The Pharma Data

FEBRUARY 1, 2021

Plegridy is the only approved pegylated interferon for MS with a proven ability to delay the progression of MS disability and reduce relapses. Plegridy was first approved by the FDA in 2014 and is proven to significantly reduce MS relapses, disability progression and brain lesions with a well-understood safety and tolerability profile.

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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

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus. Source link.

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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 September 2014—nearly ten years ago!—PTE To that end, 35 U.S.C. § 156(c)(4)

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

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Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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Broad Institute

OCTOBER 11, 2023

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

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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. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [vii]

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The Pharma Data

DECEMBER 18, 2020

Anemia in Chronic Kidney Disease; 2014 [cited 10 December 2020]. Related Articles: Roxadustat FDA Approval History. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References. National Institute of Diabetes and Digestive and Kidney Diseases. .

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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.

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The Pharma Data

OCTOBER 27, 2021

The primary endpoint is complete response rate (CRR) grounded on stylish response by central review (Lugano 2014 criteria). This transnational trial has enrolled cases from over 30 spots in 12 countries worldwide. After infusion, complaint assessments were performed every three months.

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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. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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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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NIH Director's Blog: Drug Development

JUNE 14, 2016

That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2014 Jan;32(1):40-51. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk.

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The Pharma Data

AUGUST 17, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. On March 25, 2011, the U.S.

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The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. Since October 2014, Bayer and Merck have pursued a worldwide collaboration in the field of sGC modulators. In January of this year, the U.S.

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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]. 20 (March 20, 2014). 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]. 20 (March 20, 2014). Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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The Pharma Data

JUNE 30, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. volume 4, Article number: 4782 (2014).

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Codon

AUGUST 26, 2024

Ebola tore through Western Africa in 2014, killing an estimated 11,325 people in two years. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. As a result, it is classified as a “drug-free” product and does not require FDA approval.

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The Pharma Data

APRIL 11, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China.

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The Pharma Data

SEPTEMBER 8, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. On March 25, 2011, the U.S.

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The Pharma Data

JANUARY 20, 2021

Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF) and is available in more than 60 countries worldwide. Esbriet was FDA-approved for use in people with IPF in October 2014. Esbriet U.S. Indication. It is not known if Esbriet is safe and effective in children.

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The Pharma Data

JANUARY 18, 2021

This pioneering research led to the clinical development of a humanized anti-VEGF Fab (Ranibizumab, Lucentis ® ), which has also been approved as a therapy for neovascular age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular edema. Enquiries: OKYO Pharma Limited. Gary S. .

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The Pharma Data

DECEMBER 21, 2020

With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. Related Articles: Tagrisso (osimertinib) FDA Approval History.

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Agency IQ

JUNE 2, 2023

These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014. Curiously, there is no direction for the patient to seek out the full FDA-approved labeling.

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Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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Codon

JUNE 18, 2024

His 2014 paper , published in Nature Nanotechnology , was the first demonstration that gas vesicles could be imaged and popped in vivo. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval. An engineer’s mind, however, does not sit idle for long.

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The Pharma Data

NOVEMBER 5, 2020

BRILINTA is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack. Lancet Neurol 2014; 13(2):178–94.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. volume 4, Article number: 4782 (2014). BTK signaling is needed by specific cancer cells to multiply and spread. November 2020.

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The Pharma Data

MARCH 11, 2021

Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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Agency IQ

APRIL 26, 2024

Sponsors should submit a completed copy of Form FDA 2253, plus any “specimens of mailing pieces and any other labeling or advertising devised for promotion of the reference product or biosimilar product” at the time of its initial publication or dissemination. Yes, the guidance confirms.

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Codon

MARCH 28, 2023

DARPA invested more than $200 million in support of the White House’s Brain Research through Advancing Innovative Neurotechnologies ( BRAIN ) Initiative between 2014 and 2016 alone. Researchers used an off-the-shelf, FDA-approved machine, developed by Blackrock Neurotech ; the algorithms were the main advancement.)

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Molecular Design

OCTOBER 14, 2018

The first was reported in 2014 by AstraZeneca( 16 ) and the second in 2016 by academic researchers and called Badapple.( It is instructive therefore to introduce two more recent and fully statistically validated frequent-hitter analytical methods that are assay platform-independent.

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The Pharma Data

AUGUST 1, 2021

AbbVie also presented an updated analysis from the Phase 3 ARTEMIS studies assessing the efficacy and duration of Durysta (bimatoprost intracameral implant), the first and only FDA-approved dissolvable implant to reduce eye pressure in people with open angle glaucoma or high eye pressure.

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