XTalks

APRIL 3, 2025

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials.

Trials 59

Trials Clinical Trials Clinical Trials Genetics 59

Pharmaceutical Technology

OCTOBER 18, 2022

MacroGenics is also entitled to get payments totalling up to $1.7bn in target nomination, option fees, regulatory, development and commercial milestones. Additionally, Gilead will make tiered royalty payments on global net MGD024 sales and a flat royalty on international net product sales under the two research programmes to MacroGenics.

Antibody 130

Antibody Development Sales Clinical Trials 130

Pharmaceutical Technology

AUGUST 30, 2022

Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs. The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . All the clinical and other development expenses will be handled by Insud.

Development 130

Development Drugs Bioavailability Production 130

Pharmaceutical Technology

JUNE 2, 2023

Furthermore, Amarin will receive tiered double-digit percentage royalties on the net sales of Vascepa in the territory.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Sales 130

XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. For instance, one common barrier is language.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

DECEMBER 7, 2022

According to the deal, Pfizer and Clear Creek Bio will collaborate to detect a PLpro candidate, which would be advanced into clinical trials. On entering the clinic, Pfizer will solely handle the development and marketing works of the candidate.

Development 130

Development Clinical Trials Clinical Trials Clinical Development 130

XTalks

JANUARY 7, 2025

billion Announced : April 2021 Closed : December 2021 Thermo Fisher Scientific, a worldwide supplier of analytical instruments, clinical development solutions, specialty diagnostics, lab, pharmaceutical and biotech services, acquired PPD , a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4

Life Science 105

Life Science Manufacturing Production Clinical Development 105

XTalks

JANUARY 29, 2025

The FDAs decision was based on data from the FLOW Phase IIIb kidney outcomes trial, which investigated the effects of once-weekly Ozempic 1 mg injections on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD. With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class.

FDA Approval 66

FDA Approval Trials Clinical Trials Clinical Trials 66

Worldwide Clinical Trials

FEBRUARY 22, 2023

Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. Rob: When I was diagnosed, my mother was adamantly against a clinical trial.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Pharmaceutical Technology

DECEMBER 14, 2022

Additionally, for WVE-006, GSK will make development and launch milestone payments of up to $225m to Wave, which is also eligible to get up to $300m in milestone payments based on sales. On completion of the first-in-patient clinical trial by Wave, GSK will be in charge of the development and marketing works.

Life Science 162

Life Science Development Gene Therapy Genetics 162

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

Pharmaceutical Technology

MARCH 23, 2023

Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma. The company also has several promising agents in early clinical development.

Licensing 147

Licensing Licensing Sales Trials 147

Pharmaceutical Technology

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Clinical Trials 100

Clinical Trials Clinical Trials Production Drugs 100

Pharmaceutical Technology

FEBRUARY 17, 2023

Capricor will handle the clinical development of CAP-1002 and sell commercial products to Nippon Shinyaku. Additionally, Capricor will receive up to $89m in further development and sales-based milestones, along with a double-digit share of revenue based on product sales.

Gene Therapy 130

Gene Therapy Clinical Development Sales Gene 130

pharmaphorum

JANUARY 5, 2022

GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. There’s also regulatory annd sales milestones totaling up to $200 million at the back end of the deal, and BioNTech will also get a share of gross profits from any future sales.

Vaccine 105

Vaccine Vaccination Sales Clinical Development 105

pharmaphorum

AUGUST 4, 2020

Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial. The biotech based at AZ’s former UK R&D site in Alderley Park, Cheshire, could receive a further $360 million in development and commercial milestones plus tiered royalties.

Drugs 109

Drugs Clinical Trials Clinical Trials Pharma Companies 109

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine 100

Medicine Hormones Production Clinical Trials 100

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine 100

Medicine Hormones Production Clinical Trials 100

XTalks

FEBRUARY 24, 2025

In 2024, Qalsody brought in $32 million, and Wainua generated $85 million in global sales , with $4 million and $20 million in royalties for Ionis, respectively. Despite limited markets for the rare disease drugs, analysts predict that Wainua could reach $700 million in peak sales in just the ATTRv-PN indication.

Trials 59

Trials RNA Allergies Drugs 59

Pharmaceutical Technology

FEBRUARY 24, 2023

According to Globaldata, it is involved in 10 clinical trials, of which 4 were completed, 5 are ongoing, and 1 is planned. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV).

Sales 113

Sales Production Medicine Clinical Trials 113

Pharmaceutical Technology

JUNE 15, 2023

Verve Therapeutics will be responsible for advancing the research and development of the Lp(a) programme by completing Phase I clinical development. Lilly will handle the subsequent development, manufacture and commercialisation activities of the programme. Lilly will provide funding for the Phase I clinical trials.

Gene Editing 130

Gene Editing Gene Gene Therapy In-Vivo 130

The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

Clinical Development 52

Clinical Development Gene Therapy Development Gene 52

Pharmaceutical Technology

FEBRUARY 18, 2023

According to Globaldata, it is involved in 11 clinical trials, of which 8 were completed, and 3 are ongoing. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). million in FY2020.

Clinical Trials 100

Clinical Trials Clinical Trials Development Drugs 100

Pharmaceutical Technology

FEBRUARY 20, 2023

According to Globaldata, it is involved in 17 clinical trials, of which 11 were completed, and 6 were terminated. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). million in FY2020.

Sales 100

Sales Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Pharmacy 100

Pharmacy Production Development Clinical Trials 100

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. In return, it will get a royalty on sales if the new version gets approved.

Trials 97

Trials Sales Drug Delivery Antibody 97

pharmaphorum

NOVEMBER 17, 2020

Based in Oss-Netherlands, Lead will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to 260 million euros, plus royalties on worldwide sales. Roche last year signed a $792.5

Development 72

Development Drugs Sales Clinical Trials 72

The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November. billion euros.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Branding 52

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

Drugs 100

Drugs Development Production Pharmacy 100

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. source Link.

Clinical Development 52

Clinical Development Medicine Development Containment 52

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. This will support us to maintain manufacturing capacity in the years to come,” said Dr. Avideh Nazeri, Novo Nordisk’s vice president of clinical development, in an email to this news service.

Drugs 264

Drugs Manufacturing Hormones Clinical Trials 264

pharmaphorum

NOVEMBER 12, 2020

The Independent reported that AstraZeneca’s rival vaccine, which is based on a viral vector and is also nearing the end of clinical development, could be easier to work with. million on Monday as part of a pre-planned sale on the day of the vaccine news release – which sent the company’s stock price soaring.

Vaccine 105

Vaccine Vaccination Manufacturing Regulation 105

XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines. The trial has enrolled over 1,400 adult participants with a history of migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). Buy the model here.

RNA 100

RNA Protein Antibody Vaccination 100

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

Radiology 111

Radiology Marketing Genome Genomics 111

The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52