Qualitative Concept – Page 4

MannKind to Acquire scPharmaceuticals in Up to $360M Deal

2 weeks ago talkbio0Tagged Acquisition, cardiometabolic diseases, cardiorenal medicine, FDA-approved, FUROSCIX, MannKind, merger agreement, ReadyFlow Autoinjector, scPharmaceuticals, Tender

MannKind; scPharmaceuticals; acquisition; Furoscix; cardiorenal medicine; cardiometabolic diseases; FDA-approved infuser; ReadyFlow autoinjector; merger agreement; tender offer

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

3 weeks ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

FDA Begins Daily Publication of Drug Adverse Event Data

3 weeks ago talkbio0Tagged Adverse event, Daily, data modernization, drug safety, FAERS, public health medicine (field), real-time monitoring, United States Food and Drug Administration

FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health

Data Lakes & FAIR Principles: Making Scientific Data Accessible and Actionable

3 weeks ago talkbio0Tagged accessible, Data Lakes, Data Management, Fair Language Proficiency, Findable, Interoperable, Principles, research, Scientific Data

Data Lakes; FAIR Principles; Scientific Data; Findable; Accessible; Interoperable; Reusable; Research Data Management

Dynavax Highlights Comparable Efficacy and Improved Tolerability of Z-1018 Shingles Vaccine vs. Shingrix

3 weeks ago talkbio0Tagged aspects of adverse effects, Dynavax, Effectiveness, Herpes zoster disease, Immunogenicity (package insert), Shingrix, Vaccines, Z-1018

Dynavax; Z-1018; shingles vaccine; Shingrix; vaccine efficacy; side effects; Phase 1/2 trial; immunogenicity

Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns

3 weeks ago talkbio0Tagged Adverse event, aspects of adverse effects, Clinical Trials, Contraceptives, Oral, drug efficacy, gastrointestinal, Obesity, Stock Crash, Viking, VK2735, Weight Loss

Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy

FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies

3 weeks ago talkbio0Tagged Clinical Research, Complete Response Letter, drug efficacy, factor IX, Friedreich 's ataxia, Rejection, United States Food and Drug Administration, vatiquinone

FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

3 weeks ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

Conflicts of Interest Among Federal Vaccine Advisors at Historic Lows Through 2024

4 weeks ago talkbio0Tagged ACIP, Advisory Committees, Centers for Disease Control and Prevention (U.S.), JAMA study, Robert F. Kennedy Jr., Translucent, United States Food and Drug Administration, Vaccines, VRBPAC

conflicts of interest; vaccine advisory committees; ACIP; VRBPAC; CDC; FDA; transparency; Robert F. Kennedy Jr.; JAMA study

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

4 weeks ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials