Novavax wins FDA emergency approval for updated Covid-19 vaccine
Pharmaceutical Technology
SEPTEMBER 2, 2024
The US regulatory agency has also approved updated versions of Covid-19 vaccines from Moderna and Pfizer / BioNTech’s in the past two weeks.
Sat.Aug 31, 2024 - Fri.Sep 06, 2024
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A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology
Bio Pharma Dive
SEPTEMBER 4, 2024
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
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J&J sweetens controversial talc settlement deal
pharmaphorum
SEPTEMBER 5, 2024
J&J is reported to have raised its offer to settle claims that its talc products caused cancer by $1.1bn, as it reaches agreement with a holdout law firm.
HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period
Pharmaceutical Commerce
SEPTEMBER 5, 2024
In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.
AstraZeneca staffers detained in China over patient data collection, drug imports: Bloomberg
Fierce Pharma
SEPTEMBER 5, 2024
AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.
ArsenalBio raises $325M in one of the year’s largest biotech funding rounds
Bio Pharma Dive
SEPTEMBER 4, 2024
The funding comes amid a slowdown in venture investment for gene and cell therapy startups, and will support development of multiple solid tumor programs.
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September 5, 2024: Pragmatic Trial of Pain Management in a Military Population, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
SEPTEMBER 5, 2024
In this Friday’s PCT Grand Rounds, Ardith Doorenbos of the University of Illinois, Chicago, and Diane Flynn of Madigan Army Medical Center will present “Conventional, Complementary, and Integrative Pain Therapies in a Military Population With Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design.” The Grand Rounds session will be held on Friday, September 6, 2024, at 1:00 pm eastern.
The Life Sciences Generative AI Council and a sustainable technological future
pharmaphorum
SEPTEMBER 5, 2024
Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.
New research could ease concerns over suicide risk of obesity drugs
Bio Pharma Dive
SEPTEMBER 3, 2024
While results from two after-the-fact analyses were “reassuring,” outside experts urged “continued vigilance” to ensure GLP-1 drugs don’t worsen problems in people with preexisting mental health conditions.
How to optimize efficiencies at site-centric clinical trials
Pharmaceutical Technology
SEPTEMBER 4, 2024
By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.
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
September 4, 2024: NIH HEAL Initiative Supports New Funding Opportunity for Pragmatic Trials in the Pain Management Collaboratory
Rethinking Clinical Trials
SEPTEMBER 4, 2024
The National Center for Complementary and Integrative Health (NCCIH), with support from the Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , published a notice of funding opportunity for pragmatic clinical trials within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-011).
China detains AstraZeneca workers in data, imports probe
pharmaphorum
SEPTEMBER 5, 2024
A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches
Lilly builds case for weekly insulin shot
Bio Pharma Dive
SEPTEMBER 5, 2024
New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.
ESC 2024: GLP-1RAs show lower CV risk in 32,883-strong meta-analysis
Pharmaceutical Technology
SEPTEMBER 2, 2024
GLP-1RAs’ reduce CV risk, including reducing all-cause mortality and risk of MI, promoting weight loss and enhancing blood pressure control.
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.
Biogen to seek approval for high-dose version of SMA stalwart Spinraza after trial win
Fierce Pharma
SEPTEMBER 4, 2024
Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.
GSK says Nucala hits the target in new COPD trial
pharmaphorum
SEPTEMBER 6, 2024
GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.
Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares
Bio Pharma Dive
SEPTEMBER 3, 2024
The company's value jumped by several billion dollars as trial results showed its experimental shot could match and, in some cases, even outperform Pfizer's market-leading Prevnar 20.
UAE MoHAP and Novo Nordisk partner for obesity management
Pharmaceutical Technology
SEPTEMBER 3, 2024
The UAE has partnered with Novo Nordisk Pharma Gulf to develop a national scientific guide for obesity management and weight control.
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.
Radioligand Therapy Advances with Novartis’ Development of Two New US Facilities
XTalks
SEPTEMBER 6, 2024
Novartis announced it has broken ground on the construction of two new radioligand therapy manufacturing facilities in the US. The facilities are part of the company’s plans to expand its manufacturing and supply chain capabilities. Novartis is investing $200 million into expanding its Indianapolis, Indiana, site for in-house production of radioisotopes and constructing a brand new one in Carlsbad, California.
Company Profile: Medscape WebMD
pharmaphorum
SEPTEMBER 5, 2024
Medscape WebMD is a leading provider of medical information and services online, catering to the Medical Affairs field. Learn more about their company profile and offerings.
Sanofi finds a silver lining in mixed MS drug results
Bio Pharma Dive
SEPTEMBER 3, 2024
Tolebrutinib, which Sanofi acquired in a $3.7 billion deal, failed two studies in people with relapsing disease, but succeeded in a type of multiple sclerosis that has no approved therapies.
Why the Importer of Record (IoR) is vital in the clinical supply chain
Pharmaceutical Technology
SEPTEMBER 3, 2024
In clinical supplies, the Importer of Record (IoR) provides a critical service in facilitating logistics and easing the burden for sponsors.
FDA grants expanded approval for Emergent Bio’s mpox vaccine
BioPharma Reporter
SEPTEMBER 3, 2024
The U.S. company Emergent BioSolutions recently announced the FDA approval of its application to expand the indication for ACAM2000 â previously approved for smallpox â to include the prevention of mpox in high-risk individuals.
Alnylam hails vutrisiran data, but investors seem sceptical
pharmaphorum
SEPTEMBER 1, 2024
Alnylam Pharma has been riding high since revealing top-line results from its HELIOS-B trial of vutrisiran in transthyretin-mediated amyloidosis (ATTR) – but a look at the full data seems to have disappointed investors.Shares in the company retreated after the presentation of the results at the European Society of Cardiology (ESC) conference, which confirmed a 28% reduction in the primary endpoint of deaths from any cause and recurrent cardiovascular events after at least 33 months of follow-up.
AI specialist Recursion says lead drug is safe, but efficacy less clear
Bio Pharma Dive
SEPTEMBER 3, 2024
The Phase 2 results for Recursion’s cerebral cavernous malformation treatment are the first in a series of important trial readouts for the high-profile “techbio” company.
Aptose Biosciences secures funds for AML treatment development
Pharmaceutical Technology
SEPTEMBER 2, 2024
Aptose Biosciences has secured a loan of $10m through a facility agreement with Hanmi Pharmaceutical to develop tuspetinib.
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.
EU orphan designation for pulmonary arterial hypertension drug
Drug Discovery World
SEPTEMBER 4, 2024
The European Commission has granted orphan medicinal product designation (OMPD) to Cereno Scientific’s lead drug candidate CS1 for pulmonary arterial hypertension (PAH). CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed to offer improved quality of life and prolonged life for patients with PAH. Companies that obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan drugs, and market exclusivity once th
Lykos CEO steps down after MDMA is rejected by FDA
pharmaphorum
SEPTEMBER 6, 2024
The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.
Script for success: The value of digital insights in pharma
Bio Pharma Dive
SEPTEMBER 3, 2024
Pharma companies can thrive in 2024 by leveraging digital intelligence to anticipate trends, analyze sentiment, and engage audiences. Discover how data-driven insights drive success.
Actimed’s ALS candidate wins FDA orphan drug designation
Pharmaceutical Technology
SEPTEMBER 4, 2024
Actimed says S-oxprenolol shares a similar pharmacology to its lead product S-pindolol, which is being studied in cachexia.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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