The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

Laboratories 52

Laboratories Production Treatment Clinical Trials 52

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

DECEMBER 28, 2020

NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. and is a leading cause of liver transplantation. ” About Hepion Pharmaceuticals.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

The Pharma Data

JANUARY 3, 2021

This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. The last patients in the trial received their final dose on 21 December 2020. The topline data from the trial is expected to be available in January 2021. Dr.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022. The candidate demonstrated 64.7%

Trials 130

Trials Drug Trials Disease Clinical Trials 130

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Pharmaceuticals Trials Pharmacokinetics 40

The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

DECEMBER 1, 2023

About one year after its initial publication, FDA updated the guidance in February 2021. However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

FDA 40

FDA Clinical Trials Vaccine Trials 40

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability 92

Metabolic Stability Small Molecule Clinical Trials Pharmacokinetics 92

The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In June 2021, Lilly announced the U.S. vice president of pain and neurodegeneration, Lilly.

Disease 52

Disease Pharmacokinetics Treatment FDA 52

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. The approval was based on results in a prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial.

FDA Approval 52

FDA Approval FDA Pharmacokinetics Therapies 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6]. months (range, 1.6–9.9).

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

NOVEMBER 8, 2020

The New Drug Application (NDA) for the drug is based on data from four Phase III trials in pediatric patient populations from the age of 6 to 17 years, two Phase II trials, several Phase I trials, a long-term open label extension study, preclinical testing, and drug manufacturing data. This is under Priority Review.

FDA 52

FDA Trials Pharmacokinetics Pharmaceuticals 52

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. Canada and Europe.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066). We also continue to identify, develop and support potential therapies which can play a role in treating the disease.

Treatment 52

Treatment Virus Clinical Trials Government 52

Drug Discovery World

MAY 3, 2023

Study findings As previously reported, a Phase II clinical trial in patients suffering CDI demonstrated that administration of NTCD-M3 shortly after the use of antibiotics to treat the initial infection, successfully reduced recurrence of CDI from 30% in placebo to 5% in treated patients. JAMA May 5, 2015 Volume 313, Number 17.

Trials 130

Trials Clinical Trials Pharmacokinetics Research Laboratories 130

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 Disease Treatment Pharmacokinetics 52

Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Once metabolized, which occurs quickly with a half-life of approximately 1.5

Science 40

Science FDA Clinical Trials Pharmacy 40

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.

Trials 52

Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Week 96 Metabolic and Bone Outcomes of a Phase 2b Trial of Islatravir and Doravirine.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S., The full U.S.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

The Pharma Data

APRIL 14, 2021

This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Food and Drug Administration. Bamlanivimab alone. patients who recovered from COVID-19.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

The Pharma Data

MARCH 8, 2021

Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We Phase 1 Implant Study Results for Investigational Anti-HIV agent Islatravir.

Trials 52

Trials Clinical Trials Pharmacokinetics Research Laboratories 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

The Pharma Data

OCTOBER 27, 2020

INCREASE sNDA under FDA review with April 2021 action date; Remunity launch preparations continue. Tyvaso in pulmonary hypertension due to interstitial lung disease (PH-ILD). In August 2020 , the FDA accepted the sNDA for review, which we expect will be complete in April 2021. SILVER SPRING, Md. SILVER SPRING, Md.

FDA 40

FDA Production Licensing Licensing 40

The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

Doctors 52

Doctors Treatment Trials Clinical Trials 52

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Pharmacokinetics Virus Vaccine 52

The Pharma Data

APRIL 16, 2021

Going forward, Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. It was identified from a blood sample taken from one of the first U.S.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

JANUARY 19, 2021

20, 2021 11:00 UTC. Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. About ALS-4.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52