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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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.
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
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.
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.
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).
Eli Lilly’s once-weekly insulin shows promise in phase 3 trials
Pharma Times
SEPTEMBER 6, 2024
New treatment could simplify diabetes management for millions
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.
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.
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
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.
European Commission grants orphan drug designation for Vivet’s VTX-806
Pharma Times
SEPTEMBER 5, 2024
Pre-clinical data of VTX-806 in demonstrated normalisation of metabolic parameters
GSK antibody drug reduces COPD attacks in trial
Bio Pharma Dive
SEPTEMBER 6, 2024
New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.
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.
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.
AMBLor prognostic melanoma biomarker receives UKCA Mark
Pharma Times
SEPTEMBER 5, 2024
New biomarker test aims to improve early-stage melanoma treatment
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.
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.
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.
Advanz wins stay on EU revocation of Ocaliva license
pharmaphorum
SEPTEMBER 5, 2024
EU General Court suspends decision to revoke the license for Advanz Pharma's primary biliary cholangitis drug Ocaliva.
J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis
Fierce Pharma
SEPTEMBER 5, 2024
Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better chall | Johnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challenge AstraZeneca’s Tagrisso.
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.
EC approves Merck’s KEYTRUDA-Padcev combo for urothelial cancer
Pharmaceutical Technology
SEPTEMBER 4, 2024
Merck has gained EC approval for KEYTRUDA plus Padcev for adults with unresectable or metastatic urothelial carcinoma.
Illumina avoids hefty EU fine over Grail merger
pharmaphorum
SEPTEMBER 3, 2024
EU had no grounds to probe Illumina's takeover of Grail, says ECJ, but while spinoff has already taken place Illumina can now avoid a €432m fine
Cash-crunched ImmunityBio, on heels of FDA nod for Anktiva, lays off staffers
Fierce Pharma
SEPTEMBER 5, 2024
With dwindling funds after a prior snub from the FDA, ImmunityBio’s journey to bag approval for its Merck-rivaling bladder cancer drug Anktiva wasn’t easy. | The drugmaker laid off 20 employees as it attempts to recoup from dwindling funds during its Anktiva launch in bladder cancer.
Lykos CEO to depart after FDA rejection, layoffs
Bio Pharma Dive
SEPTEMBER 5, 2024
The departure of Amy Emerson as CEO comes three weeks after the MDMA developer revealed plans to cut 75% of its staff.
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.
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.
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