NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia
Pharmaceutical Technology
OCTOBER 7, 2024
The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.
Sat.Oct 05, 2024 - Fri.Oct 11, 2024
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New data underline cancer risk of Bluebird therapy for brain disease
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.
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Drugmakers are racing to find the next Wegovy. These obesity trials are ones to watch.
Bio Pharma Dive
OCTOBER 10, 2024
Data readouts over the next six months could set expectations for how the highly lucrative market for weight loss therapies will look in the future.
Deltaclinical is participating Bio Japan from 9 – 11 OCT.
Deltaclinical
OCTOBER 7, 2024
Would you like to learn more about our services? Visit us at booth C-24. We are happy to welcome you! But first, our CEO Geert Briers will attend the EU-Japan center conference in Osaka from 7 – 8 OCT.
October 9, 2024: In This Week’s PCT Grand Rounds, Early Diagnosis and Treatment of COPD
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.
EMA starts review into hair loss drugs about potential link to suicidal thoughts
Pharmaceutical Technology
OCTOBER 7, 2024
The safety review was requested by the French medicines agency, citing new safety reports that alter the risk profile of finasteride.
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Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list
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.
October 8, 2024: HCSRN Calls for Abstracts and Panel Presentations for 2025 Annual Conference
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.
City Therapeutics launches with $135m Series A funding
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.
Sanofi may have found a buyer for its consumer health business
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.
The New Age of Decentralized Clinical Trials
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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
Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months
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.
Grand Rounds October 4, 2024: Health Trends Across Communities – A Novel Health System-Public Health Data Partnership (Tyler Winkelman, MD, MSc; David Johnson, MPH)
Rethinking Clinical Trials
OCTOBER 9, 2024
Speakers Tyler Winkelman, MD, MSc Division Director, General Internal Medicine Hennepin Healthcare Co-Director, Health, Homelessness, and Criminal Justice Lab HHRI David Johnson, MPH Health Informatics and Epidemiology Program Manager Hennepin County Slides Keywords Electronic Health Record; Data Sharing; Public Health; Health Systems; Partnerships Key Points Collaboration across public health and health care is essential to developing actionable data
Boehringer kickstarts two Phase III trials as MASH therapy wins breakthrough status
Pharmaceutical Technology
OCTOBER 8, 2024
The Phase III trials will evaluate survodutide in metabolic dysfunction-associated steatohepatitis (MASH), fibrosis and cirrhosis.
Ex-Pfizer execs ‘threatened’ for supporting plans to shake up company, Starboard says
Bio Pharma Dive
OCTOBER 10, 2024
In a letter to Pfizer’s board, the activist investor claimed former CEO Ian Read and CFO Frank D’Amelio were pressured to abandon a Starboard-led attempt to change the company’s direction.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Pfizer, bracing for Hurricane Milton, pledges aid to emergency services and health support
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.
Sanofi in talks to sell stake in consumer health spinout
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).
Ipsen’s Elafibranor gains MHRA approval for PBC treatment
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.
Using de-identified lab data to find patients, target physicians and expedite treatment
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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
AstraZeneca heads to regulators after Airsupra asthma trial stops early thanks to 'overwhelming efficacy'
Fierce Pharma
OCTOBER 7, 2024
After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.
Scholar Rock preps filings after SMA antibody clears trial
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.
Merck unveils €290m biosafety testing facility in Maryland, US
Pharmaceutical Technology
OCTOBER 10, 2024
Germany-based Merck KGaA has announced the launch of a new €290m ($317.6m) biosafety testing facility in Rockville, Maryland, US.
Intellia starts late-stage test of CRISPR therapy for rare swelling disease
Bio Pharma Dive
OCTOBER 7, 2024
The study, of Intellia’s treatment for hereditary angioedema, is the second Phase 3 trial the biotech has begun testing its “in vivo” gene editing medicines.
Amid GLP-1 craze, Novo and Mylan ink patent settlement in Ozempic case
Fierce Pharma
OCTOBER 7, 2024
With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S. launch of their generic to Novo Nordisk's wildly popular Type 2 diabetes drug Ozempic. | Mylan Pharmaceuticals and Novo Nordisk have reached a confidential settlement in a patent lawsuit tied to generic Ozempic, also known as semaglutide, India’s Natco Pharma said.
NHS England to be given a bigger role in GP data sharing
pharmaphorum
OCTOBER 7, 2024
UK Health Secretary Wes Streeting has announced plans to allow NHS England to share primary care data with scientific researchers, taking on some of the responsibility held by GPs. The minister told the Royal College of General Practitioners (RCGP) annual conference that, while many UK patients have given their consent for their data to be shared with studies run by the likes of the UK Biobank, Genomics England, and Our Future Health, they "still see, far too often, that this data is not shared
Lilly and insitro team up to develop AI-powered siRNA metabolic drugs
Pharmaceutical Technology
OCTOBER 10, 2024
Eli Lilly and insitro said the deals offers a “new paradigm” for collaborations between major pharmaceutical companies and smaller biotechs.
Upstream prices $255M IPO in bid to challenge Amgen, AstraZeneca asthma drug
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.
The New Age of Decentralized Clinical Trials
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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.
Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and AZ
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.
UK celeb seeks funds to challenge NICE's Enhertu verdict
pharmaphorum
OCTOBER 10, 2024
Media personality Nadia Sawalha is heading a fundraising effort to launch an appeal against NICE's recent rejection of a breast cancer therapy Enhertu.
Magazine: Cell and gene therapy approvals drive paradigm change in manufacturing
Pharmaceutical Technology
OCTOBER 8, 2024
In this issue: The manufacturing shift to meet growing cell and gene therapy demand, applying lessons from the Covid-19 pandemic to address mpox, a ten-year review of Opdivo and Keytruda, and more.
Scholar Rock scores with ‘surprise’ success in SMA drug study
Bio Pharma Dive
OCTOBER 7, 2024
Phase 3 findings could position the biotech’s therapy to become part of a “new standard” for SMA, its CEO said, while boosting research into whether it can preserve muscle in people with obesity.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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