REGULATORY

• August Listing OK’ed for Evrysdi, Veklury, Verquvo, 2 CGRP Migraine Meds and More
  August 4, 2021

• Trintellix to Face 4.3% Price Cut under CEA Scheme, No Change for Coralan
  August 4, 2021

• Delytact Gets 1.43 Million Yen Price Tag
  August 4, 2021

• Temodar Label Revised to Erase Caveat for Combo Cancer Therapy
  August 4, 2021

• New Pharma Industry Vision to Push Predictability for Investment Recovery: Draft Outline
  August 3, 2021

• MHLW’s COVID-19 Guide Adds Chugai’s Cocktail Therapy
  August 3, 2021

• Veklury to Join NHI Price List to Enter Normal Distribution Channel; Peak Sales Put at 18 Billion Yen
  August 3, 2021

• Lilly’s Selpercatinib Clears Key Panel, in Line for September Approval
  August 2, 2021

• Takeda’s Pevonedistat Set to Be 1st Legally Backed Sakigake Drug
  August 2, 2021

• AstraZeneca Vaccine OK’ed for Age 40 and Up under Emergency Program
  August 2, 2021

• GMP Inspections to Be Conducted Unannounced as Basic Rule: MHLW
  July 30, 2021

• Forxiga Clears PAFSC, in Line to Become Japan’s 1st CKD Drug in August
  July 29, 2021

• LDP Project Team on Drug Discovery Capabilities Likely to Meet Aug. 4
  July 28, 2021

• Label Revisions Ordered for AstraZeneca’s COVID-19 Vaccine; Thrombocytopenia Added to Adverse Reactions
  July 28, 2021

• Panels Agree to Add Risk of Thrombocytopenia to AstraZeneca Vaccine Label
  July 27, 2021

• Prioritize Alfacalcidol Supply for Non-Osteoporosis Indications: MHLW
  July 27, 2021

• Spread of Regional Formularies Will Depend on “Human Relationships and Consensus-Building”: Professor
  July 26, 2021

• Chuikyo Reps Fret Negative Impact of Tougher Pledge Rule, but MHLW Says It’s Conducive to Stable Supplies
  July 26, 2021

• Chuikyo Roughly Approves 11 Proposals to Hone CEA System
  July 26, 2021

• MHLW to Tighten “Written Pledge” Rule on Generic Listings to Thwart Supply Issues
  July 26, 2021

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