The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. with Xolair since its initial approval in 2003. today announced that the U.S. indications. indications. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MARCH 26, 2021

The CHMP’s positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis.”. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis. [3],

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Therapies Disease Treatment Vaccine 52

The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. It is approved in Argentina as the world’s first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. All study subjects will receive the same Ampligen treatments.

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Clinical Trials Trials Virus International 52

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

Therapies 104

Therapies Engineering Molecular Biology Immune Response 104

The Pharma Data

MAY 5, 2021

GlaxoSmithKline plc (GSK) today announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE).

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Therapies Disease Treatment International 52

The Pharma Data

JULY 22, 2021

NOTE: ADUHELM TM (aducanumab-avwa)injection 100 mg/mL solutionis 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.

Disease 52

Disease Research Clinical Trials FDA 52

NIH Director's Blog: Drug Development

MAY 21, 2020

Just one infusion of this combination antibody therapy lowered the amount of viral genetic material in the animals’ lungs by as much as 30 percent compared to the amount in untreated animals. Meanwhile, there’s been other impressive recent progress towards the development of monoclonal antibody therapies for COVID-19.

Virus 52

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The Pharma Data

NOVEMBER 9, 2020

Cancer immunotherapies such as immune checkpoint inhibitors (ICIs) have shown promising clinical outcomes over the past two decades; and they are often used for patients with advanced cancers once other therapies have reached the end of their effectiveness. NBTXR3 is injected one time, directly into solid tumors. Abstract ID: 410.

Immune Response 40

Immune Response Therapies Clinical Trials Treatment 40

Drug Target Review

NOVEMBER 17, 2023

They do not induce ‘graft versus host’ disease when transplanted for allogeneic therapy and there appears little sign of immune rejection. Peripheral blood NK cells have been used in allogeneic cancer therapies and shown to be safe. Only three of the CAR-NK studies were for the treatment of solid tumours.

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The Pharma Data

OCTOBER 19, 2020

NBTXR3 is a novel radioenhancer composed of functionalized hafnium oxide nanoparticles that is administered via one-time intra-tumoral injection and activated by radiation therapy. The physical and universal mode of action (MoA) of NBTXR3 is designed to trigger cellular destruction death and adaptive immune response.

Clinical Trials 52

Clinical Trials Immune Response Trials Therapies 52

Drug Discovery World

FEBRUARY 26, 2024

The FDA said that Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma.

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. from 1993 to 1995.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

Drug Target Review

NOVEMBER 30, 2023

Then I was approached to co-found AC Immune in 2003. Our investigational active immunisation therapies could potentially delay or perhaps even prevent the onset of clinical dementia symptoms. My family and friends said I was crazy to take this step. COVID-19 has shown the revolutionary impact of vaccines.

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Disease Laboratories Therapies Treatment 95

Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. 10 Proteasome inhibitors Since the approval of Bortezomib in 2003, 11 new proteasome inhibitors have emerged with reduced side effects.

Small Molecule 126

Small Molecule Drugs Immune Response Targeted Protein Degradation 126

Drug Target Review

MAY 18, 2023

Results of the Multicenter Study of Hydroxyurea in Sickle Cell Anaemia published in the Journal of the American Medical Association in 2003, indicated that the use of hydroxyurea, the only drug approved at the time, reduced mortality as it reduced pain crises and increased foetal haemoglobin.

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Agency IQ

SEPTEMBER 15, 2023

Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure. The trials assessed change in nasal congestion score over one week of treatment.

Science 40

Science FDA Clinical Trials Pharmacy 40

Drug Target Review

DECEMBER 14, 2023

The new understanding may result in novel cancer therapies. In 2003, Dr Richard Wood, distinguished Professor at the University of Texas MD Anderson Cancer Center, was a crucial part of the first characterisation of polymerase theta. Polymerase theta TMEJ has been the most elusive DNA repair pathway.

DNA 58

DNA Clinical Trials Treatment Research 58

Codon

DECEMBER 17, 2023

A first draft of the human genome was completed in 2003. At least six CAR-T cancer therapies have now garnered F.D.A. In Switzerland, although evidence for the efficacy of iodized salt was robust, some eminent scientists spoke out against the interventions—advocating for elaborate alternative treatments.

Engineering 52

Engineering Molecular Biology Doctors DNA 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. 2003) , and Biogen lnt’l v. Patent Nos. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed.

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FDA Approval FDA Production Therapies 59

The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

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Production FDA Clinical Trials Compliance 52

New Drug Approvals

JULY 10, 2023

g/mol BASE Vazegepant BMS-742413 BHV-3500 FDA APPR 3/9/2023 Zavzpret N -[(2 R )-3-(7-methyl-1 H -indazol-5-yl)-1-[4-(1-methylpiperidin-4-yl)piperazin-1-yl]-1-oxopropan-2-yl]-4-(2-oxo-1 H -quinolin-3-yl)piperidine-1-carboxamide ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. 1] It is sold by Pfizer. [1]

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Clinical Trials Treatment FDA Trials 40

The Pharma Data

FEBRUARY 25, 2021

5 Currently there is no cure or treatment for TBE, only management of symptoms. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 2003 Dec 12;22(2):217-23. Although TBE is not endemic in the U.S., 2011;29(43):7307-19. Ehrlich HJ, et al.

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The Pharma Data

MAY 13, 2021

What I learned on the DVDs was the missing link when it comes to evaluation and eventual treatment of my clients planning for patients with muscular dysfunctions.”. ll see, and treatment strategies from some top notch names in our industry: Mike Robertson, Bill Hartman, Eric Beard, Rick Kaselj, Kevin Yates, and Dean Somerset.”.

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Production Treatment Vaccine Research 52

The Pharma Data

APRIL 25, 2021

Editor’s note: In January 2021, nirsevimab received the Promising Innovative Medicine (PIM) Designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and was also granted the Breakthrough Therapy Designation (BTD) by the China Center for Drug Evaluation (CDE) under the National Medical Products Administration.

Virus 40

Virus Trials Disease Hospitals 40

Drug & Device Law

MAY 30, 2022

The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. April 1, 2022) (the companion case to this ). at *3 (emphasis original). Hoffman-LaRoche, Inc. , 2d 806, 817 (5th Cir.

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Testimonials Doctors Production Laboratories 59