Recon: COVAX launches marketplace for vaccine inputs; UK fines 13 drug firms £260M for overcharging NHS
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval (STAT) (Reuters) (CNBC)
- Cleveland Clinic and Mount Sinai Won’t Administer Aduhelm to Patients (NYTimes)
- The ins and outs of the rare, controversial way Medicare might pay for Aduhelm (STAT)
- UnitedHealth says needs more information to decide on coverage policy for Biogen's Alzheimer's drug – CEO (Reuters)
- J&J recalls sunscreens after carcinogen found in some sprays (Reuters) (NYTimes)
- Senate Democrats eye drug pricing policies to fund $3.5 trillion budget deal (STAT) (KHN)
- Tapping Into the Brain to Help a Paralyzed Man Speak (NYTimes)
- Galapagos shares sink as first data from touted drug program disappoints (BioPharmaDive)
- Covax launches marketplace for Covid vaccine inputs to boost production (FT)
- Britain fines drug firms after steroid price for NHS rises over 10,000% (Reuters) (FT)
- Africa Sidesteps FDA’s Warning on J&J Vaccine as Cases Surge (Bloomberg)
- COVID-19 deaths in Africa surge 43% week-on-week, WHO says (Reuters)
- Fosun-BioNTech COVID-19 vaccine completes China regulator review – media (Reuters)
- Hong Kong biotech start-up Prenetics plans $1.3 billion SPAC merger (CNBC)
- EU regulator reviewing Moderna COVID shot for auto-immune blood condition (Reuters)
- Illumina, Grail deal faces full-scale EU antitrust probe -sources (Reuters) (Fierce)
- The WHO's Chief Says It Was Premature To Rule Out A Lab Leak As The Pandemic's Origin (NPR) (Reuters)
- ICMRA Discussing Substitutes for Placebo-Controlled Trials of COVID Vaccines: MHLW (PharmaJapan)
- WHO panel advises against COVID-19 vaccination proof for travel (Reuters)
- Pfizer, Johnson and Johnson yet to apply for COVID-19 vaccines licence in India: Sources (Economic Times)
- Global agencies sign tech transfer deals to boost COVID testing in Africa, Latam (Reuters)
- Vietnam approves Johnson & Johnson's COVID-19 vaccine as daily cases hit record (Reuters)
- Malaysia to stop using Sinovac vaccine after supply ends – minister (Reuters)
- Pfizer says only in talks with government bodies in Thailand (Reuters)
- Homeopathic Doctor Is Charged With Selling Fake Covid-19 Vaccine Cards (NYTimes)
- Covid Is Especially Risky for People With H.I.V., Large Study Finds (NYTimes)
- FDA new drug approvals in Q2 2021 (Nature)
- The Pandemic Has Worsened Childhood Vaccination Rates Around The World (NPR)
- Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value: report (Fierce)
- A cancer drug startup banks new funds for NK cell therapy (BioPharmaDive)
- Takeda, AbbVie, BMS, Sanofi, Lilly and others join growing tally of pharma's July price hikes: report (Fierce)
- With fewer than 400 progeria patients worldwide, testing a CRISPR cure will be challenging (STAT)
- Merck’s MET inhibitor tepotinib gains positive opinion from MHRA (PharmaTimes)
- Cancer Research UK reports ‘most successful financial year’ for its spinouts (PharmaTimes)
- Vertex Inks New Cystic Fibrosis Deals In Europe (Pink Sheet)
- Ribon Therapeutics is looking to break the mold for PARP inhibitors and has a slate of Big Pharma backers on board (Endpoints)
- Trial software group raises $45M to push decentralized studies; $120M SPAC makes its way to Nasdaq (Endpoints)
- Banking on shared experiences — and now a big investor — with brother Vivek, Shankar Ramaswamy stacks up a $100M mega-round (Endpoints)
- Tom Lynch moves to restructure Fred Hutch as academia, industry continue to push cell therapy into solid tumors (Endpoints)
- EXCLUSIVE: Shape Therapeutics raises $112M in bid to make RNA editing — and a whole lot else — a reality (Endpoints)
- Already sitting on a major stem cell bank, Generate looks to grow its regenerative medicines business (Endpoints)
- CMS again passes on national pricing for long-term cardiac monitoring, dramatically reduced rates remain (MedtechDive)
- Rockley Photonics unveils ‘clinic-on-the-wrist’ sensors, offering a potential glimpse at the Apple Watch’s future (Fierce)
- Pfizer Unit Fights Loss To MSD In Pneumonia Vaccine IP Case (Law360)
- 7th Circ. Orders Judge Consider Copay Groups In Opana Cert (Law360)
- Guilty Ruling for Ono Employees Now Final and Binding: Onoact Case (PharmaJapan)
- Nippon Shinyaku Sues Sarepta over DMD Therapy Patents in US (PharmaJapan)
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