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.
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.
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Pharmaceutical Technology
NOVEMBER 21, 2023
According to several key opinion leaders (KOLs) interviewed by GlobalData, pipeline gene therapy holds the greatest potential to transform the Gaucher disease landscape
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.
Pharmaceutical Technology
NOVEMBER 21, 2023
The FDA's decision on the sBLA for Abecma will be delayed beyond the set PDUFA target date of 16 December.
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.
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
In a deal worth up to $610 million, Merck will gain a pipeline of neuroscience and rare disease programs from a startup it previously backed.
Pharmaceutical Technology
NOVEMBER 21, 2023
Ensem will receive an upfront payment and will be eligible for additional payments upon the achievement of milestones, totalling up to $1.33bn.
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.
Pharmaceutical Technology
NOVEMBER 21, 2023
MIRA Pharmaceuticals has signed a licencing agreement with MIRALOGX for the development and marketing of Ketamir-2 for depressive disorders.
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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
Rethinking Clinical Trials
NOVEMBER 21, 2023
Speakers Michael Ho, MD, PhD University of Colorado Sheana Bull, PhD University of Colorado Slides Keywords Nudge, Demonstration Project, Cardiovascular, Adherence Key Points A nudge is a strategic reminder that can help people adopt healthy behaviors, using principles from behavioral economics and cognitive psychology to improve behavior commitments, communicate social norms, and narrative stories.
Pharmaceutical Technology
NOVEMBER 21, 2023
Despite a US FDA rejection for the drug earlier this year, the European Commission has approved Yorvipath for chronic hypoparathyroidism.
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.
Pharmaceutical Technology
NOVEMBER 21, 2023
Janssen has sought US FDA approval for the Rybrevant combination regimen for locally advanced or metastatic non-small cell lung cancer.
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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
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 21, 2023
Tooling is a crucial aspect in manufacturing medical devices, and developing plastic injection moulds in-house offers many advantages.
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 21, 2023
Merck & Co will acquire all outstanding shares of Caraway, which has a preclinical-stage drug portfolio, through a subsidiary.
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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.
Fierce Pharma
NOVEMBER 21, 2023
Joining drugmakers like AstraZeneca and Novo Nordisk, GSK is making big strides in its quest to clean up its carbon footprint. | GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%.
Pharmaceutical Technology
NOVEMBER 21, 2023
Zevra Therapeutics has concluded the takeover of complete outstanding shares of Acer Therapeutics in a deal valued at $91m.
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.
Pharma Times
NOVEMBER 21, 2023
SMPaeds2 aims to advance precision medicines for children with relapsed cancer - News - PharmaTimes
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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.
Outsourcing Pharma
NOVEMBER 21, 2023
OSP had a discussion with Tracy Curley, CEO of iSpecimen, and Eric Langlois, chief revenue officer of iSpecimen and Michael Howell,founder of Mountaineer Biosciences, Inc. to discuss a number of issues those working in precision medicine still face.
XTalks
NOVEMBER 21, 2023
Walmart’s president and CEO, Douglas McMillon, foresees an upcoming phase of food deflation in the US. He expressed this during an earnings call last week, saying that he’s expecting “a period of deflation in the months to come,” adding, “While that would put more unit pressure on us, we welcome it because it’s better for our customers.” He mentioned that although beef prices remain high, there has been a noticeable decrease in the cost of eggs, dairy, chicken and seafood.
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.
Pharma Times
NOVEMBER 21, 2023
Cerebral SVD contributes to 45% of dementia cases and 20% of ischaemic strokes - News - PharmaTimes
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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.
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
Outsourcing Pharma
NOVEMBER 21, 2023
Astellas Pharma Inc. and Pfizer Inc. today announced that the companies received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application for small-molecule drug Xtandi (enzalutamide).
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.
Outsourcing Pharma
NOVEMBER 21, 2023
CluePoints, a company providing risk-based study execution (RBx) and risk-based quality management (RBQM) software for clinical trials has won the best Contract Research Organization (CRO) in the specialist providers category at Citelineâs 2023 SCRIP Awards.
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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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