Recon: US begins Medicare coverage review for Biogen’s Aduhelm; EU efforts to review Sputnik stymied by data gaps

• FDA adds Guillain-Barre syndrome warning to J&J Covid shot (Politico) (Reuters) (NYTimes)
• US Officials Press Pfizer for More Evidence of Need for Booster Shot (Reuters)
• Top US officials see booster shots as inevitable (Politico)
• US officials say fully vaccinated don't need booster (Reuters)
• US starts national Medicare coverage policy review for Biogen's Aduhelm (Reuters) (Endpoints)
• House committees kick off investigation into Biogen's Aduhelm approval (Endpoints) (STAT)
• Biden’s order would pause a Trump rule forbidding march-in rights to lower drug costs (STAT)
• Congress takes first spending steps, with good news for US research agencies (Science)

• European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps (Reuters)
• J&J, AstraZeneca explore Covid vaccine modification in response to rare blood clots (WSJ) (CNBC)
• EU reviews J&J COVID-19 shot for rare nerve disorder after US warning (Reuters)
• Biogen taps Chinese biotech InnoCare in $125M midstage MS drug pact (Fierce)
• W.H.O. Experts Seek Limits on Human Gene-Editing Experiments (NYTimes)

• ‘Potentially a death sentence’: White House goes off on vaccine fearmongers (Politico)
• Russia's RDIF, India's SII to make Sputnik COVID-19 vaccine in India (Reuters)
• WHO warns against people mixing and matching COVID vaccines (Reuters)
• Vietnam to mix doses of Pfizer, AstraZeneca COVID-19 vaccines (Reuters)
• Sanofi/GSK COVID-19 Vaccine Enters PIII in Japan (PharmaJapan)
• On heels of COVID-19 test recall, Quidel notches a win with CE mark for combined COVID, flu, RSV diagnostic (Fierce)
• Gilead's Veklury shows 'no antiviral effects' against COVID-19 in small WHO study (Fierce)
• Israel partners with NRx Pharmaceuticals to commercialize COVID vaccine (Reuters)
• After questions surrounding funding, ReiThera reveals high antibody response for Covid-19 jab in PhII study (Endpoints)
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• If everyone already knows about a new biotech startup, why does it ‘launch’? (STAT)
• Women Say California Insurer Makes It Too Hard To Get Drug For Postpartum Depression (NPR)
• In multiple myeloma showdown, J&J adds another feather to Darzalex's cap (Endpoints) (FDA)
• Perceptive hits the pricing sweet spot on its latest SPAC, kickstarting the search for next forever partner (Endpoints)
• Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement (Pink Sheet)
• In search of a post-Tecfidera hit for MS, Biogen follows Sanofi, Roche down the BTK path — and bets $125M cash on a drug out of China (Endpoints)
• With Eli Lilly's backing, a team of Seagen veterans with ADC chops is looking to crash the Chinese oncology party (Endpoints)
• David Liu takes the wraps off $315M launch round for Prime Medicine and new CRISPR tech that gave Bob Nelsen a 'holy crap' moment (Endpoints)
• After monthslong lull, Big Pharma should be ready to pounce on M&A as market settles — analysts (Endpoints)
• Ionis pays Bicycle $45M to expand oligonucleotide delivery toolkit (Fierce)
• New Trade Group for Established Drugs to Launch in Japan (PharmaJapan)
• China Signals Further Clinical Trial Policy Tightening (Pink Sheet)

• Australian scientists develop pain-free blood sugar test for diabetics (Reuters)
• 'Contentious meeting' for TransMedics' liver preservation device expected ahead of FDA panel (MedtechDive)
• A decade after EU debut, Stryker's balloon implant for shoulder tears lands stateside with FDA nod (Fierce)
• Guardant nabs chief commercial officer from Gilead as it preps more 'liquid biopsy' rollouts (Fierce)
• AliveCor scores QT prolongation clearance for its portable ECG to track dangerous drug side effects (Fierce)
• FDA clears Carrot's smoking cessation sensor to be used without doctor oversight (mobihealthnews)
• Qiagen slashes full-year forecast as COVID test sales fall 17% in Q2 (Fierce)
• MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief (MedtechInsight)

• Zantac manufacturers off the hook after judge dismisses negligence and failure-to-warn claims in class-action lawsuit (Endpoints)
• Insulin Drug Makers Shed Antitrust Claims In MDL (Law360)
• Allergan Strikes $130M Deal Over Drug Price-Fixing Claims (Law360)
• Daiichi Sankyo Unit Says Rival Infringed IP As Trial Opens (Law360)
• US Trustee Calls For Hold On $29M In Purdue Bonuses (Law360)
• Humanigen, Savant Dispute Over Drug Development Narrowed (Law360)
• Hillrom ordered to complete BardyDx transaction by Delaware court (MedtechDive)
• Lack of Causation Fells Third-Payor Claims in Xarelto MDL (Drug & Device Law)
• Opioid Cos.' Sales Training Misled Doctors, Jury Hears (Law360)