While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
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- Picture of Future Regulations on Investigator-Led Clinical Research Emerging
September 9, 2014
- With No Pilot at Helm, Pharma Industry Embroiled in Confusion with Voluntary Funding Disclosures
September 1, 2014
- Wholesalers’ Q1 Earnings Remain Positive, Medical Fee Cut Rule Seen to Boost Accuracy of Financial Results in Sept.
August 25, 2014
- Japanese Drug Makers Working to Increase Pace of Drug Discovery by Optimizing Operations at Research Centers
August 18, 2014
- PMDA Sets Target Review Times for Partial Changes to Generic Approval - A New Way to Underpin Stable Supply
August 4, 2014
- Competition Fuels Personalized Medicine Market, First-Line Positions Eyed for Xalkori, Alecensa
July 28, 2014
- Can New Fast-Track Review System Perk Up Drug Makers’ Development Drive in Japan?
July 7, 2014
- June Reimbursement Listing Could Mark Watershed in Japan Generic Market
July 1, 2014
- Two Reasons MHLW Opposes Yearly NHI Price Revisions, “Annual” Dropped from Gov’t Policy Guidelines
June 17, 2014
- Delicate Balancing Act Required for SGLT-2 Inhibitor Promotions - Safety vs Efficacy
June 16, 2014
- Why Not Make RMPs for Existing Products as Differentiation Strategy?
June 9, 2014
- 2013 Earnings Signal Foreign Drug Makers Losing Steam in Japan
June 2, 2014
- Clinical Research Regulations at Crossroads: Guidelines or Legislation?
May 26, 2014
- Was the Main Paper from VART Study “Practice” for a Grad Student?
May 19, 2014
- Can CROs Become Independent Players? Compliance, Ethics Will Be Major Issues for Growing Industry
April 28, 2014
- Industry Faces Tough Road to Institutionalization of Key Premium, Eligibility Up for Discussion
April 21, 2014
- Approval of Novel Antiepileptic Drugs as Monotherapies Coming Closer to Reality
April 7, 2014
- Will Japan NIH Initiative Create a “Japanese Model” that Overcomes Its Size Disadvantage?
March 28, 2014
- CASE-J Flutter: Doesn’t Blopress Ad Overemphasize Its Benefits on Diabetes?
March 19, 2014
- “Lack of Urgency” Leads to New Rule; Penalty for Low Price Settlement Rates May Have Been Inevitable
March 12, 2014
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