The Pharma Data

AUGUST 16, 2020

Basel, 17 August 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. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease.

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The Pharma Data

OCTOBER 8, 2021

. “Today’s action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. This application was granted a rare pediatric disease voucher by the FDA.

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The Pharma Data

DECEMBER 31, 2020

Monthly News Roundup – December 2020. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. In studies, the vaccines were found to be 94% to 95% effective in preventing COVID-19 disease. In December, the U.S.

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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. References Iversen et al., link] Tang e t al.,

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. 22, 2020– Gilead Sciences, Inc. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS to 1.03).

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. Untreated children with Progeria die of heart disease at an average age of 14.5 PALO ALTO, Calif.,

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The Pharma Data

JULY 8, 2021

This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.

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The Pharma Data

JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 — The first blood test to help diagnose Alzheimer disease is now available in the United States, but some experts have a number of concerns about it. Louis is meant for people 60 years and older who have cognitive issues and are being assessed for Alzheimer disease. states and was just approved for sale in Europe.

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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. 15, 2020 (GLOBE NEWSWIRE) — Athenex, Inc., 15, 2020 (GLOBE NEWSWIRE) — Athenex, Inc., The FDA approval of Klisyri is a significant milestone for Athenex. BUFFALO, N.Y., BUFFALO, N.Y.,

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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

DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. LN, or inflammation of the kidneys, is a common system of systemic lupus erythematosus (SLE), one of the most prevalent autoimmune diseases.

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The Pharma Data

DECEMBER 30, 2020

The year 2020 will certainly go down in history as the year of COVID-19. Gilead Sciences Makes Multiple Bets : When Gilead Sciences wasn’t working on remdesivir in COVID-19, the company seemed to be constantly flexing its M&A muscle over the course of 2020. It began in May with the $4.9 But the U.K.-based

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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Food and Drug Administration (FDA) approval. The FDA Since 1983. FDA Expedited Programs.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. 18, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the U.S. BASEL, Switzerland, Dec.

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The Pharma Data

DECEMBER 12, 2020

12, 2020 – The U.S. Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. Centers for Disease Control and Prevention advisory panel. © 2020 HealthDay.

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The Pharma Data

JANUARY 19, 2021

NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021 , before the U.S. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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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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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. About Biogen.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [19] FDA prescribing information for zilucoplan. Blood 129(13): 1823-1830. link] [13] Eng et al.,

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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. in 2020, approximately 60-90 thousand of the three million cases of prostate cancer were mCRPC.(2) 2) HRR gene mutations are found in approximately 25% of tumors from men with mCRPC and have been associated with aggressive disease and poor prognosis.(3,4,5,6)

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 – The first rapid coronavirus test that can be taken at home with results delivered in 30 minutes was cleared for emergency use by the U.S. The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. .”

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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).

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The Pharma Data

OCTOBER 31, 2020

1, 2020 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) ( Taiwan : 4157) announced today that U.S. 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.

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Broad Institute

APRIL 25, 2024

He started to imagine how the deadly and contagious disease, if confirmed, might spread to half the city’s population. Eight of the 20 patients died, but the spread of the disease in Nigeria stopped there. Blood and urine samples from the man were waiting for Happi in his lab. Happi felt chilled. They called the idea Sentinel.

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AUGUST 31, 2020

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy. Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S.

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The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. Disease Highlights.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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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

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The FDA first approved Benlysta for lupus in 2011.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. ” As previously announced, the planned trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease. In this trial the overall response rate of stable disease or better was 44%. .

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The Pharma Data

OCTOBER 27, 2020

27, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. EST on Monday, November 9, 2020. Cowen Virtual Presentation Series – 2020 IO Next Summit at 1:15 p.m. EST on Friday, November 13, 2020. GMT ) on Tuesday, November 17, 2020. TARRYTOWN, N.Y. , Jefferies Virtual London Healthcare Conference at 7:20 a.m.

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NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system.

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Codon

NOVEMBER 3, 2024

Physicians working in the early 20th century had little choice but to treat the world’s most rampant infectious disease with methods such as these. But even now, more than a century later, TB remains the deadliest infectious disease on Earth, killing about 1.2 Cell (2020). million people every year. Credit: Stokes J.M.

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FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History.

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The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people.

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