pharmaphorum
NOVEMBER 21, 2023
The rare disease treatment revolution: Pioneering patient-centric transformation in pharmaceutical customer engagement Mike.
BioSpace
NOVEMBER 21, 2023
After reviewing the outcomes of 1,200 clinical studies, the firm says it can help most biopharmas set their trials up for success while cutting costs in half.
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XTalks
NOVEMBER 20, 2023
Today’s healthcare landscape is rapidly shifting, with an emphasis on the need for patient-centered care. Xtalks’ recent discussion with Rebekah Angove, PhD, Executive VP of Research and Evaluation at the Patient Advocate Foundation (PAF), offers a deeper understanding of incorporating patient narratives into clinical trials. Established over 25 years ago, the PAF has been dedicated to providing direct services to patients experiencing access and affordability challenges, especially those with c
BioSpace
NOVEMBER 19, 2023
BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.
Worldwide Clinical Trials
NOVEMBER 21, 2023
Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. We recently partnered with Every Cure , a nonprofit organization, to help them advance their mission of unlocking the full potential of every existing medicine to treat as many diseases as possible — with a specific focus on rare diseases.
BioSpace
NOVEMBER 19, 2023
Successful drugs from Novo Nordisk and Eli Lilly are just the beginning of what one analyst says could be “the largest therapeutic class of drugs that the biopharma industry has ever seen.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 21, 2023
The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.
Fierce Pharma
NOVEMBER 21, 2023
With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.
BioSpace
NOVEMBER 21, 2023
As artificial intelligence (AI) continues to be adopted by the pharmaceutical industry, regulatory bodies in the United States and other countries are evolving to tackle challenges within the industry. These include data privacy, bias, accuracy, access, as well as appropriate uses of AI and incorporating checks and balances into its usage. On October 30, the White House’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (EO) instructed agencies
Pharmaceutical Technology
NOVEMBER 21, 2023
Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.
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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
Bio Pharma Dive
NOVEMBER 21, 2023
Studying somatic mutations could be “the next wave of opportunity” to develop more precise medicines, said Mike Stratton, one of Quotient’s scientific co-founders.
Fierce Pharma
NOVEMBER 21, 2023
The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. | The U.S. Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process. And it's Sanofi’s turn to land in the crosshairs.
BioSpace
NOVEMBER 21, 2023
Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
Pharmaceutical Technology
NOVEMBER 24, 2023
Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.
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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.
Bio Pharma Dive
NOVEMBER 22, 2023
The company said it had not found “a viable alternative” to closing down in the months since it hit a clinical setback and laid off staff.
Fierce Pharma
NOVEMBER 22, 2023
Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victo | Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic.
BioSpace
NOVEMBER 21, 2023
In an SEC filing, the biotech launched by Flagship Pioneering said there was no viable alternative to dissolution as its cash ran out and anti-inflammatory assets failed to achieve clinical success.
Pharmaceutical Technology
NOVEMBER 22, 2023
The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Bio Pharma Dive
NOVEMBER 20, 2023
Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.
Fierce Pharma
NOVEMBER 22, 2023
Pfizer, working through a $3.5 billion cost-cutting drive, is not done yet making changes to its workforce in Ireland. | Pfizer's commercial office in Citywest, Dublin, will move to its Ringsend office building, the Irish Independent reports. The moves could end in more job cuts in the company's commercial division.
BioSpace
NOVEMBER 21, 2023
When twins Kenzie and Kaylie were diagnosed with Rett syndrome in 2016, there was no dedicated treatment for the neurodevelopmental disorder. That changed this year with the approval of Acadia Pharmaceuticals’ Daybue.
Pharmaceutical Technology
NOVEMBER 20, 2023
Takhzyro has been approved for the routine prevention of recurrent hereditary angioedema attacks in patients aged 2 years and older.
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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
Bio Pharma Dive
NOVEMBER 20, 2023
The regulator plans to convene an advisory panel to discuss an expanded indication for Abecma, presenting another hurdle for Bristol Myers and partner 2seventy bio.
Fierce Pharma
NOVEMBER 21, 2023
Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades.
BioSpace
NOVEMBER 21, 2023
After a negative review by an Independent Data Monitoring Committee, InDex Pharmaceuticals has decided to discontinue the late-stage CONCLUDE program evaluating its cobitolimod in ulcerative colitis.
Pharmaceutical Technology
NOVEMBER 22, 2023
Pfizer and BioNTech countersued Moderna following an initial August 2022 suit alleging that its patents were overly broad.
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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.
Bio Pharma Dive
NOVEMBER 21, 2023
Surging demand for GLP-1 agonists has put medtech firms like Medtronic under pressure, even as they argue the hit to their businesses will be minimal.
Fierce Pharma
NOVEMBER 20, 2023
After blasting the U.K.’s drug pricing policy, the pharma industry has secured a new government spending deal featuring a higher revenue cap and an innovative drug-friendly rebate mechanism. | After blasting the U.K.’s drug pricing policy, the pharma industry has secured an improved government spending deal. The agreement will double the annual growth rate for prescription meds over the coming years.
BioSpace
NOVEMBER 20, 2023
The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.
Pharmaceutical Technology
NOVEMBER 24, 2023
Bayer announced the launch of a Berlin, Germany-based manufacturing facility to meet future demands from the US, China and Europe.
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