Wed.Sep 13, 2023

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Moderna aims for the stars again with ambitious drug development plan

Bio Pharma Dive

The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.

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FDA to start review of subcutaneous Entyvio for Crohn’s disease

Pharmaceutical Technology

The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.

Drugs 264
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FDA panel backs Alnylam drug despite doubts over benefit

Bio Pharma Dive

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

Drugs 183
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Eli Lilly’s Mounjaro approved on NHS for use in type 2 diabetes

Pharmaceutical Technology

Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Akili cuts 40% of workforce, plans shift to non-prescription model

Bio Pharma Dive

The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

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Results from Rybrevant trial solidify Janssen’s foothold in EGFR-mutated NSCLC

Pharmaceutical Technology

Currently, NSCLC patients with EGFR exon 19 deletions or L858R substitution face limited therapeutic options after seeing disease progression post-front-line treatment.

Trials 130

More Trending

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Vaxess raises $9m to accelerate mRNA vaccine patch development

Pharmaceutical Technology

The patch allows for vaccine storage and transport at room temperature along with at-home administration.

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Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Rethinking Clinical Trials

   Speakers Matthew Prekker, MD, MPH Associate Professor of Emergency Medicine and Pulmonary and Critical Care Medicine Hennepin County Medical Center University of Minnesota Medical School Jonathan Casey, MD, MSc Assistant Professor of Pulmonary and Critical Care Vanderbilt University Medical Center Director, Coordinating Center, Pragmatic Critical Care Research Group Slides Keywords Critical Care Medicine, Pragmatic Trial, DEVICE, Laryngoscope Key Points Emergency tracheal intubation is a c

Trials 147
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Avalo drops three rare disease assets amid ongoing challenges

Pharmaceutical Technology

The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.

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September 13, 2023: PCT Grand Rounds to Feature Real-World Trial of Food Choice Incentives for Lower-Income Adults

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Pasquale Rummo of the NYU Grossman School of Medicine will present “Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings.” The Grand Rounds session will be held on Friday, September 15, 2023, at 1:00 pm eastern. Rummo is an associate professor of population health in the NYU Grossman School of Medicine.

Trials 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Bristol Myers Squibb’s Reblozyl reinforces market share in first-line MDS Space

Pharmaceutical Technology

On August 28, the FDA approved the label expansion of Bristol Myers Squibb’s Reblozyl, which is set to improve MDS patients’ quality of life.

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Oregon Project Extends Benefits of Clinical Trials to More Hispanics/Latinos

ACRP blog

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00

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FDA calls out eight companies for selling unapproved eye drugs

Pharmaceutical Technology

The US Food and Drug Administration has sent letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.

Drugs 130
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It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

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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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Dewpoint and Chemify partner for cancer drug discovery

Pharmaceutical Technology

Dewpoint Therapeutics entered a collaboration with Chemify to expedite the discovery of molecules that target cancer and neurodegeneration.

Drugs 130
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Moderna CEO expects endemic COVID vaccine market will take ‘a few years’ to fully develop

Fierce Pharma

Moderna has spent the last several years riding the ups and downs of the COVID-19 pandemic. | Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response.

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Do diet drugs pull their weight?

Pharmaceutical Technology

Diet and weight-loss drugs have entered the public consciousness, particularly for their usefulness in treating obesity-related diabetes.

Drugs 130
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Moderna looks to scale back manufacturing for COVID booster to cope with falling demand: Reuters

Fierce Pharma

While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Axolotl Biologix and Carmell Therapeutics enter merger deal

Pharmaceutical Technology

Moonshot incubator client Axolotl Biologix has finalised a merger with Carmell Therapeutics to bolster the regenerative medicine sector.

Medicine 130
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Insights into New Alzheimer’s Treatments: Treating Agitation and First THC-Based Therapeutic in Trials — Interview with IGC’s Ram Mukunda and Claudia Grimaldi – Xtalks Life Science Podcast Ep. 127

XTalks

This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma , a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s.

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Signal: Roche to refile subcutaneous Tecentriq with FDA after UK approval

Pharmaceutical Technology

Roche planned to launch its new subcutaneous Tecentriq formulation this year, but it will be pushed back after tweaks requested by FDA.

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Escape to Italy with Virtual Vibes

Intouch Solutions

As summer comes to a close, we’re recapping a few of the employee virtual events hosted through our Virtual Vibes program. Virtual Vibes is a program for ‘INTOUCHers’ developed by ‘INTOUCHers’ with the goal of bringing employees together, both in-person and virtually, to build relationships, culture, and community beyond the day-to-day. In our “Escape to Italy” Virtual Vibes series, Agency Culture Influencer, Michael Tatasciore, planned a variety of Italian summer-inspired events for employees t

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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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Menarini signs agreement for Astellas’s rheumatoid arthritis therapy

Pharmaceutical Technology

Menarini Asia-Pacific has entered a long-term exclusive agreement to license Astellas Pharma’s Smyraf to treat rheumatoid arthritis.

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Ferring begins bladder cancer gene therapy rollout through focused program

Fierce Pharma

After securing approval at the end of last year for a potential alternative to bladder removal in certain bladder cancer patients, Ferring Pharmaceuticals has given the gene therapy Adstiladrin to | While it scales up manufacturing, the company is rolling out its Adstiladrin through an early, focused program at certain clinics. The program will also be used for a real world evidence study.

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Hasten and LIB Therapeutics enter $325m CVD drug development deal

Pharmaceutical Technology

Hasten Biopharmaceutical has signed an agreement to develop and commercialise LIB Therapeutics’ lerodalcibep in Greater China.

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Despite FDA doubts, Alnylam wins expert backing for Onpattro expansion into rare heart disease

Fierce Pharma

After Alnylam faced FDA doubts about its bid to expand RNA-silencing drug Onpattro into a rare heart disease called transthyretin amyloidosis cardiomyopathy (ATTR-CM), the company has picked up key | An FDA advisory committed voted in favor of Alnylam's bid to expand its RNA-silencing drug Onpattro into the rare heart disease called ATTR-CM. But comments at Wednesday’s panel suggest the drug could carry a disadvantage in its upcoming clash with Pfizer.

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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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Eisai launches new digital business company for dementia

Pharma Times

Theoria technologies aims to empower those affected by dementia - News - PharmaTimes

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5 reasons why it's so hard to find clinical trial volunteers

Antidote

Globally, there are thousands of research studies and clinical trials conducted each year, all with the shared goal of bringing new treatment options and medical devices to the market. However, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.

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Moderna Axes Four Clinical Development Programs, Two AstraZeneca Had Dropped

BioSpace

During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.

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White Bagging Update 2023: Saving Money or Shifting Costs?

Drug Channels

Time for our annual update on the channels for provider-administered drugs. For 2023, specialty pharmacies—via white, brown, and clear bagging—retained a meaningful share of the distribution channels for provider-administered oncology drugs. Despite the concerted efforts of insurers such as UnitedHealthcare and Elevance Health, however, buy-and-bill remains the most common channel for these products.

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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.