STAT

MARCH 5, 2025

It responds poorly to chemotherapy and is usually driven by a mutation that can’t be drugged with traditional approaches.   Chimerix’s drug, known as dordaviprone, isn’t a cure. But in a clinical trial presented last year , 14 out of 50 patients with relapsed disease saw their tumors shrink.

Chemotherapy 201

Chemotherapy Drug Development 201

STAT

MAY 17, 2023

— As post-lunch drowsiness settled on an auditorium full of leaders from the drug development industry, Peter Fernandes, CEO of Bellerophon Therapeutics, seized the presentation clicker and jolted them awake. TARRYTOWN, N.Y.   “And I love nightmares.

Drug Development 280

Drug Development 280

STAT

OCTOBER 24, 2023

MADRID — If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting , a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates.

Compounding 328

Compounding Drug Development 328

STAT

MAY 28, 2024

“That’s what really inspired me to think about developing a drug.” ” Decades later, Shu is closer than ever to such a drug. In October, he presented extraordinary data at a conference: His team had successfully enabled hearing in four congenitally deaf children using gene therapy.

Drug Development 362

Drug Development 362

Express Pharma

DECEMBER 2, 2024

This alarming trend presents a lucrative opportunity for drugmakers. The success of GLP-1R-targeting drugs highlights their viability as a treatment approach. Morley concludes, “With expected drug sales for GLP1Rs in obesity estimated to surpass $126 billion by 2030, this drug category presents a lucrative market for drug developers.

Labelling 126

Labelling Diabetes Drug Development 126

FDA Law Blog: Biosimilars

APRIL 8, 2025

Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

Documentation 141

Documentation Labelling Drug Development 141

STAT

APRIL 10, 2024

But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner. SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade.

Vaccines 363

Vaccines Immunization Immunity Drug Development 363

STAT

NOVEMBER 13, 2023

PHILADELPHIA – Novo Nordisk, which has dominated the diabetes and obesity markets with its blockbuster drugs Ozempic and Wegovy, now also wants to be a major player in heart disease.

Diabetes 346

Diabetes Drug Development 346

STAT

OCTOBER 5, 2023

While overall estimates suggest this industry emits millions of tons of carbon dioxide each year, it’s often tough to pinpoint the exact sources of those emissions, presenting a challenge as companies seek to reduce their footprints and outside organizations seek to evaluate their efforts. Read the rest…

Pharmaceutical Companies 325

Pharmaceutical Companies Pharmaceutical Companies Drug Development 325

STAT

SEPTEMBER 13, 2024

One of the big presentations of this year’s ESMO (at least in our view) comes tomorrow morning bright and early. This is the online edition of ESMO in 30 Seconds, a pop-up newsletter from the European Society for Medical Oncology’s annual meeting in Barcelona, Spain. Sign up for the remaining editions here.

Drug Development 271

Drug Development 271

STAT

DECEMBER 12, 2023

Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients. SAN DIEGO — One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene.

Drug Development 279

Drug Development 279

Express Pharma

APRIL 11, 2023

So, a new project should be initiated only when the one being worked on at present is completed. should be completed before a new drug development is started. The post Generic drug development: The way forward appeared first on Express Pharma. FDA submissions happen faster, and the workplace becomes happier!

Drug Development 98

Drug Development Generic Medicine Documentation 98

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. FDA presentation. Thompson, LA.

Drug Development 122

Drug Development Pharmaceutical Companies Pharmaceutical Companies Documentation 122

European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. AI brings exciting opportunities to generate new insights and improve processes.

Drug Development 98

Drug Development Documentation 98

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work.

Drug Development 98

Drug Development Communication Dosage Chemotherapy 98

STAT

APRIL 23, 2024

So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story. Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

Drug Development 279

Drug Development 279

STAT

OCTOBER 23, 2023

MADRID — Results presented Monday could expand the use of a Novartis therapy for metastatic prostate cancer, moving it from a treatment used after chemotherapy to one with demonstrated benefits beforehand as well.

Chemotherapy 289

Chemotherapy Drug Development 289

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

Drug Development 98

Drug Development Dosage Diabetes Process Improvement 98

STAT

OCTOBER 23, 2023

A primetime presentation here Monday amounted to the latest salvo. At the annual meeting of the European Society for Medical Oncology, J&J unveiled three studies of its drug Rybrevant in different patient groups with non-small cell lung cancer with EGFR mutations.

Drug Development 283

Drug Development 283

pharmaphorum

DECEMBER 21, 2021

Dr Jeff Keefer, VP and Head of the Pediatric and Rare Disease Center of Excellence at IQVIA, was one of the three panellists present at the webinar, and he stated that what makes the space unique is the “strength and depth of the relationships that form within the Rare Disease community.”. The potential to leverage genomic data.

Drug Development 98

Drug Development Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

STAT

OCTOBER 23, 2023

MADRID — Questions about one of AstraZeneca’s key cancer drug candidates — and the dribs and drabs that have come out about its performance — have been dogging the company for months. On Monday, data presented here from a trial of the drug in advanced non-small cell lung cancer provided at least a fuller look.

Chemotherapy 289

Chemotherapy Drug Development 289

STAT

JUNE 23, 2023

The full   results,  published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference. The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year.

Diabetes 261

Diabetes Drug Development 261

Pharmaceutical Technology

DECEMBER 7, 2022

At CTAD, experts presented data from the Clarity AD clinical trial , where lecanemab met the primary endpoint—a mean change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale—by reducing clinical decline by 27% compared to placebo , at 18 months of treatment. Please check your email to download the Report.

Drug Development 105

Drug Development Communication Immunity Immunization 105

STAT

JUNE 26, 2023

Among 98 patients with nonalcoholic fatty liver disease, those on the highest dose tested of the drug, retatrutide, experienced an 86% decrease in liver fat over 48 weeks, with most of the reduction occurring early on in treatment, according to data presented here at the American Diabetes Association conference Monday.

Diabetes 251

Diabetes Drug Development 251

Pharmaceutical Technology

SEPTEMBER 12, 2022

Full data will be presented at an upcoming conference. Development bogged down by complexity. While there is an unmet need, drug development remains slow due to neurological complexity. “We The post A tough puzzle: complexity slows drug development for concussions appeared first on Pharmaceutical Technology.

Drug Development 94

Drug Development Compounding 94

PharmaTech

MARCH 28, 2025

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T.

Drug Development 52

Drug Development 52

STAT

SEPTEMBER 21, 2022

The findings, presented at the CAR-TCR Summit in Boston, come from an early-stage clinical trial by Scripps Research of patients with B cell cancers.

Drug Development 246

Drug Development 246

STAT

SEPTEMBER 12, 2024

where puppets present you with some delicious poetry bites. Designed in 2012 to encourage drug development for rare childhood diseases, the program provides vouchers to groups who get a drug in that area approved. It’s an account (run by a Teresa with no H, not me!) A lifeline or a pharma handout?

Drug Development 144

Drug Development 144

Pharmaceutical Technology

DECEMBER 7, 2022

At CTAD, experts presented data from the Clarity AD clinical trial , where lecanemab met the primary endpoint—a mean change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale—by reducing clinical decline by 27% compared to placebo , at 18 months of treatment. Please check your email to download the Report.

Drug Development 98

Drug Development Communication Immunity Immunization 98

Pharmaceutical Technology

FEBRUARY 23, 2023

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. As formulators, we are often able to directly impact the amount of drug absorbed through formulation optimization and improve exposure.

Drug Development 98

Drug Development Compounding Dosage Packaging 98

STAT

JUNE 13, 2023

In presentations at a press briefing and at a session for late-breaking studies, researchers outlined what they portrayed as promising Phase 2 results indicating rusfertide helped stabilize red blood cells at healthier levels and improved patients’ symptoms, including fatigue and brain fog.

Drug Development 246

Drug Development 246

STAT

JULY 14, 2023

But despite the hard-won victories, the arrival of the new therapies presents a new set of challenges in Europe as countries plan for their possible rollouts, scientists and doctors told STAT. Health systems will have to adapt to diagnose people earlier and monitor them for side effects associated with the treatments.

Drug Development 238

Drug Development 238

Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

Compounding 97

Compounding Drug Development Documentation Pharmaceutical Companies 97

European Pharmaceutical Review

NOVEMBER 25, 2024

An increasing trend of outsourcing boosts growth of the market as pharmaceutical companies are utilising advanced testing capabilities and optimising their drug development processes.

Drug Development 52

Drug Development Biosimilars Compounding Pharmaceutical Companies 52

Safe Biologics

JULY 13, 2023

The webinar focused on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines.

Drug Pricing 130

Drug Pricing Biosimilars Drug Development 130

pharmaphorum

JULY 1, 2021

CDISC standards that are required for submission by the FDA: SEND (Standard for Exchange of Non Clinical Data) describes a way to collect and present non clinical data. These CDISC standards must be successfully implemented at different stages in the drug development process. appeared first on.

Drug Development 72

Drug Development Communication 72

Pharmaceutical Technology

MARCH 27, 2025

Bioconjugation presents an new frontier for pharmaceutical development, providing an option for improved drug efficacy across modalities.

Drug Development 52

Drug Development 52