Recon: Biden admin endorses COVID vaccine boosters beginning September; Sacklers threaten to exit opioid settlement without immunity

• U.S. health officials recommend booster shots against Covid-19 (AP) (Politico) (NYTimes) (HHS)
• Over 100 lawmakers ask FDA about timeline for vaccines for children (The Hill)
• Purdue's Sackler: family has 'responsibility' to help curb opioid crisis but wants liability shields (Reuters) (Endpoints) (STAT) (Law360) (NYTimes)
• Sesen Bio cancer drug trial marked by misconduct, worrisome side effects, documents show (STAT)
• Breathing Machine Recall Over Possible Cancer Risk Leaves Millions Scrambling for Substitutes (NYTimes)
• Federal Vaccine Program Hasn’t Helped Those Whose Lives Were Altered by Covid Shot (KHN)
• FDA seeks more power for medical device cybersecurity mandates (MedtechDive)

• No need for COVID booster jabs for now, vaccine supplies short – WHO (Reuters)
• Delta surging in areas of low COVID-19 vaccine coverage – WHO (Reuters)
• Third Pfizer dose 86% effective in over 60s, Israeli HMO says (Reuters)
• Russia says Sputnik Light 93.5% effective in Paraguay vaccination campaign (Reuters)

• In a Handful of States, Early Data Hint at a Rise in Breakthrough Infections (NYTimes)
• Joint Statement from Unitaid and the World Health Organization (on behalf of the Access to COVID-19 Tools Accelerator) regarding availability of tocilizumab (WHO)

• Biotech co-founder settles major research misconduct allegations with HHS (Reuters)
• Verily scoops up a fellow software maker as Amy Abernethy scales its clinical trials platform (Endpoints) (STAT)
• Xellia spent $200M and 5 years to fix up former Boehringer site in Cleveland. Now, it’s up and running again (Fierce)
• Bristol Myers' $1.2B discovery pact with Exscientia strikes gold as first drug candidate selected (Fierce)
• Stuart Schreiber’s bid to tackle huge class of crucial proteins nabs another $50M (Endpoints)
• Still reeling from Zejula setback, GlaxoSmithKline gets a breather with expanded PD-1 approval (Endpoints)
• Anger as NICE pauses advice on chronic fatigue syndrome therapy (Pharmafile)
• Calls Grow For New ‘Hispa-NICE’ HTA Agency In Spain (Pink Sheet)
• As use of widely prescribed stimulants increases, experts see troubling parallels to opioid crisis (STAT)
• Touting CD161 as a test case for single-cell tech, Longwood-backed Immunitas bags $58M for next-gen I/O work (Endpoints)
• Vigil Neuroscience raises $90M in neuroscience 'renaissance.' Is an IPO around the corner? (Endpoints)
• Searching for ways to boost CAR-T response, Penn researchers find a capable wingman in BET inhibitors (Endpoints)
• ExeVir doses first patients with llama-derived anti-Covid antibody (Endpoints)
• US FDA Adcomm Modernization Includes How Meetings Are Scheduled (Pink Sheet)
• Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions (Pink Sheet)

• Akili expands its prescription video game portfolio with $37M offer for Tali's attention-improving tech (Fierce)
• Predicting the future of healthcare: 10 takeaways from HIMSS21 (MedtechDive)
• Swing Therapeutics lands FDA breakthrough designation for fibromyalgia platform (Mobihealthnews)
• J&J's DePuy Synthes launches shoulder replacement system geared toward smaller surgical centers (Fierce)
• New MDR And IVDR Implementing Acts Due Imminently (MedtechInsight)
• BrainsWay clinches FDA nod for magnetic stimulation device to ease anxious depression (Fierce)

• DOJ Defends Glenmark, Teva Executive Interviews Abroad (Law360)
• Actavis Drug Didn't Cause Man's Heart Attack, Jury Finds (Law360)
  'No End In Sight' As Endo, Arnold & Porter Reveal Opioid Files (Law360)
• Judge Lets Most Of Xyrem Antitrust Suit Against Jazz Survive (Law360)
• Recent Second Circuit Implied-Preemption Decision Confirms That A ‘Major Change’ Is A Big Deal In Pharmaceutical Litigation (Drug & Device Law)
• 8th Circ. Leaves 3M Surgical Warming Device Verdict In Place (Law360)