The Pharma Data

FEBRUARY 12, 2022

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care. About the BLISS-LN trial. About lupus.

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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.

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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.

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PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. “Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients. The original approved was in 2003 to treat a type of Gaucher disease. October is Niemann-Pick Awareness Month.

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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.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

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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.

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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.

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Drug Target Review

SEPTEMBER 11, 2024

What specific advantages do morADC offer in terms of blood-brain barrier penetration and potency, compared to existing treatments? This complex nature of neurodegeneration means that being able to provide a dual targeted therapy in this way could be a significant advantage in treatment.

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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?

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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.

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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.

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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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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.

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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]

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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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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.

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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.

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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). .

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The Pharma Data

MARCH 8, 2021

At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.

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

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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.

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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.

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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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Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Human constraints also play a role at a later stage, when clinical trials are involved.”

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Heroin Treatment in the UK "Heroin Assisted Treatment (HAT) is an alternate treatment modality for people for whom more traditional forms of OST have been ineffective. 2003 ) and strong results from RIOTT indicating improved outcomes for ‘treatment refractory’ people (i.e. 2010 ; van den Brink et al., Moore, H.

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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.

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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.

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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.

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