Recon: Senate finance chair probes AbbVie over corporate tax strategy; Abernethy goes to Verily to head clinical research

| 03 June 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden admin probes risk of low-level contamination in vaccines made at troubled plant (Politico)
  • Ejected from a troubled plant, AstraZeneca is in talks about producing vaccine for US government at another site. (NYTimes) (Reuters)
  • Lawsuit says Bristol-Myers avoided $6.4 bln payment by delaying cancer drug (Reuters)
  • As FDA decides on Biogen drug for Alzheimer’s, patients and families hold out hope (Boston Globe) (Endpoints)
  • GSK scores a win in Zofran case after FDA said pregnancy risk data did not require label changes (Endpoints)
  • FDA Approves Pricey Pill to Treat Vaginal Yeast Infections (NYTimes) (Endpoints)
  • Senate finance chair investigates AbbVie over its corporate tax strategy (STAT) (Endpoints)
  • Unproven stem cell therapy subject to FDA regulation -11th Circ (Reuters) (Endpoints) (Law360)
  • Verily adds former FDA #2 Amy Abernethy as president of clinical research (Endpoints)
  • Sackler Empire Is Poised To Win Immunity From Opioid Lawsuits (NPR)
In Focus: International
  • Britain hosts G7 health summit amid pressure to broaden COVID vaccine access (Reuters)
  • Canada will soon allow vaccine mixing for second doses. (NYTimes)
  • Taiwan says in vaccine talks with Pfizer and J&J (Reuters)
  • India's Serum Institute seeks approval to make Russia's Sputnik V vaccine – 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
  • White House's vaccine push now includes longer pharmacy hours, free childcare — and beer (Politico)
  • White House weighs sending states' unused vaccine doses abroad — before they expire (Politico)
  • Science chief wants next pandemic vaccine ready in 100 days (AP)
  • WHO rules out new 'hybrid' COVID variant in Vietnam – Nikkei (Reuters)
  • Moderna enters supply deal with Botswana for COVID-19 vaccine (Reuters)
  • Valneva's not too late in COVID-19 as analysts eye $1.1B in 2022 vaccine sales (Fierce)
  • Alarm raised over use of antibiotics for UK Covid patients (FT)
  • Pfizer likely to get indemnity in India (Economic Times)
  • Serum Institute seeks indemnity after talks for waiving off liabilities for foreign vaccine makers (Economic Times)
Pharma & Biotech
  • Carl June’s Tmunity encounters a lethal roadblock as 2 patient deaths derail lead trial, raise red flag forcing a rethink of CAR-T for solid tumors (Endpoints) (Fierce)
  • Orchard discreetly axes license for 'bubble boy' gene therapy, despite recent positive long-term data update (Endpoints)
  • How One Biotech Company Narrowed the Gender Gap in Its Top Ranks (Harvard Business Review)
  • Most Americans Support Medicare Negotiation for Drug Prices Despite Claims It Would Hurt Innovation (West Health)
  • CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Helps Drive Numbers, Cavazzoni Says (Pink Sheet)
  • Industry payments to doctors are associated with increased prescribing of long-acting insulin (STAT)
  • The parents hoped an existing drug might keep their kids from having seizures. Then they saw the price (STAT)
  • Relying on an ultra-rare variant, David Liu unveils a new approach to editing sickle cell (Endpoints)
  • Chamath Palihapitiya, the outspoken 'King of SPACs,' turns his eyes to biotech with plans to cash an $800M blank check (Endpoints) (FT)
  • Japan to Establish Ecosystem to Deliver Innovative Drugs: Draft Growth Strategy (PharmaJapan)
  • Nordic Capital acquires ADVANZ PHARMA for $846m (PMLive)
  • NICE draft guidance does not recommend Evrysdi for SMA (PharmaTimes)
  • Novartis’ CAR T therapy Kymriah shows promise in follicular lymphoma (PharmaTimes)
  • Opdivo, Yervoy combination approved to treat malignant pleural mesothelioma (PharmaTimes)
  • Bayer doubles down on radiotherapy with acquisitions of 2 tiny biotech players built around research from Cornell (Endpoints)
  • After flops and setbacks, Auris Medical pivots to RNA with Trasir Therapeutics buyout (Fierce)
  • Salvaging 'ugly fruit': After a series of protein degradation bets, Versant turns to protein stabilization platform out of Columbia (Endpoints)
  • Locking horns with AbbVie, J&J boasts post-TNF data for next-gen drug Tremfya in psoriatic arthritis (Endpoints)
  • #ASCO21: Novartis keeps building out survival data for Kisqali, hoping to add pressure on Pfizer's Ibrance (Endpoints)
  • #ASCO21: Novartis gears up for CAR-T fight with Gilead in follicular lymphoma — and safety could define the battle (Endpoints)
  • BARDA looks to get the jump on next pandemic with VC arm targeting 'transformative' tech (Endpoints)
  • Celltrion's rheumatoid arthritis drug meets both endpoints in PhIII; New company Tribune emerges to take on fibrotic diseases (Endpoints)
  • FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities (MedtechDive) (FDA)
  • FDA OKs Edwards' AI, finger sensor combo to predict dangerously low blood pressures (Fierce)
  • Amid pricing tumult, iRhythm CEO resigns after 4 months in office (MedtechDive)
  • Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers (FDA 1, 2)
  • The Biomed Guys Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
  • MHLW Mulls Sakigake System for SaMD with Medical Device as a Model: Official (PharmaJapan)
  • Deregulation Panel Prods Govt to Fuel SaMD Development (PharmaJapan)
Government, Regulatory & 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 Docs)
  • Anthem Patient Wants 9th Circ. Revival Of Device Denial Suit (Law360)
  • Anticompetitive Drug Rebates May Need FTC Rulemaking For Timely Reform, Commissioners Say (Pink Sheet)
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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