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Regulatory Focus™ > News Articles > 2021 > 6 > Recon: FDA issues EUA for Roche’s Actemra for severe COVID; EMA signs off on an additional manufactu

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

Posted 25 June 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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