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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]
  • Regulators Meet In Beijing To Balance Local With Global
    • Abstract: During an international summit striving to shed light on how to enhance cooperation to expand timely access to new drugs, the China FDA has emphasized integration with respect to national regulations.
      PubDate: Tue, 25 Nov 2014 20:05:02 -050
       
  • Indian Court Rejects Bayer’s Plea to Halt Natco Sorafenib Exports
    • Abstract: Bayer has suffered yet another setback in its long battle to defend its Nexavar patent in India. A recent decision permitted the local firm Natco to export a small quantity of sorafenib to Hisun of China.
      PubDate: Tue, 25 Nov 2014 20:00:01 -050
       
  • Roche Invests $142m in Shanghai Infectious Disease R&D Center
    • Abstract: Roche is showing its confidence in treatments for infectious diseases in China through a substantial new investment - as much as CHF136 million ($142 million) – to build a new laboratory facility for its R&D Innovation Center in Shanghai.
      PubDate: Tue, 25 Nov 2014 18:35:02 -050
       
  • India’s Price Watchdog Mulls Price Caps On Selected Oncology Drugs
    • Abstract: India’s NPPA has started a consultative process with stakeholders on including several key anticancer drugs in the new list of essential medicines in India. If the decision goes through, widely used products like trastuzumab, erlotinib and rituximab may be brought under price controls.
      PubDate: Sun, 23 Nov 2014 21:05:01 -050
       
  • China Looks Across Straits For New Drug Opportunities
    • Abstract: A first-ever pharma collaboration signals strengthening links between asset-hungry Chinese drug makers and the burgeoning Taiwanese biotech sector.
      PubDate: Sun, 23 Nov 2014 19:55:01 -050
       
  • Complera Among Latest Japan Approvals
    • Abstract: Japan's ministry of health, labour and welfare has issued formal marketing authorizations for a handful of new drugs, including for HIV, and additional indications.
      PubDate: Sun, 23 Nov 2014 19:50:00 -050
       
  • 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
       
 
 
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