Into the unknown: How quickly can vaccines be developed for Disease X
Pharmaceutical Technology
SEPTEMBER 13, 2024
R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.
Fri.Sep 13, 2024
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Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 13, 2024
Illustration of a cancer cell. (Science Photo Library/Canva Pro) Scientists have discovered a remarkable way to destroy cancer cells. Stimulating aminocyanine molecules with near-infrared light caused them to vibrate in sync, enough to break apart the membranes of cancer cells. [link] Aminocyanine molecules are already used in bioimaging as synthetic dyes.
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Moderna, trailing rivals, checks its RSV shot expectations
Bio Pharma Dive
SEPTEMBER 13, 2024
During an investor presentation Thursday, executives admitted to being overly optimistic their vaccine could wrest significant market share away from GSK's and Pfizer's products this year.
FDA approves Roche’s Tecentriq Hybreza for cancer
Pharmaceutical Technology
SEPTEMBER 13, 2024
The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.
Subcutaneous Tecentriq gets FDA OK; Gilead shot succeeds in second HIV trial
Bio Pharma Dive
SEPTEMBER 13, 2024
Roche has now beat Merck and Bristol Myers to market with its under-the-skin immunotherapy. Elsewhere, Sanofi bought into radiopharmaceuticals and Mene Pangalos joined Biogen's board.
Japan approves updated Covid-19 vaccine to tackle JN.1 variant
Pharmaceutical Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
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Eli Lilly to invest $1.8bn in manufacturing capacity in Ireland
Pharmaceutical Technology
SEPTEMBER 13, 2024
Lilly has announced a significant expansion of its manufacturing presence in Ireland, with a $1bn investment earmarked for its Limerick site.
Apple AirPods get FDA okay for use as OTC hearing aids
pharmaphorum
SEPTEMBER 13, 2024
It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.
Sobi and Enable Injections partner for Aspaveli distribution
Pharmaceutical Technology
SEPTEMBER 13, 2024
Sobi and Enable Injections have entered an agreement for the development and distribution of Aspaveli in combination with enFuse.
Lilly ramps up Irish manufacturing investment by $1bn
pharmaphorum
SEPTEMBER 13, 2024
Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above $2 billion and reinforcing the company's close ties to Ireland's pharma manufacturing 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
Oncternal stock crashes by 60% as it lays off staff and scraps trials
Pharmaceutical Technology
SEPTEMBER 13, 2024
Oncternal is halting the development of two cancer candidates, ONCT-534 and ONCT-808, after disappointing trial results.
Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus
Fierce Pharma
SEPTEMBER 13, 2024
When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.
Sanofi signs radioligand therapy licensing deal for rare cancers
Pharmaceutical Technology
SEPTEMBER 13, 2024
Sanofi has signed a licensing agreement with RadioMedix and Orano Med to advance a radioligand therapy, AlphaMedix.
ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases
Fierce Pharma
SEPTEMBER 13, 2024
Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.
Cidara axes 30% of staff to focus on flu prevention drug
Pharmaceutical Technology
SEPTEMBER 13, 2024
The company plans to focus its resources on conducting clinical trials for CD388 influenza prevention therapy.
Syneos Health Communications takes the crown at PM Society Digital Awards
pharmaphorum
SEPTEMBER 13, 2024
The PM Society Digital Awards 2024, an annual event in the healthcare marketing industry sponsored by Twist Health, held its 15th ceremony at The Brewery in London on 12th September.
ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as Pharma&'s combo disappoints
Fierce Pharma
SEPTEMBER 13, 2024
In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. | In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that Pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.
US puts $25m behind Cellino's cell and tissue printing tech
pharmaphorum
SEPTEMBER 13, 2024
Cellino Biotech has received funding from the US government to develop a scalable biomanufacturing platform for personalised regenerative medicines derived from patients' own stem cells.The $25 million award from the Advanced Research Projects Agency for Health (ARPA-H) will be used to develop Cellino's NEBULA system, which according to the firm's chief technology Matthias Wagner can "effectively print new cells and new tissues for patients using their own DNA.
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.
ESMO: AstraZeneca stands by Truqap despite surprise breast cancer flop
Fierce Pharma
SEPTEMBER 13, 2024
As if a limited initial FDA approval was not bad enough, AstraZeneca’s Truqap has recorded a pivotal trial flop that could raise additional doubts around the first-in-class AKT inhibitor. | AstraZeneca is detailing Truqap's pivotal trial flop in triple-negative breast cancer, a result that could raise additional doubts around the first-in-class AKT inhibitor.
Nxera and Cancer Research UK to present promising cancer drug trial at ESMO
Pharma Times
SEPTEMBER 13, 2024
Innovative immunotherapy drug HTL0039732 shows potential in trials
ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value added from new cancer approvals
Fierce Pharma
SEPTEMBER 13, 2024
ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value added from new cancer approvals kdunleavy Fri, 09/13/2024 - 07:38
Reducing drug shortages: The power of AI in pharma supply chain management
pharmaphorum
SEPTEMBER 13, 2024
AI-driven solutions are revolutionising the pharmaceutical supply chain management process, particularly in reducing drug shortages. Learn more about the power of AI in this field.
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
ESMO: Merck unpacks a mixed bag of gynecological cancer results for Keytruda
Fierce Pharma
SEPTEMBER 13, 2024
Even for Merck’s oncology powerhouse Keytruda, the emerging role of immunotherapies in gynecological cancer treatment represents a bit of a mixed bag. | The company unveiled new data from its KEYNOTE-A18 study in late stage cervical cancer and its failed KEYNOTE-B21 trial testing Keytruda as an adjuvant therapy in newly diagnosed endometrial cancer.
World Sepsis Day 2024 highlights need for better sepsis treatments
Pharma Times
SEPTEMBER 13, 2024
GlobalData emphasises importance of Improved clinical trials
Armed with $100m funding, F2G prepares to refile antifungal
pharmaphorum
SEPTEMBER 13, 2024
UK biotech F2G has raised $100 million as it prepares to refile its olorofim candidate for invasive fungal infections, which was turned down last year by the FDA.The Manchester-based company said the new cash will help it to complete the late-stage development of olorofim, a novel oral antifungal for invasive aspergillosis and other serious fungal infections, to support the company during the regulatory review process, and prepare for a commercial launch in the US.
This week in drug discovery (9-13 September)
Drug Discovery World
SEPTEMBER 13, 2024
News round-up for 9-13 September by DDW Senior Digital Content Editor Diana Spencer. This week, DDW has opened registrations for its webinar ‘ The latest advancements driving neuroscience drug discovery research ’, so our news highlights focus on developments in neuroscience, including a novel drug that has been shown to reduce neuronal death, and a potential disease-modifying treatment for dementia.
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.
Mobility week | New research confirms the health impacts caused by traffic-related air pollution in Belgium
Sciensano
SEPTEMBER 13, 2024
Recent research provides critical insights into the impact of air pollution and high ambient temperatures on the health of Belgian citizens , emphasizing the need for long-lasting and effective measures to reduce air pollution in Belgium. In Belgium, air pollution from road traffic is a major environmental health risk. It consists of pollutants such as nitrogen dioxide, fine particulate matter, and benzene, all of which are known to cause serious health issues, including respiratory and cardiova
QL Biopharm announces new obesity drug results
Drug Discovery World
SEPTEMBER 13, 2024
QL Biopharm, a clinical stage biopharmaceutical company developing biologic drugs for the treatment of metabolic diseases, has shared Phase Ic clinical data for its lead drug candidate ZT002. The data was presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, Madrid, Spain. The presentation was titled ‘ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose Phase I
Building Inclusive Trials: Insights from CTTI’s Diversity Initiatives
XTalks
SEPTEMBER 13, 2024
Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments. The Clinical Trials Transformation Initiative (CTTI) aims to change this narrative by developing recommendations and driving the adoption of practices that support inclusivity and repre
First biologic achieves improvements in bullous pemphigoid
Drug Discovery World
SEPTEMBER 13, 2024
A Dupixent (dupilumab) pivotal study (ADEPT) in bullous pemphigoid (BP) has met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease. In the study, five times more Dupixent patients achieved sustained disease remission compared to those on placebo. Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy use during
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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