Regulatory Focus™ > News Articles > 2021 > 4 > Recon: FDA approves Supernus ADHD drug Qelbree; Valneva to begin Phase 3 trial of its COVID vaccine

Posted 06 April 2021 | By Michael Mezher 

Recon: FDA approves Supernus ADHD drug Qelbree; Valneva to begin Phase 3 trial of its COVID vaccine

2826 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna Vaccine Production Pace to Increase at CMO Catalent (WSJ) (Endpoints)
  • Walgreens Not Following US Guidance on Pfizer Vaccine Spacing (NYTimes)
  • Biden Tax Plan Seen Hitting Tech, Pharmaceutical Companies (Bloomberg)
  • Biden to speed up eligibility for vaccine as US hits milestone (Reuters)
  • Former USAID chief tapped to lead vaccine diplomacy efforts (Politico) (Reuters)
  • White House says monitoring coronavirus vaccine distribution in Florida (Reuters)
  • Novavax starts allowing participants on placebo to get COVID-19 vaccine in trials (Reuters)
  • FDA OKs first new ADHD drug in over a decade for children (AP) (Axios)
In Focus: International
  • EMA Official Links AstraZeneca Vaccine And Thrombosis (AFP) (Reuters)
  • Europe medicines watchdog to update on AstraZeneca vaccine safety April 7 or 8 (Reuters)
  • EU denies blocking 3.1 million AstraZeneca shots to Australia (Reuters)
  • EU blames AstraZeneca 'failure' as it misses vaccination target (The Guardian)
  • EU expects to vaccinate majority by end-June – Bloomberg (Reuters)
  • UK health regulator may restrict AstraZeneca shot for younger people, Channel 4 says (Reuters) (The Guardian)
  • South Korea flags possible vaccine export curbs to secure COVID-19 shots (Reuters)
  • Valneva's COVID-19 shot set for Phase Three trial this month (Reuters) (FT)
Coronavirus Pandemic
  • Global COVID-19 death toll surpasses 3 million amid new infections resurgence (Reuters)
  • The Story of One Dose: Inside the sprawling operational puzzle of bringing the Johnson & Johnson COVID vaccine to the public. (NYMag)
  • New IMF reserves could fund vaccinations for low-, middle-income countries -report (Reuters)
  • South Africa signs deal for 20 million Pfizer vaccine doses (Reuters)
  • Ortho signs $53.7M government contract to triple its COVID-19 test production (Fierce)
Pharma & Biotech
  • Drug prices: the lucrative world of not-so-cheap imitations (FT)
  • Furious Acadia takes shot at FDA, alleging sudden about-face in costly Nuplazid rejection (Fierce)
  • FDA Neuroscience Director Dunn's Appearance At Tanezumab AdComm Confirms Neurology Office Is Intact (Pink Sheet)
  • New CAR-T therapy from Bristol, Bluebird effective but too costly, ICER finds (BioPharmaDive)
  • Alexion Secures Funding OK In England For GI Bleeding But Wants More (Pink Sheet) (PharmaTimes)
  • EC approval for Ontozry (PharmaTimes)
  • AstraZeneca’s big ADC partner pledges to pour $13.6B into cancer R&D over next 5 years — and Enhertu looms large (Endpoints)
  • Alnylam publish successful results from Phase III study of ultra-rare disease (Pharmafile)
  • Janssen agrees $780 million deal for authorisation of Cidara flu treatment (Pharmafile)
  • Amarin launches Vascepa in all-important Europe as it slowly bleeds share to US generic (Fierce)
  • Pharma Companies Need To ‘Think A Little Bigger’ To Avoid Government Enforcement Actions (Pink Sheet)
  • Lilly is a holdout among companies that agree to disclose when executive pay is clawed back (STAT)
  • In 1-2 punch, Molecular Templates cuts first-gen candidate and loses a Big Pharma partner; Charles River teams up with Valence to provide AI discovery platform (Endpoints)
  • 'Unsurprising' but 'deeply disappointing': Deerfield report finds vast gender gap in VC-backed healthcare (Fierce)
  • After Novartis walks on last STING drug, Chinook spits out orphan Aduro assets (Endpoints)
  • Mineralys emerges with a new take on an old idea for the treatment of hypertension and $40M to play with (Endpoints)
  • With fresh investor cash in hand, Volastra partners with Microsoft to develop metastatic cancer biomarker platform (Endpoints)
  • Big Pharma R&D veteran with blockbuster credentials returns to his biotech roots as Prothena's new CMO (Endpoints)
  • The 20(+1) under 40: Inside the next generation of biotech leaders (Endpoints)
  • UK Medtechs Say Conditional Reimbursement Will Open Doors To Innovation Adoption (MedtechInsight)
  • Dexcom G6 Sensor: untested barrier methods to reduce skin reactions (MHRA)
  • Dexcom links with Welldoc to chart a digital path for its CGM into Type 2 diabetes (Fierce)
  • MHLW Launches New Office to Fuel SaMD Commercialization (PharmaJapan)
Government, Regulatory & Legal
  • Pharmacies Can't Escape More Trials In Opioid MDL (Law360)
  • Justices Won't Revive Teva-IBSA Thyroid Drug Patent Fight (Law360)
  • 9th Circ. Revives Claims That Medtronic Skirted FDA Review (Law360)
  • First Circuit Closes Front and Back Door on Massachusetts Pharmacy Liability Case (Drug & Device Law)
  • Teva, Pharmacies Want Humana's Copay Fraud Claims Tossed (Law360)
  • CVS Wants Tribe To Arbitrate Prescription Reimbursement Suit (Law360)
  • Illumina Wants FTC's Suit Over $8B Grail Deal Moved To Calif. (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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