XTalks

APRIL 21, 2021

More cases of blood clots in those vaccinated against COVID-19 — this time in six women who took the J&J shot — has US regulators recommending that vaccination efforts be paused. Read the full articles here: First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation.

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Life Science Vaccine Vaccination FDA Approval 52

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Another was hospitalised with suicidal ideation.

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Drugs Life Science Clinical Development Regulation 116

XTalks

FEBRUARY 18, 2025

Biosimilars are biological products highly similar to an already FDA-approved reference product, with no clinically meaningful differences in terms of safety, purity and potency. million Americans depend on insulin therapy either rapid-acting, long-acting or both to regulate their blood sugar. Approximately 8.4

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Insulin FDA Approval Production Hormones 59

XTalks

OCTOBER 6, 2020

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial.

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XTalks

DECEMBER 18, 2024

Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development.

Genetics 116

Genetics Hormones Trials Drugs 116

XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain. Tryngolza works by targeting a protein in the liver, apoC-III, which regulates triglyceride metabolism.

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FDA Approval Drugs Clinical Trials Clinical Trials 59

XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

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FDA Approval Drugs Life Science Cosmetics 52

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

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Clinical Trials Clinical Trials Compliance Trials 105

XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

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FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. The FDA approval of Tecvayli makes it the first bispecific BCMA-directed CD3 T-cell engager approved in the US.

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FDA Approval Antibody Drugs Trials 52

XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. JAK inhibitors block cell signaling that cause inflammation, providing patients an alternative method to regulating an overactive immune system.

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FDA Approval Clinical Trials Clinical Trials DNA 52

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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Drugs Gene Hormones Clinical Trials 317

XTalks

AUGUST 19, 2021

With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns. GHB has now become a strictly regulated medication for treating narcolepsy, which is also associated with excessive daytime sleepiness.

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FDA Approval Drugs Regulation Sales 64

XTalks

JUNE 12, 2023

Recent FDA Approvals of Cell Therapy Manufacturing Facilities in the US Successful commercialization of novel cell therapy requires exemplary performance at all stages, including upstream and downstream processing, process development, testing and manufacturing services.

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Manufacturing Gene Therapy FDA Approval Gene 95

XTalks

FEBRUARY 21, 2025

Related: Obesity-Focused Metsera Launches IPO Amid Much Anticipation Aardvarks approach centers on developing novel, small-molecule drugs that harness the bodys natural hunger-regulating mechanisms.

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Genetics Hormones Gene Expression Gene 59

Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. The drug is also known for its illegal recreational use.

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Research Trials Drugs Generic Drugs 275

XTalks

APRIL 6, 2023

Mounjaro (tirzepatide) is a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist, which makes it the first-in-class drug that activates both receptors to help regulate blood sugar and appetite. Lilly is, however, expecting an FDA approval later this year for a weight loss version of Mounjaro.

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FDA Approval Regulation Drugs Trials 97

XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG).

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FDA Approval Antibody Protein Engineer 98

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

SEPTEMBER 4, 2024

Gudeman helped continue the clinical development of Lumryz (sodium oxybate) through to its approval, which was approved last May and is the first and only FDA approved once-at-bedtime oxybate for individuals living with narcolepsy. Narcolepsy affects the brain’s ability to regulate sleep-wake cycles.

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Life Science Clinical Development FDA Approval Regulation 52

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. In the first quarter of 2024, Vabysmo sales leaped 108 percent to $927.4

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FDA Approval Clinical Trials Clinical Trials Sales 104

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 1: There are too many challenges with adopting an ECA.

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Clinical Trials Clinical Trials Life Science Trials 89

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. More than half a million individual ads referencing GLP-1s were monitored by LegitScript in just the last two months.

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Pharmacy Drugs Production Sales 104

pharmaphorum

JULY 8, 2022

We have also seen the regulators actively support the use of these hybrid decentralised research approaches. These devices and/or the endpoints they generate are with the rigour required to be submitted to regulators. It needs to be performed with a benchmark, an FDA-approved device.”.

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Clinical Trials Clinical Trials Trials Regulation 100

XTalks

DECEMBER 28, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

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Trials Clinical Trials Clinical Trials Antibody 97

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. The export regulations were later incorporated into the Food and Drug Regulations ( FDR ) in 2021.

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Drugs Regulation FDA Approval Manufacturing 52

XTalks

SEPTEMBER 30, 2024

UNION now plans to advance orismilast to a Phase III trial , pending US Food and Drug Administration (FDA) approval of the trial design. A notable reduction in the biomarker TARC (CCL17/thymus and activation-regulated chemokine) was also observed, with end-of-treatment levels approaching those of non-lesional skin. percent, 24.3

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Clinical Trials Clinical Trials Dermatology Trials 98

XTalks

SEPTEMBER 5, 2024

percent ruxolitinib, a topical Janus kinase (JAK) inhibitor, is US Food and Drug Administration (FDA)-approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older. The initial FDA approval for atopic dermatitis paved the way for the 2022 FDA approval for vitiligo.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Containment 52

XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. The US is among the few places in the world where DTC ads for health and medical products are legal; it is banned in most countries.

Drugs 105

Drugs Allergies Branding FDA Approval 105

XTalks

MAY 31, 2024

This novel combination antibiotic treatment is approved for complicated urinary tract infections (cUTIs), including pyelonephritis (a urinary tract infection when one or both kidneys become infected). Efficacy and Safety of Exblifep The FDA approved Exblifep based on clinical evidence that included the Phase III ALLIUM trial.

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Bacteria FDA Approval Trials Drugs 52

XTalks

MAY 12, 2023

The MeCP2 protein plays a crucial role in regulating the activity of genes involved in brain development. In March, the US Food and Drug Administration (FDA) approved Daybue (trofinetide) , the first and only treatment for Rett syndrome. Daybue (trofinetide) is the first and only FDA-approved drug for Rett syndrome.

FDA Approval 97

FDA Approval Genetics Trials Drugs 97

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Nurses 64

XTalks

JULY 3, 2023

The group blasts the “outdated” regulations around the treatment, saying that because cells come from deceased donors, the FDA should treat islet transplantation as an organ transplant rather than a drug, which other regulatory bodies have.

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Insulin Gene Therapy Gene Regulation 98

XTalks

JULY 27, 2022

XTALKS WEBINAR: Delivering Patient Data through a Regulated Platform to Improve Trial Oversight. RELATED: Qelbree: The First FDA-approved Nonstimulant ADHD Drug for Adults in 20 Years. Live and On-Demand: Wednesday, September 7, 2022, at 11am EDT (4pm BST/UK). The Benefits of a Long-Acting Treatment.

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Clinical Trials Clinical Trials Trials Production 98

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Sales FDA Approval Pharmacy Production 52

XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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FDA Approval Protein Containment Genetic Disease 64

XTalks

JUNE 20, 2022

The sacral nerve regulates the body’s bowel, bladder and pelvic floor muscle movements. It is currently the only FDA-approved implant for UI symptoms. Previous research suggests that OAB occurs in 23.3 percent of the US population, and women report OAB almost twice as frequently compared with men (30 percent vs. 16.4

Clinical Trials 96

Clinical Trials Clinical Trials Trials FDA Approval 96