Drug Discovery World
AUGUST 9, 2024
The first patient has been dosed in a Phase I clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. Developer Angiex is focused on nuclear-delivered antibody-drug conjugates (ND-ADCs), which release therapeutic payloads directly into the nucleus or cytosol, where the site of payload action is located.
Science Daily: Pharmacology News
AUGUST 9, 2024
Scientists have recovered the first long section of rocks that originated in the Earth's mantle, the layer below the crust and the planet's largest component. The rocks will help unravel the mantle's role in the origins of life on Earth, the volcanic activity generated when it melts, and how it drives the global cycles of important elements such as carbon and hydrogen.
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Drug Discovery World
AUGUST 9, 2024
News round-up for 5-9 August by DDW Senior Digital Content Editor Diana Spencer. The news highlights this week all centre around significant US Food and Drug Administration (FDA) regulatory decisions, including new approvals for drugs for solid tumours, hepatitis B and glioma. The top stories: Retinoblastoma therapy gets FDA rare paediatric drug designation Theriva Biologics’ VCN-01 for retinoblastoma has been granted rare paediatric drug designation (RPDD) by the US Food and Drug Administration
Science Daily: Pharmacology News
AUGUST 9, 2024
A 'loopy' discovery in bacteria is raising fundamental questions about the makeup of our own genome -- and revealing a potential wellspring of material for new genetic therapies.
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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.
Drug Discovery World
AUGUST 9, 2024
Biotechnology company Rejuvenate Biomed has announced a partnership with analytics company SAS to develop a drug repurposing discovery tool to help researchers and scientists uncover medically relevant insights about drugs, diseases, and biological networks. The tool will be developed using SAS’ artificial intelligence (AI) and data platform, Viya. It will take data from known biomedical relationships and use SAS-based analytics to implement algorithms to uncover non-trivial and novel biological
BioPharma Drive: Drug Pricing
AUGUST 9, 2024
The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
BioPharma Drive: Drug Pricing
AUGUST 9, 2024
Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.
Science Daily: Pharmacology News
AUGUST 9, 2024
Catastrophic volcanic eruptions that warmed the planet millions of years ago shed new light on how plants evolve and regulate climate. Researchers reveal the long-term effects of disturbed natural ecosystems on climate in geological history and its implications for today.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- In findings that offer compelling evidence of the power of childhood vaccines, a new government report shows the routine shots have prevented hundreds of millions of illnesses, tens of millions of hospitalizations and more.
Science Daily: Pharmacology News
AUGUST 9, 2024
A discovery may boost the effectiveness of stem-cell transplants, commonly used for patients with cancer, blood disorders, or autoimmune diseases caused by defective stem cells, which produce all the body's different blood cells.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- Pollen is a known trigger for seasonal allergies and asthma, but new research suggests that certain plant species release pollen that are especially tough on asthmatics.Species-specific pollen alerts could help keep people.
Science Daily: Pharmacology News
AUGUST 9, 2024
While seeking to unravel how marine algae create their chemically complex toxins, scientists have discovered the largest protein yet identified in biology. Uncovering the biological machinery the algae evolved to make its intricate toxin also revealed previously unknown strategies for assembling chemicals, which could unlock the development of new medicines and materials.
BioPharma Drive: Drug Pricing
AUGUST 9, 2024
The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.
Science Daily: Pharmacology News
AUGUST 9, 2024
Researchers invented a technique that uses a specialized light projector and a photosensitive chemical additive to imprint two- and three-dimensional images inside any polymer. The light-based engraving remains in the polymer until heat or light are applied, which erases the image and makes it ready to use again. The technology is intended for any situation where having detailed, precise visual data in a compact and easily customizable format could be critical, such as planning surgeries and dev
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- A wearable brain scanner could improve research into Parkinson’s disease, dementia and other debilitating disorders, new research shows.The brain scanner -- called the Ambulatory Motion-enabling PET (AMPET) -- fits on a p.
Science Daily: Pharmacology News
AUGUST 9, 2024
In September 2023, a megatsunami in remote eastern Greenland sent seismic waves around the world, piquing the interest of the global research community. The event created a week-long oscillating wave in Dickson Fjord, according to a new report in The Seismic Record.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- People who are nervous about administering a rescue shot for anaphylaxis finally have a new alternative in a nasal spray.The U.S. Food and Drug Administration on Friday announced that it has approved neffy, the first.
Conversations in Drug Development Trends
AUGUST 9, 2024
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials. By allowing protocol adjustments based on interim data analysis, these designs preserve the integrity of studies while effectively addressing the unique challenges of multi-regional clinical trials (MRCTs).
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- There’s a good chance that if one child in a family has autism, another will also develop the disorder, a new study suggests.Children are seven times more likely to be diagnosed with autism if an older sibling has the d.
Perficient: Drug Development
AUGUST 9, 2024
Welcome to another insightful installment in our UX in Universal Design series! This time, we’ll be focusing on the importance of large touch targets within health systems. As healthcare increasingly relies on digital interfaces—whether through patient portals, check-in kiosks, or mobile health apps—it’s crucial to ensure that these technologies are accessible to all users, including those with physical disabilities or dexterity challenges.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- Patients discharged from a hospital stay are bringing antibiotic-resistant “superbugs” home with them, a new study warns.Family members of recently discharged patients are 71 times more likely to get a MRSA infection after th.
Agency IQ
AUGUST 9, 2024
By Laura DiAngelo, MPH Last month, the FDA published a new draft guidance document on diversity action plans. While the new version of the guidance is greatly expanded as compared to an earlier version from 2022, it has left plenty of important questions unanswered. In this piece, AgencyIQ answers some of the most common questions we’ve received about the guidance – and raise a few of our own.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- Folks can overcome their genetic risk for type 2 diabetes through healthy diet and regular exercise, a new study says.A healthy lifestyle reduced the risk of type 2 diabetes by 70% among a group of people with a high genetic.
Agency IQ
AUGUST 9, 2024
By Amanda Conti In its inaugural meeting, FDA’s Genetic Metabolic Diseases Advisory Committee heard Zevra’s second try for arimoclomol to treat ultra-rare lysosomal storage disorder Niemann-Pick Type C. The committee voted 11-5 in favor of the drug’s effectiveness, leaving FDA to test the limits of its regulatory flexibility toward post hoc analysis and lackluster confirmatory evidence.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- Women exposed to TikTok videos that make eating disorders look cool and glamorous tend to have worse body image, a new study finds.These videos include what researchers call "pro-anorexia" clips, as well as other videos.
Agency IQ
AUGUST 9, 2024
By Sebastian Godoy, MPH Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. Despite intense interest in their use, no psychedelic products are approved in the European Regulatory Medicines Network, with drug developers facing legal and regulatory obstacles, including a dearth of guidance.
Drug Target Review
AUGUST 9, 2024
What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). This involves combining the API with various excipients – non-active ingredients that enhance the drug’s stability, solubility, bioavailability and generally enhance the API’s ability to interact with the pharmacological target. 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with opt
Agency IQ
AUGUST 9, 2024
By Scott Stephens, MPA The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). Specifically, the EU executive’s proposal seeks to harmonize the POPs Regulation, carving out exclusions for mechanical separators in blood collection tubes, triacetyl cellulose film in polarizers, and photographic paper, among other exempted articles containing UV-328.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- People who are nervous about administering a rescue shot for anaphylaxis finally have a new alternative in a nasal spray. The U.S. Food and Drug Administration on Friday announced that it has approved neffy, the first.
Drug Patent Watch
AUGUST 9, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
Drugs.com
AUGUST 9, 2024
FRIDAY, Aug. 9, 2024 -- Radiation therapy following surgery can keep breast cancer from returning for up to 10 years, a new study claims.The study supports the current standard of care for early-stage breast cancer, which involves surgery followed.
Antidote
AUGUST 9, 2024
Obesity is a common condition, impacting nearly 3 in 4 adults over the age of 20 in the United States. Research into obesity medications has increased significantly in recent years, resulting in novel weight-management drugs that are continuing to drive interest and demand. However, although obesity disproportionately impacts people of color, many of these studies are still made up of predominantly white individuals, creating a gap in knowledge about the effectiveness of these medications.
Drug Channels
AUGUST 9, 2024
Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx. Chris reviews recent developments for the Inflation Reduction Act of 2022 (IRA). He then recommends four IRA-related adjustments that manufacturers should make to their patient support programs. To learn more, register for ConnectiveRx’s free webinar on September 17: IRA Reality Check: Adapting Hub and Copay Programs to Ensure Patient Access and Affordability.
Agency IQ
AUGUST 9, 2024
Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). Specifically, the EU executive’s proposal seeks to harmonize the POPs Regulation, carving out exclusions for mechanical separators in blood collection tubes, triacetyl cellulose film in polarizers, and photographic paper, among other exempted artic
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