Recon: FDA issues EUA for Roche’s Actemra for severe COVID; EMA signs off on an additional manufacturing site for J&J vaccine

• FDA authorizes Roche drug for emergency use against severe COVID-19 (Reuters) (FDA)
• FDA pushes back decisions on AbbVie's Rinvoq sNDAs to further review a failed Pfizer trial (Endpoints)
• ODAC echoes FDA concern over Incyte PD-1, as Pazdur signals broader shift for accelerated approval (Endpoints) (BioPharmaDive)
• ACIP backs use of dengue vaccine in high-risk areas, despite delivery challenges (STAT)
• With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt (BioPharmaDive)
• 5 Key Details To Know Before Epic Opioid Trial Starts In NY (Law360)
• US Companies Shifted To Make N95 Respirators During COVID. Now, They're Struggling (NPR)
• Lawmakers reintroduce diagnostic regulation bill that split the industry (MedtechDive)

• WHO estimates COVID-19 boosters needed yearly for most vulnerable (Reuters)
• More funds approved for COVAX vaccines, tighter access planned – statement (Reuters)
• Additional manufacturing site for COVID-19 Vaccine Janssen (EMA)
• Mexico's OKs Pfizer's COVID-19 vaccine for use in kids 12 years and up (Reuters)
• Philippines approves emergency use of Bharat Biotech COVID-19 vaccine (Reuters)
• Russia launches Sputnik Light vaccine into wide circulation (Reuters)
• WTO Panel Debates EU's Alternative To IP Waiver Proposal (Law360)
• Drug firms giving MPs ‘hidden’ funding, research shows (The Guardian)

• In India, concern mounts over a variant called Delta Plus. (NYTimes)
• Iran's leader gets locally made coronavirus vaccine shot (Reuters)
• Antibodies triggered by Chinese COVID-19 shots less effective on Delta variant – researcher (Reuters)
• Denmark continues exclusion of J&J, AstraZeneca COVID-19 vaccines (Reuters)
• Tapeworm drug to be trialled nationally as COVID treatment (Pharmafile)
• FDA greenlights its first saliva-based COVID-19 antibody test (Fierce)

• New Therapy for Aggressive Prostate Cancer Improves Survival (NYTimes)
• Will FDA quickly review a Lilly drug to alleviate cost concerns for Alzheimer’s treatments? (STAT)
• Another Corbus program hits the skids after late-stage flop, plummeting the small biotech's shares (Endpoints)
• Q&A: When the pandemic struck, Catalent's CCO had just joined the team (Endpoints)
• Graphite Bio leads this week's IPO squad, looking to turn the tide on sickle cell disease with gene editing (Endpoints)
• Sanofi, Regeneron's Libtayo cleared for basal cell carcinoma (PharmaTimes)
• Sanofi’s NSCLC drug gains EC approval (Pharmafile)
• Japan Pharma Market Forecast to Decline through FY2025: IQVIA (PharamJapan)
• Biosimilar Momentum Unabated in Japan Even with Supply Concerns (PharmaJapan)
• AstraZeneca's Pulmicort, Bayer's Xarelto among big losers in China's largest round of price cuts on generics (Fierce)
• Merck taps longtime insider Klobuchar to lead strategy after clinching $9B from Organon split (Fierce)
• A French CDMO looks to add even more cell and gene therapy capacity at a Paris-area site (Endpoints)
• J&J, Legend unveil plans for Belgian cell therapy manufacturing facility as the partners await approval for lead drug (Endpoints)
• With the ground broken on a Vancouver headquarters, antibody maker AbCellera will add manufacturing space next door (Endpoints)
• Alzheimer's biotech Acumen prices $125M IPO, targets phase 2 data on amyloid-beta prospect (Fierce)
• Mirati steps on the gas with KRAS inhibitor, looking to claim second approval behind Amgen's Lumakras (Endpoints)
• Miromatrix goes hog-wild with upsized $43M IPO to bioengineer pig organs into human transplants (Fierce)

• Boston Scientific spends $295M to snap up rest of cardiac ablation maker Farapulse (MedtechDive)
• Contentious device breakthrough payment rule codified in Cures 2.0 proposal (MedtechDive)
• Grail delivers final study results showing its blood test’s accuracy in spotting 50 different cancers (Fierce)
• GE Healthcare finds new CEO in Integra LifeSciences’ longtime chief (Fierce)
• FDA Issues Draft Guidance Distinguishing Remanufacturing from Servicing (FDA Law Blog)
• Liquid Biopsy Company Adela Makes Debut With $60M In Series A Financing (MedtechInsight)
• Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication (FDA)

• Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial (Fierce)
• 11th Circ. Backs Pfizer Unit's Win Over False Ad Suit (Law360)
• Otsuka Hits Indian Pharma Co. With IP Suit Over Kidney Drug (Law360)
• Medline Accused Of Trying To Hurt Rival With Disinformation (Law360)
• AstraZeneca Sues Cancer Research Co. Over License Breach (Law360)