Recon: Senate finance chairman polls AbbVie on corporate tax strategy; Abernethy goes to Verily at h

Posted on June 03, 2021 | Through Michel mezher

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

Focus: United States

  • Biden administrator probes risk of low-level contamination in vaccines made at ailing factory (Politics)
  • Ejected from a struggling factory, AstraZeneca is in talks to produce a vaccine for the US government at another site. (NY Times) (Reuters)
  • Lawsuit says Bristol-Myers avoided $ 6.4 billion payment by delaying cancer drug (Reuters)
  • As FDA decides on Alzheimer’s drug Biogen, patients and their families remain hopeful (Boston Globe) (End points)
  • GSK Gets Victory in Zofran Case After FDA Says Data on Pregnancy Risk Does Not Require Label Changes (End points)
  • FDA approves expensive pill to treat vaginal yeast infections (NY Times) (End points)
  • Senate Finance Chairman is investigating AbbVie over its corporate tax strategy (STAT) (End points)
  • Unproven stem cell therapy subject to FDA regulation -11th Circ (Reuters) (End points) (Law360)
  • Verily adds former FDA # 2 Amy Abernethy as Clinical Research President (End points)
  • Sackler Empire is set to gain immunity from opioid lawsuits (NPR)

Focus: international

  • Britain hosts G7 health summit amid pressure to expand access to COVID vaccine (Reuters)
  • Canada will soon allow mixing of vaccines for second doses. (NY Times)
  • Taiwan says in vaccine talks with Pfizer and J&J (Reuters)
  • Indian Serum Institute seeks approval to manufacture Russian vaccine Sputnik V – sources (Reuters)
  • Hungary in talks with Russia to produce Sputnik V vaccine (Reuters)
  • Japan plans to donate 1.2 million AstraZeneca COVID-19 vaccines to Taiwan – NHK (Reuters)

Coronavirus pandemic

  • The White House vaccination campaign now includes longer pharmacy hours, free child care – and beer (Politics)
  • The White House weighs unused vaccine doses from sending states abroad – before they expire (Politics)
  • Chief scientist wants next pandemic vaccine to be ready in 100 days (PA)
  • WHO rules out new ‘hybrid’ COVID variant in Vietnam – Nikkei (Reuters)
  • Moderna signs supply agreement with Botswana for COVID-19 vaccine (Reuters)
  • Valneva is not too late in COVID-19 as analysts forecast $ 1.1 billion in vaccine sales in 2022 (Fierce)
  • Alarm triggered by the use of antibiotics for UK Covid patients (FT)
  • Pfizer is likely to be compensated in India (Economic times)
  • Serum Institute seeks compensation after talks to waive liability of foreign vaccine makers (Economic times)

Pharma & Biotech

  • Carl June’s Tmunity Encounters Deadly Roadblock As Death Of 2 Patients Derails Main Trial, Raises Red Flag Forcing To Rethink CAR-T For Solid Tumors (End points) (Fierce)
  • Orchard is quietly axing a license for ‘bubble boy’ gene therapy, despite the recent positive long-term data update (End points)
  • How a biotech company narrowed the gender gap in its top ranks (Harvard business review)
  • Most Americans support Medicare’s negotiation of drug prices despite claims it would hurt innovation (Western health)
  • CDER hiring is booming: The flexibility of remote working during the pandemic is helping to boost the numbers, says Cavazzoni (Pink sheet)
  • Industry payments to physicians have been associated with increased prescriptions for long-acting insulin (STAT)
  • Parents hoped that an existing drug could prevent their children from having seizures. Then they saw the price (STAT)
  • Based on an ultra-rare variant, David Liu unveils a new approach to sickle cell editing (End points)
  • Chamath Palihapitiya, the outspoken ‘king of SPAC’, turns to biotechnology with the intention of cashing a blank check for $ 800 million (End points) (FT)
  • Japan to Establish Ecosystem to Provide Innovative Medicines: Draft Growth Strategy (PharmaJapan)
  • Nordic Capital acquires ADVANZ PHARMA for $ 846 million (PMLive)
  • The NICE guidance project does not recommend Evrysdi for SMA (PharmaTimes)
  • Novartis Kymriah’s CAR T therapy shows promise in follicular lymphoma (PharmaTimes)
  • Opdivo, Yervoy combination approved for the treatment of malignant pleural mesothelioma (PharmaTimes)
  • Bayer doubles radiotherapy with the acquisition of 2 tiny players in biotechnology built around Cornell’s research (End points)
  • After failures and setbacks, Auris Medical turns to RNA with the takeover of Trasir Therapeutics (Fierce)
  • Recovering “ugly fruits”: After a series of bets on protein degradation, Versant turns to Columbia’s protein stabilization platform (End points)
  • Locking the horns with AbbVie, J&J claims post-TNF data for next-generation psoriatic arthritis drug Tremfya (End points)
  • # ASCO21: Novartis continues to build survival data for Kisqali, in hopes of increasing pressure on Pfizer’s Ibrance (End points)
  • # ASCO21: Novartis gears up for CAR-T fight with Gilead in follicular lymphoma – and security could define the battle (End points)
  • BARDA seeks to gain the upper hand over the next pandemic with the VC arm targeting ‘transformative’ technology (End points)
  • Celltrion’s rheumatoid arthritis drug meets both endpoints in PhIII; The new Tribune company is born to tackle fibrotic diseases (End points)


  • FDA warns device makers against falsified records at Italian ethylene oxide sterilization facilities (MedtechDive) (FDA)
  • FDA approves Edwards’ AI and finger sensor combo to predict dangerously low blood pressures (Fierce)
  • Amid the price tumult, iRhythm CEO resigns after 4 months in office (MedtechDive)
  • Discontinuing New Medtronic HVAD System Implants – Letter to Healthcare Providers (FDA 1, 2)
  • The Biomed Guys is recalling the scope of the Alaris 8100 Infusion Pump Module due to the possibility of cracked or separated scope repair posts (FDA)
  • MHLW Mulls Sakigake System for SaMD with medical device as model: official (PharmaJapan)
  • The deregulation panel urges the government to fuel the development of SaMD (PharmaJapan)

Government, Regulation and Legal

  • Kentucky accuses CVS Health of fueling opioid crisis in new lawsuit (The hill)
  • Bio-Rad Laboratories, Inc. v. International Trade Comm. (Fed. Cir. 2021) (Patent documents)
  • Hymn Patient Wants 9th Circ. Revival Of Device Denial Suit (Law360)
  • Discounts on anti-competitive drugs may require FTC regulation for timely reform, Commissioners say (Pink sheet)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

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

© 2021 Society of Regulatory Affairs Professionals.

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