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] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

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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. That did not happen.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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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. The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients. Related Articles: Roxadustat FDA Approval History.

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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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The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

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The Pharma Data

JANUARY 20, 2021

Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet ® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021. Since its U.S. mL, p=0.002).

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Drug Discovery World

JULY 13, 2023

The MHRA Early Access to Medicines Scheme (EAMS) was launched in 2014 and aims to give people access to promising new drugs that are not yet licensed for life threatening or severely debilitating conditions when no other treatment is available. What are the risks?

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The Pharma Data

NOVEMBER 5, 2020

The approval by the US Food and Drug Administration (FDA) was based on positive results from the THALES Phase III trial that showed aspirin plus BRILINTA 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA. for aspirin alone.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. Novo Nordisk.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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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 21, 2020

21 December 2020 — AstraZeneca’s Tagrisso ( osimertinib ) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. 0.23; p<0.0001). 0.27; p<0.0001).

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The Pharma Data

AUGUST 17, 2021

Applications based on positive results from the Phase 3 CheckMate -648 trial, in which both Opdivo -based combinations demonstrated a significant survival benefit over chemotherapy alone. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial. About CheckMate -648.

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Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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The Pharma Data

JUNE 18, 2021

. “We are encouraged by these promising results, which indicate ibrutinib and venetoclax combined has the potential to serve as an important chemotherapy-free, fixed-duration treatment option for people living with CLL,” said Dr. Paolo Ghia , M.D., 95% irrespective of subsequent randomized treatment ( Wierda, ASH 2020 ).

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The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

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The Pharma Data

OCTOBER 27, 2021

The FDA has also granted precedence review to the company’s sBLA for Kymriah in adult cases with r/ r FL. The nonsupervisory cessions are grounded on positive data from the vital Phase II ELARA trial, which delved the efficacity and safety of Kymriah in adult cases with r/ r FL.

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The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. We look forward to engaging health authorities worldwide with the goal of bringing this immunotherapy-based treatment option to patients as soon as possible.”.

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The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. Opdivo plus Yervoy is the first dual immunotherapy regimen approved in the European Union for colorectal cancer. CheckMate -142 Efficacy and Safety Results.

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The Pharma Data

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Summary of Presentations. All times noted are Central European Summer Time (CEST).

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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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

JUNE 18, 2021

The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Three months after the completion of treatment uMRD was observed in 51.9% and 17.1%, respectively. vs. 11.4%) (p < 0.0001). .

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The Pharma Data

MARCH 11, 2021

“We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. Waxman, M.D.,

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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

JUNE 26, 2021

Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients. Learn more: [link].

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The Pharma Data

MAY 16, 2021

Description: Say goodbye to expensive and dangerous teeth whitening treatments forever! Plus, many of these kits claimed to be EU or FDA approved, when they were anything but… Quite simply, they were ILLEGAL, but I was still able to buy them online – and so can you. This 100% safe, cheap and. whistle-blower?

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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Codon

JUNE 18, 2024

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. His 2014 paper , published in Nature Nanotechnology , was the first demonstration that gas vesicles could be imaged and popped in vivo.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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Drug Discovery World

DECEMBER 19, 2022

Decentralised clinical trials that employ mobile apps and wearable devices are a particularly successful example of how patients are being empowered to take control of their own health and work in partnership with biopharmaceutical and healthcare companies. million from the ALS Association. . Misinformation and politicisation .

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Agency IQ

MARCH 7, 2024

The appropriations package refers to the FDA’s ongoing work on diagnostics policy, which has been an extremely active area for policymaking over the last few months [ See AgencyIQ’s analysis, “CDRH diagnostics update: An IVD down-classification initiative, CDx and LDTs, and next steps for diagnostics regulation ].

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PLOS: DNA Science

DECEMBER 21, 2023

It’s a history of gene therapy told through the voices of the patients, families, researchers, and clinicians behind the first FDA approvals, which didn’t come until 2017. FDA just approved the first CRISPR-based gene treatment , for sickle cell disease. Results can vary.

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