Pharmacist Digest

STAT+: Eli Lilly reports tirzepatide MASH success during Q4 earnings

STAT

FEBRUARY 6, 2024

The blockbuster weight loss and diabetes drug sold by Eli Lilly also appears to improve fatty liver disease, according to early clinical trial data the pharmaceutical company released Tuesday. Around 74% of adults in the trial taking the drug were free of MASH after 52 weeks, compared to approximately 13% of the placebo group.

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies

STAT+: Breast cancer drug from AstraZeneca, Daiichi hits goal in late-stage trial

STAT

SEPTEMBER 22, 2023

LONDON — AstraZeneca said Friday an experimental drug tamped down the progression of a certain type of breast cancer in a Phase 3 trial, a win for the company after the same drug produced underwhelming results in a lung cancer trial over the summer. The trial is continuing.

Chemotherapy

Enhertu improves progression-free survival in breast cancer trial

Pharma Times

AUGUST 9, 2021

Trial compared Enhertu with T-DM1 in patients with HER2-positive breast cancer

Opinion: Bashing accelerated approval isn’t supported by the data

STAT

APRIL 23, 2024

The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall survival (progression-free survival). ” Read the rest…

Drug Development

Senti Bio cuts 37% of workforce to free funds for cell therapy cancer trials

Pharmaceutical Technology

JANUARY 8, 2024

The layoffs and scaling back of R&D activities will extend Senti Biosciences' cash runway into Q1 2025, according to a press release.

Phesi's free service to identify 'zombie trials' during a time of 'chronic challenge'

Outsourcing Pharma

OCTOBER 16, 2023

A free of charge service to help sponsors identify any âzombie trialsâ has been launched by Phesi in a bid to save sponsors time and money.

STAT+: AstraZeneca shares fall after lung cancer drug underwhelms in trial

STAT

JULY 3, 2023

LONDON — AstraZeneca said on Monday that a new lung cancer treatment outperformed standard-of-care chemotherapy in a trial, but investors found the results less impressive than anticipated, sending company shares down in early trading. But investors had been hoping for a clearer signal of benefit.

Chemotherapy

Chemotherapy Drug Development

STAT+: Leaked version of EFTA-India free trade deal sparks alarm over access to medicines

STAT

FEBRUARY 14, 2024

A leaked version of a proposed agreement between India and the European Free Trade Association is causing alarm among civil society and patient advocacy groups over concerns the deal would delay access to affordable generic versions of newer, lifesavings medicines for several years.

STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia

STAT

NOVEMBER 16, 2023

Clinical trials have shown the one-time treatment enabled many sickle-cell patients to live free of debilitating pain crises and freed thalassemia patients from needing regular blood transfusions. LONDON — Regulators in the U.K.

Drug Development

Combination treatment could provide new standard-of-care for aggressive lymphoma

European Pharmaceutical Review

MAY 3, 2024

An interim analysis of a Phase III trial of Calquence (acalabrutinib) plus chemoimmunotherapy has revealed positive progression-free survival outcomes for adults with untreated mantle cell lymphoma. Calquence (acalabrutinib) is a next-generation, Bruton’s tyrosine kinase (BTK) inhibitor.

STAT+: Pharmalittle: We’re reading about MorphoSys drug risks, an AstraZeneca admission, and more

STAT

APRIL 29, 2024

Please feel free to join us. In a challenge to the pharmaceutical industry, Doctors Without Borders has revealed the detailed costs of a study it ran for a tuberculosis treatment regimen and maintained this is the first time that expenses incurred for an individual clinical trial had been publicized , STAT writes.

How telehealth startups are trying to fill the menopause care vacuum

STAT

JULY 17, 2023

But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. More than two decades later, menopause experts have come to think about the results of the trial very differently.

PulmCrit hot take: VAP prophylaxis (PROPHY-VAP trial)

EMCrit Project

JANUARY 22, 2024

background: ANTHARTIC trial Prophylaxis against VAP (ventilator associated pneumonia) has is already supported by a few studies in the literature, perhaps most notably the ANTHARTIC trial. Antibiotic therapy reduced early-onset VAP, with a trend towards more ventilator-free […] EMCrit Project by Josh Farkas.

Combination treatment could minimise cancer relapse risk

European Pharmaceutical Review

MARCH 22, 2024

Research suggests that combining ribociclib with hormone therapy improved invasive-free survival in stage 2 or 3 HR-positive, HER2-negative early breast cancer. The trial data showed that at three years: Combination treatment facilitated a 91.7 percent recurrence-free survival, compared to 88.6 percent for the combination arm.

Opinion: Support family caregivers to improve and diversify clinical trials

STAT

OCTOBER 21, 2022

The clinical trial enterprise, however, has yet to appreciate caregivers — and fully engage them — as critical partners in recruiting and supporting people who are older, disabled, or have Alzheimer’s disease, cancer, or other chronic medical conditions for research studies.

STAT+: Pharmalittle: Wegovy cuts heart attack risk in milestone trial; AstraZeneca prioritizes U.S. for RSV drug amid surge

STAT

NOVEMBER 13, 2023

Please feel free to join us. In August, the company announced the results of the trial, called Select, found Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%. Our choice today is pistachio creme. Have a wonderful day, and do keep in touch.

Diabetes

Amylyx wields axe as it pulls ALS drug from the market

pharmaphorum

APRIL 4, 2024

Amylyx confirmed today that it will withdraw its amyotrophic lateral sclerosis (ALS) therapy Relyvrio/Albrioza from the market in the US and Canada, shortly after the drug failed a clinical trial.

STAT+: Pharmalittle: FDA approves new type of psoriasis drug; U.S. starts late-stage trial to test an antiviral against monkeypox

STAT

SEPTEMBER 12, 2022

Please feel free to join us. National Institutes of Health is launching a Phase 3 clinical trial to determine the efficacy of tecovirimat — the smallpox antiviral better known as TPOXX — for use in treating monkeypox, as current data on its effectiveness against the virus is limited , The Hill writes. … The U.S.

Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

Pharmaceutical Technology

APRIL 19, 2024

Pharmaceutical Technology Has Listed Some of the Leading Providers of Clinical Trial Packaging Services. Download For Free Here.

Packaging

STAT+: Pharmalittle: We’re reading about an AstraZeneca deal, a WHO pandemic pact, and more

STAT

MARCH 19, 2024

Please feel free to join us. The lead candidate, FPI-2265, in the Fusion pipeline is in a Phase 2 trial for metastatic castration-resistant prostate cancer. As for us, we are engaged in the usual rituals, starting with brewing cups of stimulation. Our choice today is salted caramel, a veritable whiff of the Jersey shore.

AstraZeneca shares results for Imfinzi in phase 3 trial for small cell lung cancer

Pharmafile

APRIL 5, 2024

AstraZeneca has announced positive high-level results from the phase 3 ADRIATIC trial, which demonstrated that Imfinzi (durvalumab) had a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC) (..)

Clinical trials and development services

Pharmaceutical Technology

APRIL 4, 2024

Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.

STAT+: Pharmalittle: We’re reading about an OptumRx contract, 340B dispute resolution, and more

STAT

APRIL 22, 2024

Please feel free to join us. Food and Drug Administration to withdraw its approval and demand it be pulled from the market after a confirmatory trial failed to replicate results of a key study. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

Specialty Pharmacies

GSK shares data from phase 3 trial for Jemperli combinations for endometrial cancer treatment

Pharmafile

MARCH 18, 2024

GSK has announced positive results from part 1 and part 2 of its RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial for Jemperli (dostarlimab) in combinations for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

Enhertu shows positive results in DESTINY-Breast06 Phase III trial

Express Pharma

APRIL 29, 2024

A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer). The trial will continue as planned to further assess OS and other secondary endpoints.

Chemotherapy

GSK propels its progress to Net Zero

European Pharmaceutical Review

NOVEMBER 21, 2023

Phase III trials of a low carbon version of GSK’s metered dose inhaler, Ventolin (salbutamol), using a next generation, lower carbon propellant, are set to start in 2024. Metered dose inhalers: propellant versus propellant free Propellants in all current metered dose inhalers contribute to greenhouse gas emissions.

STAT+: Pharmalittle: Bioscience job market is upside down; Sanofi and Regeneron’s blockbuster Dupixent may find bigger market

STAT

NOVEMBER 27, 2023

Do feel free to join us. … The inflammation-targeting therapy Dupixent succeeded in a Phase 3 trial in patients with the chronic lung disease COPD, results that could propel the blockbuster medicine into a massive new market , STAT reports. Our choice today is the deliciously smooth butter pecan.

Top 5 All-Time Hypertension Clinical Trials

Med Ed 101

JANUARY 25, 2023

In this article, we lay out our top 5 all-time hypertension clinical trials. If you remember previously, we covered the top 5 landmark clinical trials in hyperlipidemia. It was a tough call with many options, but here’s our list of hypertension clinical trials. Feel free to comment below if you feel we missed one!

Intravesical drug delivery system exhibits bladder cancer benefit

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.

Hospitals

Researchers publish final results of key clinical trial for gene therapy for sickle cell disease

World Pharma News

APRIL 24, 2024

In a landmark study, an international consortium led by researchers at Children's Hospital of Philadelphia (CHOP) published the final results of a key clinical trial of the gene therapy CASGEVY (exagamglogene autotemcel) for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises (VOCs).

Hospitals

STAT+: Pharmalittle: We’re reading about Wegovy approved for heart risks, an ALS drug puzzle, and more

STAT

MARCH 11, 2024

Please feel free to join us. The decision was based on a large, five-year trial showing Wegovy cut the risk of cardiovascular problems by 20% in that population. So time to give it a nudge in a better direction with a cup of stimulation. Meanwhile, here are a few items of interest to help you charge your battery.

Labelling

Labelling Documentation Diabetes

Ferring reveals long-term data for cancer gene therapy

European Pharmaceutical Review

NOVEMBER 29, 2023

Ferring’s gene therapy: what the data showed The data showed that at the 36-month mark, a quarter of these patients remained free of high-grade recurrence. A 90 percent three-year overall survival rate was observed in the trial. percent of patients were cystectomy-free at 36 months. Additionally, 53.8 percent, 36.6

Top 5 Heart Failure Clinical Trials of All Time

Med Ed 101

FEBRUARY 12, 2023

I outline my top 5 heart failure clinical trials of all time. Feel free to leave a comment if you have a different top 5 or if you feel […] The post Top 5 Heart Failure Clinical Trials of All Time appeared first on Med Ed 101. Guideline-based standards of care now include numerous medications. How did we get there?

Medication Guidelines

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

APRIL 3, 2023

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). Novartis stated that the adalimumab citrate-free HCF 100 mg/mL formulation provides an almost 50% decrease in injection volume compared with the 50mg/ml concentration.

Biosimilars

Biosimilars Packaging

GSK shares results from phase 3 trial for Blenrep as multiple myeloma treatment

Pharmafile

NOVEMBER 27, 2023

GSK has announced positive results from a planned interim efficacy analysis of the phase 3 DREAMM-7 head-to-head trial which assessed Blenrep (belantamab mafodotin) as a second line treatment for relapsed or refractor multiple myeloma.

Results show potential of J&J’s TAR-210 to transform treatment of bladder cancer with FGFR alterations

Express Pharma

MAY 5, 2024

Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence free (RF) survival rate was 90 per cent (95 per cent confidence interval (CI), 66-97). First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.

Labelling

Regulatory Submissions Filed for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

Pharmaceutical Commerce

FEBRUARY 7, 2024

Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.

Chemotherapy

Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

PharmExec

FEBRUARY 7, 2024

Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.

Chemotherapy

Roche’s Alecensa smashes phase 3 as adjuvant therapy for lung cancer

Outsourcing Pharma

SEPTEMBER 4, 2023

The small molecule drug alectinib (Alecensa) developed by the big pharma company Roche has improved disease-free survival in patients with a specific form of non-small cell lung cancer (NSCLC) when delivered as an adjuvant therapy in a phase 3 trial.

Sanofi stops development of lung cancer drug

European Pharmaceutical Review

DECEMBER 22, 2023

The decision comes after interim analysis from a Phase III clinical trial , CARMEN-LC03, did not meet a primary end point. Trial participants will have the option to stay on their current therapy if they are benefitting, or to transition to an appropriate standard-of-care therapy.

Labelling

Merck discontinues Phase 3 KeyVibe-010 trial

Express Pharma

MAY 13, 2024

Merck announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria.

Communication

Communication Immunity Immunization

AstraZeneca’s Imfinzi meets primary endpoint for liver cancer treatment

Pharmafile

NOVEMBER 13, 2023

AstraZeneca has announced positive results from the EMERALD-1 phase 3 trial for Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab for the treatment of patients with hepatocellular carcinoma (HCC) eligible for embolisation.

Try Your Hand at 4 Free Surgical Technologist Board Practice Questions

Board Vitals - Pharmacist

MARCH 17, 2024

Try your hand at 4 free surgical tech practice questions from the new bank and see if you’re ready! The BoardVitals Question bank for the National Board of Surgical Technology and Surgical Assisting (NBSTSA) Certified Surgical Technologist (CST) Exam consists of 1,750 practice questions and two FREE mock exams. How did you do?

Chemo-free regimen demonstrates efficacy in NSCLC

European Pharmaceutical Review

SEPTEMBER 29, 2023

Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ).

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Chemotherapy Immunity

STAT+: Eli Lilly reports tirzepatide MASH success during Q4 earnings

STAT+: Breast cancer drug from AstraZeneca, Daiichi hits goal in late-stage trial

Trending Sources

Enhertu improves progression-free survival in breast cancer trial

Opinion: Bashing accelerated approval isn’t supported by the data

Senti Bio cuts 37% of workforce to free funds for cell therapy cancer trials

Phesi's free service to identify 'zombie trials' during a time of 'chronic challenge'

STAT+: AstraZeneca shares fall after lung cancer drug underwhelms in trial

STAT+: Leaked version of EFTA-India free trade deal sparks alarm over access to medicines

STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia

Combination treatment could provide new standard-of-care for aggressive lymphoma

STAT+: Pharmalittle: We’re reading about MorphoSys drug risks, an AstraZeneca admission, and more

How telehealth startups are trying to fill the menopause care vacuum

PulmCrit hot take: VAP prophylaxis (PROPHY-VAP trial)

Combination treatment could minimise cancer relapse risk

Opinion: Support family caregivers to improve and diversify clinical trials

STAT+: Pharmalittle: Wegovy cuts heart attack risk in milestone trial; AstraZeneca prioritizes U.S. for RSV drug amid surge

Amylyx wields axe as it pulls ALS drug from the market

STAT+: Pharmalittle: FDA approves new type of psoriasis drug; U.S. starts late-stage trial to test an antiviral against monkeypox

Clinical trial packaging services in contract manufacturing for the pharmaceutical industry

STAT+: Pharmalittle: We’re reading about an AstraZeneca deal, a WHO pandemic pact, and more

AstraZeneca shares results for Imfinzi in phase 3 trial for small cell lung cancer

Clinical trials and development services

STAT+: Pharmalittle: We’re reading about an OptumRx contract, 340B dispute resolution, and more

GSK shares data from phase 3 trial for Jemperli combinations for endometrial cancer treatment

Enhertu shows positive results in DESTINY-Breast06 Phase III trial

GSK propels its progress to Net Zero

STAT+: Pharmalittle: Bioscience job market is upside down; Sanofi and Regeneron’s blockbuster Dupixent may find bigger market

Top 5 All-Time Hypertension Clinical Trials

Intravesical drug delivery system exhibits bladder cancer benefit

Researchers publish final results of key clinical trial for gene therapy for sickle cell disease

STAT+: Pharmalittle: We’re reading about Wegovy approved for heart risks, an ALS drug puzzle, and more

Ferring reveals long-term data for cancer gene therapy

Top 5 Heart Failure Clinical Trials of All Time

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

GSK shares results from phase 3 trial for Blenrep as multiple myeloma treatment

Results show potential of J&J’s TAR-210 to transform treatment of bladder cancer with FGFR alterations

Regulatory Submissions Filed for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer

Roche’s Alecensa smashes phase 3 as adjuvant therapy for lung cancer

Sanofi stops development of lung cancer drug

Merck discontinues Phase 3 KeyVibe-010 trial

AstraZeneca’s Imfinzi meets primary endpoint for liver cancer treatment

Try Your Hand at 4 Free Surgical Technologist Board Practice Questions

Chemo-free regimen demonstrates efficacy in NSCLC

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