Tue.Mar 12, 2024

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After surprise trial failure, ALS doctors brace for one less treatment option

Bio Pharma Dive

Physicians are preparing for tough conversations with patients on Amylyx Pharmaceuticals’ drug, Relyvrio, while holding out hope it still may help some with the disease.

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Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

AuroBlog - Aurous Healthcare Clinical Trials blog

Two hundred and seventeen. That’s how many vaccines a man in Germany claims to have received for COVID-19 in just 29 months – and his body isn’t reacting the way some scientists thought it would.

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Terns scores FDA orphan designation for CML therapy

Pharmaceutical Technology

TERN-701 is a BCR-ABL tyrosine-kinase inhibitor being studied in a Phase I study, with data expected in H2 this year.

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Should You Let Your Dog Lick Your Face? Here’s The Science

AuroBlog - Aurous Healthcare Clinical Trials blog

Any dog owners reading this will know the joy of getting home and being greeted with utter delight by their pet – tail wagging wildly before enthusiastic but face-drenching licks.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease

Bio Pharma Dive

Allogene’s partnership with Arbor is designed to help the company stand out in what’s quickly become one of the industry’s hottest areas of drug research.

Drugs 171
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Jaguar Health balances ambitions for human and animal pharmaceuticals

Pharmaceutical Technology

In an exclusive interview, Jaguar Health’s CEO discussed plans for the investigation of crofelemer in human and animal studies.

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More Trending

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Selecta Biosciences files patent for enhanced gene therapy using viral vectors and immunosuppressants

Pharmaceutical Technology

Enhance gene expression and reduce immune responses with Selecta Biosciences' patented method using viral vectors and nanocarriers attached to immunosuppressants. Learn more about this innovative approach for improved therapeutic outcomes.

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Acadia drug fails schizophrenia trial, setting back company’s expansion plans

Bio Pharma Dive

The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects.

Drugs 120
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J&J seeks label expansion for Tremfya in ulcerative colitis

Pharmaceutical Technology

Johnson & Johnson’s Tremfya is approved for plaque psoriasis and active psoriatic arthritis, with a label for ulcerative colitis now on the horizon.

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Why gut bacteria is the next frontier in medicine

pharmaphorum

Discover why gut bacteria are considered the next frontier in medicine in this informative article. Learn about the importance of the microbiome, its impact on health, and how it relates to conditions like Clostridiales difficile.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Indena’s CDMO services: Full manufacturing capabilities for pharma ingredients

Pharmaceutical Technology

In a challenging CDMO framework, Indena has acquired the experience and the equipment to handle high potent NCEs and commercial…

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What do volunteers for research studies do after finding a trial?

Antidote

For many people, participating in a research study presents an interesting opportunity with many benefits to volunteering. While there are many types of clinical research, all with distinct goals and timelines, trial volunteers will follow a similar path when taking part. Read on to learn more about the process.

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A review of changing regulatory and analytical requirements of free amino acid monographs of the European Pharmacopoeia

Pharmaceutical Technology

Butterworth Laboratories looks at the current amino acid testing landscape since the changes in monographs introduced in 2013.

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Changing Faces: Agency, consultancy, and investor hires from February 2024

pharmaphorum

Discover the latest agency, consultancy, and investor hires from February 2024, including personnel from OVID Health, Avalere, WE Communications, and Eurozeo. Stay updated with industry movements and key players.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Tierra raises $11.4 in Series A round for predictive AI protein maker

Pharmaceutical Technology

The US company is part of a burgeoning artificial intelligence (AI) market in early-stage drug development.

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Avoiding the data swamp: The transformative power of AI

pharmaphorum

In the latest episode of the pharmaphorum podcast, host Nicole Raleigh speaks (virtually) with Nathan Clark, founder and CEO of Ganymede, a modern data platform and Cloud infrastructure for science, to discuss the evolving role of the Cloud in biopharma and some rather revolutionary tools in AI drug discovery.

Drugs 115
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Enanta Pharmaceuticals files patent for 17ß-HSD13 inhibitors for treating metabolic disease

Pharmaceutical Technology

Discover Enanta Pharmaceuticals' groundbreaking patent for Formula (I) compounds as 17ß-HSD13 inhibitors, targeting metabolic diseases and liver conditions. Learn about the potential therapeutic applications and pharmaceutical compositions covered in the patent application.

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Older Adults’ Experience with Opioid Use, Deprescribing

Pharmaceutical Commerce

A qualitative study explores how these drugs are impacting these patients’ lives, while digging deeper into the possibility of deprescribing, with insight from primary care physicians.

Drugs 111
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The New Age of Decentralized Clinical Trials

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.

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Bayer files patent for method for screening chemical substances using plant material

Pharmaceutical Technology

Discover Bayer AG's innovative patent for screening chemical substances using plant material. Learn about the process involving phenotypical characteristics, site of action, and sensor technology. Publication Number: US20240036034A1.

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Pfizer’s Velsipity heading for NHS use in ulcerative colitis

pharmaphorum

Up to 25,000 patients in England with ulcerative colitis are eligible for treatment with Pfizer’s Velsipity after NICE backed use of the drug on the same day as its MHRA approval.

Drugs 105
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Bristol-Myers Squibb files patent for inhibitors of KRAS G12d

Pharmaceutical Technology

Discover Bristol-Myers Squibb's groundbreaking patent for compounds inhibiting KRas G12D activity, offering hope for treating various cancers. Explore the potential therapeutic applications and dosages outlined in the patent application.

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Amid Moderna's 'transition year,' CEO Stéphane Bancel's total pay fell by about 5%

Fierce Pharma

Despite Moderna’s efforts to prove its mRNA thesis beyond COVID-19 in 2023, the post-pandemic hangover took a toll on the company. | Despite Moderna’s efforts to prove its mRNA thesis beyond COVID-19 in 2023, the post-pandemic hangover took a heavy toll on the company. In turn, much of the company’s top brass—including CEO Stéphane Bancel—saw their total compensation fall for the year.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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AbbVie files patent for treatment of rheumatoid arthritis with specific pharmaceutical composition

Pharmaceutical Technology

Discover AbbVie Inc.'s innovative patent for an extended-release tablet to treat rheumatoid arthritis. Learn about the specific compound and unique features of this groundbreaking pharmaceutical product.

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Pfizer aims Adcetris for expansion into large B-cell lymphoma after trial win

Fierce Pharma

The antibody-drug conjugate (ADC) Adcetris has given Pfizer’s oncology department its first pivotal trial win from the legacy Seagen portfolio since the $43 billion merger. | The antibody-drug conjugate Adcetris has given Pfizer’s oncology department its first pivotal trial win from the legacy Seagen portfolio since the $43 billion merger.

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Dr. Reddy’s Laboratories files patent for 6-substituted pyridazine compounds for treating diseases dependent on SMARCA2/SMARCA4

Pharmaceutical Technology

Discover how Dr. Reddy's patent for innovative pyridazine compounds offers promising treatments for diseases dependent on SMARCA2 and SMARCA4 proteins, including various cancers. Explore detailed chemical structures and potential therapeutic benefits.

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Acadia to end Nuplazid testing after schizophrenia trial flop and years of failed expansion efforts

Fierce Pharma

Acacia Pharmaceuticals is calling it quits on future testing of Nuplazid after a string of expansion efforts have come up short. | The company will not conduct any further clinical trials of the drug, which is currently approved to treat Parkinson’s disease psychosis. The decision comes after years of failed expansion bids in other uses.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Zealand Pharma files patent for pharmaceutical composition with GLP-1/GLP-2 dual agonist and preservatives

Pharmaceutical Technology

Discover Zealand Pharma's innovative patent for GLP-1/GLP-2 dual agonist compositions with specific preservatives. Learn about the unique formula and formulation details for this groundbreaking pharmaceutical composition.

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Angelini Pharma partners with Wazoku to improve target identification in epilepsy

Outsourcing Pharma

International pharmaceutical firm Angelini Pharma has initiated a creative crowdsourcing campaign aimed at enhancing target identification in epilepsy, particularly focusing on drug-resistant phenotypes.

Drugs 105
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AstraZeneca files patent for improved production of aav vectors using specific plasmid sequence

Pharmaceutical Technology

Discover how AstraZeneca's new patent revolutionizes AAV vector production with specific polynucleotide sequences, excluding cap genes.

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Weight Loss Blockbuster Wegovy Wins Expanded Approval for Heart Benefits

XTalks

Novo Nordisk’s blockbuster obesity and weight loss drug Wegovy (semaglutide) has scored a major label expansion after receiving approval from the US Food and Drug Administration (FDA) for a heart indication to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.

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Accelerating Clinical Supply Through Integrated Drug Development

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.