Regulatory Focus™ > News Articles > 2021 > 9 > Recon: US buys additional doses of Lilly, Regeneron antibodies; Centrists throw wrench in House Dems

Recon: US buys additional doses of Lilly, Regeneron antibodies; Centrists throw wrench in House Dems' drug pricing plans

Posted 15 September 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech                                                                                                     
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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