Bio Pharma Dive
NOVEMBER 15, 2023
Since halting work on a sickle cell treatment early this year, Graphite Bio has laid off staff, shed assets and, now, agreed to be subsumed via a merger with Lenz Therapeutics.
Pharmaceutical Technology
NOVEMBER 15, 2023
Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.
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Bio Pharma Dive
NOVEMBER 15, 2023
The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.
Pharmaceutical Technology
NOVEMBER 15, 2023
The company has struggled this year on the back of reduced Covid-19 medication sales and is now streamlining costs.
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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.
Bio Pharma Dive
NOVEMBER 15, 2023
Now independent Mural Oncology will focus on advancing a pipeline of engineered cytokines for cancer, while Alkermes has recast itself as a “pure-play” neuroscience company.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 15, 2023
Timing is everything. For early risers and late-nighters alike, listening to your internal clock may be the key to success. From the classroom to the courtroom and beyond, people perform best on challenging tasks at a time of day that aligns with their circadian rhythm.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 15, 2023
The UK JCVI has recommended the addition of chickenpox vaccine to the country's routine immunisation programme for children.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 15, 2023
The National Institute of Mental Health and Neuro Sciences (NIMHANS) in partnership with the University of Liverpool along with a £1.5 million fund support from Pratiksha Trust, will now accelerate the pace of research in mental health & neurosciences. This includes Japanese Encephalitis which requires early detection and neurocysticercosis, another serious brain infection.
Pharmaceutical Technology
NOVEMBER 15, 2023
The use of validated methods for sterilising primary packaging before aseptic fill-and-finish plays a critical role in patient safety.
Fierce Pharma
NOVEMBER 15, 2023
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.
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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
Pharmaceutical Technology
NOVEMBER 15, 2023
T-Therapeutics plans to use the Series A funds to develop T-cell therapies for cancer and auto-immune disorders.
BioSpace
NOVEMBER 15, 2023
The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.
Pharmaceutical Technology
NOVEMBER 15, 2023
Atreca has made significant cuts to its workforce (by 40%) for the second consecutive quarter in 2023 in an effort to cut costs.
Fierce Pharma
NOVEMBER 15, 2023
If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.
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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.
Pharmaceutical Technology
NOVEMBER 15, 2023
The liquid suspension requires no preparation or refrigeration and treats bacterial infections such as rosacea and pelvic inflammatory disease.
Fierce Pharma
NOVEMBER 15, 2023
How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? | How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? The craze is such that Germany’s drug regulator is considering banning the export of Ozempic, according to a report in Der Spiegel magazine.
Pharmaceutical Technology
NOVEMBER 15, 2023
Almirall has entered into a collaboration with Absci for the development and commercialisation of new treatments for dermatological ailments.
Fierce Pharma
NOVEMBER 15, 2023
CorMedix went through a lot to secure its FDA approval for DefenCath. | CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers. And it took a novel pathway for the approval to finally come through on Wednesday.
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
Pharmaceutical Technology
NOVEMBER 15, 2023
Is the pharmaceutical industry prepared to phase out HFAs used in pressurised metered-dose inhalers (pMDI) for the treatment of asthma?
BioSpace
NOVEMBER 15, 2023
The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.
Pharmaceutical Technology
NOVEMBER 15, 2023
Despite negotiations being ongoing since COP27, they have been slowed down by a lot of disagreements on how the fund will work.
BioSpace
NOVEMBER 15, 2023
After Bristol Myers Squibb picked up Augtyro as part of its $4.1 billion takeover of Turning Point Therapeutics last year, the ROS1-positive non-small cell lung cancer drug reached the regulatory finish line on Wednesday.
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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.
Pharmaceutical Technology
NOVEMBER 15, 2023
Autifony Therapeutics and Jazz Pharmaceuticals have signed a $770.5m deal for the discovery and development of drug candidates.
BioSpace
NOVEMBER 15, 2023
Approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, CorMedix’s DefenCath reduces the incidence of catheter-related bloodstream infections in adult hemodialysis patients.
Pharmaceutical Technology
NOVEMBER 15, 2023
At BIO-Europe 2023, experts highlighted challenges in fundraising and concerns about impending EU legislative changes.
BioSpace
NOVEMBER 15, 2023
This is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
XTalks
NOVEMBER 15, 2023
Starry soda, Pepsi’s innovative entry in the lemon-lime soda market, has nearly completed its first year on the market. Introduced in January 2023, this strategic move was aimed at competing with Sprite, Coca-Cola’s dominant lemon-lime beverage, which boasts a seven percent share in the $82 billion US soda market. Sierra Mist, Pepsi’s previous contender, only managed to secure about 0.1 percent of this market share.
BioSpace
NOVEMBER 15, 2023
Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.
Pharma Times
NOVEMBER 15, 2023
CHD is a common birth defect that affects the development of the heart and brain - News - PharmaTimes
BioSpace
NOVEMBER 15, 2023
The Empire State is seeing large infusions of funds from the state and the Chan Zuckerberg Initiative to develop therapies for cancer and other applications.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
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