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 and around the globe.”. In 2019, the U.S. About the Phase 1/2 Trial. Takeda’s Commitment to Oncology.

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The Pharma Data

JANUARY 3, 2021

Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated. Among the positive results patients reported, the most common was that the treatment resulted in the rapid improvement in smell sensation, which is frequently lost in COVID-19 patients.”. .

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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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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

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

FEBRUARY 25, 2022

“Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”. Biosimilars play an important role in the treatment of autoimmune conditions.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. Additionally, this review excluded pharmacokinetic and animal studies. In that ten-year period, there were 67 drugs approved with a requirement to conduct a postmarketing pregnancy study, and 99 studies.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Although much of the U.S. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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DrugBank

FEBRUARY 5, 2025

Conversely, conjugation involves chemically attaching the drug to the nanoparticle surface, allowing for targeted delivery and improved pharmacokinetics. The Impact of Nanotechnology on Disease Nanotechnology is revolutionizing the treatment of various diseases, offering new hope for patients and healthcare providers.

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Codon

APRIL 2, 2023

When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read A one-time gene therapy injection for spinal muscular atrophy. Turning universal O into rare Bombay type blood. Andreano E.

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The Pharma Data

MARCH 8, 2021

Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a single agent.

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Agency IQ

JUNE 9, 2023

Even so, nonclinical studies are generally expected to be complete prior to the initiation of Phase 3 clinical studies in which the product is evaluated in much larger human populations and/or for longer periods of treatment. Cell and gene therapy products, adjuvanted vaccines, and blood products all fall outside the scope.

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Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

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The Pharma Data

MARCH 23, 2021

The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor , has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.

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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

DECEMBER 23, 2020

The European Union (EU) authorized ViiV Healthcare ’s Vocabria (cabotegravir injection and tablets) in conjunction with Janssen’s Edurant (rilpivirine tablets) for the treatment of HIV-1 infection in adults who are virologically suppressed. Maat is developing a capsule formulation of Maat033, its lead biotherapeutic for this indication.

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The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.

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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

JULY 23, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. Roche’s Chief Medical Officer and Head of Global Product Development.

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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. Ultimately, flexibility in dual-payload ADC development means better treatments could reach patients sooner.

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The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

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The Pharma Data

MARCH 5, 2021

The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3

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Agency IQ

AUGUST 16, 2024

Even though chemotherapies, both as monotherapy and in combination with other products, have become a mainstay in the treatment of most cancers today, they present many drawbacks. In parallel, stakeholders have advocated for recognizing the importance of treatment tolerability when determining doses and regimens.

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The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease. Pfizer Inc.

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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. 2,3 In the U.S.,

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The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

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The Pharma Data

APRIL 7, 2021

TYSABRI is a well-established high-efficacy treatment that now provides two routes of administration enabling flexibility to meet patients’ individual preferences and needs. The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians beyond the infusion setting.

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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

MARCH 11, 2021

In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Lilly’s chief scientific officer and president of Lilly Research Laboratories.

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The Pharma Data

OCTOBER 6, 2021

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said” Vulnerable populations suchlike as the immunocompromised hourly are n’t suitable to mount a self-protective response following vaccination and continue to be at trouble of developing COVID-19. AZD7442 was well- let. Griffin MP, et al. Yu XQ, et al.

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PerkinElmer

JUNE 3, 2022

1 Although effective COVID-19 vaccines have been developed, variants of SARS-CoV-2 have already emerged for which vaccines are less effective, and many people remain unvaccinated due to certain medical conditions, personal choice, or global access challenges. For research use only. Not for use in diagnostic procedures.

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The Pharma Data

MAY 7, 2021

The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About VIR-7831 / GSK4182136.

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The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

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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. Pfizer Inc. NYSE: PFE) and ReViral Ltd.

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The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D.,

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The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients. Author: Zhang.

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