Bio Pharma Dive
NOVEMBER 3, 2023
The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.
Pharmaceutical Technology
NOVEMBER 3, 2023
The large amendment to Poland’s Reimbursement Act (Duża Nowelizacja Ustawy Refundacyjnej, DNUR) finally came into legal force on November 1, although a small number of its regulations will only come into force in 2024 and 2025.
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Bio Pharma Dive
NOVEMBER 3, 2023
Seres, Kronos Bio and Rani Therapeutics joined Sangamo in announcing job cuts, while private biotech LocanaBio revealed it's shutting down.
Pharmaceutical Technology
NOVEMBER 3, 2023
Driven by success of recent GLP1R-targeting drugs, there has been a surge in the number of active pipeline drugs addressing this target for type 2 diabetes.
Fierce Pharma
NOVEMBER 3, 2023
Pfizer’s plunging COVID-19 product demand has spurred a companywide cost-cutting campaign, with nearly 200 jobs now on the chopping block in Michigan. | Pfizer is cutting roughly 200 positions at its Kalamazoo site following a review of demand for its COVID-19 vaccine and antiviral Comirnaty and Paxlovid.
Pharmaceutical Technology
NOVEMBER 3, 2023
In May 2022, Terremoto raised $75m on Series A financing for its lysine-based covalency drug development platform.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 3, 2023
The European Commission (EC) has approved Gedeon Richter and Sumitomo Pharma’s Type II Variation application for RYEQO for endometriosis.
Intouch Solutions
NOVEMBER 3, 2023
In October 2023, we proudly observe National Disability Employment Awareness Month (NDEAM). EVERSANA INTOUCH used the opportunity to spotlight one of our remarkable employees, Emelia Patterson. Emelia embodies the spirit of diversity, inclusion, and innovation, making her a true asset to our EVERSANA INTOUCH family. Emelia Patterson, Account Director, is hard of hearing.
Pharmaceutical Technology
NOVEMBER 3, 2023
Bayer and the Broad Institute of MIT and Harvard have expanded their ten-year research partnership to further develop cancer treatments.
Outsourcing Pharma
NOVEMBER 3, 2023
From Disney to the drug world, Liss Easy has had a fascinating journey to where she is now in her role as vice president and general manager of clinical operations at IQVIA.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
NOVEMBER 3, 2023
I-Mab and HI-Bio have received breakthrough therapy designation from the US FDA for the investigational CD38 antibody, felzartamab
Pharma Times
NOVEMBER 3, 2023
Over 63,000 cancer cases were diagnosed between one and five years after referral - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 3, 2023
Eli Lilly and Company has posted a net loss of $57.4m for Q3 2023 compared to a net income of $1.4bn in the same quarter last year.
Fierce Pharma
NOVEMBER 3, 2023
Bausch Health’s gastroenterology unit Salix Pharmaceuticals has chalked up a win in its long-running fight to fend off a generic to its irritable bowel syndrome diarrhea (IBD-D) med Xifaxan. | The D.C. federal court denied Alvogen's bid to force the FDA to grant full approval to its proposed Xifaxan generic. The agency previously gave the generic a tentative approval before some patents expire in 2029.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Pharmaceutical Technology
NOVEMBER 3, 2023
Kronos Bio joins other pharma companies in workforce reductions, cutting 19% of its employees to support clinical development.
Drug Channels
NOVEMBER 3, 2023
Today’s guest post comes from Greg Morris, Chief Strategy Officer at CareMetx. Greg highlights the value of therapeutic area expertise in enhancing the performance of hub services. He explains how CareMetx's hub used its experience in the retina space to improve a new brand-name product’s launch. To learn more about the impact of hub service on brand launch success, download CareMetx’s latest report: Patient Service Trends Point the Way to Better Hub/ Provider Partnerships.
Pharmaceutical Technology
NOVEMBER 3, 2023
The rapid rollout of direct oral anticoagulants has prevented an estimated 17,000 strokes and 4,000 deaths, says the NHS.
Fierce Pharma
NOVEMBER 3, 2023
In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo (tabelecleucel), Atara Biotherapeutics is turning to the same partner it used to gain a green light | In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo, Atara Biotherapeutics is turning to the same partner it used to gain a green light in Europe—Pierre Fabre Laboratories.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
NOVEMBER 3, 2023
Getting shipments from factories to end users on time and in top condition is a major priority for pharma firms
pharmaphorum
NOVEMBER 3, 2023
Scientists in the C-Suite: Attracting investors takes more than good science Mike.
Pharmaceutical Technology
NOVEMBER 3, 2023
The achievement for Phathom Pharmaceuticals comes after a period of delay and scrutiny by the FDA for Voquezna.
Drug Patent Watch
NOVEMBER 3, 2023
Annual Drug Patent Expirations for LEQVIO Leqvio is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are seventeen patents protecting… The post New patent expiration for Novartis drug LEQVIO appeared first on DrugPatentWatch - Make Better Decisions.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
NOVEMBER 3, 2023
Gotistobart is under clinical development by OncoC4 and currently in Phase II for Solid Tumor.
Drug Patent Watch
NOVEMBER 3, 2023
Annual Drug Patent Expirations for ONPATTRO Onpattro is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are sixteen… The post New patent expiration for Alnylam Pharms drug ONPATTRO appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
NOVEMBER 3, 2023
Aspacytarabine hydrochloride is under clinical development by Ayala Pharmaceuticals and currently in Phase II for Myelodysplastic Syndrome.
Drug Patent Watch
NOVEMBER 3, 2023
Annual Drug Patent Expirations for BRUKINSA Brukinsa is a drug marketed by Beigene and is included in one NDA. It is available from one supplier. There are five patents protecting… The post New patent for Beigene drug BRUKINSA appeared first on DrugPatentWatch - Make Better Decisions.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Pharmaceutical Technology
NOVEMBER 3, 2023
RBX-7455 is under clinical development by Rebiotix and currently in Phase I for Crohn's Disease (Regional Enteritis).
Drug Patent Watch
NOVEMBER 3, 2023
Annual Drug Patent Expirations for NEXTSTELLIS Nextstellis is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There is one patent… The post New patent for Mayne Pharma drug NEXTSTELLIS appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
NOVEMBER 3, 2023
Oleclumab is under clinical development by AstraZeneca and currently in Phase II for Pancreatic Ductal Adenocarcinoma.
Drug Patent Watch
NOVEMBER 3, 2023
Annual Drug Patent Expirations for QINLOCK Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. It is available from one supplier. There are fifteen patents… The post New patent for Deciphera Pharms drug QINLOCK appeared first on DrugPatentWatch - Make Better Decisions.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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