Autobahn raises $100M on investor interest in neuropsych drugs
Bio Pharma Dive
JULY 24, 2024
Autobahn’s lead candidate is designed to stimulate thyroid hormone receptors as a way to complement existing antidepressants.
Wed.Jul 24, 2024
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Mice That Eat Less Live Longer – And We May Finally Know Why
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 24, 2024
We’ve known for over a century that mice and rats live longer when they are fed less, but a new study reveals the secret might be an imbalance between energy consumed and burned, rather than a lack of energy or protein.
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Standing ovation for Gilead as it boasts perfect efficacy in HIV PReP trial
Pharmaceutical Technology
JULY 24, 2024
The crowd and panel gave Gilead a standing ovation after the full data from the Phase III PURPOSE trial was announced at AIDS 2024.
July 24, 2024: In This Week’s PCT Grand Rounds, Fonarow to Discuss Interventions for Optimizing Guideline-Directed Medical Therapy
Rethinking Clinical Trials
JULY 24, 2024
In this Friday’s PCT Grand Rounds, Gregg Fonarow of the University of California, Los Angeles, will present “Interventions for Optimization of Guideline-Directed Medical Therapy.” The Grand Rounds session will be held on Friday, July 26, 2024, at 1:00 pm eastern. Fonarow is the Eliot Corday Professor of Cardiovascular Medicine and Science at UCLA, director of the Ahmanson-UCLA Cardiomyopathy Center, and codirector of the UCLA Preventative Cardiology Program.
Novartis invests in bispecifics for cancer; Bob Langer steps down from Moderna board
Bio Pharma Dive
JULY 24, 2024
The Swiss pharma is paying Dren Bio $150 million to partner on “targeted myeloid engagers.” Elsewhere, Geron is losing its commercial chief and Biovectra will sell to Agilent for $925 million.
India’s lower-income groups severely impacted with financial challenges to treat cancer
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 24, 2024
India’s lower-income groups face significant financial challenges when it comes to cancer treatment. High medical costs, lack of insurance coverage, and limited access to quality healthcare services exacerbate the situation. Many families are seen to opt between basic necessities and treatment, leading to increased mortality rates and a higher burden of disease.
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PBMs battle bipartisan scrutiny as lawmakers eye reforms
Bio Pharma Dive
JULY 24, 2024
Top executives at CVS Caremark, Optum Rx and Express Scripts made a rare congressional appearance to defend their companies’ drug pricing policies.
Merck and GTRI to develop gene therapy for Parkinson’s disease
Pharmaceutical Technology
JULY 24, 2024
Merck has entered a non-binding MoU with the Gene Therapy Research Institution (GTRI) to produce a gene therapy for Parkinson's disease.
Pfizer says hemophilia gene therapy meets late-stage study goal
Bio Pharma Dive
JULY 24, 2024
While the study results were positive, questions remain about the longer-term potential of hemophilia treatments like Pfizer’s.
The new frontiers of supply chain disruption – and how pharma firms are responding
Pharmaceutical Technology
JULY 24, 2024
The pharmaceutical industry is facing supply chain challenges, resulting in drug shortages and prompting reorganisation by the pharma sector.
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
Biogen, Sage tremor drug fails key trial
Bio Pharma Dive
JULY 24, 2024
Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.
Pipeline power: Sionna’s AbbVie deal could redefine CF therapeutics
Pharmaceutical Technology
JULY 24, 2024
Sionna Therapeutic has strengthened its position in the cystic fibrosis (CF) therapeutic landscape through a licensing agreement with AbbVie.
FDA medical device chief Shuren to step down after 15 years
Bio Pharma Dive
JULY 24, 2024
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices office.
The potential of 3D printing in drug development and delivery
Pharmaceutical Technology
JULY 24, 2024
3D printing is replacing traditional prototype development approaches across various industries, and use in healthcare is increasing fast.
ASCO 2024 - Matteo Levisetti
pharmaphorum
JULY 24, 2024
Stay updated on Matteo Levisetti, the chief medical officer at CUE Biopharma, post ASCO 2024. Learn about his latest research and contributions in the field of biopharma.
MHRA approves Novo Nordisk’s semaglutide to cut cardiovascular risk
Pharmaceutical Technology
JULY 24, 2024
The UK MHRA has approved a new indication of Novo Nordisk’s semaglutide to lower the risk of serious heart problems in overweight adults.
Study suggests targeting amyloid beta production could be promising in AD
Pharma Times
JULY 24, 2024
The neurodegenerative disease is currently the most common cause of dementia
AstraZeneca grows oncology portfolio with Pinetree’s EGFR degrader
Pharmaceutical Technology
JULY 24, 2024
AstraZeneca will pay $45m upfront and up to $500m in milestone-based payments for licencing Pinetree’s preclinical EGFR degrader.
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.
PBMs under the cosh at House hearing on drug pricing
pharmaphorum
JULY 24, 2024
The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.
New study suggests CAR-T therapy monitoring time could be slashed
Pharmaceutical Technology
JULY 24, 2024
The study found that the risk of certain side effects peak by two weeks for lymphoma patients receiving three CAR-T therapies.
DIA 2024: Charting new horizons in patient-centered R&D
pharmaphorum
JULY 24, 2024
Explore the latest developments in the life sciences industry with a focus on patient-centred research and development (R&D) at DIA 2024. Chart new horizons and stay updated on key trends shaping the future of healthcare.
BeiGene opens biologics facility in New Jersey, US
Pharmaceutical Technology
JULY 24, 2024
BeiGene has announced the opening of its new US biologics manufacturing and clinical R&D facility at Hopewell, New Jersey.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Despite Near 30% Drop in Humira Sales, AbbVie Beats Wall Street’s Q2 Revenue Expectations
BioSpace
JULY 24, 2024
While Humira sales were impacted by cheaper biosimilars, AbbVie reported in its second-quarter earnings results Thursday that revenues jumped nearly 45% for Skyrizi and almost 56% for Rinvoq year over year, respectively.
BioAtla receives FDA fast track designation for ozuriftamab vedotin
Pharmaceutical Technology
JULY 24, 2024
The Phase II antibody drug conjugate received FDA fast track designation against treatment-resistant head and neck carcinoma.
FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and more
Fierce Pharma
JULY 24, 2024
From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. | From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.
Telix’s prostate cancer imaging kit set for FDA review
Pharmaceutical Technology
JULY 24, 2024
Telix’s ‘cold kit’ will “improve equity of access” to PSMA-PET imaging, the company’s CEO says.
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.
BeiGene CEO eyes biologics deals for new US innovation center in New Jersey
Fierce Pharma
JULY 24, 2024
HOPEWELL, NEW JERSEY—A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics. | A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics.
J&J forecast to dominate BiTE market
Pharmaceutical Technology
JULY 24, 2024
Bispecific T-cell engagers (BiTEs) are a rapidly emerging new therapeutic.
Viking Takes Obesity Candidate into Phase III to Rival Lilly, Novo
BioSpace
JULY 24, 2024
With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday.
Drafting Detailed Drug Patent Claims: The Art and Science of Pharmaceutical IP Protection
Drug Patent Watch
JULY 24, 2024
In the high-stakes world of pharmaceutical innovation, drafting detailed drug patent claims is a critical process that can make or break a company’s future.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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