Abstract: On Sept. 30 Sanofi India made a seemingly plain announcement: a tie up with the Apollo Hospitals group to collaborate on the expansion of Apollo Sugar Clinics that provide integrated diabetes care programs in India.
      PubDate: Sun, 19 Oct 2014 19:25:01 -040
  • Pharma R&D Center Stage As Japan Preps For New Agency
    • Abstract: Japan’s government is gearing up for major changes in how it funds basic pharma and medtech R&D, with a new agency due to be set up next March as part of a broader health care policy initiative approved earlier this year.
      PubDate: Fri, 17 Oct 2014 02:20:02 -040
  • Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 65)
    • Abstract: Australia’s TGA eases rules to market for local medical device makers.
      PubDate: Thu, 16 Oct 2014 20:35:01 -040
  • Clinical Trials Approvals Rise In India, But Is It Only In Numbers'
    • Abstract: Data suggests that approvals for clinical trials have accelerated in India over the past year, but the ground reality may be disappointing. CRO executives tell PharmAsia News that sponsors are not keenly participating in India, given restrictive guidelines which are at times impractical to follow.
      PubDate: Thu, 16 Oct 2014 20:25:03 -040
  • India Gives Go-Ahead For Batch Of Biosimilar Trials
    • Abstract: India has permitted more than a dozen clinical trials for rDNA-based drugs this year, including for biosimilar versions of cetuximab (Bristol-Myers Squibb/Eli Lilly’s Erbitux), bevacizumab (Roche Pharma AG's Avastin) and rituximab (Roche/Biogen Idec's Rituxan/MabThera) by a clutch of domestic companies.
      PubDate: Thu, 16 Oct 2014 20:20:02 -040
  • Emerging Markets Earnings Roundup: Johnson & Johnson (Part 1)
    • Abstract: Third quarter earnings news from Johnson & Johnson was slim on emerging markets insight, but the company’s views on a possible Remicade challenge from Celltrion in the United States came across loud and clear.
      PubDate: Thu, 16 Oct 2014 20:10:03 -040
  • Rare Crackdown Unveils Academic Corruption In China
    • Abstract: As drug makers increasingly look to key researchers and top academic institutions in China for fresh ideas, a recent high-profile academic anti-graft case has shown the perils of the funding system.
      PubDate: Thu, 16 Oct 2014 02:45:00 -040
  • Pharmaceutical Company News from Turkey
    • Abstract: PharmAsia News brings you a look at Turkey’s drug market by capturing recent moves by international and domestic firms.
      PubDate: Thu, 16 Oct 2014 02:05:00 -040
  • Indian Firms Blame U.S. Price Hikes On Compliance Costs
    • Abstract: Put simply, Indian generic firms’ take on why the prices of some of their products have surged in the United States is down to strict inspections and the costs of compliance. Dr Reddy's Laboratories has clarified that it doesn't even market one of the products in question.
      PubDate: Wed, 15 Oct 2014 20:05:01 -040
  • Akynzeo To Help Eisai Over Aloxi Exclusivity Loss'
    • Abstract: The new U.S. regulatory clearance for Eisai and Helsinn Group's Akynzeo is the first to be granted to a single-capsule anti-emetic product targeting two distinct treatment pathways, and will be an important addition to Eisai's oncology franchise.
      PubDate: Wed, 15 Oct 2014 20:00:04 -040
  • Cut Dominance Of Sun, Ranbaxy Combine, Says CUTS
    • Abstract: A united Sun Pharma and Ranbaxy may become a strong global generics firm but its fallout on the Indian market is being studied carefully. Consumer activists have upped their ante raising concerns of impending market dominance in several areas.
      PubDate: Wed, 15 Oct 2014 00:15:03 -040
  • Pharma Import Alert: FDA Working Towards Consistency, Better Decision
    • Abstract: FDA’s broad reorganization may not create the same super-specialization for the import staff that is coming to other parts of the agency, but a process overhaul appears on its way regardless.
      PubDate: Tue, 14 Oct 2014 20:10:02 -040
  • China Health Authority Urges Mega Hospitals To Buy Local High-End Devices
    • Abstract: China’s largest hospitals are now in the front seat to switch to domestic devices, underscored by a recent move by the National Health and Family Planning Commission. Seizing the opportunity, leading domestic makers such as Mindray are ramping up operations with new product lines and enhanced R&D capabilities, notes Citi analyst Richard Yeh.
      PubDate: Tue, 14 Oct 2014 20:05:02 -040
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