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PharmAsia News
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   Full-text available via subscription Subscription journal
     ISSN (Print) 1875-7774
     Published by Informa plc Homepage  [13 journals]
  • Japan Listing Sets Stage For Edoxaban, Vaniprevir Launches
    • Abstract: Japan has granted reimbursement prices to a batch of new drugs, including a new therapy for hepatitis C, a novel anticoagulant and a new insomnia treatment.
      PubDate: Fri, 21 Nov 2014 01:25:02 -050
       
  • Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 72)
    • Abstract: Australia and New Zealand scrap plans for a joint regulatory agency, while Australia starts a device conformity system.
      PubDate: Fri, 21 Nov 2014 01:20:01 -050
       
  • FDA Head: U.S. Has ‘Deep Relationship’ With China
    • Abstract: Cooperation with China is a key issue for FDA Commissioner Margaret Hamburg – so much so that she used the word literally eight times during an address at Peking University in Beijing on the first day of her visit there this week.
      PubDate: Thu, 20 Nov 2014 18:35:00 -050
       
  • New Tools To Combat Hospital-Associated Infections in India
    • Abstract: A joint initiative of J&J’s Advanced Sterilization Products and Joint Commission International for a toolkit with standard guidelines to control hospital-associated infections has been unveiled in India. The partners hope this will be a good start to bridge an important need gap by educating health care institutions on following globally recognized standards.
      PubDate: Thu, 20 Nov 2014 17:40:11 -050
       
  • Regulators In Focus As Amgen Launches Innovative Biologics Plant In
           Singapore
    • Abstract: Amgen has launched a state-of-the art biologics manufacturing plant in Singapore that required one-quarter of the capital investment of a conventional operation, operates one-third cheaper and took half the time to build, according to CEO and Chairman Bob Bradway, who added the company plans to build a second one at the same site. But clinical and GMP certifications mean a wait until 2016 before commercial output.
      PubDate: Thu, 20 Nov 2014 02:10:00 -050
       
  • Round One To U.S. FDA In Ranbaxy’s Valcyte, Nexium Lawsuit
    • Abstract: A Washington, D.C. Court has backed the U.S.
      PubDate: Thu, 20 Nov 2014 00:10:01 -050
       
  • Big Pharma China Roundup: Roche Struggles, GSK Rebounds
    • Abstract: Despite big pharma firms generally accelerating growth in China, which was up 18% in the third quarter from 10% in the previous quarter, growing domestic competition has caused some to struggle.
      PubDate: Wed, 19 Nov 2014 17:35:01 -050
       
  • Big Pharma China Roundup: Merck Soars, Novartis Sees No Slowdown
    • Abstract: The third quarter proves to be upbeat for big pharma firms in China, with average growth accelerating to 18% compared to 10% in the last quarter. Part 1.
      PubDate: Wed, 19 Nov 2014 17:30:04 -050
       
  • Emerging Markets Not China-Only Story: Execs
    • Abstract: As an economic slowdown starts impacting sales and rising competition erode profits, companies are beginning to come to terms that the emerging market growth story is not all about China.
      PubDate: Wed, 19 Nov 2014 17:25:02 -050
       
  • Third Quarter Emerging Earnings Roundup
    • Abstract: Third quarter earnings in emerging markets focused on China even as the legacy of a compliance crackdown last year lingered over sales efforts. But other markets are gaining note as an economic slowdown in the Middle Kingdom has a noticeable impact on forward-looking earnings commentary.
      PubDate: Wed, 19 Nov 2014 17:15:01 -050
       
  • Big Pharma Continues Emerging Market Growth Trajectory
    • Abstract: While it may appear that the emerging markets have faded somewhat as the new darlings of big pharma, an analysis by Deutsche Bank of the latest financial performance of large European pharma companies suggests that they are still able to achieve a measure of growth in the region, just not as quickly as previously hoped.
      PubDate: Wed, 19 Nov 2014 17:05:01 -050
       
  • Ranbaxy Claims ‘Buyer’s Remorse’ Behind U.S. ANDA Moves
    • Abstract: Suit argues the U.S. FDA granted tentative approvals of generic versions of Valcyte and Nexium to maintain Ranbaxy’s marketing exclusivity.
      PubDate: Wed, 19 Nov 2014 04:05:18 -050
       
  • U.S. FDA Slams Ranbaxy’s Claims In Nexium, Valcyte Lawsuit
    • Abstract: The U.S. drug regulatory agency highlighted Ranbaxy’s faulty manufacturing practices, strongly retaliating to its claims in a lawsuit challenging the recent decision to rescind tentative approvals for generic versions of Nexium and Valcyte. Among others, the FDA brought up a few strong points like how it had backed arguments in the past that led to Ranbaxy gaining exclusivity approvals on two drugs.
      PubDate: Wed, 19 Nov 2014 04:05:02 -050
       
  • Emerging Markets Regulatory Tracker: China (Vol. 4 No. 71)
    • Abstract: China signs GMP understandings with Canada and Brazil on the sidelines of a recent World Health Organization conference in Beijing.
      PubDate: Wed, 19 Nov 2014 01:15:01 -050
       
  • Read In Tokyo: No AZ Clues But PD-L1 Draws Explained
    • Abstract: If its recent potential multi-billion dollar deal for Merck KGaA's anti-PD-L1 antibody has affected Pfizer's interest in AstraZeneca as a possible takeover target, the U.S. firm's chairman and CEO is giving nothing away.
      PubDate: Tue, 18 Nov 2014 23:40:01 -050
       
  • Australia’s Bionomics Unveils Therapeutic Action Of BNC210
    • Abstract: Australia’s Bionomics unveils the therapeutic action of its BNC210 compound and faced shareholder questions all in one busy week for the biotech.
      PubDate: Tue, 18 Nov 2014 17:30:02 -050
       
  • Advertising Proposals Kick Off Singapore Drug Rule Revisions
    • Abstract: Singapore's Health Sciences Authority is seeking comments on a proposal to replace its pre-approval system for drug advertisements with a new mechanism that would allow the pharmaceutical industry to self-regulate based on a set of rules and guiding principles.
      PubDate: Tue, 18 Nov 2014 17:25:02 -050
       
  • BeiGene Raises New Funds For Oncology Pipeline
    • Abstract: Chinese bioventure BeiGene has raised additional funding from existing and new investors, providing it with new resources to take forward through early clinical trials several molecules for cancer.
      PubDate: Tue, 18 Nov 2014 17:20:01 -050
       
  • What Do Chinese Investigators, Reviewers Really Want'
    • Abstract: The rules are tightening up requirements and study sponsors are increasingly competing for the attention of primary investigators at limited clinical trial sites, while changing regulatory thinking is complicating the issue. How can study success be ensured in this environment?
      PubDate: Mon, 17 Nov 2014 18:10:05 -050
       
  • Eisai Pans German Fycompa Rejection, But Court Case Unlikely
    • Abstract: After Germany’s reimbursement watchdog G-BA vehemently rejected Eisai's criticism of its negative decision on Fycompa, the Japanese company fired back angrily – but it is unlikely to launch a legal challenge.
      PubDate: Mon, 17 Nov 2014 18:05:02 -050
       
  • Takeda, GE Healthcare Join Forces On Liver Disease
    • Abstract: Takeda Pharmaceutical has entered into an alliance with GE Healthcare focused on hepatic fibrosis research for the development of treatments for liver diseases.
      PubDate: Mon, 17 Nov 2014 18:00:01 -050
       
  • Sun’s Tildrakizumab Deal: A Calculated Bet'
    • Abstract: If approved, tildrakizumab, licensed in globally by Sun Pharma but developed by Merck, will be pitted against established competitors in a crowded market of advanced biologics for plaque psoriasis. But experts believe several advantages can help the top Indian generic firm leap into the wide world of dermatology and anti-inflammatory compounds.
      PubDate: Mon, 17 Nov 2014 17:50:03 -050
       
  • Asia To Get ‘Cost Competitive’ Vaccines From Abivax Deal
    • Abstract: Several countries in Asia are set to see the availability of additional vaccines for the prevention of some of the most common bacterial diseases in the region, by way of an alliance between a new European venture and a Cuban scientific research institute.
      PubDate: Mon, 17 Nov 2014 17:45:00 -050
       
  • Roche Diagnostics Bets On China With New $468 Million Plant
    • Abstract: Already growing north of 20% in China, Roche Diagnostics hopes its first manufacturing site in Asia will meet China and the region’s ever-increasing appetite for testing services.
      PubDate: Sun, 16 Nov 2014 23:10:02 -050
       
  • Abilify Delivers But Patent Cliff Looms For Otsuka
    • Abstract: Otsuka's mainstay product, the atypical antipsychotic Abilify (aripiprazole), has again put in a strong performance but will leave a large revenue hole after U.S. exclusivity expires next year.
      PubDate: Sun, 16 Nov 2014 18:05:13 -050
       
 
 
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