Recon: Novartis plans thousands of job cuts as part of global restructuring; FDA lifts stranglehold on Gilead’s blood

Posted on April 12, 2022 | By Joanne S. Eglovitch

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

In brief: United States

  • Gilead announces the termination of the NDS and AML Magolimab studies (Bloomberg) (Endpoints) (Fierce) (Reuters)
  • FDA warns of websites illegally selling ADHD drug Adderall (Reuters)
  • Will Biogen sue Medicare over restrictions on Alzheimer’s drug Aduhelm? And other big legal questions about the decision (STAT)
  • Drug pricing is taking over the user fee hearing – and that could be good news for the industry (The pink leaf)
  • Manufacturing issues trigger another clinical hold for the struggling Covid-19 vaccine – the latest in a series of roadblocks (Endpoints)
  • Hours after Pfizer, Moderna appoints its own new CFO with dental, healthcare and automotive chops (Endpoints)
  • The FDA is quietly discussing drug import plans with states – signaling that Biden is not ready to dispense with Trump’s idea (Endpoints)
  • Mice occupy FDA offices after leaving food during pandemic (Politics)
  • The rules for the protection of research volunteers are evolving towards the harmony of the agency (Bloomberg)

Focus: International

  • Novartis will cut thousands of jobs as part of a global overhaul (Reuters) (Endpoints)
  • European Clinical Trials Portal: the Commission reassures on the state of preparation of the Member States (The pink leaf)
  • How to transfer clinical trial participants from Ukraine to EU sites (The pink leaf)
  • India hopes ‘Pharma City’ will break China’s grip on the industry (Bloomberg)
  • A Year of Struggle: How Japan Recovers Damaged Generic Supplies After Quality Violations (Certificate)
  • Trade group demands mRNA vaccines as Guangzhou begins lockdown (Certificate)
  • Approvals of new local drugs in Korea hit an all-time high in 2021 (The pink leaf)
  • One dose of HPV vaccine protects against cancer, according to WHO (Bloomberg)

coronavirus pandemic

  • Some 3 million doses of the COVID vaccine will expire in Germany by the end of June (Reuters)
  • A new drug has reduced the number of deaths among patients with severe Covid, the manufacturer claims (NYT)

Pharmaceuticals and biotechnology

  • Myovant and Pfizer’s path to getting a second nod to Myfembree is becoming unclear – and investors are reacting quickly (Endpoints)
  • Novartis jumps into the KRAS race with a positive first snapshot — and a full slate of trials planned for an ambitious bid to topple Amgen (Endpoints)
  • There is still a decade left for new antibiotics unless policymakers and investors step in, warns the CEO of AMR Action Fund (Fierce)
  • Carlyle’s acquisition of Abingworth brings $2 billion to fuel investment in life sciences (Fierce)
  • Eyes on the Prize: Aurion Biotech Raises $120 Million for “Global Cornea Transformation” (Fierce)
  • AACR: Exuma aims to be the first to the clinic with CAR cell therapy of cancer under the skin without complex manufacturing (Fierce)
  • The 340B hot air balloon market reaches nearly 15% of US pharmaceutical sales in 2021, according to IQVIA (Endpoints)
  • “Transient ischemic attacks,” which can be severe, may need a new name (NYT)
  • The pandemic has led to fewer teens being vaccinated against HPV, according to the CDC (Washington Post)

medical technology

Government, regulation and legal

  • Federal appeals court overturns $137 million patent verdict against Roche – but the case is not yet closed (Endpoints)
  • Bayer, J&J Sue Shanghai Pharma Unit to block copies of Xarelto (Bloomberg)
  • Otsuka and Lundbeck sue Viatris to block copies of Abilify Maintena (Bloomberg)
  • J&J Unit Reduces Mesh Fake Ad Loss to $302 Million on Appeal (Law360)
  • Feds say Holmes conviction in Theranos trial should stand (Law360)
  • Walgreens executives made profits in Florida’s opioid crisis. Jury Told (Law360) (Reuters)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© 2022 Society of Regulatory Affairs Professionals.

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