Recon: US buys additional doses of Lilly, Regeneron antibodies; Centrists throw wrench in House Dems' drug pricing plans
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed (Reuters)
- Pfizer says third COVID-19 shot warranted in FDA document (Reuters)
- Biden to meet US CEOs in 'rallying cry' for vaccine mandates (Reuters)
- Centrists throw wrench in House Democrats’ drug pricing plans (Politico) (STAT) (NYTimes)
- Key senator opposes Democrats’ target for drug pricing savings (STAT)
- US buys additional doses of Eli Lilly, Regeneron COVID-19 therapy (Reuters)
- AbCellera and Moderna team up to develop antibody therapies (Reuters)
- Biden's team tightens grip on state use of Covid antibody treatments (Politico)
- Pfizer to apply for US vaccine approval for younger children in November (FT)
- Facing pressure from ALS patients and advocates, the FDA does about-face on review of potential treatment (STAT) (Endpoints)
- MHRA statement on COVID-19 booster vaccines (MHRA)
- Brussels lobbyists waged war against Pfizer jab in favour of European rivals (The Telegraph)
- EU to donate another 200 mln COVID-19 vaccine doses (Reuters)
- Cuba seeks WHO approval of COVID-19 vaccines as toddlers next for shot (Reuters)
- Biden administration pressuring India to restart vaccine exports: report (The Hill)
- WHO reports first drop in global infections in two months (The Hill)
- Biden Admin. Hit With 1st State AG Suit Over Vax Mandate (Law360)
- Russia's Sputnik V vaccine shows 97.2% COVID-19 efficacy in Belarus – RDIF (Reuters)
- China has fully vaccinated 91% of students aged 12-17 against COVID -state media (Reuters)
- Saudi Arabia signs agreements with Pfizer and AstraZeneca -SPA (Reuters)
- Five months after getting slapped with a clinical hold, KalVista gets the OK to restart oral HAE program (Endpoints)
- CEOs of AbbVie, BMS, Lilly, GSK and more raise concerns about Washington's intensifying drug-pricing push (Fierce)
- Theravance to lay off 75% of employees alongside larger restructuring (BioPharmaDive)
- Pain player Allay makes good on launch promises, locking down latest fundraising round to advance lead implant (Endpoints)
- Boston, the Bay Area and San Diego dominate the life sciences real estate market. Where to next? (Endpoints)
- Novo Nordisk Foundation teams up with Broad Institute, Harvard for diabetes, obesity research hub (Fierce)
- Citing 'less-than-optimal' outcomes for Roche's Evrysdi, Biogen launches high-dose Spinraza trial (Fierce)
- Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion (Pink Sheet)
- Back-to-back pivotal failures force Theravance to lay off 270 staffers, prune R&D focus (Endpoints)
- Three more biotechs hit Nasdaq as the sector, now with more than $13B raised, continues barreling toward record (Endpoints)
- NICE backs Opdivo for head and neck cancer (PharmaTimes)
- SMC OKs three new meds in latest decisions (PharmaTimes)
- Allay Therapeutics rakes in $60M for ‘tunable’ non-opioid treatment for joint replacement pain (Fierce)
- Medtechs are boosting DTC investment, but industry still years behind pharma (MedtechDive)
- FDA Slaps Class I Label On Recall Of Eco-Med Ultrasound Gels, Lotions (MedtechInsight)
- Zimmer latest medtech to warn of delta wave drag in Q3 (MedtechDive)
- Australian medtech startup emerges from stealth, unveils tomographic ultrasound robot (MobiHealthNews)
- Mesa Labs puts $300M on the table for genetic testing developer Agena Bioscience (Fierce)
- Generics Group, Intel Back Mylan's Fintiv Fight At High Court (Law360)
- Patent board issues split decision on key neuromod IP in Medtronic-Axonics dispute (MedtechDive)
- 'Red Flag' Expert's Opinion Limited In Opioid MDL (Law360)
- Apotex, Mylan Urge Full Fed. Circ. To Ax Cancer Drug Patent (Law360)
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