Recon: WHO cites concerns about Sputnik V plant; GSK’s drug arm to get $11B windfall from consumer spin-off
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
