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. It was developed with Genmab.

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Drug Discovery World

APRIL 27, 2023

With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9 Biotechnology company Tiziana Life Sciences is initiating a programme to develop intranasal foralumab for the treatment or prevention of type 1 diabetes.

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The Pharma Data

APRIL 20, 2023

FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the United States.

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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. an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. in March, 2021.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc.

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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. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

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Drug Discovery World

SEPTEMBER 7, 2023

4 Recent regulatory initiatives in the United States and Europe have aimed to increase the study of novel anti-cancer therapies in children. 4 Recent regulatory initiatives in the United States and Europe have aimed to increase the study of novel anti-cancer therapies in children.

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Drug Discovery World

SEPTEMBER 14, 2023

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business. As a result of these moves, William Pao, M.D.,

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Drug Discovery World

JULY 14, 2022

Following what Actigen calls a positive response to the meeting, the company is now submitting its IND application and will begin clinical trials for GNR-055 if it receives FDA approval. . It occurs primarily in males and current treatment options such as enzyme replacement therapy, only offer a partial solution.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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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. 2] Names Lazertinib is the international nonproprietary name. [7] 20 August 2024.

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Drug Discovery World

AUGUST 30, 2022

TPOXX is an FDA-approved antiviral drug for the treatment of smallpox. In a research letter published in the Journal of the American Medical Association (JAMA), UC Davis infectious disease experts presented insights on 25 patients with monkeypox who were given tecovirimat therapy. Context and treatment. Nine patients had HIV.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Therapy was initiated at Verquvo 2.5 KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

FEBRUARY 24, 2022

Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed. Coinciding with February’s annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease.”.

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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.,

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

MAY 18, 2021

Roche/GSK collaboration represents an important step towards a personalised healthcare strategy that can help identify patients who are most likely to benefit from a specific therapy. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. CA Cancer J Clin.

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Fierce BioTech

SEPTEMBER 11, 2023

Aligning cross-functional teams across the organization to ensure medical, marketing, and market access are all in lock-step is even more crucial when launching a therapy into a rare disease market.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] mg/dL, a magnesium concentration ≥1.3

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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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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PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. The therapy is “ ex vivo and, autologous”: it’s done outside the body using the patient’s cells.

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Drug Discovery World

JULY 2, 2024

An internal study performed recently, highlighted how Basel is outstanding in scientific collaboration with industry, measured via joint publications and at the same time how the local industry excels globally in the number of patents filed.” Three years ago, we started our venture into the radiotherapy space.

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PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. Keytruda illustrates more recently approved cancer drugs.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

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Drug Discovery World

MAY 9, 2023

Despite considerable progress in cancer drug development over the past few decades, there remains a chasm between the number of investigational new drug (IND) approvals and commercialised oncology drugs. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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The Pharma Data

FEBRUARY 1, 2021

Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”. 2 Multiple Sclerosis International Federation. Chief Medical Officer at Biogen. 3 Zhao Y, et al. Source link.

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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.

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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The Pharma Data

MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who continued relugolix combination therapy remained responders through Week 104. of women who discontinued treatment at Week 52 (p < 0.0001). weeks after discontinuation.

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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. and CHICAGO , Oct.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. cell and gene therapies), with other therapeutic areas then pushing it further. Patients may be wary of joining an experimental trial and taking on those potential risks when approved therapies are already available.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] [9] [10] Names Etrasimod is the international nonproprietary name. [11]

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The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. UNION is headquartered in Hellerup ( Denmark ) and is managed by an experienced international team. For more information please visit: www.uniontherapeutics.com.

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Drug Target Review

MAY 27, 2024

What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans? At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs.

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New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). 12 (1): 267–287. PMC 9837340.

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