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September 30, 2020
by Michael Mezher

Recon: House kicks off two-day hearing on drug prices; Moderna COVID-19 vaccine appears safe in early study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna COVID-19 vaccine appears safe, shows signs of working in older adults (Reuters) (NEJM)
  • All Eyes Are on Pfizer as Trump Pushes for Vaccine by October (NYTimes)
  • Trump’s debate highlights his hunger for a rushed, election-eve vaccine approval (STAT)
  • Trump claims his policies made insulin ‘so cheap, it’s like water.’ But for most people, it costs just as much as before (STAT)
  • House panel says drugmakers inflated prices to boost profits and reap bonuses (Politico) (STAT)
  • Unsustainable Drug Prices: Testimony from the CEOs (House Oversight and Reform)
  • Regeneron’s Covid-19 antibody may help non-hospitalized patients recover faster, early data show (STAT)
  • Democrats eye Wednesday vote on $2.2T COVID-19 relief bill (The Hill)
  • Congress Set To Approve CR, Freezing FDA Spending Level For Next Three Months (MedtechInsight)
In Focus: International
  • China Greenlights Another Covid-19 Vaccine for Human Testing (WSJ) (Reuters)
  • WHO chief urges more countries to join COVAX as death toll exceeds 1 million (Reuters)
  • UN chief: time for national plans to help fund global COVID-19 vaccine effort (Reuters)
  • Oxford to study anti-inflammatory drug Humira as potential COVID-19 treatment (Reuters)
  • CureVac plans global late-stage COVID-19 vaccine trial in fourth quarter (Reuters)
  • Russia completes clinical trials of second potential COVID-19 vaccine: RIA (Reuters)
  • 15-minute coronavirus test gets the green light in Europe (CNBC)
  • Pfizer infuses $200M into CStone, scoring a second PD-L1 and outlining a sprawling China pact (Endpoints)
Coronavirus Pandemic
  • GlaxoSmithKline CEO optimistic COVID-19 vaccine widely available in 2021 (Reuters)
  • How Operation Warp Speed's Big Vaccine Contracts Could Stay Secret (NPR)
  • On the road with Operation Warp Speed, the U.S. COVID-19 vaccine effort (Science)
  • Lonza confident of 2020 target for Moderna COVID-19 vaccine supply (Reuters)
  • Huge Study of Coronavirus Cases in India Offers Some Surprises to Scientists (NYTimes)
  • What We Know About the Airborne Spread of the Coronavirus (KHN)
  • Patents Not 'Barrier' To COVID-19 Vaccine Access, Iancu Says (Law360)
  • Trump-touted hydroxychloroquine shows no benefit in COVID-19 prevention: study (Reuters)
  • Relief Therapeutics announces supply deals while awaiting COVID-19 trial data (Reuters)
  • Testing devices for COVID-19: Antigen testing devices (Health Canada)
  • ANVISA suspends expedited registrations for COVID-19 products (Emergo)
  • MHLW Urges Healthcare Stakeholders to Comply with Distribution Guidelines Even in COVID-19 Outbreak (PharmaJapan)
Pharma & Biotech
  • New research shows older adults are still often excluded from clinical trials (STAT)
  • 5 FDA approval decisions to watch in the 4th quarter (BioPharmaDive)
  • BioIndustry Association Slams New UK Guidance On Batch Testing (Pink Sheet)
  • UnitedHealth has acquired DivvyDose, a competitor to Amazon’s PillPack (CNBC)
  • Where are the bugs? FDA knocks Indian manufacturer for 'crude' microbe testing (Fierce)
  • Fujifilm Kyowa Kirin’s Avastin Biosimilar Approved in Europe (PharmaJapan)
  • MHLW’s Health Policy Bureau Requests New Budgets to Forge Clinical Trial Network in Asia (PharmaJapan)
  • NICE gives go-ahead for Sandoz's Rizmoic to treat opioid-induced constipation (Pharmafile)
  • MHRA deems Sanofi’s avalglucosidase alfa ‘promising’ for Pompe disease (PharmaTimes)
  • Alnylam phase 3 links lumasiran to 'clinically significant' improvement in infants (Fierce)
  • Takeda taps Elektrofi's microparticle delivery platform for potential subq plasma offerings (Fierce)
  • For two decades, the FDA approval process for opioids had numerous shortcomings, study finds (STAT)
  • Brent Saunders rides $400M wave to the top of the SPAC boom (Endpoints)
  • RNAi trailblazer Alnylam teases more positive data for a potential third commercial drug (Endpoints)
  • A pharma exec gets $100M to chase a cancer-fighting idea uncovered in a 2017 Novartis study (Endpoints)
  • News briefing: Ovid shows mixed results on epilepsy program; Iliad reports positive whooping cough data (Endpoints)
  • BARDA boosts the fight against antibiotic-resistant infections with $144M awards (Endpoints)
  • Jeffrey Bluestone recruits a trio of biopharma vets to the startup team at Sonoma — while adding $30M to the launch round (Endpoints)
Medtech
  • Medtronic to expand dialysis access position with Avenu Medical buyout (MedtechDive)
  • Medtech M&A exploded in August and September. Will 2020 go out with a bang? (MedtechDive)
  • Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra (MedtechDive)
  • Head Of New Digital Health Center Looking For A Few Good FDA Staff (MedtechInsight)
Government, Regulatory & Legal
  • Judge allows $1.5 billion Tamiflu stockpiling lawsuit against Roche to go ahead (Pharmafile)
  • Surgery Robot Maker Accused Of Banning Third-Party Repairs (Law360)
  • J&J, Mallinckrodt Push For Stay Of NY Opioid Fraud Cases (Law360)
  • 3rd Circ. Vexed By Vagueness In Abbott Artery Device Suit (Law360)
  • Full Fed. Circ. Won't Undo Sandoz Loss In Patent Fight (Law360)
  • Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020) (Patent Docs)
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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