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.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In the US, it is estimated that 1.45 million people are currently living with type 1 diabetes.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

XTalks

NOVEMBER 23, 2022

In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made.

Life Science 52

Life Science FDA Approval Vaccination Vaccine 52

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. Teplizumab is thought to work by preventing the activation of T cells that attack those cells.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

FEBRUARY 21, 2022

Oral, non-steroidal mineralocorticoid receptor (MR) antagonist Kerendia claimed its first regulatory approval in the US last summer, the culmination of several years of clinical development and a hefty investment in three large-scale clinical trials.

Drugs 122

Drugs Trials Insulin FDA Approval 122

STAT News

DECEMBER 5, 2022

Meantime, the FDA told ImmunoGen and ADC Therapeutics, which have been developing cancer drugs, that it would not grant a speedy approval until they had begun follow-up studies. The study is the second to show positive effects of the drug in an advanced clinical trial. Pluvicto

Insulin 52

Insulin Manufacturing Medicine Drugs 52

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas.

Insulin 246

Insulin FDA Approval Research Clinical Trials 246

Delveinsight

DECEMBER 7, 2020

Development in the technology has made it possible for solutions to surface, primarily related to R&D, clinical trials, and diagnostics and treatment, as well as patient management, leading to even more significant innovative potential and promise for AI in the industry.

Protein 56

Protein Insulin Hormones FDA Approval 56

pharmaphorum

MARCH 3, 2022

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

Insulin 52

Insulin Production Generic Drugs FDA Approval 52

XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Since then, several more GLP-1 agonists have been approved by the FDA. And the demand won’t be easing anytime soon.

Insulin 98

Insulin Hormones FDA Approval Sales 98

XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Nizoral is prescribed off-label, while the others are FDA approved.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. Wegovy had a price tag of $1,297 a month when it was first launched.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

JUNE 12, 2023

The growth is attributed to regulatory approvals, strategic partnerships and the acquisitions of innovative medical technology companies. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Drug Discovery World

JULY 13, 2023

The FDA says that it permits some unapproved drugs to be marketed if they are relied on by healthcare professionals to treat serious medical conditions when there is no FDA-approved drug to treat the condition or there is insufficient supply of FDA-approved drugs.

Drugs 94

Drugs Medicine Regulation Licensing 94

The Pharma Data

APRIL 4, 2023

Initiate treatment with insulin as clinically indicated. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials. Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis Monitor patients for hyperglycemia or other signs and symptoms of diabetes.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. Anti-CD40L Antibody.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

JULY 23, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. SURPASS-2 was a 40-week, randomized, open-label trial comparing the efficacy and safety of tirzepatide to semaglutide as an add-on to metformin in adults with type 2 diabetes.

Insulin 52

Insulin Clinical Trials Clinical Trials Hormones 52

XTalks

MAY 20, 2022

Mounjaro’s FDA approval was based on data from five clinical trials either as a single therapy or in combination with other diabetes medications. The efficacy of Mounjaro was compared to placebo, Novo Nordisk’s semaglutide and two long-acting insulin analogs. percent more than insulin degludec and 1.0

Insulin 52

Insulin Life Science Drugs Sales 52