Bio Pharma Dive
SEPTEMBER 8, 2023
Shape uses machine learning and high throughput screening to identify new AAV capsids in ways the company’s CEO compares to the generative AI tools Midjourney and DALLE-2.
Pharmaceutical Technology
SEPTEMBER 8, 2023
Eloxx has submitted an IND for a pivotal trial to study its Alport syndrome therapy ELX-02 following a positive Phase II data readout.
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Bio Pharma Dive
SEPTEMBER 8, 2023
Worth up to $840 million, the collaboration will give Alexion access to Verge Genomics’ platform, which uses human tissue data to find drug targets for diseases that degrade the nerve system.
Pharmaceutical Technology
SEPTEMBER 8, 2023
In this issue: Digital jobs in UK life sciences, generative AI changes drug discovery, and how robotics is impacting gene therapy manufacturing.
Bio Pharma Dive
SEPTEMBER 8, 2023
The PASTEUR Act could be heading for another legislative blow, but advocates say they see a future for the mechanism to fund research into antimicrobial resistance.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The European Commission granted expanded indication approval for Merck’s Ebola vaccine, Ervebo, to include children aged one year or above.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The UK NICE has recommended Eli Lilly’s tirzepatide for the treatment of adult patients with inadequately controlled type 2 diabetes.
Pharma Mirror
SEPTEMBER 8, 2023
Niclosamide is an anthelmintic medication that has been used for decades to treat various types of parasitic infections in humans and animals. Niclosamide works by disrupting the energy metabolism of the parasitic worms, specifically by interfering with their ability to generate adenosine triphosphate (ATP), which is essential for their survival. This disruption ultimately leads to the death of the parasites.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The Arena International Outsourcing in Clinical Trials UK and Ireland discussed how the UK’s clinical trial landscape has taken a hit and what improvements are needed to make it a more viable country for research.
Rethinking Clinical Trials
SEPTEMBER 8, 2023
In this Friday’s PCT Grand Rounds, Matthew Prekker of the University of Minnesota and Jonathan Casey of Vanderbilt University will present “The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management.” The Grand Rounds session will be held on Friday, September 8, 2023, at 1:00 pm eastern. Prekker is an associate professor of emergency medicine and pulmonary and critical care medicine at the University of Minnesota.
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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
Pharmaceutical Technology
SEPTEMBER 8, 2023
In 2022, global regulatory authorities awarded a record ten review designations for respiratory syncytial virus (RSV)-indicated drugs.
Pharma Times
SEPTEMBER 8, 2023
The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 8, 2023
Otsuka Pharmaceutical has entered a partnership with ShapeTX for the development of gene therapies to treat ocular diseases.
Pharma Times
SEPTEMBER 8, 2023
Clinically significant results have emerged from trial evaluating the company’s AMO-02 candidate - News - PharmaTimes
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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
Pharmaceutical Technology
SEPTEMBER 8, 2023
The PD-1/PD-L1 inhibitor landscape is at the precipice of change with the approval of Roche’s subcutaneous formulation of Tecentriq.
XTalks
SEPTEMBER 8, 2023
SkinnyDipped, a pioneer in the world of better-for-you snacks, has successfully secured $12 million in Series A funding, bringing the company’s total funding to $35.1 million. This promising financial move is geared towards introducing its offerings to more retailers and expanding its product categories. The funding round saw contributions from Hollywood stars, global musicians and prominent athletes.
Pharmaceutical Technology
SEPTEMBER 8, 2023
Biocytogen and Myricx Bio have signed an antibody evaluation, option and licence agreement for the development of ADCs.
Outsourcing Pharma
SEPTEMBER 8, 2023
A benchtop DNA sequencer developed by the U.S. DNA sequencing company Element Biosciences, Inc., has seen sales grow by triple digits and has received more than 100 orders since its launch in March 2022.
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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.
Pharmaceutical Technology
SEPTEMBER 8, 2023
The company expects a further survival readout in Q4 2023, with plans for a second Phase II trial set for H2 2023.
Fierce Pharma
SEPTEMBER 8, 2023
AstraZeneca’s Tagrisso is the standard of care in newly diagnosed, EGFR-mutated non-small cell lung cancer (NSCLC). | AstraZeneca hopes to offer patients with first-line, EGFR-mutant lung cancer a new option in the combination of Tagrisso and chemotherapy. But the lack of a patient survival showing raises some questions for the combo.
Outsourcing Pharma
SEPTEMBER 8, 2023
The U.S. company Nimbus Therapeutics has raised $210 million in a financing round to fund the development of small molecule drugs powered by computational drug discovery.
Fierce Pharma
SEPTEMBER 8, 2023
The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. | Friday, Danco Laboratories asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone.
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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.
Drug Channels
SEPTEMBER 8, 2023
Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir discusses how hubs help patients initiate and adhere to drug therapies. Based on CareMetx research, he outlines the key factors that drug manufacturers value in their hub partners. Learn more by downloading CareMetx’s full report: The Evolving Landscape of Digital Healthcare Hubs.
Fierce Pharma
SEPTEMBER 8, 2023
Three Japanese pharma companies lead our news stories from Asia this week. Astellas has abandoned its challenge against the Inflation Reduction Act. | Astellas has abandoned its challenge against the Inflation Reduction Act. Otsuka bought a Canadian psychedelic biotech. And Takeda is ordered to pay AbbVie nearly $480 million because of a manufacturing hiccup.
pharmaphorum
SEPTEMBER 8, 2023
Combining new and existing immunity: A 3D approach to killing cancer Mike.
Drug Discovery World
SEPTEMBER 8, 2023
News round-up for 4-8 September by DDW Digital Content Editor Diana Spencer. This week we have seen the vital importance of collaboration to the successful development and discovery of novel therapeutics, exemplified by the new deal agreed by the UK and EU to admit the UK back into Horizon Europe, the largest collaborative research programme in the world.
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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.
pharmaphorum
SEPTEMBER 8, 2023
Seagen partners Nurix on 'degrader-antibody conjugates' Phil.
Drug Discovery World
SEPTEMBER 8, 2023
Approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech Covid-19 vaccine that targets the Omicron XBB 1.5 subvariant. The new version of Comirnaty was found to meet the UK regulator’s standards of safety, quality and effectiveness and has been approved for use in individuals from six months of age.
pharmaphorum
SEPTEMBER 8, 2023
Lift for Roche as Alnylam drug lowers blood pressure Phil.
Drug Discovery World
SEPTEMBER 8, 2023
The first quadruplex-edited, allogeneic CAR-T cell therapy candidate has entered clinical trials in the US. The first patient has been treated with Beam Therapeutics’ BEAM-201 as part of a Phase I/II clinical study for the treatment of relapsed/refractory T-cell acute lymphoblastic leukaemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL). “As the first patient dosed with a Beam therapeutic candidate and the first patient in the US to receive a base editing therapeutic, this represents a major milest
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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