Regulatory Focus™ > News Articles > 2022 > 5 > Recon: Teva, Allergan willing to pay $5B to settle opioid suits; FTC tells Medtronic to divest Fiago

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Posted 11 May 2022 | By Michael Mezher 

Recon: Teva, Allergan willing to pay $5B to settle opioid suits; FTC tells Medtronic to divest Fiagon in Intersect takeover

2869 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer's $11.6 bln Biohaven buy could spark more biotech deals (Reuters)
  • Arkansas sues drugmakers, pharmacy benefit managers over insulin costs (Reuters)
  • Moderna CFO exits a day after taking charge as former employer launches probe (Reuters)
  • J&J appoints consumer health head Thibaut Mongon to CEO of spun-off business (Reuters)
  • Teva, Allergan Willing to Pay $5 Billion for Opioid Accord (Bloomberg)
  • CDER Launches New Accelerating Rare disease Cures (ARC) Program (FDA)
  • FTC tells Medtronic to divest Fiagon to clear barrier for $1.1B Intersect takeover (MedtechDive)
  • U.S. drug overdose deaths surpass 107,000 last year, another record (Politico) (NYTimes)
  • FDA user fee reauthorizations turns into a bipartisan lovefest at House hearing (Endpoints)
In Focus: International
  • Blow to Roche's cancer immunotherapy prospects as 2nd trial fails (Reuters) (STAT)
  • Japan's Takeda forecasts rebound despite full-year profit drop (Reuters)
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  • Is It Tougher To Conduct Decentralized Trials In The EU? ‘Don’t Fall Prey To Negative Narrative’ (Pink Sheet)
  • Novo Nordisk, Flagship's forward-thinking partnership aims to treat cardiometabolic, rare diseases (Fierce)
  • Why a controversial patent rights waiver could be a ‘missed opportunity’ to tackle the next pandemic (STAT)
  • WHO calls on Pfizer to make its COVID pill more available (AP)
Pharma & Biotech
  • Some patients reporting COVID rebounds after taking Pfizer pills (Reuters)
  • In first, Verve gets clearance to test base editing inside the body (BioPharmaDive)
  • US FDA Aims To Simplify Terminology For Remote Assessments (Pink Sheet)
  • A new biotech investment firm, headed by a pair of noteworthy VCs, seeks to ‘free the founders’ (STAT)
  • Wisconsin giving Arrowhead Pharmaceuticals some cheddar as their new manufacturing site receives several million in state and local tax benefits (Endpoints)
  • After failed SPAC and phase 3 fumble, Amicus gene therapy hits another delay to approval (Fierce)
  • Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas (Fierce)
  • AstraZeneca and Sanofi sharpen RSV pitch with new analyses, but how much weight will FDA give them? (Endpoints)
  • Iterum says FDA is in 'general alignment' on proposed new PhIII for rejected uUTI drug (Endpoints)
  • Artificial Intelligence Is Future Of Postmarketing Surveillance, US FDA’s Marks Says (Pink Sheet)
  • US FDA’s Current Technical Standards Not A Good Fit For Real-World Data, Stakeholders Say (Pink Sheet)
  • Transfusion of brain fluid from young mice is a memory-elevating elixir for old animals (STAT)
  • Cytiva's latest project to open in Switzerland at the end of the month (Endpoints)
Medtech
  • Rising Google searches for procedures suggest recovering demand at medtechs: analysts (MedtechDive)
  • Triple threat: Varian, HP and Adaptiiv form 3D printing pact to improve radiation therapy (Fierce)
  • BD, Babson set sights on bringing simple blood collection into the home (Fierce)
Government, Regulatory & Legal
  • Teva faces $100M lawsuit from Israel over unpaid Copaxone royalties: report (Fierce)
  • Gilead Slaps Rivals With Patent Suit Over HIV Drug (Law360)
  • Jury Awards Nearly $334M To MGI Tech In Illumina Patent Suit (MedtechInsight)
  • Pharma showers John Thune with campaign cash (STAT)
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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