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Regulatory Focus™ > News Articles > 2022 > 4 > Recon: Novartis plans thousands of job cuts in global restructuring; FDA lifts hold on Gilead blood

Recon: Novartis plans thousands of job cuts in global restructuring; FDA lifts hold on Gilead blood cancer trials

Posted 12 April 2022 | By Joanne S. Eglovitch 

Recon: Novartis plans thousands of job cuts in global restructuring; FDA lifts hold on Gilead blood cancer trials

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Gilead Says Hold on NDS and AML Magolimab Studies Lifted (Bloomberg) (Endpoints) (Fierce) (Reuters)
  • FDA warns websites illegally selling ADHD drug Adderall (Reuters)
  • Will Biogen sue Medicare over its restrictions on the Alzheimer’s drug, Aduhelm? And other big legal questions about the decision (STAT)
  • Drug Pricing Takes Over User Fee Hearing – And That Might Be Good News For Industry (The Pink Sheet)
  • Manufacturing problems trigger another clinical hold for troubled Covid-19 vaccine — latest in a string of roadblocks (Endpoints)
  • Hours after Pfizer, Moderna names its own new CFO with dental, healthcare and auto chops (Endpoints)
  • FDA quietly chats with states on drug import plans — signaling Biden isn't ready to dispense with Trump's idea (Endpoints)
  • Mice occupy FDA offices after food left behind in pandemic (Politico)
  • Research Volunteer Protection Rules Move Toward Agency Harmony (Bloomberg)
In Focus: International
  • Novartis to cut thousands of jobs in global revamp (Reuters) (Endpoints)
  • EU Clinical Trial Portal: Commission Reassures On Member States’ Preparedness (The Pink Sheet)
  • How To Transfer Clinical Trial Participants From Ukraine To EU Sites (The Pink Sheet)
  • India Hopes ‘Pharma City’ Will Break China’s Grip on Industry (Bloomberg)
  • A Year's Struggle: How Japan Is Recovering Damaged Generic Supplies After Quality Violations (Scrip)
  • Trade Group Calls For mRNA Vaccines As Guangzhou Starts Lock Downs (Scrip)
  • Korea’s Home-Grown New Drug Approvals Hit Record High In 2021 (The Pink Sheet)
  • One HPV Vaccine Dose Protects Against Cancer, WHO Says (Bloomberg)
Coronavirus Pandemic
  • Some 3 mln COVID vaccine doses to expire in Germany by end of June (Reuters)
  • New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims (NYT)
Pharma & Biotech
  • Myovant and Pfizer’s path to securing a second nod for Myfembree gets hazy — and investors react quickly (Endpoints)
  • Novartis jumps into the KRAS race with a positive early snapshot — and a full slate of trials planned for ambitious bid to unseat Amgen (Endpoints)
  • New antibiotics still a decade away unless policymakers, investors step up, AMR Action Fund CEO warns (Fierce)
  • Carlyle’s acquisition of Abingworth brings $2 billion to fuel life science investments (Fierce)
  • Eyes on the prize: Aurion Biotech raises $120M for ‘global transformation in the cornea (Fierce)
  • AACR: Exuma aims to be first to the clinic with under-the-skin cancer CAR cell-therapy without complex manufacturing (Fierce)
  • Ballooning 340B market reaches almost 15% of 2021 US pharma sales, IQVIA finds (Endpoints)
  • ‘Transient Ischemic Attacks,’ Which Can Be Serious, May Need a New Name (NYT)
  • Pandemic led to fewer adolescents vaccinated against HPV, CDC says (Washington Post)
Medtech
  • All Guns Blazing: Commission Brings Sector Up To Speed With Its MDR/IVDR Implementation Plans (MedTech Insight)
  • Cardiovascular Catch-Up: ACC Brings Encouraging Renal Denervation And TAVR Data For Medtronic (MedTech Insight)
  • Cardiovascular Catch-Up: Philips New AI Finds AF Needle In ECG Haystack; LimFlow Moves Closer To US Approval (MedTech Insight)
  • Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop (MedTech Dive)
Government, Regulatory & Legal
  • Federal appeals court overturns $137M patent verdict against Roche — but the case isn't closed just yet (Endpoints)
  • Bayer, J&J Sue Shanghai Pharma Unit to Block Xarelto Copies (Bloomberg)
  • Otsuka, Lundbeck Sue Viatris to Block Copies of Abilify Maintena (Bloomberg)
  • J&J Unit Trims Mesh False Ad Loss To $302M On Appeal (Law360)
  • Feds Say Holmes Conviction in Theranos Trial Should Stand (Law360)
  • Walgreens Execs Saw Profit in Opioid Crisis, Fla. Jury Told (Law360) (Reuters)
 
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.

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