The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,

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The Pharma Data

MARCH 13, 2021

“Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.”.

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The Pharma Data

APRIL 16, 2021

for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone.

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The Pharma Data

SEPTEMBER 26, 2021

VUMERITY may be a next-generation oral fumarate for the treatment of adults with relapsing-remitting MS (RRMS). With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D.,

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DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Supply issues have plagued the availability of their weight loss treatments, creating hurdles for patients seeking these medications.

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read the fact sheet. Read the blog. Watch it now.

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Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

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New Drug Approvals

DECEMBER 24, 2023

Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 6] [7] [8] Medical uses Eplontersen is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. [1] twitter +919321316780 call whatsaapp EMAIL.

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The Pharma Data

APRIL 27, 2021

Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We Additional information about Takeda’s EAP is available here. and around the globe.”.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. For more information, please visit www.inozyme.com. BOSTON, Jan. About Inozyme Pharma.

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The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. About AlgoTherapeutix AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé. Source link.

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Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. Can you provide a summary of the key findings and implications of the preclinical studies on ISM6331 for the treatment of advanced solid tumours?

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The Pharma Data

DECEMBER 15, 2020

The manuscript titled ‘Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double blind, Crossover Study in Men with Type 1 Diabetes’ is available online from today via [link]. Terms and conditions relating to the use and distribution of this information may apply.

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Advarra

JUNE 20, 2023

This can make it more difficult to anticipate safety risks in advance, especially in earlier research phases, possibly making it difficult to properly inform participants of the potential risks. This exacerbates the problem of working within a limited treatment population. It can also potentially drive up net costs of the research.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. Hepion intends to use AI-POWR to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups.

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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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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

Additionally, this review excluded pharmacokinetic and animal studies. The only example of a pregnancy PMC is for Paxlovid, for treatment of COVID-19, which is a distinguishable example because the sponsor committed to this study while the drug was still under an Emergency Use Authorization (EUA), not an NDA.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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Agency IQ

DECEMBER 1, 2023

That guidance, first issued in May 2020 , was released at a time when there were no FDA-approved drugs to treat Covid-19, and the standard-of-care for treatment relied on clinical management of symptoms and supportive care (e.g., supplemental oxygen, mechanical ventilation). drug-drug interactions) and intrinsic factors (e.g.,

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The Pharma Data

JULY 11, 2021

years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. We look forward to discussing these data with global health authorities.

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The Pharma Data

NOVEMBER 9, 2021

Donations include the impact of treatment with bulevirtide, an investigational treatment for people with habitual hepatitis delta contagion (HDV) in theU.S. Donations include the impact of treatment with bulevirtide, an investigational treatment for people with habitual hepatitis delta contagion (HDV) in theU.S.

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The Pharma Data

MARCH 25, 2022

Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine. For more information, see: who.int/initiatives/who-global-centre-for-traditional-medicine/ .

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The Pharma Data

NOVEMBER 5, 2020

Study 211 is one of the first of its kind to look at whether sustained virologic response (SVR) can be achieved after discontinuing therapy in virologically-suppressed patients who receive at least 12 to 18 months of combination treatment with VBR and a nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI).

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The Pharma Data

JULY 22, 2021

The study period was 12 months and included two arms; the prior on-demand (OD) group included patients previously taking OD VWF and the switch group included patients previously taking prophylactic plasma-derived von Willebrand factor (pdVWF) treatment [LPB0128]. The sABR was reduced by 91.5% About Takeda Hematology.

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The Pharma Data

MARCH 16, 2021

Durability: 1,2 Robust joint and skin response rates and mean improvements from baseline in outcome measures were maintained through two years, and approximately 90 percent of patients randomized to TREMFYA q4w or q8w continued treatment with TREMFYA through Week 100. TREMFYA was approved in the U.S. About DISCOVER-2 (NCT03158285) 14.

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The Pharma Data

MARCH 22, 2021

Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study. The HD community currently has no treatments to stop or slow the progression of this rare neurodegenerative disease that impacts families across generations.” said Levi Garraway, M.D.,

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The Pharma Data

JULY 29, 2021

P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline. No additional safety analyses were performed related to the presentations; for information on donanemab’s safety profile, reference the previous publication.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] It is taken by mouth. [1] 11] SYN ACS Med. 11] SYN ACS Med. .

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The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

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The Pharma Data

SEPTEMBER 1, 2021

Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Click here to learn more: [link]. Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC.

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The Pharma Data

MARCH 25, 2021

“With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”. PRESCRIBING INFORMATION. in the IBRANCE group and 68.0%

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. PRESCRIBING INFORMATION.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

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The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. For further information, please contact: Orexo AB (publ.). For more information about Orexo please visit, www.orexo.com. This information was brought to you by Cision [link].

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. For more information, visit www.scynexis.com. The study will be conducted in South Africa.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

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