The Pharma Data

JANUARY 17, 2021

18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields.

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Agency IQ

JANUARY 12, 2024

After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Fill out the form to read the full article.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism.

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Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Drug Discovery World

FEBRUARY 22, 2024

The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA). Nonetheless, there was a resilient upturn of 1.6% billion for 2023.

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Drug Discovery World

AUGUST 9, 2023

Read more: BioIVT acquires biospecimens provider PrecisionMed Biogen acquires Reata During a period of upheaval for the company, Biogen revealed its purchase of Reata Pharmaceuticals for approximately $7.3

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Drug Discovery World

NOVEMBER 29, 2023

The simulator could also be used by pharmaceutical companies to rapidly test multiple drug therapies and patient scenarios, increasing the speed and cost of drug development. The post Mathematical model can speed up Alzheimer’s drug development appeared first on Drug Discovery World (DDW).

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Drug Discovery World

SEPTEMBER 16, 2022

A slightly quieter week for news in light of national events in the UK, but the vital work of the international drug discovery community goes on and new discoveries are being made all the time. . FDA approves new first-line therapy for plaque psoriasis . Potential Alzheimer’s drug receives US patent .

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The Pharma Data

MARCH 22, 2023

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

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Drug Discovery World

JULY 31, 2023

Biogen has revealed an agreement to acquire Reata Pharmaceuticals for approximately $7.3 The approval was based on data from the Phase III Clarity AD clinical trial, in which reduced clinical decline by 27%. The post Biogen acquires Reata and cuts 1,000 jobs appeared first on Drug Discovery World (DDW).

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock.

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Drug Discovery World

MAY 1, 2024

Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1. Ben Holland, Co-Founder and CTO of Antiverse, notes that AI and machine learning now touch 10% of drug discovery projects.

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Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. billion, a decrease of $15.0

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Drug Discovery World

FEBRUARY 15, 2024

Cessation Therapeutics is a pharmaceutical company that is developing antibody therapies to prevent and reverse overdosing caused by fentanyl. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose. appeared first on Drug Discovery World (DDW).

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. Recent correspondence between the Company and the FDA resulted in modifications to the previously disclosed trial design, including designating overall survival (OS) as the primary endpoint of the study. About CNS Pharmaceuticals, Inc.

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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. Switzerland, however, boasts three (or arguably, four) separate yet complimentary centres of life science innovation.

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Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. Go-to-market Strategy.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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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.

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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.”

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Drug Discovery World

SEPTEMBER 13, 2022

Ayala Pharmaceuticals has revealed positive interim results from its ongoing RINGSIDE Pivotal Phase II and III clinical trial into gamma-secretase inhibitor AL102 in desmoid tumours. The post New treatment hope for patients with rare tumours appeared first on Drug Discovery World (DDW).

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Approximately 4,500 people in the U.S.

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Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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The Pharma Data

NOVEMBER 23, 2021

Approval is for Cytomegalovirus, a Type of Herpes Virus. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today, the U.S. It’s a type of herpes contagion.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The adverse drug reactions occurring more commonly with Verquvo than placebo and in greater than or equal to 5% of patients treated with Verquvo in VICTORIA were hypotension (16% vs 15%) and anemia (10% vs 7%). KENILWORTH, N.J.–(BUSINESS

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA). 19 August 2024. Retrieved 21 August 2024.

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Drug Discovery World

JUNE 14, 2023

An FDA approval for Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine is likely to threaten GSK’s current hold on the market, according to GlobalData. As an RNA virus, RSV is capable of rapid mutation to escape attack by new pharmaceuticals.

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DrugBank

FEBRUARY 1, 2024

There’s a lot to dig into so we’ve highlighted a few improvements we think are really going to change the game: 300% Increase in Drug-Drug Interaction Data Navigating the complex world of pharmaceuticals can be daunting. simplifies this with a significant expansion in our drug-drug interaction data.

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