The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.

FDA Approval 40

FDA Approval FDA Treatment Clinical Development 40

Drug Discovery World

JUNE 5, 2023

The acquisition provides Ariceum with an expanded portfolio of therapeutic and diagnostic assets in late preclinical and early clinical development. The post Ariceum Therapeutics expands pipeline with acquisition appeared first on Drug Discovery World (DDW). million in cash and milestone payments totalling up to $41.5

FDA Approval 130

FDA Approval FDA DNA Licensing 130

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

FDA Approval 40

FDA Approval FDA Hospitals Vaccine 40

The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Regulatory developments There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW. Chris Boshoff, M.D.,

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

Drug Discovery World

JULY 2, 2024

This article will examine the regional focus of the country’s life sciences industry, its infrastructure of bioparks, and how this foundation ensures Switzerland maintains its role as a global leader in drug discovery. In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED).

Science 147

Science Drugs Clinical Trials Licensing 147

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

FDA Approval 69

FDA Approval Drugs Organic Chemistry Small Molecule 69

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

FDA Approval 40

FDA Approval FDA Disease Research Laboratories 40

Drug Discovery World

MAY 3, 2023

The post Vicore initiates clinical proof-of-concept study of endothelial dysfunction appeared first on Drug Discovery World (DDW). Treating endothelial dysfunction could be a major breakthrough in cardiovascular disease”.

FDA Approval 130

FDA Approval Trials Pharmaceutical Companies Disease 130

Drug Discovery World

NOVEMBER 23, 2023

As part of CALYX, Minoryx is conducting an extensive pre-screening MRI-based campaign aimed at identifying eligible adult X-linked Adrenoleukodystrophy (X-ALD) patients with cALD. In June 2023, the US Food and Drug Administration (FDA) approved CALYX’s trial of leriglitazone to treat adult male X-ALD patients with cALD.

Trials 130

Trials Clinical Trials FDA Approval FDA 130

Drug Discovery World

MARCH 7, 2023

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. Here at FAB our proprietary approach aims to overcome this fundamental challenge to human health as we work to discover and develop new drugs for age-associated diseases.”

International 246

International Science Pharmaceuticals DNA 246

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Posted: November 2020.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., OPHTHALMIC ADVERSE REACTIONS.

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. TAIPEI, Taiwan , Nov. 1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S.

FDA Approval 52

FDA Approval FDA Virus Clinical Development 52

The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

Drug Discovery World

SEPTEMBER 14, 2023

“This submission, and Janssen’s ongoing study of erdafitinib, reinforces our commitment to deliver much-needed targeted therapies in the areas of high unmet need, including for devastating diseases like metastatic UC,” said Kiran Patel, Vice President, Clinical Development, Solid Tumours, Janssen Research & Development, LLC.

Treatment 130

Treatment Clinical Pharmacology FDA Approval Therapies 130

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

Clinical Development 52

Clinical Development Therapies Clinical Trials FDA Approval 52

The Pharma Data

JANUARY 6, 2021

The research collaboration is aimed at identifying novel lead compounds and repurposing existing drugs for rheumatoid arthritis and nonalcoholic steatohepatitis, leveraging Standigm’s AI-powered drug discovery platforms : Standigm BEST , Standigm Insight , and Standigm ASK. Standigm is an AI-driven drug discovery company.

FDA Approval 52

FDA Approval FDA Drugs Science 52

The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). ” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Drug Discovery World

OCTOBER 4, 2022

billion in 2013 to less than $3 billion in 2018) due to loss of patent protection for the five FDA approved pharmacologic treatments available for AD, none of which slow or stop the damage from the disease. . The post Taking a new approach to tackle neurodegenerative diseases appeared first on Drug Discovery World (DDW).

Disease 130

Disease Small Molecule Compound Screening Clinical Development 130

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What evidence is there that we can reverse aging with drugs?

Science 145

Science Disease FDA Approval Pharmaceutical Companies 145

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. When imaged, the hiPSC showed a stable beating rate.

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

The Pharma Data

OCTOBER 14, 2020

. (“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. Drug Enforcement Administration. Drug Enforcement Administration.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

NOVEMBER 18, 2021

KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of drug, Harvard Medical School. At Merck, we’re committed to supporting availability to our cancer drugs. About Merck.

FDA Approval 52

FDA Approval FDA Therapies 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.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

MARCH 28, 2022

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2.0 Ozempic ® is now approved in the US at 0.5 The FDA approval is based on the results from the SUSTAIN FORTE trial. We are pleased with the FDA approval for a higher 2.0 mg and 2.0 Ozempic ® 2.0

Treatment 52

Treatment FDA Approval FDA Trials 52

The Pharma Data

JULY 12, 2021

Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia ®. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

FDA Approval 52

FDA Approval Disease FDA 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.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. with Xolair since its initial approval in 2003. indications.

FDA Approval 52

FDA Approval Clinical Development FDA Licensing 52

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. today announced that the U.S. A decision on U.S. Actemra/RoActemra is not U.S.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

Drug Discovery World

NOVEMBER 24, 2022

The US Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with haemophilia B. . The FDA approval is supported by results from the ongoing HOPE-B trial, the largest gene therapy trial in haemophilia B to date.

FDA Approval 130

FDA Approval Therapies FDA Clinical Trials 130

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52