Cambridge study finds AI more accurately assesses eye problems compared to doctors
Pharma Times
APRIL 30, 2024
GPT-4 is trained on datasets to offer eye-related advice, diagnosis and management suggestions
Tue.Apr 30, 2024
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Enlaza gets JP Morgan, Regeneron backing for covalent biologics
Bio Pharma Dive
APRIL 30, 2024
The funds will help the cancer-focused startup Enlaza bring “several development candidates” towards human testing in the next few years, its CEO said.
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ESCMID 2024: The infectious consequences of climate change
Pharmaceutical Technology
APRIL 30, 2024
Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.
Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb
Bio Pharma Dive
APRIL 30, 2024
Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.
Precision Biosciences gets grant for engineered meganucleases for modifying human mitochondrial dna
Pharmaceutical Technology
APRIL 30, 2024
Unlock the potential of genetic modification with Precision Biosciences Inc's patented MTEM technology for precise editing of eukaryotic cells. Discover how this mitochondria-targeting engineered meganuclease is revolutionizing genetic research.
Chasing Novo and Lilly: The obesity drugs that could challenge Wegovy and Zepbound
Bio Pharma Dive
APRIL 30, 2024
Large and small drugmakers are vying for a piece of what analysts view as one of the biggest market opportunities in the pharma industry's history. Here’s what’s coming next.
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Pfizer and Genmab’s Tivdak wins full FDA approval for cervical cancer
Pharmaceutical Technology
APRIL 30, 2024
The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.
CDSCO releases draft guidance document on stability studies of IVD Medical Devices
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 30, 2024
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.
Lilly counts on manufacturing scale-up to unstick obesity drug supply
Bio Pharma Dive
APRIL 30, 2024
Increasing the production capacity for Zepbound and Mounjaro is “the most ambitious expansion plan in our company’s history,” said CEO David Ricks.
Ligand Pharmaceuticals gets grant for imidazole-fused heterocycle compounds for treating leukemia
Pharmaceutical Technology
APRIL 30, 2024
Discover Ligand Pharmaceuticals Inc's groundbreaking patent for compounds treating leukemia and hematopoietic disorders. Explore the versatile pharmaceutical compositions and potential applications for innovative drug development.
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
FDA defends lab test rule, as critics fear industry upheaval
Bio Pharma Dive
APRIL 30, 2024
The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burden could slow access to testing.
EyePoint Pharmaceuticals gets grant for treatment of ocular conditions with multi-specific compounds
Pharmaceutical Technology
APRIL 30, 2024
Discover the groundbreaking patent by EyePoint Pharmaceuticals Inc for treating ocular conditions with multi-specific compounds targeting phosphatase and receptor tyrosine kinase agonists. Revolutionize eye care with Tie2 activation and VEGF inhibition.
FTC targets Novo's Ozempic, others in crackdown on 300-plus 'junk' patent listings in FDA database
Fierce Pharma
APRIL 30, 2024
The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | The U.S. FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book. After an initial round of challenge launched in November against more than 100 patents, the FTC is back targeting another 300-plus patent listings by eight pharma firms.
Inovio Pharmaceuticals gets grant for electroporation device with adjustable needle array auto-lock assembly
Pharmaceutical Technology
APRIL 30, 2024
Discover the latest patent from Inovio Pharmaceuticals Inc for an innovative electroporation device with adjustable auto-lock assembly. Enhance precision and safety during procedures with this cutting-edge technology.
Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits
Fierce Pharma
APRIL 30, 2024
Biopharma companies and industry lobbying groups are striking out in their legal efforts to challenge price-cutting measures in the Inflation Reduction Act. | A federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on drug pricing.
Merus gets grant for treatment of clec12a positive cancer with bispecific antibody
Pharmaceutical Technology
APRIL 30, 2024
Discover a groundbreaking patent for treating CLEC12A positive cancer with bispecific antibodies. Learn about a unique dosing strategy to target cancer cells effectively while sparing hemopoietic stem cells.
Embracing new delivery models in the UK
pharmaphorum
APRIL 30, 2024
Learn about the exciting developments in healthcare delivery in the UK, including the IDX2 trial, NHS initiatives, NIHR research, and the Digital Delivery Team. Explore how these new delivery models are revolutionising healthcare.
Corcept Therapeutics gets grant for method of preparing compound of formula i
Pharmaceutical Technology
APRIL 30, 2024
Discover the latest patent from Corcept Therapeutics Inc on methods for preparing specific compounds, including 2-amino-6-((1r,4r)-4-phenylcyclohexyl)-5-(3-(trifluoromethyl)benzyl)pyrimidin-4(3H)-one. Learn about new intermediate compounds and detailed synthesis processes.
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.
Walmart retreats from healthcare, closing clinics across US
pharmaphorum
APRIL 30, 2024
For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.
Ionis Pharmaceuticals gets grant for modified oligonucleotide for reducing lRRK2 rna in neurodegenerative diseases
Pharmaceutical Technology
APRIL 30, 2024
Discover how Ionis Pharmaceuticals' patent for modified oligonucleotides offers hope in treating Parkinson's disease by reducing LRRK2 levels and alleviating symptoms. Explore the groundbreaking methods and compounds outlined in this comprehensive framework.
Eli Lilly’s growth drivers, Verzenio and Jardiance, suffer clinical setbacks
Fierce Pharma
APRIL 30, 2024
Besides the diabetes and obesity duo of Mounjaro and Zepbound, the SGLT2 inhibitor Jardiance and the CDK4/6 cancer drug Verzenio were cited as the main growth drivers for Eli Lilly’s first quarter. | Besides the diabetes and obesity duo of Mounjaro and Zepbound, the SGLT2 inhibitor Jardiance and the CDK4/6 cancer drug Verzenio were cited as the main growth drivers for Eli Lilly’s first quarter.
Axsome Therapeutics gets grant for treating narcolepsy with cataplexy using reboxetine
Pharmaceutical Technology
APRIL 30, 2024
Treat narcolepsy with cataplexy effectively with Axsome Therapeutics' patented method using reboxetine. Administer daily for reduced daytime sleepiness.
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
California to sell state-branded Narcan generic to cut costs
pharmaphorum
APRIL 30, 2024
California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices
CHMP recommends AstraZeneca’s Truqap and Faslodex combo approval
Pharmaceutical Technology
APRIL 30, 2024
The CHMP of the EMA has recommended AstraZeneca's Truqap, along with Faslodex, for approval in the European Union.
Lilly cranks up outlook, banking on GLP-1 production expansions despite continuing supply squeeze
Fierce Pharma
APRIL 30, 2024
While an ongoing production expansion push for Eli Lilly's popular tirezeptide-based medicines Mounjaro and Zepbound should help out with perpetual supply strains later this year, the expected | While Eli Lilly's supply for Mounjaro and Zepbound is scheduled to increase during the second half of the year, demand is still expected to outpace supply through 2024 and possibly into 2025, executives said.
Accord BioPharma’s HERCESSI secures FDA approval
Pharmaceutical Technology
APRIL 30, 2024
Accord BioPharma, the division of Intas Pharmaceuticals, has secured approval from the US FDA for HERCESSI, a biosimilar to Herceptin.
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.
Prime editing comes of age as FDA clears human trials
pharmaphorum
APRIL 30, 2024
Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.
FDA approves X4 Pharmaceuticals’ WHIM syndrome drug
Pharmaceutical Technology
APRIL 30, 2024
The US FDA has approved X4 Pharmaceuticals' XOLREMDI (mavorixafor) capsules for patients aged 12 and above with WHIM syndrome.
WuXi AppTec's CEO pledges to 'do the right thing' as sales slip following US biosecurity scrutiny
Fierce Pharma
APRIL 30, 2024
With WuXi AppTec’s very existence under threat from proposed biosecurity legislation in the U.S., the Chinese CDMO giant is standing its ground on its quest to preserve its business and “do the rig | With WuXi AppTec’s very existence under threat from proposed biosecurity legislation in the U.S., the Chinese CDMO giant is standing its ground on its quest to preserve its business and “do the right thing,” the company’s CEO, Ge Li, said in the company’s first-quarter earnings report.
Repertoire and Bristol Myers Squibb link on autoimmune disease vaccines
Pharmaceutical Technology
APRIL 30, 2024
Repertoire Immune has collaborated with Bristol Myers Squibb to develop tolerising vaccines aimed at treating autoimmune diseases.
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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