rf-fullcolor.png

 

July 15, 2021
by Michael Mezher

Recon: COVAX launches marketplace for vaccine inputs; UK fines 13 drug firms £260M for overcharging NHS

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval (STAT) (Reuters) (CNBC)
  • Cleveland Clinic and Mount Sinai Won’t Administer Aduhelm to Patients (NYTimes)
  • The ins and outs of the rare, controversial way Medicare might pay for Aduhelm (STAT)
  • UnitedHealth says needs more information to decide on coverage policy for Biogen's Alzheimer's drug – CEO (Reuters)
  • J&J recalls sunscreens after carcinogen found in some sprays (Reuters) (NYTimes)
  • Senate Democrats eye drug pricing policies to fund $3.5 trillion budget deal (STAT) (KHN)
  • Tapping Into the Brain to Help a Paralyzed Man Speak (NYTimes)
  • Galapagos shares sink as first data from touted drug program disappoints (BioPharmaDive)
In Focus: International
  • Covax launches marketplace for Covid vaccine inputs to boost production (FT)
  • Britain fines drug firms after steroid price for NHS rises over 10,000% (Reuters) (FT)
  • Africa Sidesteps FDA’s Warning on J&J Vaccine as Cases Surge (Bloomberg)
  • COVID-19 deaths in Africa surge 43% week-on-week, WHO says (Reuters)
  • Fosun-BioNTech COVID-19 vaccine completes China regulator review – media (Reuters)
  • Hong Kong biotech start-up Prenetics plans $1.3 billion SPAC merger (CNBC)
  • EU regulator reviewing Moderna COVID shot for auto-immune blood condition (Reuters)
  • Illumina, Grail deal faces full-scale EU antitrust probe -sources (Reuters) (Fierce)
Coronavirus Pandemic
  • The WHO's Chief Says It Was Premature To Rule Out A Lab Leak As The Pandemic's Origin (NPR) (Reuters)
  • ICMRA Discussing Substitutes for Placebo-Controlled Trials of COVID Vaccines: MHLW (PharmaJapan)
  • WHO panel advises against COVID-19 vaccination proof for travel (Reuters)
  • Pfizer, Johnson and Johnson yet to apply for COVID-19 vaccines licence in India: Sources (Economic Times)
  • Global agencies sign tech transfer deals to boost COVID testing in Africa, Latam (Reuters)
  • Vietnam approves Johnson & Johnson's COVID-19 vaccine as daily cases hit record (Reuters)
  • Malaysia to stop using Sinovac vaccine after supply ends – minister (Reuters)
  • Pfizer says only in talks with government bodies in Thailand (Reuters)
  • Homeopathic Doctor Is Charged With Selling Fake Covid-19 Vaccine Cards (NYTimes)
  • Covid Is Especially Risky for People With H.I.V., Large Study Finds (NYTimes)
Pharma & Biotech
  • FDA new drug approvals in Q2 2021 (Nature)
  • The Pandemic Has Worsened Childhood Vaccination Rates Around The World (NPR)
  • Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value: report (Fierce)
  • A cancer drug startup banks new funds for NK cell therapy (BioPharmaDive)
  • Takeda, AbbVie, BMS, Sanofi, Lilly and others join growing tally of pharma's July price hikes: report (Fierce)
  • With fewer than 400 progeria patients worldwide, testing a CRISPR cure will be challenging (STAT)
  • Merck’s MET inhibitor tepotinib gains positive opinion from MHRA (PharmaTimes)
  • Cancer Research UK reports ‘most successful financial year’ for its spinouts (PharmaTimes)
  • Vertex Inks New Cystic Fibrosis Deals In Europe (Pink Sheet)
  • Ribon Therapeutics is looking to break the mold for PARP inhibitors and has a slate of Big Pharma backers on board (Endpoints)
  • Trial software group raises $45M to push decentralized studies; $120M SPAC makes its way to Nasdaq (Endpoints)
  • Banking on shared experiences — and now a big investor — with brother Vivek, Shankar Ramaswamy stacks up a $100M mega-round (Endpoints)
  • Tom Lynch moves to restructure Fred Hutch as academia, industry continue to push cell therapy into solid tumors (Endpoints)
  • EXCLUSIVE: Shape Therapeutics raises $112M in bid to make RNA editing — and a whole lot else — a reality (Endpoints)
  • Already sitting on a major stem cell bank, Generate looks to grow its regenerative medicines business (Endpoints)
Medtech
  • CMS again passes on national pricing for long-term cardiac monitoring, dramatically reduced rates remain (MedtechDive)
  • Rockley Photonics unveils ‘clinic-on-the-wrist’ sensors, offering a potential glimpse at the Apple Watch’s future (Fierce)
Government, Regulatory & Legal
  • Pfizer Unit Fights Loss To MSD In Pneumonia Vaccine IP Case (Law360)
  • 7th Circ. Orders Judge Consider Copay Groups In Opana Cert (Law360)
  • Guilty Ruling for Ono Employees Now Final and Binding: Onoact Case (PharmaJapan)
  • Nippon Shinyaku Sues Sarepta over DMD Therapy Patents in US (PharmaJapan)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.