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

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

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

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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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In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders.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

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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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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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET.

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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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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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The Pharma Data

DECEMBER 9, 2020

Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. .

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The Pharma Data

DECEMBER 30, 2020

That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. Andexxa, was approved by the U.S.

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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

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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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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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. FDA in October 2023. The product was approved in the E.U. received a CRL from the FDA in May 2023 due to manufacturing control issues.

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

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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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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

AUGUST 31, 2021

As the treatment of genitourinary cancers becomes more complex, we continue to work with urologists and their teams to improve outcomes for patients across the continuum of disease,” said Craig Tendler, M.D., Real-World Effectiveness and Treatment Adherence of Apalutamide in Non-Metastatic Castration-Resistant Prostate Cancer Patients.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. At the time of that publication risdiplam was also in clinical trials for the treatment of SMA patients.

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Drug Discovery World

AUGUST 10, 2023

The number of people using e-cigarettes continues to climb, as the World Health Organization reported that 41 million adults used e-cigarettes globally in 2018. Research in this emerging area is limited, and there are currently no treatments that are specifically approved by the FDA for e-cigarette cessation.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018.

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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. link] [2] Zhang and Tang, 2018. 2018 Sep;8(5):721-732. Br J Pharmacol.

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The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. DEB has been a candidate for a gene therapy since 2002.

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Agency IQ

NOVEMBER 3, 2023

Because they focus on treatment of a specific condition, synthetic biotics must be studied under an investigational new drug application (IND). In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

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Agency IQ

JULY 21, 2023

It was to address this first challenge of long follow-up periods that the FDA first started accepting tumor-based endpoints such as objective response rate (ORR) and progression-free survival (PFS) for anticancer products. subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies).

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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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The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock. Most Read Today. Source link.

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The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

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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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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

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases.

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Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4.

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