Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. However, these treatments will eventually fail for the majority of patients, so there is a strong need for better CAR therapies.

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The Pharma Data

AUGUST 20, 2020

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is launching the drug in a dimethyl fumarate delayed-release oral solid formulation, both in 120mg and 240mg doses.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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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

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

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. The recruitment period for the study spanned from December 2015 to July 2017. 3 Dual primary endpoints of the study were OS and rPFS.1 About ERLEADA ® (apalutamide).

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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. 2017 Mar 29;9(383):eaag1166. Sci Transl Med. Doi: 10.1126/scitranslmed.aag1166.

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The Pharma Data

NOVEMBER 15, 2020

. “Guidelines recommend that psychosocial services are used before antipsychotic treatment and that children are carefully assessed before initiating antipsychotics,” Bushnell said in a university news release. In recent years, pervasive developmental disorders (PDD) accounted for the most antipsychotic prescribing.

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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

NOVEMBER 15, 2020

Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).

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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] Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017).

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The Pharma Data

DECEMBER 18, 2020

Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017.

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. Before 1983, only 38 orphan drugs had received U.S.

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The Pharma Data

AUGUST 22, 2021

today announced that Opdivo ® (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. 1 The approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356). months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE.

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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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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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al. Satam et al.

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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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NIH Director's Blog: Drug Development

JULY 20, 2017

Specifically, after 2 to 4 weeks of treatment with this combination of two correctors and a potentiator, such patients experienced about a 10 percentage point improvement in forced expiratory volume in 1 second (FEV1), which is a key measure of lung capacity. Cystic Fibrosis Foundation News Release, July 18, 2017.

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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

MAY 17, 2024

The bill is effectively a successor to the RACE for Children Act of 2017, which became law as part of the FDA Reauthorization Act of 2017 (FDARA). The law required some drug sponsors to assess the efficacy of adult cancer treatments in children under specific conditions. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),

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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

DECEMBER 8, 2020

CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. The impact of CNS diseases extends beyond patients—to their families and society as well.”

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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. 545:54-59 (2017). A regenerative approach to the treatment of multiple sclerosis. Molecular Autism. link] Birey F, et al.

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Vial

JUNE 12, 2024

As the names imply, disease-specific PROs measure features specific to a disease or syndrome, while condition-specific PROs describe aspects of a particular condition, intervention, or treatment not uniquely associated with one disease. Such complications may otherwise be missed if only disease-specific PROs are used.

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The Pharma Data

JUNE 18, 2021

Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17 , including findings from the informCLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN ® )-recommended regimens for CLL/SLL.

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The Pharma Data

JULY 23, 2021

We took this action following the Agency’s industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-marketing requirements demonstrating confirmatory benefit. This included a meeting of the Oncologic Drugs Advisory Committee in April and subsequent discussion with the FDA.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 [] for [PTE] request under 35 U.S.C. §

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

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The Pharma Data

MARCH 11, 2021

In HCC, despite evolution of the treatment landscape over the past few years, we believe Opdivo continues to address an unmet medical need for patients in the post-sorafenib setting, and we appreciate the opportunity to discuss this in more depth with the Committee.”. Waxman, M.D., INDICATIONS.

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FDA Law Blog: Biosimilars

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy.

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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. Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment.

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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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The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

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The Pharma Data

SEPTEMBER 10, 2021

Long-Term Real-World Effectiveness of Carbidopa/Levodopa Enteral Suspension After 36 Months of Treatment Initiation: Final Results from PROviDE Study. OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study. BOTOX ® Abstracts.

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The Pharma Data

JANUARY 21, 2021

In 2017, Regeneron became only the third sponsor of the Science Talent Search, increasing the overall awards distribution to better reward the best and brightest young minds. Unique among high school competitions in the U.S. Through its 10-year, $100 million commitment, Regeneron nearly doubled the overall award distribution to $3.1

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