Recon: WHO cites concerns about Sputnik V plant; GSK’s drug arm to get $11B windfall from consumer spin-off

• FDA documents show struggle over approval of new Alzheimer's drug from Biogen (Reuters) (WSJ) (Boston Globe) (STAT) (Politico)
• Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals (Endpoints)
• Powerful Democrat’s new drug pricing manifesto hints at a carveout for small biotechs (STAT)
• Teva agrees to pay $925,000 to Mississippi to settle generic price-fixing charges (STAT)
• CDC advisers are expected to discuss rare heart problems in vaccinated younger people. (NYTimes)

• WHO cites concerns about Russian Sputnik V plant, which says issues resolved (Reuters)
• From game-changer to back-up: J&J's COVID vaccine struggles in Europe (Reuters)
• Oxford University explores anti-parasitic drug ivermectin as COVID-19 treatment (Reuters)
• Novartis aims to bottle more than 50 mln doses of BioNTech COVID-19 vaccine in 2021 (Reuters)
• GSK's drugs arm to get $11 bln windfall from consumer spin-off (Reuters)
• GSK chief shrugs off concerns over leadership as she outlines vision (FT) (CNBC)
• Consortium of 5 drug regulators plot path to increase harmonization through 2024 (Endpoints)
• Angela Merkel receives Moderna as second jab after AstraZeneca shot (BBC)

• US has only shipped a fraction of pledged vaccine doses overseas as deadline looms (Politico)
• Illicit Covid-19 Drugs Bound for Mexico Seized by US Authorities (WSJ) (The Hill)

• With FDA filing for key gene therapy pushed back 6 months, uniQure opens the pocketbook to refresh the pipeline (Endpoints)
• Yescarta goes to China as Fosun Kite nabs historic first CAR-T OK (Endpoints)
• Sanofi, Translate Bio launch early study of mRNA flu vaccine (PMLive)
• EU approves Janssen’s treatments for amyloidosis and multiple myeloma (Pharmafile)
• A year after getting UniQure's gene therapy, hemophilia patients are still doing better (BioPharmaDive)
• Oncology Accelerated Approval In Spotlight (Again) With US FDA AdComm Review Of Incyte Retifanlimab For Anal Cancer (Pink Sheet)
• Alfasigma snares EU rights to blood clotting antibody on the hunt for patients taking AstraZeneca's Brilinta (Endpoints)
• A Recursion veteran is mapping plant life to chart a course to new therapies — and investors like what they see (Endpoints)
• With a Delaware site codenamed 'Project Dragonfly,' WuXi's STA plans to add 1,200 jobs in US expansion: reports (Fierce)
• Chasing 'Holy Grail' STAT3 target, Houston startup refuels with $74M to zero in on liver cancer (Endpoints)
• Stephen Elledge's Harvard lab again proves fruitful with the launch of high-throughput antibody startup (Endpoints)
• A pair of former MIT researchers think they've unlocked the next generation of mRNA using synbio 'logic circuits' (Endpoints)
• San Francisco-area biotech gets new cash to launch clinical program for congenital sugar processing disease (Endpoints)
• Neurona Therapeutics is dashing to the clinic with its cell therapy for epilepsy — but first, another venture round (Endpoints)
• Third Rock seeds cell therapy startup with $95M in bid to cure MS (Endpoints)
• Investors give Orum Therapeutics' unique take on protein degraders another nudge toward the clinic (Endpoints)
• Sartans Recalled In UK As Further Impurity Is Confirmed (Pink Sheet)

• Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks (MedtechDive)
• BD's at-home drainage system lands first FDA nods spanning both cancerous and benign fluid buildup (Fierce)
• Philips recall could be $300M opportunity for ResMed: analysts (MedtechDive)
• Portable dialysis machine maker Quanta lands $245M to boost U.S. reach (Fierce)
• Meet Hugo: Medtronic's robotic-assisted surgery system makes global debut in Chilean clinic (Fierce)
• Onward Secures FDA Breakthrough Designation To Improve Movement, Quality Of Life After Spinal Cord Injuries (MedtechInsight)
• Peter Bach, industry critic, joins company aiming to make blood tests to detect cancer (STAT)

• C.D. Cal. Dismisses Beovu Failure to Warn Claims (Drug & Device Law)
• Chinese Drug Co. Chief Must Testify In Tainted Valsartan MDL (Law360)
• Vaccine Mandate May Skew Opioid MDL Jury, Pharmacies Say (Law360)
• Jury awards former AstraZeneca sales manager $2.4M in whistleblower retaliation case (Fierce)
• Pharma’s 340B Dispute Resolution Arguments May Get Boost From Supreme Court’s Patent Ruling (Pink Sheet)