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Posted 14 June 2022 | by Michael Mezher

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • US FDA advisers weigh Moderna COVID vaccine heart risk for young men (Reuters)
  • FDA Advisers Considering Moderna’s Covid-19 Vaccine for Ages 6 to 17 (WSJ)
  • Alnylam wins FDA approval of rare disease drug in step toward profitability (BioPharmaDive)
  • Amylyx’s ALS drug would be more cost effective if priced around $170,000, pricing watchdog says (Reuters) (STAT)
  • Opinion: Amylyx’s case for approval of its ALS drug isn’t ironclad. Here’s why I think it will still happen (STAT)
  • Eli Lilly wins FDA approval for first-ever treatment for hair loss caused by autoimmunity (STAT) (FDA)

In Focus: International

  • EU states step up pressure on Pfizer to cut unneeded COVID vaccine supplies (Reuters)
  • Canada to suspend vaccine mandates for domestic travel, civil service (Reuters)
  • WHO set to decide if monkeypox represents health emergency (Reuters) (STAT)
  • EU signs deal with Bavarian Nordic for supply of 110,000 monkeypox vaccines (Reuters)
  • Antibiotic drugmakers take steps to self-impose environmental safeguards (Reuters)

Pharma & Biotech

  • CBER to industry: Normal operations will resume in 2023 (Endpoints)
  • BioNTech’s second act: can it transform the fight against cancer? (FT)
  • In early trial, drug shrinks tumors in majority of children with most common form of brain cancer (STAT)
  • Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation (Pink Sheet)
  • While a small sampling, BIO’s third diversity report provides ‘benchmark’ for data-focused industry to further analyze (Endpoints)
  • Cannes Lions 2022: Pharma and health creatives eager to return in person, ready to mingle with mainstream ad crowd (Endpoints)
  • BridgeBio bounces back? Phase 2 readout provides hope for approval of drug to rebalance calcium levels (Fierce)
  • J&J jumps onto Evotec’s receptor platform in drug discovery deal (Fierce)
  • With $1B already in for Dren Bio, Pfizer adds to pile in $65M financing (Fierce)
  • After backdoor attempt, Stealth will try old-fashioned FDA business meeting to save elamipretide (Fierce)
  • German manufacturer hit with Form 483 for multiple production issues (Endpoints)
  • Organon inks $103M deal for pertuzumab and denosumab biosimilars (Endpoints)
  • Chasing Sage, PureTech’s oral depression drug clears early bioavailability test (Fierce)
  • MarketingRx roundup: Pfizer keeps spotlight on JAKs with Cibinqo TV ad; Dexcom amps diabetes awareness in UK effort (Endpoints)
  • Boston startup looks to make a big manufacturing push with new funding round (Endpoints)
  • Following bispecific deal with Pfizer, quiet California biotech raises $65M, heads to the clinic (Endpoints)
  • Ameet Mallik taps fellow Novartis alum to lead business development at ADC Therapeutics (Endpoints)

Medtech

  • FDA, MDIC Eye Technology Clearinghouse For Advanced Manufacturing (MedtechInsight)
  • ResMed to acquire German health software company MediFox for $1B (MedtechDive)
  • Medical device companies to curb spending as recession threat clouds longer-term outlook: analysts (MedtechDive)
  • FDA Issues EUA For First Test That Identifies Coronavirus Strains (MedtechInsight)
  • Commission Offers Glimpse Of Actions To Speed ​​Up MDR Implementation (MedtechInsight)

Government, Regulatory & Legal

  • Klobuchar, Porter call for FTC to investigate price hikes by Janssen, Bristol Myers Squibb (STAT)
  • Compounding pharmacy agrees to stop distributing some drugs (AP)
  • Takeda Unit Warns Fed. about Antibody Patents At Risk (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.


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