Mon.Jul 08, 2024

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New DDW Highlights episode: 8 July 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The last few days have seen some interesting developments related to gene editing, including the discovery of a new mechanism for genetic programming and evidence in favour of redosing CRISPR-based therapies, as well as significant investment and new indications for gene therapies.

Therapies 147
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Brain-imaging study reveals curiosity as it emerges

Science Daily: Pharmacology News

You look up into the clear blue sky and see something you can't quite identify. Is it a balloon? A plane? A UFO? You're curious, right? A research team has for the first time witnessed what is happening in the human brain when feelings of curiosity like this arise. The scientists revealed brain areas that appear to assess the degree of uncertainty in visually ambiguous situations, giving rise to subjective feelings of curiosity.

Research 122
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How automation is fuelling self-driving labs

Drug Discovery World

James Love , Vice President of Automation and Process Optimisation at Novo Nordisk, discusses how automation can help drive efficiencies in labs and how the company has worked alongside Standardization in Lab Automation (SiLA) to improve processes. As a large pharmaceutical company, responsible for around 60,000 employees worldwide and well-known for supplying almost 50% of the world’s insulin, there are a lot of activities going on in our business.

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Mounjaro Bests Ozempic for Weight Loss

Drugs.com

MONDAY, July 8, 2024 -- Mounjaro outperforms Ozempic in helping people lose weight, a new study shows.People taking tirzepatide (Mounjaro, Zepbound) dropped significantly more pounds than those taking semaglutide (Ozempic, Wegovy), researchers.

Research 116
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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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FDA grants Fast Track designation to prostate cancer treatment

Drug Discovery World

Biopharmaceutical company Syncromune has had its lead-candidate for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) granted Fast Track designation by the FDA. Syncromune’s SYNC-T SV-102 therapy is a personalised treatment that comprises of an in situ vaccine via partial oncolysis of a tumour followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumour.

FDA 147
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Scientists Find Way to Reverse Chemo Resistance in Pancreatic Cancer Patients

Drugs.com

MONDAY, July 8, 2024 -- Pancreatic cancer is particularly aggressive and difficult to treat, partly because it’s often resistant to chemotherapy.Researchers now think they know why chemo struggles to work against pancreatic cancer – and how to rev.

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Lilly to buy Morphic in $3B bet on inflammation drug

BioPharma Drive: Drug Pricing

The deal would hand Lilly an experimental pill that could one day rival Takeda's blockbuster medicine Entyvio as a treatment for inflammatory bowel disease.

Treatment 117
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DDW Highlights: 8 July 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The last few days have seen some interesting developments related to gene editing, including the discovery of a new mechanism for genetic programming and evidence in favour of redosing CRISPR-based therapies, as well as significant investment and new indications for gene therapies.

Therapies 130
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Could a Cancer Drug Curb the Organ Damage of Severe COVID?

Drugs.com

MONDAY, July 8, 2024 -- An experimental cancer drug might be able to help prevent the organ damage caused by severe COVID infections, a new study finds.The drug, called eganelisib, inhibits an immune system enzyme called PI3K gamma that boosts.

Drugs 109
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Novartis, Pfizer, Otsuka and Novo breach the ABPI Code

Drug Discovery World

The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Novartis, Pfizer, Otsuka and Novo Nordisk have breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. The companies were judged to have “brought discredit upon”, and “reduced confidence in”, the pharmaceutical industry. Novartis was found guilty of failing to update and recertify two documents hosted on a Novartis website to include up-to-date Entresto (sacubitril/valsartan) prescribing

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Weaker ocean circulation could enhance carbon dioxide buildup in the atmosphere, study finds

Science Daily: Pharmacology News

Scientists may have to rethink the relationship between the ocean's circulation and its long-term capacity to store carbon, new research suggests. As the ocean gets weaker, it could release more carbon from the deep ocean into the atmosphere -- rather than less, as some have predicted.

Research 108
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A London biotech raises $114M to hone a new ADC payload

BioPharma Drive: Drug Pricing

Myricx Bio is developing a type of payload that it thinks could work in tumors resistant to the toxins contained in ADCs like Enhertu and Trodelvy.

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New extremely fast carbon storage technology

Science Daily: Pharmacology News

A new way to store carbon captured from the atmosphere works much faster than current methods without the harmful chemical accelerants they require.

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Wegovy, Ozempic Lower Risk of Many Obesity-Related Cancers

Drugs.com

MONDAY, July 8, 2024 -- In yet another finding that touts the health benefits of wildly popular weight-loss medications like Wegovy and Ozempic, scientists report that taking the drugs may help reduce the risk of some cancers.In a study published.

Drugs 98
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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HilleVax’s norovirus vaccine ineffective in large trial of infants

BioPharma Drive: Drug Pricing

Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

Vaccine 107
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Study Finds Arsenic, Lead in Tampon Products

Drugs.com

MONDAY, July 8, 2024 -- Researchers report they have discovered lead and arsenic in a wide variety of tampon products sold in the United States and Europe. Testing revealed lead in all 30 tampons from 14 brands obtained from major online retailers.

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Brain size riddle solved as humans exceed evolution trend

Science Daily: Pharmacology News

The largest animals do not have proportionally bigger brains -- with humans bucking this trend -- a new study has revealed.

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Postpartum Urinary Incontinence Takes Physical, Mental Toll

Drugs.com

MONDAY, July 8, 2024 -- Urinary incontinence is a common aftereffect of delivering a baby, but it can have a devastating effect on new moms, a new study warns.These bladder leaks are significantly associated with anxiety and depression in new.

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Stench of a gas giant? Nearby exoplanet reeks of rotten eggs, and that's a good thing

Science Daily: Pharmacology News

An exoplanet infamous for its deadly weather has been hiding another bizarre feature -- it reeks of rotten eggs, according to a new study of data from the James Webb Space Telescope.

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"Love Hormone" May Help Treat Obesity, Postpartum Depression

Drugs.com

MONDAY, July 8, 2024 — Researchers have identified a gene that can trigger obesity, behavior problems and postpartum depression when missing or damaged.The finding could lead to new treatments for postpartum depression and overeating: The study in m.

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Revolutionizing Treatment Through the Skin with Transdermal Drug Delivery Systems

DrugBank

Revolutionizing Treatment Through the Skin with Transdermal Drug Delivery Systems The human skin, often perceived as a passive barrier to the external environment, holds potential as a route for drug administration. Transdermal drug delivery (TDD) systems offer a novel approach to drug delivery, by increasing therapeutic efficacy and increasing adherence to chronic disease management.

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Air Pollution Exposure Tied to 40% Drop in Live Births Among IVF Patients

Drugs.com

MONDAY, July 8, 2024 -- Exposure to air pollution can significantly reduce the odds of in vitro fertilization (IVF) leading to a live birth, a new study says.The odds of a live birth are nearly 40% lower in women heavily exposed to particle.

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Ligand to buy Apeiron; Roche reports another TIGIT setback

BioPharma Drive: Drug Pricing

Acquiring Apeiron will hand Ligand rights to royalties on sales of the neuroblastoma drug Qarziba. Elsewhere, Aerovate said it’s considering strategic alternatives and CSL reported a notable milestone.

Drugs 60
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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

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 59
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Supreme Court Rules that SEC and Potentially Other Agencies Cannot Impose Civil Penalties in Administrative Proceedings

FDA Law Blog: Biosimilars

By Riëtte van Laack & JP Ellison — On Thursday, the 27 th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.

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What We Expect the FDA to do in July and August 2024

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. Fill out the form to read the full article.

FDA 59
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New patent for Gilead Sciences drug VEKLURY

Drug Patent Watch

Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier.

Science 59
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Supreme Court significantly expands time to file lawsuits over agency regulations

Agency IQ

BY WALKER LIVINGSTON, ESQ The Supreme Court has issued its opinion in Corner Post v. Board of Governors, holding that the law allows litigants to challenge agency regulations within six years of being harmed by those regulations, rather than six years from the time the agency finalized the regulations. This change, accompanied by other major Supreme Court cases this term, sets up the potential for a tidal wave of litigation against agencies in the coming years.

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New patent for Nalpropion drug CONTRAVE

Drug Patent Watch

Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It is available from one supplier.

Drugs 59
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In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

BY RACHEL COE, MSC Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Nearly fifty years later, a final rule has made concessions industry has long been calling for, but retains reporting and safety provisions the agency deems important. Medical gases such as oxygen and medical air are widely used in a variety of healthcare and home/community settings.

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Soy Foods May Be Good for Kids' Brains

Drugs.com

MONDAY, July 8, 2024 -- A diet rich in soy may help kids in the classroom, new research suggests.It found that 7- to 13-year-olds whose diets included more isoflavones were more attentive and had better thinking abilities. Soybeans and soy products.

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What we expect European regulators to do in July 2024

Agency IQ

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. and national regulators.

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American Indian/Alaska Native Breast Cancer Patients Less Likely to Get Reconstruction

Drugs.com

MONDAY, July 8, 2024 — After a mastectomy, some women are less likely than others to have breast reconstruction surgery.Rates of the surgery are consistently lower among American Indian and Alaskan native women than among non-Hispanic white women, a.

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EPA publishes interagency framework on antifungal and antibiotic resistance from pesticides

Agency IQ

BY WALKER LIVINGSTON, ESQ The EPA has published a draft framework for an interagency collaboration on better understanding the impact of pesticides on the efficacy of human and animal drugs, with a specific focus on the effectiveness of antibacterial and antifungal drugs. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is responsible for the regulation of pesticides in the United States.