Recon: Senate report says AbbVie sheltered profits from US taxes; Merck in talks to acquire Seagen for $40B

Regulatory NewsRegulatory News
| 07 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug (Endpoints) (STAT) (Reuters)
  • Senate Report Hits AbbVie’s Bermuda Tax Structure for U.S. Humira Sales (WSJ) (Washington Post)
  • Mylan Pharmaceuticals faces another recall on insulin injection pens (Endpoints)
  • US government warns health and pharma companies after series of ransomware attacks (Endpoints)
  • U.S. FDA allows pharmacists to prescribe Pfizer's COVID-19 pill (Reuters) (Bloomberg)
  • Drug Price War Gets Agency Buy-Ins as Senate Democrats Push Plan (Bloomberg)
  • In the search for an ARPA-H director, the White House is zeroing in on DARPA veterans (STAT)
  • As new monkeypox cases spike globally, Labcorp rolls out first national lab test (Endpoints)
  • Democrats Plan to Extend Medicare Solvency in New Biden Bill (Bloomberg)
  • Hospitals and for-profit PBMs are diverting billions in 340B savings from patients in need (STAT)
In Focus: International
  • EU drugs regulator open to COVID boosters that target older Omicron offshoots (Reuters)
  • Pace Of Omicron Variants Hindering Work On Adapted COVID-19 Vaccines (The Pink Sheet)
  • Germany: Leaked Pricing Measures Could Have ‘Drastic’ Consequences For Orphans (The Pink Sheet)
  • WHO reports two new monkeypox deaths, cases in new areas (Reuters)
  • Slovakia confirms first case of monkeypox -public health authority (Reuters)
  • WTO faces new battle over COVID tests, drugs (Reuters)
  • Africa CDC says it has signed MOU with Pfizer for COVID pill (Reuters)
Pharma & Biotech
  • Merck Is in Advanced Talks to Buy Seagen for Roughly $40 Billion or More (WSJ) (Biospace)
  • Diamedica Sinks as FDA Places Clinical Hold on ReMEDy2 Trial (Bloomberg)
  • Skyhawk Teams With Sanofi on Oncology and Immunology Targes in Deal Worth Potentially $2 Billion (FDANews)
  • GSK's consumer health spinoff Haleon preps launch with $12B+ in debt (Endpoints)
  • Sarepta, Roche Tout Promising Data for Muscular Dystrophy Gene Therapy (Biospace)
  • Legend scraps early stage CAR-T for lymphoma 6 weeks after clinical hold lifted (Fierce)
  • As ALS patients unite around Amylyx, a new paper hints at potential druggable targets (Endpoints)
  • ‘Unconscious biases’ and lack of trust lead to gaps in routine healthcare for LGBTQ+ community — study (Endpoints)
Medtech
  • European Commission Expects Eudamed To Be Fully Ready By Q2 2024 (MedTech Insight)
  • SD Biosensor agrees to buy Meridian Bioscience for $1.53B in bid to enter U.S. IVD market (MedTech Dive)
  • Cracked, Broken Power Switches Lead To Class I Recall For Getinge Anesthesia Systems (MedTech Insight) (MedTech Dive)
  • DeHealth Applies Blockchain To Medical Data Transactions In Bid For Transparency (MedTech Insight)
  • Insilico Medicine’s AI uncovers 28 new potential targets for ALS (Fierce)
  • Pfizer acquisition target ResApp reels in FDA nod for iPhone app to detect sleep apnea (Fierce)
Government, Regulatory & Legal
  • AstraZeneca Loses Bid to Dismiss Seroquel Pay-for-Delay Lawsuits (Bloomberg)
  • Teladoc, Amwell Settle Patent Suit on Remote Health-Care Tech (Bloomberg)
  • Jury Finds Endo Pharmaceuticals’ Pay-for-Delay Deal Didn’t Break Antitrust Laws (FDAnews)
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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