Pharmaceutical Technology
JULY 15, 2024
Australia is fast becoming the place to be for innovative life sciences companies, as proved by Melbourne’s latest FDI wins from the likes of BioNTech and Moderna.
Bio Pharma Dive
JULY 15, 2024
Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.
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Pharmaceutical Technology
JULY 15, 2024
AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 15, 2024
Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success.
Bio Pharma Dive
JULY 15, 2024
The company claims the results support exploring the possibility of an accelerated approval, citing flexibility by FDA officials in reviewing rare disease gene therapies.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 15, 2024
The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
JULY 15, 2024
While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.
Pharmaceutical Technology
JULY 15, 2024
AusperBio has raised $37m in a Series A financing round to progress the clinical development of AHB-137 for chronic hepatitis B (CHB).
Fierce Pharma
JULY 15, 2024
It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.
Pharmaceutical Technology
JULY 15, 2024
The US Food and Drug Administration (FDA) has granted fast track designation to Mabwell’s antibody-drug conjugate (ADC).
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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
Fierce Pharma
JULY 15, 2024
After two decades headquartered in the West London suburb of Brentford, GSK is officially coming home to central London. | After two decades headquartered in the West London suburb of Brentford, GSK's new digs are officially open and will house 3,000 workers in London's Knowledge Quarter.
Pharmaceutical Technology
JULY 15, 2024
Nona Biosciences has partnered with biotechnology company Alaya.bio to work on advancing CAR-T cell therapies.
Fierce Pharma
JULY 15, 2024
CAR-T specialist Legend Biotech has reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser to evaluate its options, StreetInsider
Pharmaceutical Technology
JULY 15, 2024
The company will initiate Phase Ib and Phase II studies in major depression in 2024 and 2025, respectively.
BioSpace
JULY 15, 2024
Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race.
Pharmaceutical Technology
JULY 15, 2024
AbbVie is seeking regulatory approval in the US and EU for Rinvoq as a treatment for giant cell arteritis.
BioPharma Reporter
JULY 15, 2024
When she was a teenager, Dr Jasmina Jankicevic wanted to research and promote better ways for children and adults to stay healthy, or regain health and well-being.
Drug Patent Watch
JULY 15, 2024
The Strategic Advantage of Complex Drug Delivery Systems In the highly competitive pharmaceutical landscape, adopting complex drug delivery systems can […] Source
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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.
BioSpace
JULY 15, 2024
Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.
Pharma Times
JULY 15, 2024
Affecting parts of the body involving breathing, RTIs impact one in five people in England
BioSpace
JULY 15, 2024
To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
Pharmaceutical Commerce
JULY 15, 2024
A study explores the cost-effectiveness of combining methotrexate with various drugs as a way to combat failed methotrexate monotherapy.
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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
BioSpace
JULY 15, 2024
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
Pharma Times
JULY 15, 2024
Almost 50% of adults living with type 1 diabetes experience high levels of diabetes distress
pharmaphorum
JULY 15, 2024
An experimental gene therapy developed by Lexeo Therapeutics has shown early promise in treating one of the most serious complications of rare neurodegenerative disorder Friedreich's ataxia (FA).In a phase 1/2 SUNRISE-FA trial, the LX2006 therapy showed a reduction in cardiomyopathy – the most common cause of death in FA – in an initial group of patients with enlarged hearts at the start of the trial.
Fierce Pharma
JULY 15, 2024
To receive Vertex and CRISPR Therapeutics’ $2.2 million gene therapy Casgevy for sickle cell disease (SCD) and transfusion dependent beta thalassemia (TDT), patients must first undergo chemotherapy | Vertex has filed a lawsuit in federal court in Washington, D.C. against the U.S. Department of Health and Human Services (HHS) seeking to overturn the “erroneous legal positions” of the agency’s Office of the Inspector General (OIG).
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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.
BioSpace
JULY 15, 2024
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
pharmaphorum
JULY 15, 2024
Germany inches closer to confidential pricing for patented medicines, with passage of Medical Research Act
FDA Law Blog
JULY 15, 2024
By John W.M. Claud & JP Ellison — The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions.
pharmaphorum
JULY 15, 2024
Framework governing early-stage clinical trials in the UK is stifling research and needs to be simplified, says BJCP paper
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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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