The Pharma Data

JUNE 26, 2021

Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

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The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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ASPET

JUNE 27, 2024

Secondary VAS and pharmacokinetic (PK) endpoints and adverse events were assessed. Drug Liking and all other VAS outcomes were greatest for nabilone 3mg and 6mg, which is a currently FDA-approved medication. Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg).

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. Related Articles: Imcivree (setmelanotide) FDA Approval History.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

MAY 5, 2021

A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. The primary composite endpoint included reduction in kidney function, progression to kidney failure, or CV- or kidney-related death.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “For BASEL, Switzerland, Dec.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] 2] Mayo Clinic.

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The Pharma Data

FEBRUARY 24, 2022

In diabetic patients, the most common adverse events were urinary tract infections and female fungal infections. The side effects in clinical studies with Jardiance for patients with heart failure were generally consistent with side effects for patients with diabetes.

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The Pharma Data

SEPTEMBER 27, 2021

1 High levels of LDL-C starting at birth accelerate the event of atherosclerotic disorder , resulting in an overall increased risk of cardiovascular events, including attack and other vascular conditions, at an earlier age.2 HeFH is an inherited, genetic condition with a prevalence of 1 in 250 people worldwide.1

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Broad Institute

NOVEMBER 6, 2024

Despite being one of the rarer complications of ICI therapy, this form of myocarditis leads to dangerous cardiac events such as arrhythmia and heart failure in 50 percent of cases, and about a third who develop the condition will die from it, despite current treatments.

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The Pharma Data

MAY 6, 2022

The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose.

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The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. The primary endpoint was the frequency of all adverse events, including serious adverse events.

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The Pharma Data

NOVEMBER 18, 2020

The most common serious adverse event was fatigue, with 3.7 The trial results — delivered less than a year after researchers began working on the vaccine — shattered all speed records for vaccine development, the Times reported. The vaccine’s efficacy was consistent across age, race and ethnicity, the companies said.

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The Pharma Data

DECEMBER 16, 2020

Forward-looking statements in this press release include, without limitation, the ability of the Company and WPD to initiate clinical trials during the first quarter of 2021, and whether the planned clinical trial will provide data to the FDA to allow an expedited pathway for development. . .

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The Pharma Data

DECEMBER 21, 2020

However, Myovant’s drug dropped the percentage of major cardiovascular events to 2.9% The secondary endpoint for increasing lifespan for patients with metastatic prostate cancer came in at 74% still alive after treatment with Orgovyx compared to 75% of those on Lupron. . compared to AbbVie’s at 6.2%.

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The Pharma Data

MAY 31, 2022

There were no treatment-related adverse events leading to withdrawal. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D.,

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The Pharma Data

JULY 12, 2021

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits). Bayer announced today that the U.S.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

HPM is ably represented by seasoned drug product development and authorization attorney—and former FDA counsel— Deborah Livornese. Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.

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The Pharma Data

JULY 8, 2021

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in the development and commercialization of ADUHELM; risks relating to the launch of ADUHELM, including preparedness of healthcare providers to treat patients, (..)

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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BMG Labtech

JANUARY 18, 2023

And if you need to take an FDA-approved drug, there’s around a one in three chance that it’s a drug that targets a GPCR. But what are the best ways to study this diverse group of molecules and the cascade of signaling events that ensue in the cell?

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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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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

DECEMBER 1, 2020

In order to listen to the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. ABOUT AURINIA.

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The Pharma Data

NOVEMBER 8, 2021

” In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% Additional study treatment-related adverse events reported by ?2% versus 38.9%). .” versus 38.9%). versus 31.2%).

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Collaborative Drug

OCTOBER 7, 2024

CDD Vault provides conventional SAR tables of course, but it also gives you access to data from multiple public sources for comparison with hundreds of published sources, including popular MLSMR, GlaxoSmithKline TCAMs, and FDA-Approved Re-purposed Drugs data sets.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Assessing Endpoints A final hurdle faced in oncology trials is trial endpoints, or the event(s) or outcome(s) being measured to determine whether the study intervention is safe and effective.

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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. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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The Pharma Data

JANUARY 7, 2021

EST. In order to listen to the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (LN).

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The Pharma Data

OCTOBER 29, 2021

Food and Drug Administration (FDA) blessing of VUITY ™ (pilocarpine HCl ophthalmic result)1.25 VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of theU.S. Allergan, an AbbVie ( company, moment blazoned theU.S. adult population.

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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. Key Takeaway RWD and RWE play an important role in rare diseases, where capturing relevant data to support drug development is challenging.

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The Pharma Data

JULY 12, 2021

Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the U.S. We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.

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The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The most common non-ocular adverse event was headache (1%). Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery.

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The Pharma Data

MARCH 5, 2021

Food and Drug Administration (FDA) approved Actemra ® /RoActemra ® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. 1-3 SSc affects about 2.5

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