The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. The sBLA submission is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. A decision on U.S.

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The Pharma Data

AUGUST 11, 2020

Photo by FDA/CDC. Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients. The treatment is already available on an emergency basis for people suffering with severe symptoms from coronavirus. The drug would go under the brand name of Veklury.

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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. 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

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

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Drug Target Review

NOVEMBER 20, 2023

A team of scientists at Mass General Brigham in the US has developed a visualisation tool combining high-speed cameras, that can detect changes happening in a billionth of a second, and FDA-approved fluorescent injections to distinguish tumour tissue from normal tissue across several cancer types.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. If an allergic reaction occurs, treatment with DALVANCE should be discontinued. AbbVie (NYSE: ABBV) today announced that the U.S.

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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. Now, all that being said, with the Covid-19 pandemic, there is a recommendation from the National Comprehensive Cancer Network for patients with cancer to avoid hospitals and clinics as much as possible.

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The Pharma Data

DECEMBER 3, 2020

“ORLADEYO offers people with HAE and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents an important and welcome step in making more treatment options available to physicians and patients,” said Anthony J. attacks per month at baseline, to a mean of 1.0 attacks per month.

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The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

DECEMBER 16, 2020

Effective treatment can greatly improve health outcomes and reduce the long-term costs associated with managing lupus-related kidney disease.” “Standard-of-care treatment for lupus nephritis has relied upon using strong immunosuppressant drugs and high doses of corticosteroids. ” Dr. Susan M.

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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. Jude Children’s Research Hospital.

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KIF1A

APRIL 25, 2024

Her mother, Megan, has offered to share their experience and journey with everyone to help us understand the process and to share in their hopes, fears, challenges, and successes that come along with ASO treatment. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane. Hello KIF1A Community!

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. About the REGN-COV2 Trial in Hospitalized Patients. Regeneron Pharmaceuticals, Inc.

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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

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.,

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. BXCL501 has been granted Fast Track Designation by the U.S.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Does this signal a return in 2024 to in-person meetings? ” Volume of Meetings and Outcomes.

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The Pharma Data

MAY 17, 2021

. In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package insert for situations such as drug repurposing and de-escalation of therapy.

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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

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

OCTOBER 25, 2020

.” SQI’s RALI-dx COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI is working with agencies in both the U.S.

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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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The Pharma Data

JUNE 28, 2021

Million People in Japan[1],[2] Aimovig is the First and Only Approved Treatment in Japan to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R) That Plays an Important Role in Migraine[3] Aimovig Continues to be the Most Utilized Anti-CGRP Pathway Therapy, With More Than Half a Million Patients Prescribed Worldwide[4].

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The Pharma Data

JANUARY 5, 2021

“Benuvia is excited to partner with the leadership of Radius Health to progress the late-stage development and commercialization of our synthetic cannabidiol oral solution for the treatment of rare and underserved diseases. We look forward to supporting Radius through our U.S. Davis, executive chairman of Benuvia. Benuvia Therapeutics Inc.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved in the U.S. In the U.S., Outside of the U.S.,

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The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. El Sahly, M.D.,

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The Pharma Data

OCTOBER 25, 2020

To help health care providers achieve the best possible outcomes, the Breethe system will be supported 24 hours a day, 7 days a week by Abiomed’s experienced field-based, in-hospital clinical team and on-call team from the Clinical Support Center. commercial availability expected in calendar year 2021. ABOUT ABIOMED. The Impella 2.5®,

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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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The Pharma Data

NOVEMBER 29, 2020

The FDA approved the drug on November 24. It is the first treatment ever approved for this indication. PH1 affects patients of all ages,” said Sally-Anne Hulton, consultant pediatric nephrologist, Birmingham Women’s and Children’s Hospital NHS Trust, UK. This mean treatment difference was 53%. and Europe.

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The Pharma Data

DECEMBER 23, 2020

a Miami, Florida-based clinical-stage biopharmaceutical company focused on harnessing the power of nanoparticles for the treatment of degenerative diseases, is awaiting a decision from the FDA regarding an investigational new drug (IND) application for a clinical trial of its proprietary therapeutic, Zofin, in COVID Long-haulers. .

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NIH Director's Blog: Drug Development

JULY 20, 2017

The first genetic mutation that causes CF was discovered by a collaborative effort between my own research lab at the University of Michigan, Ann Arbor, and colleagues at the Hospital for Sick Children in Toronto—more than 25 years ago [1]. All told, there is now some sort of approved targeted treatment for about 40 percent of people with CF.

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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. Additionally, the Company sells insulin API products.

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The Pharma Data

FEBRUARY 23, 2022

. * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: * 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease * 57.9% Favorable safety profile following both primary series and booster vaccinations.

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The Pharma Data

NOVEMBER 10, 2020

FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (“PMX”). Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. ” About Spectral and Dialco.

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The Pharma Data

FEBRUARY 18, 2022

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D.,

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