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

• 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)

• 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)

• 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)

• 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)