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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XTalks

SEPTEMBER 12, 2022

Sanofi picked up its first Xenpozyme approval for the treatment of Niemann-Pick from Japanese regulators in March followed by an approval from European officials in May. The FDA approval was based on data from the randomized, double-blind, placebo-controlled ASCEND study involving 31 adult patients.

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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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XTalks

DECEMBER 2, 2022

As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Rebyota is not indicated for the first occurrence of C.

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Previous animal model studies of Friedreich’s ataxia showed a dysfunction in the regulation of Nrf2 signaling, a pathway associated with reduced inflammatory response and improved mitochondrial function.

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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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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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XTalks

JUNE 2, 2021

The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies. The oral treatment was approved for adults with locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

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pharmaphorum

JULY 19, 2021

Over 50% identified a better understanding of complex medicines by regulators as key to developing this field. Recent successes in FDA approvals of antibody–drug conjugates (ADCs), RNA therapeutics and the UK’s regulatory leadership in coronavirus vaccines show that complex medicines are having a global impact.

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XTalks

SEPTEMBER 16, 2022

Tyrosine kinases are enzymes that regulate signaling pathways with downstream effects on cell growth, differentiation and death. The FDA approval of a new oral treatment is exciting news for the psoriasis community. Phototherapy involves the use of ultraviolet irradiation to slow skin growth and lower inflammation.

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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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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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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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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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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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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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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.

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Drug Discovery World

MARCH 16, 2023

With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. The biopharma industry must industrialise cell and gene therapy manufacturing to bring these life-saving therapies to a larger scale than ever before, says Dominic Clarke, CTO of Cell & Gene Therapies at Discovery Life Sciences.

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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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XTalks

APRIL 21, 2023

And in 2015 the US Food & Drug Administration (FDA) approved an assay on Theranos’ proprietary technology.” Life science startups face unique challenges given the highly regulated and complex nature of the industry. Outsiders who reviewed the technology said it worked.

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XTalks

SEPTEMBER 17, 2021

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s Accelerated FDA Approval Modeled on Aduhelm. This has brought criticism that US regulators are moving too slow on a drug that has clinical promise and is being backed by other international regulators.

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XTalks

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. Diverse Voices for Lively Discussions. Sarah is also an experienced webinar moderator.

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XTalks

APRIL 25, 2024

Recent advancements in autonomic regulation therapy have introduced electrical devices designed to restore the autonomic nervous system’s balance. These receptors play a crucial role in regulating blood pressure by balancing sympathetic and parasympathetic activity.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile.

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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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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

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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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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.

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Drug Discovery World

SEPTEMBER 28, 2023

Probiotics offer a relatively straightforward, minimally regulated avenue to correcting dysbiosis, and a significant market exists already. However, fewer companies have pursued the avenue of regulated therapeutics. Osel is one company leading the charge to bring regulated therapeutics to market.

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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.

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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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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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Approval Drugs Sales Development 52

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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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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