Recon: FDA issues EUA for Roche’s Actemra for severe COVID; EMA signs off on an additional manufacturing site for J&J vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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