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

• 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)

• 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)

• 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)

• 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)

• 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)