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]. Veozah (Fezolinetant): A Promising Non-Hormonal Treatment for Vasomotor Symptoms in Menopause.

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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. One step closer to a novel treatment.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Food and Drug Administration in 2017.

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The Pharma Data

AUGUST 31, 2020

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. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 About HIV-1 and HIV-2 in the U.S. million people were living with HIV in the United States.

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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

NOVEMBER 2, 2020

GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States. This morning, California-based GW said it will launch the first Phase III trial studying nabiximols, which is known as Sativex outside the United States, as a potential treatment for multiple sclerosis-associated spasticity.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. There are two things of note from this year.

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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. 1 It was approved by the FDA on August 19, 2024. 20 August 2024. 20 August 2024.

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The Pharma Data

JANUARY 18, 2021

Given the pandemic, 2020 can’t be viewed as a typical year, but Prevision noted that the number of applications for new drugs or indications sent to the committees had already decreased steadily pre-pandemic, with only 23 in 2019 and 30 in 2018.

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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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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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New Drug Approvals

AUGUST 26, 2023

Zuranolone CAS 1632051-40-1 Zurzuvae FDA APPROVED 8/4/2023, To treat postpartum depression Press Release WeightAverage: 409.574 Monoisotopic: 409.272927379Chemical FormulaC 25 H 35 N 3 O 2 SAGE 217 SAGE-217 SAGE217 Zuranolone , sold under the brand name Zurzuvae , is a medication used for the treatment of postpartum depression. [1]

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The Pharma Data

JUNE 18, 2021

June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. IRVINE, Calif. Experience the interactive Multimedia News Release here: [link] . Each story is unique. Each story is unique.

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Drug Target Review

AUGUST 3, 2023

Precision medicine , with its focus on personalised treatments tailored to an individual’s genetic makeup, has seen remarkable progress in recent years. What preclinical research methods are commonly employed in precision medicine, and how do they contribute to the development of personalised treatments?

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The Pharma Data

JUNE 28, 2021

Million People in Japan[1],[2] Aimovig is the First and Only Approved Treatment in Japan to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R) That Plays an Important Role in Migraine[3] Aimovig Continues to be the Most Utilized Anti-CGRP Pathway Therapy, With More Than Half a Million Patients Prescribed Worldwide[4].

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The Pharma Data

SEPTEMBER 2, 2020

New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence. Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations.

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Drug Target Review

JULY 5, 2024

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 15(9):700-706 (2018) [link] Deshmukh V, et al. A regenerative approach to the treatment of multiple sclerosis. 12(3) (2023).

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APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Alzheimer’s Disease (AD). P6: Neuromuscular Disorders and Clinical Trials.

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The Pharma Data

AUGUST 1, 2021

The FDA cited its ongoing review of Pfizer’s post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis (RA). Additional presentations showcased the importance of understanding patient preferences and patient-reported outcomes in IBD treatments. years in patients with RA.

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The Pharma Data

DECEMBER 27, 2020

Following changes to our leadership team in late 2018 and early 2019, we have sought to transform Lineage into the preeminent allogeneic cell transplant company. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). Recent Events. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. AbbVie announced that the U.S.

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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. ENSPRYNG treatment is administered every four weeks after an initial loading dose. Basel, 17 August 2020.

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The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA is approved in the U.S.

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Drug Target Review

JUNE 21, 2023

4 For the treatment of rare genetic disorders especially, drugs with genetically supported targets are more than twice as likely to be approved 5 , thereby indicating genetics and genomics can empower companies to develop better drugs. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs.

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Eye on FDA

AUGUST 4, 2021

Each committee is comprised of a number of experts, diverse for their expertise, geography and specialty – with some focused on statistics while others may be focused on areas of concentration within the category, such as the treatment of pediatric patients. Fewer meetings – more approvals.

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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

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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JUNE 30, 2021

The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; 21 U.S.C. §

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). FDA Approves Opdivo + Yervoy for Malignant Pleural Mesothelioma. .

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. While stimulant use disorder is increasing, there are currently no FDA-approved medications.

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The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD,” said Professor Anthony Traboulsee, M.D.,

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Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Chemical Research in Toxicology 2018 31 (7), 570-584, [link] [8] Interindividual Variability in Cytochrome P450 3A and 1A Activity Influences Sunitinib Metabolism and Bioactivation. Bourgeois, James A. Perkins, Arsany A. Abouda, Kahari J.

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The Pharma Data

SEPTEMBER 28, 2021

additionally , all five babies maintained the power to swallow and were ready to feed exclusively orally after 12 months of treatment. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Evrysdi for the treatment of SMA in adults and youngsters 2 months aged and older.

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