pharmaphorum

MAY 21, 2021

Based in Cambridge, Arecor has proprietary formulation technology and plans to enter development partnerships and licence out drugs to big pharma companies, looking for milestone payments and royalties as they progress through the development process and on commercialisation.

Insulin 52

Insulin Drugs Production Marketing 52

pharmaphorum

FEBRUARY 21, 2022

The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy.

Drugs 120

Drugs Trials Insulin FDA Approval 120

The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. People with type 1 diabetes cannot produce insulin.

Development 40

Development Insulin Drugs Clinical Trials 40

The Pharma Data

JULY 8, 2021

When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.

Trials 52

Trials Doctors Doctor Medicine 52

Drug Discovery World

JANUARY 15, 2024

Chiesi and Oak Hill Bio Chiesi Group and Oak Hill Bio have entered a collaboration to develop OHB-607, a clinical-stage investigational drug candidate to treat complications of extremely premature birth. Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan.

Drugs 59

Drugs Licensing Licensing Protein 59

Drug Discovery World

JULY 13, 2023

There are various schemes in force that allow patients access to unlicensed medicines that are in the late stages of clinical development (i.e., In 2010, the US National Eye Institute launched the Comparison of AMD Treatments Trials (CATT), a two-year clinical trial, comparing the two drugs head-to-head for the first time.

Drugs 94

Drugs Medicine Regulation Licensing 94

Delveinsight

AUGUST 20, 2020

In revealing the complete response letter, Gilead said the FDA had asked data from two ongoing clinical trials, MANTA and MANTA-Ray, which evaluated the effect of the 200-mg dose of JAK1 inhibitor filgotinib on sperm concentrations. Alzheon bags USD 47 Million NIH grant to bankroll Alzheimer’s trial.

Gene Therapy 52

Gene Therapy Research Gene Antibody 52

The Pharma Data

DECEMBER 2, 2020

The new plant will as a first priority produce recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd ® currently in late-stage clinical development. The diabetes vaccine Diamyd ® is an antigen-specific immunotherapy for the preservation of endogenous insulin production.

Production 52

Production Insulin Vaccination Vaccine 52

The Pharma Data

JUNE 28, 2021

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. The trial randomized 1,879 study participants across the U.S., The study randomized 1,879 participants, who had a mean duration of diabetes of 8.6

Insulin 52

Insulin Clinical Trials Clinical Trials Hormones 52

The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM.

Trials 52

Trials In-Vitro Insulin Protein 52

The Pharma Data

MARCH 5, 2021

Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to injectable semaglutide 1 mg in adults with type 2 diabetes in Eli Lilly and Company’s (NYSE: LLY) 40-week SURPASS-2 clinical trial. About SURPASS-2 and the SURPASS clinical trial program.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Hormones 52

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.

Medicine 52

Medicine Insulin FDA Approval Trials 52

The Pharma Data

JANUARY 7, 2021

In addition, icosabutate lowered triglyceride levels, improved insulin resistance and lowered hsCRP by an impressive 50%, biomarker changes that improve the patient’s cardiovascular risk profile. I look forward to the final results from this trial.”. – Ends – Notes to Editors. About NorthSea Therapeutics.

Engineer 40

Engineer Insulin Development Licensing 40

The Pharma Data

JUNE 28, 2021

Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes after 40 weeks of treatment in Eli Lilly and Company’s (NYSE: LLY) SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. mg, 5 mg and 7.5

Clinical Trials 40

Clinical Trials Clinical Trials Hormones Trials 40

XTalks

AUGUST 2, 2023

This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. billion in 2022. billion ($8.72

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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. The maximum achievable ACR CRISS score is 1.0.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

MARCH 11, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. 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.

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JULY 23, 2021

The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. 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.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

APRIL 4, 2023

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

Delveinsight

AUGUST 25, 2021

Apart from these, Xarelto (for PAD) and Darzalex (for Amyloidosis and Refractory Multiple Myeloma) are in Phase III of clinical trials, while Tremfya (for Crohn’s Disease), Seltorexant (for insomnia), and Ciltacabtagene Autoleucei (BCMA CAR-T) (for multiple myeloma) are in Phase II of development. billion), 0.3% (1.5

Vaccination 98

Vaccination Vaccine Sales Drugs 98