The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Approval was granted to Myovant Sciences. © 2020 HealthDay.

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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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Metabolite Tales Blog

APRIL 10, 2024

It is approved for treatment of severe alopecia areata in which inflammatory processes play a major role, with associated increased reactive oxygen species formation and reduced levels of GSH. 2020; 50(5): 559-569. link] [3] FDA Review application number 216059Orig1s000 for Jaypirca (pirtobrutinib (Loxo-305)).

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The Pharma Data

AUGUST 27, 2020

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. FoundationOne Liquid CDx is available to order, as of 28 August 2020, replacing Foundation Medicine’s currently available liquid biopsy test FoundationOne Liquid.

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The Pharma Data

JANUARY 17, 2021

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. are expected to be approved by the U.S. .

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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] Comenzo, M.D.,

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.

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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. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis . Professional. In December, the U.S.

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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 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc., Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. We are excited to achieve its approval in the U.S.

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The Pharma Data

DECEMBER 30, 2020

The Feverish Pricing of MS Treatments. Towards the end of March, the FDA approved two new treatments for multiple sclerosis (MS): Mayzent (siponimod) and Mavenclad (cladribine). Drug treatments for MS have been climbing an expensive staircase for a number of years. Posted: December 2020. Consumer News.

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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] [5] FDA prescribing information for fezolinetant. Health Sci Rep. 6(10):e1610.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN) will host a webcast on Monday, December 7, 2020 at 4:30pm EST. Management will discuss data presented at the American Society of Hematology (ASH) 2020 Annual Meeting as well as provide updates on the Company’s broader oncology and hematology portfolio.

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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. We at the LRA are thrilled to share this news about belimumab and look forward to future approvals of other lupus nephritis treatment options.”.

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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 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

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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 ®. Bayer announced today that the U.S. There are more than 160 million patients living with CKD and T2D worldwide.

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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. ADUHELM can also cause serious allergic reactions.

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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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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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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. Metastatic CRPC is a form of prostate cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone. in 2020, approximately 60-90 thousand of the three million cases of prostate cancer were mCRPC.(2)

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The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. billion, as of June 30, 2020. June 30, 2020 on. Second Quarter. . . Total Revenues.

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The Pharma Data

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The DURYSTA data presentations coincide with the two-year anniversary of the U.S.

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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. TARRYTOWN, N.Y. , 19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. financial markets open.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. . HOUSTON , Dec.

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The Pharma Data

MAY 18, 2021

VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI ( dostarlimab-gxly ). Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients.

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The Pharma Data

AUGUST 31, 2020

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Reviewed June 8, 2020. Accessed July, 24 2020. J Clin Virol.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. 10 months. [5]

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The Pharma Data

AUGUST 14, 2020

In other news, Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy and Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo. Russia becomes world’s first country to grant regulatory approval for a coronavirus vaccine.

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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. WASHINGTON , Dec. Gibson , president and CEO, Lupus Foundation of America.

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The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

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The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I About the Phase 1/2 Trial for HPN217.

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The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

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The Pharma Data

FEBRUARY 22, 2022

Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. In 2020, an estimated 21 million adults had at least one major depressive episode. VRAYLAR is also approved for the treatment of schizophrenia in adults (1.5

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He is co-inventor of SEED Biosciences’ core technology called DISPENCELL and co-authored several patents and scientific articles that made the cover of SLAS Technology in 2020.

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