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                Regulatory Focus™ > News Articles

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                  ReconRecon

                  Recon: US FDA gives thumbs up to GSK anemia drug; Vax makers kept $1.4 billion in COVID shot prepayments

                  • 02 February 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Glaxo’s Jesduvroq as Oral Treatment for Anemia ( Reuters ) ( Endpoints ) COVID-19 tracker: Merck pill linked to new mutations, study says ( Fierce ) ( Bloomberg ) FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test ( Inside Health Policy ) ( Endpoints ) What Changes When the COVID Emergency Ends in May? ( MedPage Today ) Modern...
                • Story Thumbnail
                  ReconRecon

                  Recon: US to end COVID emergencies on 11 May; Amgen launches first Humira biosimilar in US

                  • 31 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. to end COVID-19 emergency declarations on May 11 ( Reuters ) ( Bloomberg ) ( STAT ) As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions ( Pink Sheet ) FDA Launches Plans for Food Program Revamp After Watchdog Review ( Bloomberg ) End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timefr...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA approves Keytruda as adjuvant for NSCLC; Philips to cut 6,000 more jobs after Q4 losses

                  • 30 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting ( Endpoints ) ( FDA ) ( MedPage Today ) Lilly Gets U.S. FDA Approval of Jaypirca to Treat MCL ( Bloomberg ) ( BioSpace ) ( Endpoints ) FDA approves Italy-based pharma's oral SERD for some breast cancer patients ( Endpoints ) ( Fierce ) Drugmakers prevail in dispute over U.S. ...
                • Story Thumbnail
                  ReconRecon

                  Recon: US FDA joins global regulators investigating contaminated cough syrup; AstraZeneca’s Evusheld no longer authorized in the US

                  • 26 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA joins global regulators probing tainted overseas cough syrup ( Reuters ) ( CBS News ) AstraZeneca’s Covid Drug No Longer Authorized for Use in the US ( Bloomberg ) ( STAT ) Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines ( STAT ) Inhibikase, FDA find common ground to lift hold on Parkinson’s drug ( Fierce ) Updated COVID v...
                • Story Thumbnail
                  ReconRecon

                  Recon: WHO investigating cough syrup deaths; EU patient groups push for greater measures to address antibiotic shortages

                  • 24 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Many pediatric drug study results were never posted to a U.S. government database ( STAT ) COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel ( Pink Sheet ) US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible ( Pink Sheet ) Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rar...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA proposes annual COVID shots; Takeda pledges up to $1.13B for Hutchmed’s fruquintinib

                  • 23 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA scientists propose an annual Covid shot matched to current strains ( STAT ) ( Reuters ) With TheracosBio green light, another SGLT2 wades into diabetes arena ( Fierce ) Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal ( Pink Sheet ) FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA urges federal judge to reject Texas lawsuit challenging abortion pill; EU, Israeli regulators find no stroke signal with Pfizer COVID shot

                  • 19 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA argues public harm if court reverses abortion pill approval ( The Hill ) ( Endpoints ) ( Bloomberg ) ( Fierce ) Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs ( Endpoints ) ( Fierce ) Diversity in Clinical Trials as FDA Gets a Boost From New Law ( Bloomberg ) FDA’s Novel Approvals Again Led By Oncology And Neurology, But D...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA approves Luye’s long-acting schizophrenia drug Rykindo; EU proposes changes to pharma law to avoid shortages

                  • 17 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Entering J&J’s fiefdom, Luye wins FDA approval of long-acting schizophrenia drug ( Fierce ) ( Pharmaphorum ) Reversing abortion drug's approval would harm public interest, U.S. FDA says ( Reuters ) Orphan Drug Exclusivity Remains a Priority in 2023, Says FDA Deputy Commissioner ( FDAnews ) FDA’s Biosimilar Regulatory Science Pilot Launches With Five Projects (...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA, CDC link Pfizer’s bivalent COVID booster to possible strokes in older adults; Eisai files for Japanese approval of Alzheimer’s drug Leqembi

                  • 16 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Bivalent Shot Shot Linked to Stroke in One Safety Database ( Bloomberg ) ( MMWR ) ( Reuters ) Novo Nordisk's GLP-1 for Type II diabetes approved for first-line treatment ( Endpoints ) ( Biospace ) AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales ( Fierce ) David Kessler, Biden official key to covid vaccine effort, steps down...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA rejects Biocon insulin biosimilar; Olympus says it’s fixing issues raised by FDA at Japanese facilities

                  • 12 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Novel Dual Rescue Inhaler for Asthma in Adults ( MedPage Today ) FDA rejects Biocon insulin biosimilar over data, manufacturing concerns ( Fierce ) JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response ( Fierce ) Physicians group urges FDA to convene expert panel before finally approving an ...
                • Story Thumbnail
                  ReconRecon

                  Recon: FDA’s increased use of clinical holds; BioNTech buys AI startup InstaDeep for up to $682M

                  • 10 January 2023
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. experts recommend weight-loss drugs for obese children ( Reuters ) Abbvie raises sales outlook of two immunology drugs to more than $17.5 bln in 2025 ( Reuters ) Sen. Sanders asks Moderna not to hike COVID vaccine price ( Reuters ) ( STAT ) FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises” ( STAT ) FDA Increasingly Halting Hum...
                • Story Thumbnail
                  ReconRecon

                  Recon: Eisai seeks full approval for Alzheimer’s drug Leqembi; AstraZeneca buys Cincor Pharma for up to $1.8B

                  • 09 January 2023
                  • By Joanne S. Eglovitch
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Supreme Court rebuffs Pfizer plan to help patients pay for heart medication ( Reuters ) ( Bloomberg ) FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate ( Endpoints ) Lundbeck and Otsuka win FDA priority review of Alzheimer’s agitation drug ( Medwatch ) Doctors inclined to prescribe new Alzheimer’s drug despite conce...
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