Recon: GSK to buy Affinivax for up to $3.3B; FDA approves Roche’s SMA drug Evrysdi for infants under 2 months old

• Roche SMA drug approved in youngest infants, challenging Novartis and Biogen (BioPharmaDive) (Endpoints)
• U.S. doctors reconsider Pfizer's Paxlovid for lower-risk COVID patients (Reuters)
• Paxlovid Becomes Household Name for Covid-19 Patients (WSJ)
• U.S. FDA declines to approve Eton Pharma's anti-seizure drug (Reuters)
• BioMarin delays planned FDA filing for hemophilia gene therapy (BioPharmaDive)
• America’s hospital regulator wasn’t designed for a pandemic (Politico)
• Abbott’s Libre 3 glucose monitor gets FDA clearance as CGM market intensifies (MedtechDive)
• ViiV will make it easier for generic companies to copy its HIV prevention shot, but it’s not clear when (STAT)
• While a law designed to thwart counterfeit medicines lurches into full force, fake pills keep circulating (STAT)
• Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals (STAT)

• GSK to spend up to $3.3 bln on Affinivax to boost vaccines roster (Reuters) (BioPharmaDive) (FT)
• Takeda says drugmakers could cut prices in face of global crises (FT)
• Why Africa’s first Covid vaccine factory struggles to find customers (FT)
• UK signs first post-Brexit life science agreement with Sweden (FT)
• First steps in reforming global health emergency rules agreed at WHO meeting (Reuters)
• New WHO panel to speed up pandemic response, address shortcomings (Reuters)
• The World Health Assembly moves to bolster clinical trials, but some say it falls short (STAT)
• Bavarian Nordic raises 2022 annual guidance again after monkeypox vaccine deals (Reuters)
• EU in talks for common purchase of vaccine, antiviral against monkeypox (Reuters)
• Swissmedic weighing new COVID booster recommendation for children (Reuters)

• FDA presses pause on trial for OTC version of anti-impotence drug Cialis (Reuters) (Endpoints)
• After Axsome’s migraine med rejection, phase 3 data keeps hope alive for depression drug (Fierce)
• After $500M IPO, HK inno.N enters exosome drug delivery via Ilias pact (Fierce)
• Long after the blockbuster shoutouts faded to a whisper, TherapeuticsMD gets an M&A deal (Endpoints)

• Boston Scientific would be ‘good fit’ for increasingly acquisitive J&J, analysts say (MedtechDive)
• FDA Plans 2-Day Meeting On Skin Cancer Detection Tools (MedtechInsight)
• Medtronic Starts Planned Portfolio Simplification With DaVita Renal Care Spin Off (MedtechInsight)
• EU Clarifies Requirements On Use Of Assays In The Context Of Clinical Trial Regulation (MedtechInsight)
• 23andMe posts $217M net loss during 'transitional' fiscal year (mobihealthnews)

• Former AstraZeneca exec committed insider trading on landmark 2019 Enhertu deal, SEC alleges (Endpoints)