Bio Pharma Dive
OCTOBER 11, 2024
The French pharmaceutical giant said it’s in negotiations to sell a controlling stake of Opella to the private equity firm CD&R, in a deal that reportedly could be worth more than $16 billion.
Rethinking Clinical Trials
OCTOBER 15, 2024
A new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials. Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharmaceutical Technology
OCTOBER 9, 2024
City Therapeutics has announced its launch accompanied by a $135m Series A financing to lead advancements in RNAi-based medicine.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 13, 2024
(Valerii Apetroaiei/Getty Images) Exercise is great for improving heart health. But the thought of hitting the gym or going for a jog might put some people off from doing it. And, if you have a heart condition already, such dynamic exercises may not be safe to do.
Worldwide Clinical Trials
OCTOBER 14, 2024
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Rethinking Clinical Trials
OCTOBER 9, 2024
Dr. Shawn Aaron In this Friday’s PCT Grand Rounds, Shawn Aaron of the University of Ottawa will present “Early Diagnosis and Treatment of Asthma and COPD.” The Grand Rounds session will be held on Friday, October 11, 2024, at 1:00 pm eastern. Aaron is a professor of medicine at the University of Ottawa and the director of the Canadian Respiratory Research Network.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 8, 2024
The Phase III trials will evaluate survodutide in metabolic dysfunction-associated steatohepatitis (MASH), fibrosis and cirrhosis.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 14, 2024
(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.
Worldwide Clinical Trials
OCTOBER 14, 2024
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Bio Pharma Dive
OCTOBER 9, 2024
Many pharma companies are now using de-identified lab data to identify potential patients and their physicians in time to impact the patient’s treatment plan. In this Q&A, learn how lab data can be used to increase patient access.
Advertisement
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
OCTOBER 14, 2024
Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.
Fierce Pharma
OCTOBER 8, 2024
With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.
pharmaphorum
OCTOBER 14, 2024
Damage to a Baxter manufacturing facility caused by Hurricane Helene, which rolled across the east US a couple of weeks ago, has led to shortages in some critical medicines.The plant in North Cove, North Carolina, was severely affected by flooding and had to be shut down at the end of September. It is Baxter's biggest manufacturing site and is also the largest supplier of intravenous and peritoneal dialysis solutions to the US market.
Rethinking Clinical Trials
OCTOBER 8, 2024
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel proposals for its 2025 Annual Conference until December 9, 2024. This year’s meeting will be held in St. Louis, Missouri, from April 8 to 10, 2025. Information about conference registration, preconference workshops, and accommodations is also available. Early-bird registration is open through February 21.
Advertisement
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
OCTOBER 14, 2024
The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.
Pharmaceutical Technology
OCTOBER 14, 2024
RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.
Fierce Pharma
OCTOBER 11, 2024
Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.
pharmaphorum
OCTOBER 11, 2024
Rumours that Sanofi was in discussion with private equity groups over the sale of its consumer health business Opella have been confirmed – at least partially.The French pharma group confirmed this morning that it has entered into talks with US-based Clayton Dubilier & Rice to sell a controlling 50% stake in the unit for what has been estimated by Reuters to be in the region of €15 billion ($16.4 billion).
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.
Drug Channels
OCTOBER 11, 2024
Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos. Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues. To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.
Bio Pharma Dive
OCTOBER 14, 2024
The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.
Pharmaceutical Technology
OCTOBER 14, 2024
Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.
Fierce Pharma
OCTOBER 8, 2024
Editor's Note: Is your company bracing for Milton or working to provide aid in anticipation of the storm? | Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Hurricane Milton touches down this week.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
pharmaphorum
OCTOBER 14, 2024
GSK's six-monthly IL-5 inhibitor depemokimab clears two phase 3 trials in chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication
Outsourcing Pharma
OCTOBER 10, 2024
The big pharma company AstraZeneca has forged a licensing pact worth $2 billion with the Chinese firm CSPC Pharmaceutical Group for access to an experimental small molecule treatment for dyslipidemia.
Bio Pharma Dive
OCTOBER 10, 2024
Seven young boys given Bluebird's Skysona later developed blood cancers, findings that could shape how doctors balance the gene therapy’s risks against its benefit.
Pharmaceutical Technology
OCTOBER 9, 2024
Ipsen has received the UK MHRA's approval for its Elafibranor (Iqirvo) for the treatment of primary biliary cholangitis (PBC) in adults.
Fierce Pharma
OCTOBER 10, 2024
As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio. | As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio.
pharmaphorum
OCTOBER 8, 2024
Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory filings in early 2025.The stock rocketed 362% after the announcement, taking Scholar Rock's market cap above $2.7 billion, as analysts started to talk about a blockbuster sales opportunity for the selective myostatin inhibitor.
BioPharma Reporter
OCTOBER 11, 2024
Jane Koo, head of regulatory affairs at CTMC, plays an important role in accelerating the development and commercialization of innovative cellular therapies.
Bio Pharma Dive
OCTOBER 10, 2024
The offering will fund testing of a potential rival to Amgen’s Tezspire and is already the sixth for an immune drug developer this year, the most since 2021.
Advertisement
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.
Expert insights. Personalized for you.
279 
Let's personalize your content