Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug developme

Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug development deal

Posted 18 June 2021 | By Michael Mezher 

Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug development deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner (Endpoints) (The Hill) (Letter)
  • Over 300 cases of heart issue after Covid vaccination reported in young people, CDC says (NBC)
  • White House to finish allocating 80 mln U.S.-made COVID-19 shots for shipment abroad (Reuters)
  • Analysis: Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug (Reuters)
  • Billions spent on prescription drug ads may have increased Medicare spending (STAT) (GAO)
  • FDA Approves Bayer’s Nasal Antihistamine for Nonprescription Use (FDA) (Fierce)
  • Genetic testing company 23andMe rises in first trade after Richard Branson SPAC merger (CNBC)
  • As drugmakers spend $6B annually on DTC ads, senators revive bill to include list prices in ads (Endpoints)
In Focus: International
  • Bristol-Myers, Eisai in up to $3.1 bln deal to develop cancer drug candidate (Reuters) (Endpoints)
  • AstraZeneca says EU loses legal bid for more vaccine supplies by end-June (Reuters) (FT)
  • AstraZeneca must use Britain's plant if needed to meet EU's vaccine commitments - EU lawyer (Reuters)
  • CureVac may let contractors make rival vaccines if own shot fails -CEO (Reuters)
  • TimesCureVac to press on with mRNA vaccine despite disappointing trials (FT)
  • Danish ‘meme stock’ Orphazyme plunges after drug setback (Reuters) (Fierce)
  • EU drug regulator records 415 cases of possible rare blood clotting (Reuters)
Coronavirus Pandemic
  • Coronavirus G7: Could a billion more vaccines for poorer countries make a difference? (BBC)
  • High Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled in the US (NYTimes)
  • Delta COVID variant becoming globally dominant, says WHO official (Reuters)
  • Thailand scraps plan for 16-week dose gap on AstraZeneca vaccine (Reuters)
  • Merck’s COVID-19 Drug Candidate Enters PIII in Japan (PharmaJapan)
  • Bharat Biotech's pre-submission meeting for Covaxin EUL with WHO on June 23 (Economic Times)
  • Zydus Cadila likely to seek EUA in India for ZyCoV-D COVID-19 vaccine in the next 7-8 days (Economic Times)
Pharma & Biotech
  • Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says (Pink Sheet)
  • Athira Pharma CEO placed on leave amid allegations of altered images in her research papers (STAT)
  • Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets (Pink Sheet)
  • Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis (PharmaTimes)
  • Another four IPOs complete busy week as biotech raise continues to match 2020's record pace (Endpoints)
  • Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs? (Pink Sheet)
  • Biogen doses first patient in phase 3 systemic lupus erythematosus study (PMLive)
  • As spotlight trains on biopharma diversity, most companies kept their C-suites exactly the same in 2020 — report (Endpoints)
  • In an effort to safely deliver mRNA, Stanford University teams up with German biotech Evonik (Endpoints)
  • Can semiconductor expertise be applied to biopharma manufacturing? Entegris bets $40M that it can (Fierce)
  • EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’ (Pink Sheet)
  • Cost watchdog ICER will bless some high-priced gene and cell therapies, but only with solid proof of benefit: Analyst (Fierce)
  • Lupin’s US Advair Generic Plans Turn Awry As Celon Pact Nears End (Scrip)
  • Bristol Myers Squibb Receives European Commission Approval for Onureg® (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia (Press)
  • The prostate cancer drug market (Nature)
  • Noncoding RNA therapeutics — challenges and potential solutions (Nature)
  • FDA Publishes OMUFA Arrears List and Answers Fee-Related Questions (FDA Law Blog)
Medtech
  • FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery (FDA)
  • ‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic (MedtechInsight)
  • IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows (MedtechInsight)
  • MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March (PharmaJapan)
  • Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings (FDA)
Government, Regulatory & Legal
  • Pandemic Swells Medicaid Enrollment to 80 Million People, a ‘High-Water Mark’ (KHN)
  • Del. Judge OKs Mallinckrodt Toss Of Ill. City's Ch. 11 Claims (Law360)
  • Ex-Merck Sales Rep Asks 9th Circ. To Revive Kickback Fight (Law360)
  • Walmart CEO Faces Opioid MDL Grilling Despite Protest (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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