Recon: Roche CEO to step down after 14 years; WHO to roll out first malaria vaccine in Africa

ReconRecon
| 21 July 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Officials reorganize HHS to boost pandemic response (Washington Post) (Reuters) (Politico)
  • Worried by Supreme Court, U.S. House votes to protect contraception (Reuters)
  • Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief (STAT)
  • President Biden tests positive for Covid-19, but has ‘very mild symptoms’ (STAT)
  • Biogen agrees to pay $900 million to settle whistleblower case alleging kickbacks and sham speaking events (STAT)
  • Test makers urge House, Senate to include diagnostic reforms in user-fee bill (MedtechDive)
  • Vertex to tackle liver disease with Verve, putting up $60M to partner on gene editing program (Fierce)
In Focus: International
  • German vaccine panel to recruit more experts to be more pandemic-minded (Reuters)
  • Germany must prioritise first doses of monkeypox vaccine, experts say (Reuters)
  • Roche’s chief executive to step down and become chair (FT) (Endpoints)
  • Valneva's Covid-19 vaccine contract with Europe collapses to just a fraction of the original deal (Endpoints) (Reuters)
  • UK watchdog fines Pfizer, Flynn Pharma $84 mln for overcharging NHS (Reuters)
  • WHO moves to roll out first malaria vaccine in Africa (Washington Post)
  • Over 285,000 medicines and medical devices seized UK-wide in global action (MHRA)
  • Cambridge biotech Abcam to abandon London listing for Nasdaq (FT)
  • So Far So Good: EU Member States On ‘Limited’ Experience With Clinical Trial Portal (Pink Sheet)
Pharma & Biotech
  • Biosimilar inspections still lagging as the FDA looks to clear its backlog (Endpoints)
  • Parents Become Drug Developers to Save Their Children’s Lives (KHN)
  • 'Like a bulletproof vest': Cancer cells make their own kind of collagen. Can piercing through make treatments better? (Endpoints)
  • Small UK biotech touts long-term data for hemophilia B gene therapy as it attempts a comeback (Endpoints)
  • Spanish heparin manufacturer draws the ire of the FDA in its latest warning over quality concerns (Endpoints)
  • Pfizer, Gilead and others seek clarifications on trial designs outlined in FDA's UC and Crohn's draft guidance (Endpoints)
  • Roche trims out some pipeline failures while flagging a PhIII flop for Tecentriq (Endpoints)
  • Pfizer to make major investment in vaccine R&D and manufacturing site in New York (Endpoints)
  • X4 slashes pipeline, lays off staff just three weeks after netting a $55M PIPE (Endpoints)
  • Study shows AstraZeneca's Covid-19 mAb Evusheld may not work against dominant Omicron strain (Endpoints)
  • John McHutchison throws in the towel on HBV drug, triggering layoffs as Assembly shifts to next-gen approaches (Endpoints)
  • Opinion: 6 ways to bolster FDA’s guidance for diversifying participation in clinical trials (STAT)
  • For ANDAs, Pre-Submission Facility Correspondence Has Improved, But Still Not Ideal (Pink Sheet)
Medtech
  • Smiths Medical’s recall of syringe infusion pumps labeled Class I event after injuries, death (MedtechDive)
  • Masks And Gowns Off FDA Device Shortage List, But AEDs Among Devices Added (MedtechInsight)
  • Multiplex IVDs Position Paper Could Help Relieve Pressure On Notified Bodies (MedtechInsight)
  • Abbott’s Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain (MedtechDive)
  • Boston Scientific Brings Remote Clinical Support To Europe, Africa And Middle East (MedtechInsight)
Government, Regulatory & Legal
  • Medicare pays $700M+ annually for discarded drugs. That's about to change (Endpoints)
  • Impax Inks $145M Deal With Direct Purchasers In Opana MDL (Law360)
  • Two Florida Medical Study Coordinators Plead Guilty in Connection with Scheme to Falsify Clinical Trial Data (DoJ)
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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