Recon: Supreme Court rebuffs Amarin, Abbvie in separate rulings; Moderna to ramp up vaccine production
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Supreme Court rebuffs insurers on Obamacare reimbursements (Reuters)
- Supreme Court denies Amarin's bid to revive Vascepa drug patents (Reuters)
- Supreme Court rebuffs AbbVie appeal in patent fight involving AndroGel drug (Reuters) (Law360)
- Moderna plans to expand COVID-19 vaccine production (Reuters) (WSJ)
- HHS backs down in legal fight over drug discount program with AstraZeneca, Eli Lilly, Novo and Sanofi (Endpoints) (Law360)
- Gilead's remdesivir reduces COVID-19 mortality risk- data (Reuters)
- 8 key clinical trials to watch for the rest of 2021 (BioPharmaDive)
- S.Africa's Ramaphosa accuses Big Pharma of 'selfish, unjust' vaccine policy (Reuters)
- WTO head says South Africa, Senegal, Rwanda and Nigeria considered as vaccine production hubs (Reuters)
- Study confirms GSK-Vir antibody drug reduces hospitalization, death in COVID-19 patients (Reuters)
- GSK to boost spending power of pharma business post break-up (Reuters)
- GSK faces struggle to convince investors as activist Elliott lurks (FT)
- Vaccitech chief confident of beating mRNA in cancer treatment (FT)
- India in talks to find 'middle ground' with Pfizer, others for vaccine imports -govt official (Reuters)
- NZ regulator approves Pfizer vaccine for 12-15 year olds (Reuters)
- S.Korea's SK bioscience to invest $132 mln to boost vaccine production (Reuters)
- Ebola outbreak in Guinea is over: WHO (The Hill)
- With Vaccination Goal in Doubt, Biden Warns of Variant’s Threat (NYTimes)
- European Union loses bid for faster deliveries of AstraZeneca Covid-19 vaccine (STAT)
- Fight Over Covid’s Origins Renews Debate on Risks of Lab Work (NYTimesv
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- Cuba’s homegrown Covid vaccine shows promise (FT)
- Models predict U.S. coronavirus infections could surge this fall if vaccination rates lag, former FDA chief says (Washington Post)
- Philippines seals biggest COVID-19 vaccine order yet, for 40 mln Pfizer doses (Reuters)
- Not done yet: Roche nets new FDA COVID-19 authorization for point-of-care PCR screening test (Fierce)
- Medical journal argues a drug maker’s libel suit is really a public relations campaign to chill research (STAT)
- FDA’s Budget: Advancing the Goal of Ending the Opioid Crisis (FDA)
- A California law that bans drug coupons failed to increase generic use (STAT)
- EU approves Onureg for patients with acute myeloid leukemia (Pharmafile)
- EC approves Sanofi’s Aubagio for paediatric MS patients (PharmaTimes)
- Japan OKs 2021 Fiscal Policy Blueprint, Vows Transparency in Drug Pricing (PharmaJapan)
- LAG-3 continues generating heavy buzz as Australia's Immutep locks down new funds (Endpoints)
- Allogene, Overland woo an experienced hand from WuXi to steer their allogeneic CAR-T JV (Endpoints)
- Roche's Alzheimer's antibody lowers biomarkers in inherited form of disease, though impact on symptoms is unclear (Fierce)
- Orphan drug specialist Horizon looks to double down on its gout expertise with acquired rights to Arrowhead's RNAi med (Endpoints)
- Activist investor Elliott in talks with other GlaxoSmithKline investors about replacing Emma Walmsley, spinning off vaccine business — report (Endpoints)
- Novartis burnishes Zolgensma data in presymptomatic patients as Roche's Evrysdi continues eating away at the SMA pie (Endpoints)
- Tarsus nabs key data in hunt to repurpose dog drug as cure for eye parasite (Endpoints)
- Cadila, Bayer extend JV partnership for three years (Economic Times)
- Alkem gets two observations from USFDA for St Louis-based formulation plant (Economic Times)
- Expert Panel Review Likely For Just 10% To 20% Of Files Submitted (MedtechInsight)
- NeuraLace ties up FDA clearance for chronic pain-relieving nerve stimulation device (Fierce)
- New Treatment From Shockwave Medical For Clogged Arteries Gets CMS Pass-Through Payment (MedtechInsight)
- Amazon Halo's AI-powered body fat calculator on par with lab-quality devices, study finds (Fierce)
- Democrats seek new ways to expand Medicaid in holdout states (The Hill)
- Biden nominates HHS official targeted by Trump (The Hill)
- Bard Hit With $3M Verdict In Vein Filter Suit (Law360)
- GSK Gets Top Court Assist In MDL Victory 'Roadmap' (Law360)
- J&J Accused Of Seeking 'Secrecy' In Fired Exec's Bias Suit (Law360)
- Can – or Should – State Tort Law Force Defendants To Prevent Off-Label Use? (Drug & Device Law)
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