Recon: Vaccine makers shift sights to boosters; Europe launches SPAC aimed at acquiring CDMOs

ReconRecon | 09 May 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark (Endpoints) (House Select Subcommittee on the Coronavirus Crisis)
  • U.S. elections may thwart Democratic effort to cap insulin cost (Reuters)
  • Bausch + Lomb valued at $6.5 billion after stock ticks up in NYSE debut (Reuters)
  • COVID shots made Moderna biotech’s biggest star, but what now? (Boston Globe)
  • White House documents detail a looming squeeze on Covid-19 boosters (STAT)
  • White House warns of Covid surges in the winter (Politico)
  • Over 10 years later, FDA officially pulls a BMS accelerated approval, and a Teva copycat falls with it (Endpoints)
In Focus: International
  • COVID vaccine makers shift focus to boosters (Reuters)
  • BioNTech's Q1 vaccine sales triple but it still flags full-year decline (Reuters)
  • WHO, Gavi not planning COVID vaccine buys from S.Africa's Aspen (Reuters)
  • ‘Please Pay Attention’: Scientist Flagged Heart-Pill Toxins Early On (Bloomberg)
  • Europe launches first SPAC focused on production of complex drugs (Reuters)
  • WTO meeting on COVID vaccine rights waiver went 'very well,' chair says (Reuters)
  • Third Ebola patient dies in northwest Democratic Republic of Congo (Reuters)
  • Pivotal Trials For EU Approval Still Underrepresent Minorities, Study Finds (Pink Sheet)
  • As Poor Nations Seek Covid Pills, Officials Fear Repeat of AIDS Crisis (NYTimes)
  • Europe’s first psychedelic drug trial firm to open in London (The Guardian)
Pharma & Biotech
  • LogicBio's sun and shares rise again after FDA releases clinical hold on pediatric genome editing therapy (Fierce) (Endpoints)
  • From burst bubble to medical marvel: How lipid nanoparticles became the future of gene therapy (STAT)
  • Psoriasis and psoriatic arthritis drugs crisscross categories, but derm and rheum docs split on preferences (Endpoints)
  • After 2 years, Sanofi's drug ingredients spinoff takes flight (Fierce) (Endpoints)
  • Ex-Sanofi CEO on board, a new $158M SPAC debuts looking to shake up the European CDMO market (Endpoints)
  • Belgian eye biotech gets hammered by investors after PhII trial fails efficacy on key endpoints (Endpoints)
  • That big R&D PARP win Clovis CEO Mahaffy touted a few weeks ago? The FDA isn't buying it (Endpoints)
  • Myovant's Myfembree sNDA gets new PDUFA after CRL speculation; InxMed bags more funds for pivotal studies (Endpoints)
  • FDA and its research take aim at thyroid association's guideline on not using levothyroxine generics (Endpoints)
  • A record number of small biotechs are now trading below cash. Is this the bottom yet? (Endpoints)
  • Exclusive: Aspen Neuroscience collects large Series B to compete against Bayer's Parkinson's cell therapy (Endpoints)
  • AstraZeneca, GSK's cancer rival Clovis quietly unveils crippling FDA delay as its troubles deepen (Fierce)
  • Sweeping reorg at Orion — centered around cancer and pain — claims 30 staffers (Endpoints)
  • Consortium to automate cell therapy manufacturing welcomes Thermo Fisher and Charles River Labs (Endpoints)
  • With Sarepta in its sights, PepGen prices IPO to fund DMD trials (Fierce)
  • J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic (BioPharmaDive)
  • Biogen taps digital therapeutics biotech for music-based therapy to help people with MS improve their walking (Endpoints)
  • Getting Out Of A Jam: Titan Medical Pulls Itself From The Brink With Medtronic Deal (MedtechInsight)
  • Insulet to swap CEOs amid Omnipod 5 insulin pump rollout (Fierce)
  • Imagene nets $21.5M for cancer biopsy-scanning AI (Fierce)
  • UK On Cusp Of Integrated Care And New Regulatory Fees But Innovation Adoption Pressures Remain (MedtechInsight)
Government, Regulatory & Legal
  • Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill (Pink Sheet)
  • Spinal Device Co. Inks $1M Midtrial Deal To End FCA Claims (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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you