The Pharma Data

JULY 12, 2021

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. There are more than 160 million patients living with CKD and T2D worldwide.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

Production 40

Production FDA Trials FDA Approval 40

The Pharma Data

DECEMBER 15, 2020

16, 2020 02:47 UTC. Nasdaq: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the pricing of an underwritten public offering of 3,725,000 shares of its common stock at a public offering price of $21.50

FDA Approval 40

FDA Approval Disease Therapies Clinical Development 40

The Pharma Data

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . 1 Olumiant Prescribing Information, 2020. INDIANAPOLIS , Oct. 2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653. SOURCE Eli Lilly and Company.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020. Accessed October 2020. Posted: November 2020. NCT identifier: NCT04380688. Available online.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

Disease 52

Disease FDA FDA Approval Treatment 52

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA 52

FDA Clinical Trials FDA Approval Treatment 52

The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM).

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

NOVEMBER 3, 2020

4, 2020 13:00 UTC. DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. BEDFORD, Mass.–(

Clinical Trials 52

Clinical Trials FDA Approval Treatment Production 52

The Pharma Data

NOVEMBER 22, 2020

Blueprint Medicines had a target action date of November 23, 2020 for pralsetinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The FDA approved it under the brand name Gavreto on September 4. The drug was approved for that indication on November 13.

FDA 52

FDA Licensing Licensing Treatment 52

The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

JULY 29, 2021

for the same period in 2020. This was primarily driven by the impact of higher in-process research and development (“IPR&D”) expenses in the second quarter 2020 related to the Forty Seven, Inc. billion as of December 31, 2020. billion compared to the same period in 2020. Second Quarter 2021 Financial Results.

Science 52

Science Production Treatment FDA 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

APRIL 4, 2022

The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. About Eosinophilic Esophagitis (EoE).

FDA 52

FDA Treatment Disease FDA Approval 52

The Pharma Data

JANUARY 15, 2021

Results from the DESTINY-Gastric01 trial were presented at the 2020 American Society of Clinical Oncology (ASCO) meeting and published in The New England Journal of Medicine. Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity. mg/kg) is approved in the U.S.

Treatment 52

Treatment Trials Disease Therapies 52

The Pharma Data

OCTOBER 25, 2020

26, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” With no FDA-approved treatments for this condition, current guidelines recommend sedative medications to maintain a light level of sedation in adult patients, which is frequently not achieved with commonly used therapies. NEW HAVEN, Conn.,

Treatment 40

Treatment Trials FDA Hospitals 40

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

The Pharma Data

AUGUST 17, 2021

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. To date, the Opdivo clinical development program has treated more than 35,000 patients. On March 25, 2011, the U.S.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

JUNE 30, 2021

Food and Drug Administration (FDA) in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

JUNE 26, 2021

In 2020, the trial was stopped early due to a significant improvement in OS. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. The primary endpoints were OS and progression-free survival, and secondary endpoints included objective response rate, duration of response and quality of life. About Libtayo.

Treatment 52

Treatment Trials Disease FDA Approval 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

FDA 40

FDA Treatment Drugs FDA Approval 40

The Pharma Data

DECEMBER 29, 2020

30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Nagasaka et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Nagasaka et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. ,

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended June 30, 2020. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

26, 2020 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. 26-31, 2020. We’re pleased to be at ASCAT 2020, where we are sharing real-world effectiveness data demonstrating that the benefits of treatment of sickle cell patients with Oxbryta were consistent with the results of our Phase 3 HOPE Study.”. FDA approval.

Treatment 40

Treatment Disease FDA FDA Approval 40

The Pharma Data

NOVEMBER 9, 2020

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020. Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

Codon

MARCH 24, 2024

Once approved, patent-protected drugs are the highest-margin physical products on the planet—even with the high price of bioreactors. The real cost is clinical development. In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. Why rock the boat?

Engineering 84

Engineering Vaccine Production RNA 84

The Pharma Data

OCTOBER 27, 2020

28, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. PHILADELPHIA, Oct.

Disease 40

Disease FDA Treatment Clinical Trials 40

The Pharma Data

DECEMBER 27, 2020

28, 2020 13:00 UTC. NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

Therapies 40

Therapies Clinical Trials Production Treatment 40

The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 5, 2020

5, 2020 /PRNewswire/ — 63% response rate in patients treated with the highest reported dose. The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. and the world, respectively, in 2020. TARRYTOWN, N.Y. ,

Production 40

Production Trials Treatment Disease 40

The Pharma Data

APRIL 11, 2021

.” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50

Research 52

Research Therapies Treatment Trials 52

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability. When should this occur? at the end-of-phase 2 meeting).

FDA 40

FDA Science Trials Clinical Trials 40