Recon: Allakos cuts its workforce by 50%, halts lead inflammatory candidate; Takeda wins another FDA approval for immune globulin therapy HyQvia

• The new NIH director is walking a tightrope on Biden’s drug pricing vision (STAT)
• Many doctors are in the dark about how FDA approves devices and drugs, survey finds (STAT)
• Takeda picks up 2nd FDA-approved indication for immune globulin treatment HyQvia (Fierce Pharma)
• US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19 (Pink Sheet)
• FDA Action Alert: Satsuma, Theratechnologies and Heron (BioSpace)

• The WHO and drug regulators want to reformulate the flu vaccine. It’s easier said than done (STAT)
• German trade union opposes Bayer’s business split proposal (Endpoints)
• GSK pumps £200M+ into UK manufacturing network to bolster commercial ambitions, API supply (Fierce Pharma)
• European Member States Call For Direction On Falsified Medical Devices (MedTech Insight)
• UK’s MHRA Faces Questions On Capacity Of New International Recognition Scheme (Pink Sheet)
• EMA OKd 77 New Products in 2023, Including 17 Orphans & One Gene-Editing Therapy (Pink Sheet)
• South Africa & Zimbabwe Sign Deal On Joint Drug Reviews, Inspections (Pink Sheet)
• France Warns Of Risk Of Severe Skin Reactions With Lung Cancer Drug Krazati (Pink Sheet)
• Japan Review/Outlook: Pricing Tweaks Considered After Year Of Change (Pink Sheet)
• Orion Invests $415M in Korean Biotech LegoChem, Secures Majority Stake (BioSpace)
• WHO appeals for $1.5 bln to address crises from Gaza to Afghanistan (Reuters)

• Looking past COPD, Regeneron CSO George Yancopoulos says Dupixent's 'next big thing' is reversing allergies (Endpoints)
• Deerfield adds another academic partner in $130M Washington University pact (Endpoints)
• Allakos halves workforce, drops lead inflammatory program (Endpoints)
• Biopharma Layoff Tracker 2024: Allakos, C4, Affimed and More Cut Staff (BioSpace)
• Disco debuts with €20M seed round to advance surfaceome-based platform, with support from AbbVie (Endpoints)
• Lilly exec says supply, reimbursement are factors for new Mounjaro launches (Reuters)
• Merck's Keytruda again bags industry-first cervical cancer nod—with limitation (Fierce Pharma)
• Alto, Kyverna Join Growing Number of Biotech IPO Filings in 2024 (BioSpace)
• 7 Deals Emerge During JPM Week in Strong Start to 2024 (BioSpace)
• Q&A: MindMed’s Dan Karlin Discusses Phase II Win and the Therapeutic Potential of Psychedelics (BioSpace)

• How pharma giants like GSK and Bristol Myers are using tech to shape their future (Endpoints)
• ResMed says its masks to remain on market despite FDA classification (Reuters)
• Apple, locked in patent fight with Masimo, redesigns smartwatch (MedTech Dive)
• Integer acquires Pulse Technologies for $140M (MedTech Dive)
• EssilorLuxottica integrates tech into glasses to target hearing loss market (MedTech Dive)
• Deals Shaping The Medtech And Diagnostics Industries, December 2023 (MedTech Insight)

• HHS Unveils Schedule III Recommendation For Marijuana (Law360)
• HIV stigma a persistent problem, threatening work to end transmission: survey (Fierce Pharma)
• Updated: Vivek Ramaswamy gives up presidential bid, endorses Trump, no plans to return to Roivant (Endpoints)