Bio Pharma Dive
SEPTEMBER 5, 2023
The FDA-approved therapy, called Palforzia, was little used, leading Nestle to abandon a business it had secured in a $2.6 billion deal three years ago.
Pharmaceutical Technology
SEPTEMBER 5, 2023
Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.
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Bio Pharma Dive
SEPTEMBER 5, 2023
The announcement marks progress for Beam after trial delays, and is the first time in the U.S. that a patient has received a base editing treatment.
Pharmaceutical Technology
SEPTEMBER 5, 2023
A new set of European Society of Cardiology (ESC) guidelines was shared at the 2023 ESC conference in Amsterdam, Netherlands.
Bio Pharma Dive
SEPTEMBER 5, 2023
The signals of a return to growth are emerging. As commercial leaders gear up for 2024 planning, they must prepare to fight for resources in a budget constrained environment.
Pharmaceutical Technology
SEPTEMBER 5, 2023
The UK MHRA has granted marketing authorisation for AbbVie’s Aquipta (atogepant) for the prophylaxis of migraine in adults.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
SEPTEMBER 5, 2023
The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to share advances in the design and analysis of pragmatic clinical trials. Join us on the first Friday of each month, October through January, to hear the latest best practices and explore emerging questions with experts from the program’s Biostatistics and Study Design Core.
Bio Pharma Dive
SEPTEMBER 5, 2023
The hub-and-spoke biotech has raised more than $190 million in total to fund drug development for rare autoimmune and blood conditions.
Pharmaceutical Technology
SEPTEMBER 5, 2023
The Nordics are a well-known powerhouse of pharmaceutical innovation and production. But what opportunities do the region’s own pharma markets offer industry players, and what do marketing authorisation holders need to know when bringing new medicines to these countries?
Bio Pharma Dive
SEPTEMBER 5, 2023
The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.
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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
SEPTEMBER 5, 2023
The Danish company's blockbuster Wegovy arrives the UK after the US, Denmark, Norway and Germany amid struggles to meet increasing demands.
Drug Patent Watch
SEPTEMBER 5, 2023
Pharmacists play a crucial role in drug repurposing due to the vast amount of opportunities that exist in this innovative approach. Drug development and registration can be costly, time-consuming, and… The post Pharmacists Can Play Key Role in Drug Repurposing appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
SEPTEMBER 5, 2023
Professor Lucy Chappell hopes that research will be more common in the UK's NHS with hospital trusts and GP practices getting involved.
Pharma Times
SEPTEMBER 5, 2023
Candidate ESO-101 will treat participating patients across five European countries - News - PharmaTimes
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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
SEPTEMBER 5, 2023
In this 2023 study, Sjoland and other researchers found an elevated excess risk of VTE after 180 days in patients hospitalised for Covid-19.
Pharma Times
SEPTEMBER 5, 2023
The funding will boost the University of Nottingham spinout’s development of bone regeneration treatment - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 5, 2023
The Series C funding will support the clinical advancement of Vega Therapeutics’ antibody candidate for treating von Willebrand disease.
Fierce Pharma
SEPTEMBER 5, 2023
Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act (IRA). | Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act. The case was filed Friday in New Jersey federal court, three days after the CMS revealed that Novartis’ heart failure treatment Entresto was among 10 drugs subject to price negotiations in 2026.
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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
SEPTEMBER 5, 2023
DOAC use may not be approved in VTE cancer patients, but GlobalData KOLs share that these drugs are becoming commonplace as a treatment.
Outsourcing Pharma
SEPTEMBER 5, 2023
CymaBay announced recently the initiation of its 52-week, placebo-controlled, randomized, phase 3 study â 'Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase (ALP) Levels in subjects with Primary Biliary Cholangitis (PBC)' known as IDEAL.
Pharmaceutical Technology
SEPTEMBER 5, 2023
Cipla Medpro South Africa has signed a binding term sheet to acquire Actor Pharma to bolster over-the-counter (OTC) product portfolio.
Fierce Pharma
SEPTEMBER 5, 2023
As the Federal Trade Commission (FTC) scrutinizes Pfizer’s $43 billion Seagen buyout, the antibody-drug conjugate (ADC) specialist has notched a phase 3 win that could broaden its cervical cancer a | The drug boosted overall survival, progression-free survival and objective response rates in patients with recurrent or metastatic cervical cancer who had disease progression on or after a front-line therapy.
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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
SEPTEMBER 5, 2023
Lack of diversity in clinical trials is a result of lack of trust from those in the community but there are methods to overcome this.
Fierce Pharma
SEPTEMBER 5, 2023
Despite scoring a number of federal contracts in recent years, it’s lights out for government-backed rescue autoinjector maker AktiVax. | AktiVax, also known as Aktiv Pharma Group, informed the state of Colorado that “the company must shut down substantially all of its operations,” citing “unexpected circumstances.” In turn, the company is mothballing three manufacturing facilities and laying off around 70 employees.
Pharmaceutical Technology
SEPTEMBER 5, 2023
The Chinese NMPA approved for AstraZeneca’s Calquence to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma in adults.
Fierce Pharma
SEPTEMBER 5, 2023
CanSino Biologics' recent mRNA manufacturing tie-up with AstraZeneca represents just the tip of the iceberg, the company’s CEO has said. | After jumping into the mRNA game back in 2018, CanSino has built a facility in Shanghai that can produce up to 200 million vaccine doses a year, the company’s co-founder and CEO Xuefeng Yu told Reuters in a recent interview.
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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
SEPTEMBER 5, 2023
Up to 45% of the trial costs for the dose-determining Phase 1b trial will be funded by the Austrian research promotion agency.
Fierce Pharma
SEPTEMBER 5, 2023
After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia. | After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia.
Pharmaceutical Technology
SEPTEMBER 5, 2023
Arecor Therapeutics’ subsidiary Tetris Pharma has announced a commercialisation agreement with Goodlife for Ogluo.
Fierce Pharma
SEPTEMBER 5, 2023
One year after Vifor Pharma officially joined the fold at CSL thanks to an M&A deal, the iron deficiency specialist is shedding 85 staffers based in California. | A year after Vifor Pharma joined CSL under an M&A deal, the company has cut 85 employees based out of Vifor's Redwood City location in California.
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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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