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. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. with placebo.

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The Pharma Data

SEPTEMBER 27, 2021

Food and Drug Administration (FDA) has approved Repatha® (evolocumab) as an adjunct to diet and other LDL cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous hypercholesterolemia (HeFH) to scale back LDL-C. No new safety risks were identified.5

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The Pharma Data

DECEMBER 16, 2020

We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. These statements relate to future events, future expectations, plans and prospects.

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The Pharma Data

DECEMBER 21, 2020

We know from our research that the majority of men prefer an oral treatment to an injection,” Myovant CEO Lynn Seely said. 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. .

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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

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 initiation of treatment requires no loading dose or oral supplementation.

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The Pharma Data

MARCH 26, 2021

Despite continuous innovations in the treatment landscape, unmet needs remain. If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.”. 5] The MAA will now be reviewed by the European Commission (EC) for the treatment of adults with RMS. vs. 10.4%).

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The Pharma Data

JANUARY 17, 2021

a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma. GAITHERSBURG, Md.

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The Pharma Data

JULY 8, 2021

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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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.

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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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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I About the Phase 1/2 Trial for HPN217.

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The Pharma Data

NOVEMBER 8, 2021

“The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.” “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.” versus 38.9%). .

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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.

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. As a result, researchers now often use composite endpoints in lieu of the customary single primary endpoint.

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The Pharma Data

MAY 7, 2021

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at [link] by calling 1-800-822-7967.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass., Source link.

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The Pharma Data

OCTOBER 29, 2021

Food and Drug Administration (FDA) blessing of VUITY ™ (pilocarpine HCl ophthalmic result)1.25 for the treatment of diplopia, generally known as age- related vague near vision, in grown-ups. There were no serious adverse events observed in actors entering VUITY in either the GEMINI 1 or GEMINI 2 study. adult population.

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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

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

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.

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The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease. nM and 13.81

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement.

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The Pharma Data

AUGUST 19, 2021

. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events.

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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. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles. This means study startup times can vary greatly.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. The Company plans to initiate a Phase 2 trial within the next several months. “We

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. EINSTEIN-Jr.

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The Pharma Data

MARCH 24, 2021

of women who discontinued treatment at Week 52 (p < 0.0001). of women who discontinued treatment relapsed with heavy menstrual bleeding, on average 5.9 This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years. weeks after discontinuation.

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New Drug Approvals

DECEMBER 16, 2023

2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. This approval was based on favorable results obtained from the phase III APPL-PNH and APPOINT-PNH studies, where 82.3% 1] It is a complement factor B inhibitor that was developed by Novartis. [1]

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DrugBank

DECEMBER 18, 2024

DTx interventions include sensor-equipped wearable devices, remote patient monitoring tools, and virtual reality platforms integrated with conventional pharmaceutical treatments.   Empowering Patients and Enhancing Outcomes A cornerstone of treatment success lies in patient engagement and treatment adherence.

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The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

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The Pharma Data

DECEMBER 28, 2020

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid. Noted products are trademarks or registered trademarks of their respective owners.

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The Pharma Data

SEPTEMBER 7, 2021

Marco Pravetoni, PhD, a leading expert of biologics for the treatment of substance use disorders and developer of the vaccine candidate, is an associate professor of pharmacology and medicine at the University of Minnesota Medical School. The study plans to enroll up to 45 volunteers. The study plans to enroll up to 45 volunteers.

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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 that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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