Fri.Feb 03, 2023

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Magenta to explore sale, merger after study setback

Bio Pharma Dive

The biotech recently stopped a trial of its experimental conditioning regimen over safety concerns. Now it’s halting further development work as it undertakes a strategic review.

Sales 317
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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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COVID-19 vaccine maker Medicago to close down

Bio Pharma Dive

The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment.

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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.

Sales 246
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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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Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs

Bio Pharma Dive

Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics.

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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

The field of genomic medicine has reached a true turning point. With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting.

Genome 244

More Trending

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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Being jointly developed by AstraZeneca and Amgen, Tezspire is a first-in-class human monoclonal antibody and inhibits TSLP, an important epithelial cytokine that plays a vital role in multiple inflammatory cascades.

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The possible effects of cinnamon on memory and learning

Medical Xpress

Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.

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Price point is a key factor for wider market adoption of Amgen’s Amjevita in the US

Pharmaceutical Technology

Biologic therapies are a mainstay in the management of various immunology indications, including rheumatoid arthritis (RA), psoriasis (PsO), axial spondyloarthritis (axSpA), atopic dermatitis (AD), Crohn’s disease (CD), and ulcerative colitis (UC), and serve as the key growth drivers in terms of commercial value in these indications. AbbVie’s Humira (adalimumab) has been a blockbuster drug on this front across several of the aforementioned diseases.

Marketing 130
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This winter's U.S. COVID surge is fading fast, likely thanks to a 'wall' of immunity

NPR Health - Shots

The main reason the surge is ebbing now, pandemic experts suspect, is the significant immunity many people in the U.S. have acquired from prior infections and COVID vaccinations many received.

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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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Karuna signs licence deal with Goldfinch Bio for TRPC4/5 candidates

Pharmaceutical Technology

Karuna Therapeutics has entered an exclusive licence agreement with Goldfinch Bio for investigational transient receptor potential canonical 4 and 5 (TRPC4/5) channel candidates. Karuna signed the deal with GFB, the assignee of the Goldfinch Bio assignment estate. Under the deal, Karuna will have an exclusive worldwide licence for the development, manufacturing, and commercialisation of multiple Goldfinch Bio’s TRPC4/5 candidates, including GFB-887, the lead clinical-stage candidate.

Licensing 130
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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry. There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another.

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Manufacturer recalls eye drops after possible link to bacterial infections

NPR Health - Shots

EzriCare artificial tears are suspected to be the cause of an outbreak of the VIM-GES-CRPA strain of Pseudomonas aeruginosa, which the CDC said is the first outbreak of its kind in the U.S.

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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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The FTC is finally ready take on health data leaks. The problem is bigger than GoodRx

STAT News

The Federal Trade Commission took aim at prescription drug coupon site GoodRx this week in an early attempt to crack down on the unfettered sharing of consumers’ health data for advertising. It was the first time the agency had gone after such a health data violation. But with the vast amounts of patient information now being mined and shared online, it’ll be far from the last.

Drugs 119
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New treatment approach for prostate cancer could stop resistance in its tracks

Medical Xpress

For the first time, researchers have discovered that prostate cancer can be killed by targeting a single enzyme, called PI5P4Kα. The findings, published recently in Science Advances, could help address the growing threat of treatment resistance in prostate cancer and could also lead to improved treatments for other cancers, such as those affecting the breast, skin, and pancreas.

Research 105
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STAT+: Turkish court hands Novartis and Roche a rare win over their efforts to promote an eye treatment

STAT News

A Turkish court overturned a decision by the national antitrust regulator that two years ago fined Roche and Novartis more than $30 million for conspiring to spread misinformation about an eye treatment, a rare victory for the companies after legal setbacks elsewhere. In response to appeals filed by both drugmakers, an administrative court in Ankara, Turkey, determined that the Turkish Competition Board failed to demonstrate that Novartis and Roche colluded illegally to promote the eye medicatio

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Elevated plasma methylmalonic acid is related to increased cardiovascular events: Study

Medical Xpress

A recent study from UiB shows that elevated plasma methylmalonic acid predicts increased risk of acute myocardial infarction and mortality in patients with suspected or verified coronary heart disease.

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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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Opinion: Public health layoffs and tech layoffs: a world of difference

STAT News

Layoffs in the tech sector — think Google, Amazon, Meta, and the like — from jobs once thought to be secure and prestigious are making headlines. I’ve been seeing an outpouring of media coverage, including support extended toward newly unemployed tech workers, judgements passed on tech leaders, practical suggestions of opportunities , and analyses of underlying causes and next steps.

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Drop race adjustment for AFP prenatal testing, study urges

Medical Xpress

A race-based adjustment to test-result values from a common prenatal screening should be discontinued, according to a study published this week in Obstetrics and Gynecology. The adjustment has historically been applied only with Black women.

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STAT+: Leading ALS advocacy group roiled by infighting over money and priorities

STAT News

A blistering battle has broken out between the ALS Association and more than a dozen of its state and local chapters, which are resisting a move by the national headquarters to dismantle their offices and run operations around the U.S. Fifteen chapters claim the national office is attempting the takeover in order to grab a larger share of revenue these local offices send to association headquarters, according to a lawsuit filed in a Delaware state court.

Research 105
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Australia to legalise MDMA and magic mushrooms for medical use

Medical Xpress

Australia's drugs watchdog on Friday announced that psychedelic substances MDMA and psilocybin—more commonly known as ecstasy and magic mushrooms—will soon be used in the treatment of depression and post-traumatic stress.

Drugs 98
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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.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

Research 105
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Study finds link between blood components and brain disorders

Medical Xpress

A Mater Research study has identified a previously unknown genetic link between platelets and Parkinson's Disease, with findings published in Cell Genomics.

Genome 105
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Opinion: The FDA is the right agency to regulate CBD products, but it needs help

STAT News

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Certification by the Food and Drug Administration that these products are safe and useful against many common ailments could unleash a $60 billion annual market by 2030.

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US neighborhood walkability influences physical activity, BMI levels

Medical Xpress

For the first time, a study examined perceived neighborhood walkability, physical activity, and obesity indicators on a national level, finding that people who lived in walkable neighborhoods were more likely to be physically active and have lower BMIs—but this association differed among Black, Hispanic, and Asian populations.

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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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STAT+: They were the 10% left out of life-changing treatments. Now these cystic fibrosis patients may finally get help

STAT News

Vertex Pharmaceuticals revolutionized the treatment of cystic fibrosis. It also has unfinished business. The Boston drugmaker’s medicines for the genetic disease — which damages the lungs and other organs — have transformed the lives of patients, helping them abandon other time-consuming treatments, shrug off what would have been dangerous respiratory infections, and just live breathing easier.

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A new tumor-suppressive gene that boosts personalized treatment response in breast cancer

Medical Xpress

A research team from LKS Faculty of Medicine, the University of Hong Kong (HKUMed) discovered that somatic deletion of a tumor suppressor gene AKTIP promotes luminal breast cancer development and resistance to endocrine therapy. The findings are now published in Cell Reports.

Gene 98
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STAT+: Pharmalittle: ALS Association and its chapters battle over money and priorities; eye drops recalled over links to drug-resistant infections

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to catch up on our reading, stroll about with our official mascot, and, given the frigid weather in our neighborhood, stay indoors to hold another listening party with Mrs.

Drugs 98
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Research demonstrates positive impact of online brain training

Medical Xpress

The Strategic Memory Advanced Reasoning Tactics (SMART) brain health training protocol has been shown to improve symptoms of depression, anxiety and stress when delivered in person. New research from Center for BrainHealth at The University of Texas at Dallas demonstrates the effectiveness of online delivery of SMART.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.