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. Biogen Inc.

Disease 52

Disease Research Clinical Trials FDA 52

The Pharma Data

NOVEMBER 18, 2020

. “I think it would make my mother so happy to know that I’m doing something to help other families who are going through what my family went through because it was the greatest trial of our lives,” Kaling said. Since 2003, the organization has invested $126 million in pancreatic cancer research. © 2020 HealthDay.

Disease 52

Disease Research Treatment Trials 52

The Pharma Data

NOVEMBER 23, 2020

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. OSLO, Norway , Nov. The next survival analysis is planned in first half of 2021. References.

FDA Approval 40

FDA Approval Trials Treatment Virus 40

The Premier Consulting Blog

DECEMBER 28, 2023

3] Understanding Medicare Coverage for IDE Studies The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allows for Medicare coverage of the routine costs of care provided to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. [4]

Regulations 52

Regulations FDA Packaging Clinical Trials 52

NIH Director's Blog: Drug Development

MARCH 18, 2021

Now, Veesler and his lab are turning to another mammal in their search for new leads for the next generation of antiviral treatments, including ones aimed at the coronavirus that causes COVID-19, SARS-CoV-2. And, how can those structural differences serve as blueprints for promising new treatments to combat many potentially deadly viruses?

Virus 52

Virus Immune Response Clinical Trials Vaccine 52

The Pharma Data

OCTOBER 19, 2020

Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. Nanobiotix is also running an Immuno-Oncology development program.

Clinical Trials 52

Clinical Trials Immune Response Trials Therapies 52

The Pharma Data

NOVEMBER 9, 2020

Additionally, the vast majority of patients only receive a temporary benefit or no benefit from ICIs, as they either develop resistance to the treatment during the course of therapy or are non-responsive to the treatment altogether (only 15%-20% of patients respond, according to published data). Next Steps in Immunotherapy.

Immune Response 40

Immune Response Therapies Clinical Trials Treatment 40

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.

FDA Approval 130

FDA Approval FDA Clinical Trials Trials 130

PLOS: DNA Science

JULY 27, 2023

That information led, thanks to vaccine shelved from the first SARS circa 2003, to the rapid development and deployment of mRNA vaccines against the new infectious disease. These patterns can foretell which treatments will likely work and which won’t, how likely and quickly the cancer will spread, and its path in the body.

Disease 69

Disease DNA Virus RNA 69

NIH Director's Blog: Drug Development

MAY 21, 2020

Because of these and other factors, many experts think antibody-based therapies may offer one of the best near-term options for developing safe, effective treatments for COVID-19. So, what exactly led up to this latest scientific achievement? In the U.S.

Virus 52

Virus Vaccine Laboratories Small Molecule 52

The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 mmol/kg) for CNS imaging. it had been further approved within the U.S.

Clinical Trials 52

Clinical Trials Hospitals Production International 52

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).

Therapies 52

Therapies Disease Treatment International 52

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 FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40

Science FDA Clinical Trials Pharmacy 40

The Pharma Data

NOVEMBER 5, 2020

has been appointed to the additional role of president and will oversee the growth of the company’s technology portfolio for the treatment of ischemic and hemorrhagic stroke. Sussman has also had leadership experience in industry as the founder and vice president of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

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

Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.

Therapies 117

Therapies Cell Biology Clinical Trials Trials 117

Drug Target Review

NOVEMBER 30, 2023

Then I was approached to co-found AC Immune in 2003. We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! It means that we are not making the same progress in developing treatments for patients that we could be. We also have different perspectives as women.

Disease 95

Disease Laboratories Therapies Treatment 95

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.

Disease 80

Disease Clinical Trials Drugs Trials 80

The Pharma Data

DECEMBER 10, 2020

The Company expects to use the net proceeds from the Global Offering to advance the overall development of NBTXR3, prioritizing the treatment of locally advanced head and neck cancers, as follows (assuming an exchange rate of €1.00 = $1.2115, the exchange rate on December 10, 2020): approximately $48.5 million (non audited). .

Marketing 52

Marketing Regulations Treatment Clinical Trials 52

Drug Target Review

DECEMBER 14, 2023

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. His and Dr Stroik’s new research will help new cancer drugs called polymerase theta inhibitors, which are currently in clinical trials. Annual Review of Genetics.

DNA 58

DNA Clinical Trials Treatment Research 58

The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

Virus 40

Virus Trials Disease Hospitals 40

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.

Production 52

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]

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). 5 Currently there is no cure or treatment for TBE, only management of symptoms. 2003 Dec 12;22(2):217-23. “If approved in the U.S., 2%; up to 20% in Russia), people may die.

FDA 52

FDA Vaccine Virus Clinical Trials 52

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA.

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 1, 2023

The linchpin of our proposed language, or anything similar, is – of course – the requirement that trial judges act as “gatekeepers” to preclude the admission of inadequately supported – under whatever test a particular jurisdiction applies – expert opinions. So we did it by state. Ex parte George , So.3d 3d , 2021 WL 68997, at *23 (Ala.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d Because mesh such as [plaintiff’s claimed alternatives] were not cleared by the FDA for treatment of stress [plaintiff’s condition] at the time of [her] surgery, they were not legally available at the time and, in this Court’s view, they do not qualify as safer alternative designs as a matter of law.

FDA 59

FDA FDA Approval Testimonials Vaccine 59