Study reveals AI insights can predict development of disease a decade in advance
Pharma Times
AUGUST 8, 2024
The study predicted the development of conditions including Alzheimer’s and heart disease
Thu.Aug 08, 2024
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Lilly boosts outlook on rising Zepbound revenue
Bio Pharma Dive
AUGUST 8, 2024
Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.
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Purdue receives clearance for opioid overdose injector for younger individuals
Pharmaceutical Technology
AUGUST 8, 2024
Coming in response to a rise in teenage overdoses across the US, the Purdue auto-injector device is designed to be used by anyone.
Hospitals Are Running Out of Saline, And It’s a Global Problem
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2024
Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. The shortage is due to higher-than-expected demand and manufacturing issues. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution). Both fluids are made with salts.
US FDA approves Novartis’ Fabhalta in IgAN treatment
Pharmaceutical Technology
AUGUST 8, 2024
Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.
Indian healthcare sector concerned on quality & accuracy of Point-of-Care diagnostic test results
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2024
The Indian healthcare sector is now concerned on quality and accuracy of Point-of-Care (PoC) diagnostic test results. This apprehension is because of limited training or experience with these devices and those handling the same. Hands-on practice and ongoing education to remain updated with changes in technology are issues.
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Sarepta reveals lower Elevidys sales, but points to ‘massive’ opportunity ahead
Bio Pharma Dive
AUGUST 8, 2024
Company executives claimed “unprecedented demand” for the Duchenne gene therapy will soon cause a sales surge, countering a dip in quarterly sales and financial projections that raised concerns among investors.
Conduit acquires three first-in-class assets from AstraZeneca
Pharmaceutical Technology
AUGUST 8, 2024
Conduit plans to advance two assets, AZD1656 and AZD5658, into Phase II testing for autoimmune disorders.
Apellis plans FDA filing after drug success in kidney trial
Bio Pharma Dive
AUGUST 8, 2024
Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.
August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials
Rethinking Clinical Trials
AUGUST 8, 2024
Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that addresses the urgent need for better and faster implementation of research findings into pat
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
Recursion to absorb Exscientia in ‘techbio’ deal
Bio Pharma Dive
AUGUST 8, 2024
The two AI drug discovery firms, which have each lost most of their value since going public, believe their complementary skills can better speed the development of new medicines.
CRISPR-based Casgevy is made accessible in England following NICE guidance
Pharmaceutical Technology
AUGUST 8, 2024
The gene editing therapy will now be accessible to NHS England patients with beta-thalassemia, potentially replacing lifelong transfusions.
Merck TIGIT drug fails another trial; Intellia therapy succeeds in HAE study
Bio Pharma Dive
AUGUST 8, 2024
Merck stopped a Phase 3 TIGIT study for futility. Elsewhere, shares in Cabaletta Bio sank on safety worries and Vertex secured Casgevy reimbursement in England.
Takeda’s ADZYNMA gains EU approval for cTTP treatment
Pharmaceutical Technology
AUGUST 8, 2024
The European Commission (EC) has approved Takeda's ADZYNMA (recombinant ADAMTS13) for congenital thrombotic thrombocytopenic purpura (cTTP).
Zepbound shortages ease, but Lilly cautions pharmacy availability may remain ‘choppy’
Bio Pharma Dive
AUGUST 8, 2024
After months of supply strains, Lilly has begun to catch up with demand. Consumers may still need to wait for their prescriptions to be filled, however.
Pharmacosmos ventures into oncology and merges with G1 Therapeutics
Pharmaceutical Technology
AUGUST 8, 2024
Pharmacosmos will secure its second FDA-approved drug and first oncology therapy, G1 Therapeutics’ Costela as part of the merger.
Eli Lilly lifts sales guidance by $3B as supplies of Mounjaro and Zepbound recover
Fierce Pharma
AUGUST 8, 2024
While a glut of drugmakers have raised their 2024 financial guidance after the second quarter, those upgraded sales expectations pale in comparison to Eli Lilly’s new forecast for the year. | Lilly, which reported a 36% sales increase year-over-year to $11.3 billion in the second quarter, is raising its guidance for the full year by a staggering $3 billion.
GSK’s Jemperli approved for advanced endometrial cancer in Singapore
Pharmaceutical Technology
AUGUST 8, 2024
GSK Singapore obtained the Singapore HSA approval for a new indication for Jemperli for advanced or recurrent endometrial cancer.
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.
Sandoz lifts guidance after Humira biosimilar drives another quarter of sales growth
Fierce Pharma
AUGUST 8, 2024
After taking a market share lead in the crowded Humira biosimilar space and with other key launches in the works, Novartis spinout Sandoz is raising its full-year sales guidance. | The company touts leading biosimilar market share for its version of AbbVie's Humira.
Bavarian Nordic tops up US smallpox/mpox vaccine stockpile with $156.8m order
Pharmaceutical Technology
AUGUST 8, 2024
The contract will see bulk product for Jynneos replenished and additional services for dose storage.
An interview with Dr. Robert Cupelo on Alzheimer’s Treatment and the Legacy of Lecanemab
Velocity Clinical Research
AUGUST 8, 2024
It’s been just over a year since the monoclonal antibody Lecanemab received traditional approval from the FDA as a treatment for Alzheimer’s disease. This marked a turning point in the disease’s treatment, a drug that interrupted progression for the first time rather than simply addressing the symptoms. It was this type of breakthrough that Robert Cupelo, MD hoped for when he joined Velocity’s Syracuse site as Principal Investigator in 2017.
Amneal’s CREXONT gains FDA approval for Parkinson’s treatment
Pharmaceutical Technology
AUGUST 8, 2024
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' CREXONT extended-release capsules for PD.
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
Does Roche have buyer's remorse for Flatiron takeover?
pharmaphorum
AUGUST 8, 2024
Roche is said to be considering a sale of cancer data specialist Flatiron Health, just a few years after it bought the company for $1.
As Novavax comes full circle, it's 'actively exploring' sale of Czech manufacturing plant
Fierce Pharma
AUGUST 8, 2024
It was 2020 and Maryland biotech Novavax was thinking big. It had a plan to become a COVID vaccine powerhouse, with enough manufacturing capacity to supply the U.S. | As Novavax presented its quarterly earnings, finance chief Jim Kelly said the company was “actively exploring” the sale of its manufacturing facility in the Czech Republic. Novavax purchased the site in May of 2020 for $167 million with the intent of it producing more than 1 billion doses annually there.
AI biotechs Exscientia and Recursion agree $688m merger
pharmaphorum
AUGUST 8, 2024
Recursion Pharma has agreed to merge with rival AI-powered drug discovery firm Exscientia in an all-stock deal valued at $688 million
How Universal Brain is using neuroscience to transform psychiatric care
Outsourcing Pharma
AUGUST 8, 2024
In the evolving landscape of precision psychiatry, Universal Brain stands at the forefront, focusing on neuroscience and technology to transform the standard of care for psychiatric conditions.
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.
Bavarian Nordic scores $157M contract to replenish US supplies of smallpox/mpox vaccine Jynneos
Fierce Pharma
AUGUST 8, 2024
Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.
A Breadcrumb of Serialized Data
Pharmaceutical Commerce
AUGUST 8, 2024
In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the Drug Supply Chain Security Act, along with opportunities for improvement.
Citius notches first FDA approval, scoring with Lymphir for cutaneous T-cell lymphoma
Fierce Pharma
AUGUST 8, 2024
A year after it was hit with a rejection from the FDA, Citius Pharmaceuticals has scored an approval for Lymphir to treat cutaneous T-Cell Lymphoma.
After a no in sickle cell, NICE OKs Casgevy for thalassaemia
pharmaphorum
AUGUST 8, 2024
NICE backs Vertex's gene-editing therapy Casgevy as a treatment for beta thalassaemia, a few months after turning it down for sickle cell disease
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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