The Pharma Data

MARCH 25, 2021

Chief Development Officer, Oncology, Pfizer Global Product Development. Real-world evidence is increasingly used to complement traditional randomized clinical trial data to better understand a therapy’s effectiveness in routine clinical practice and inform treatment decisions,” said Angela DeMichele, M.D., 2,3 In the U.S.,

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Drug Target Review

JULY 12, 2023

We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy. We are pleased that to date our lead product candidate has aligned DCI profiles as expected.

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The Pharma Data

DECEMBER 17, 2020

Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to integrate tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. “At It’s a big bet for Merck.

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The Pharma Data

MAY 5, 2021

Its indicated dose of 8 mg is notably higher than the previously approved doses of 2 and 4 mg for other naloxone nasal spray products. . It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . controlled trial had not received previous systemic therapy for metastatic disease.

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The Pharma Data

JUNE 7, 2022

Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan ® , in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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The Pharma Data

MARCH 23, 2021

We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

APRIL 7, 2022

“At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Sisunatovir has been granted Fast Track designation by the U.S.

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The Pharma Data

MARCH 9, 2022

PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a pediatric clinical study PAXLOVID is currently authorized under U.S. About Pfizer: Breakthroughs That Change Patients’ Lives.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

The Pharma Data

DECEMBER 14, 2020

The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. before expanding it into Europe.

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Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

FEBRUARY 25, 2022

The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

MARCH 25, 2022

To date, 170 of the 194 WHO Member States have reported the use of traditional medicine, and their governments have asked for WHO’s support in creating a body of reliable evidence and data on traditional medicine practices and products. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”.

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The Pharma Data

MARCH 22, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. said Levi Garraway, M.D.,

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

The Pharma Data

DECEMBER 15, 2020

16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.

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The Pharma Data

APRIL 27, 2021

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

Advarra

JUNE 20, 2023

years , with biotechnology-derived products potentially adding another year or more. cell and gene therapies), with other therapeutic areas then pushing it further. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles.

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Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

NOVEMBER 5, 2020

As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.

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The Pharma Data

NOVEMBER 8, 2020

Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL.”. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

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The Pharma Data

DECEMBER 27, 2020

phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. Phase I Trial. This trial also investigates the food effect on ASC42 exposure.

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The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. Safety outcomes were consistent with those seen in previous trials.

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Drug Target Review

OCTOBER 16, 2024

By fostering the fluid movement between research and clinical practice, we can better contribute to the development of therapies, which has been the most rewarding aspect of my career. This flexibility fosters creativity and productivity. As a woman in STEM, what unique perspectives or strengths do you believe you bring to your work?

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The Pharma Data

APRIL 7, 2021

The new route of administration offers comparable efficacy and safety to the TYSABRI intravenous (IV) formulation building on the therapy’s long-term data, established clinical benefits and well-characterized safety profile. TYSABRI is a trusted high-efficacy therapy with a well characterized safety profile for patients living with MS.

Clinical Trials 52

Clinical Trials Treatment Virus Pharmacokinetics 52

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. 19, 2020 09:00 UTC. SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. We are initially focused on developing a novel therapy to treat ENPP1 and ABCC6 deficiencies. Food and Drug Administration cleared Investigational New Drug Application. BOSTON, Jan.

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Clinical Trials Trials Treatment FDA 52

Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence. Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications.

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International Laboratories Drugs Pharmacokinetics 52

The Pharma Data

DECEMBER 29, 2020

NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A., Galactosidase-A enzyme.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 26, 2020

NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,

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The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. Food and Drug Administration (FDA). 2,3 In the U.S., About Pfizer Oncology.

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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. The US Patent and Trademark Office (USPTO) has issued a new patent protecting the product until 2039. Both of these patents protect the respective products until 2039.

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The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. ” In June 2021, AbbVie Inc.

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The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

MARCH 17, 2021

Verzenio (abemaciclib) : Abstract # P008 : Patients’ quality of life and side effect perceptions in monarchE, a study of abemaciclib plus endocrine therapy in adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (Sara M. Accepted as ePoster – Adjuvant Systemic Therapy. Selected for one of the three St.

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Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

OCTOBER 25, 2020

Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. A therapy that quickly and effectively reduces agitation, without causing excessive sedation, is needed to speed up recovery time and improve patient outcomes. BioXcel Therapeutics, Inc.

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