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2nd July 2021
by Michael Mezher

Recon: GSK, Alector in $2.2B deal for Parkinson’s, Alzheimer’s drugs; Merck to withdraw accelerated approval for Keytruda in 3rd-line gastric cancer

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • J&J's COVID-19 vaccine shows promise against Delta variant (Reuters)
  • Does new Alzheimer’s drug work? Answers may miss 2030 target (AP)
  • Merck to withdraw dangling accelerated approval for Keytruda in third-line stomach cancer (Endpoints) (Press)
  • Pharma in the crosshairs: How the FTC is expanding its antitrust powers under its new chair (Endpoints) (FTC)
  • US cancer drug prices were higher at launch than in three European countries — and just kept climbing (STAT)
In Focus: International
  • GSK, Alector to develop Parkinson's, Alzheimer's drugs in $2.2 bln deal (Reuters) (Bloomberg)
  • GSK rejects activist Elliott's demands for board and consumer business (Reuters)
  • Nestlé Health Science will split profits from Seres microbiome drug, if it’s approved (STAT)
  • WHO welcomes report on efficacy of longer gaps between AstraZeneca doses (Reuters)
  • EU working to allow acceptance of AstraZeneca's India vaccine jab, Commission says (Reuters)
  • Novavax says Taiwan has opted to get firm's COVID-19 vaccine via COVAX (Reuters)
  • Germany alters vaccine mix to better tackle Delta variant (Reuters)
  • Servier Beats NHS' £220M Drug IP Suit At Top UK Court (Law360)
Coronavirus Pandemic
  • Opinion: It’s Time for the FDA to Fully Approve the mRNA Vaccines (NYTimes)
  • Zydus Cadila seeks emergency use nod for its 3-dose vaccine (Economic Times)
Pharma & Biotech
  • European Commission clears AstraZeneca's $39B bid for Alexion and a future in rare diseases (Endpoints)
  • US FDA Wades Into Reimbursement Issues With Upcoming Stakeholder Meeting On Alzheimer’s Drug Coverage, Evidence Challenges (Pink Sheet)
  • A New Era For FDA Regulation Of Cell And Tissue Products (Law360)
  • Some Generics May Get To Skip Fed Study Requirement If US FDA Research Pans Out (Pink Sheet)
  • Ultra-Rare Disease Approvals By US FDA Could Take More ‘Mechanistic,’ Less ‘Empirical’ Approach (Pink Sheet)
  • The 'dovetail' partnership meant to turn Boston Children's into a hub for gene therapy startups (BioPharmaDive)
  • Regeneron’s George Yancopoulos talks CRISPR, obesity drugs, and the next generation of Covid antibody cocktails (STAT)
  • Lundbeck sells off flopped Alzheimer's drug as Aduhelm approval ups interest (Fierce)
  • Amgen recruits renowned cancer drug investigator Jean-Charles Soria to lead a growing pipeline play (Endpoints)
  • Rinvoq scores positive results as a maintenance therapy for ulcerative colitis (PharmaTimes)
  • WuXi will add 500 jobs at Delaware manufacturing campus as it looks to bolster its CDMO arm (Endpoints)
  • Years after bankruptcy, Dendreon adds a contract manufacturing wing (Endpoints)
  • Evotec expands presence in Italy with acquisition of former GlaxoSmithKline R&D site (Endpoints)
  • The class of molecules behind one of biotech's biggest Alzheimer's failures gets a new lease on life (Endpoints)
  • Sirnaomics puts off an IPO a little longer as it pockets another megaround. Is an S-1 around the corner this time? (Endpoints)
  • Arrowhead slams brakes on early-stage cystic fibrosis study after rat study triggers lung inflammation concerns (Fierce)
Medtech
  • FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again (MedtechInsight)
  • PMA apps could hit record in 2021, pressuring a COVID-19 stressed FDA (MedtechDive)
  • Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods (MedtechDive)
  • EU HTA Regulation: ‘Another Layer Of Bureaucracy For Medtech To Overcome’ (MedtechInsight)
  • EchoNous shoots for the stars with $60M for Kosmos handheld, AI-powered ultrasound (Fierce)
  • With updated European approval, NuVasive eyes late summer launch for new spine surgery platform (Fierce)
  • Abbott racks up 2 more US, EU approvals for Xience family of drug-eluting stents (Fierce)
  • Scientists devise a battery-free pacemaker that can be absorbed by the body (STAT)
Government, Regulatory & Legal
  • Retailers, Pharmacies Freed From Zantac Personal Injury MDL (Law360)
  • Mylan sues generic rival Teva over 'sophisticated scheme' to block Copaxone copycats (Fierce)
  • Masimo accuses Apple of patent infringement (mobihealthnews)
  • MHLW Urges Wholesalers to Strictly Enforce Legal Compliance after Bid-Rigging Ruling (PharmaJapan)
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.