MangoRx hits back at Eli Lilly’s weight loss drug copycat claims
Pharmaceutical Technology
OCTOBER 22, 2024
Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.
Sat.Oct 19, 2024 - Fri.Oct 25, 2024
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RNA editing: emerging from CRISPR’s shadow
Bio Pharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
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Roche trial confirms Vabysmo efficacy in minorities
pharmaphorum
OCTOBER 21, 2024
A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.
October 21, 2024: BEST-ICU and Chat 4 Heart Health Have Updated Study Snapshots, Ethics and Regulatory Documentation
Rethinking Clinical Trials
OCTOBER 21, 2024
Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.
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
Sanofi in 'exclusive negotiations' to sell 50% stake in €16B consumer health unit Opella
Fierce Pharma
OCTOBER 21, 2024
Sanofi is now in “exclusive negotiations” with U.S. | Sanofi is now in “exclusive negotiations" with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business Opella, the company said. The deal values the consumer group at 16 billion euros.
Intellia data spark debate about CRISPR drug’s potential
Bio Pharma Dive
OCTOBER 24, 2024
Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.
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October 22, 2024: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference
Rethinking Clinical Trials
OCTOBER 22, 2024
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant t
Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment
Fierce Pharma
OCTOBER 22, 2024
Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job. | Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.
Editas, changing course again, looks to partner lead CRISPR therapy
Bio Pharma Dive
OCTOBER 22, 2024
The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.
EU CHMP recommends AstraZeneca and Ionis’ Wainzua for ATTRv-PN
Pharmaceutical Technology
OCTOBER 22, 2024
The European Union's CHMP has recommended the approval of AstraZeneca and Ionis Pharmaceuticals’ Wainzua to treat ATTRv-PN.
October 24, 2024: APA-SM Trial Joins the NIH Pragmatic Trials Collaboratory
Rethinking Clinical Trials
OCTOBER 24, 2024
The NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary and Integrative Health.
In boon for Pfizer and Merck, CDC panel backs expanded use of pneumococcal vaccines
Fierce Pharma
OCTOBER 23, 2024
With an expanded recommendation from the Center for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines (PCV) from Pfizer and | The CDC's immunization committee voted to expand the recommendation for pneumococcal conjugate vaccines, including both Pfizer’s Prevnar 20 and Merck’s newer Capvaxive.
Pharmaceutical research on mRNA and CAR T-cell therapy in cancer: Pioneering the future of oncology
Bio Pharma Dive
OCTOBER 21, 2024
Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?
A slow start for self-amplifying mRNA vaccines
Pharmaceutical Technology
OCTOBER 23, 2024
A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
October 23, 2024: Impacts of Hybrid Remote Work on Retention and Performance, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
OCTOBER 23, 2024
In this Friday’s PCT Grand Rounds, Nicholas Bloom of Stanford University will present “Hybrid Working From Home Improves Retention Without Damaging Performance.” The Grand Rounds session will be held on Friday, October 25, 2024, at 1:00 pm eastern. Bloom is the William D. Eberle Professor of Economics at Stanford University, a senior fellow of the Stanford Institute for Economic Policy Research (SIEPR), and the codirector of the Productivity, Innovation and Entrepreneurship pro
Otsuka eyes early filing of IgAN drug after phase 3 readout
pharmaphorum
OCTOBER 22, 2024
Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen
PureTech thinks the ‘hub-and-spoke’ startup model is still a good bet. If only investors agreed.
Bio Pharma Dive
OCTOBER 21, 2024
Shares in the Boston-based biotech creator, which had a standout success in forming Karuna Therapeutics, trade around cash levels — a "huge value disconnect" its leaders are trying to bridge.
AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients
Pharmaceutical Technology
OCTOBER 21, 2024
This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).
How Machine Learning Drives Clinical Trial Efficiency
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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.
October 23, 2024: Impacts of Hybrid Remote Work on Retention and Performance, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
OCTOBER 23, 2024
In this Friday’s PCT Grand Rounds, Nicholas Bloom of Stanford University will present “Hybrid Working From Home Improves Retention Without Damaging Performance.” The Grand Rounds session will be held on Friday, October 25, 2024, at 1:00 pm eastern. Bloom is the William D. Eberle Professor of Economics at Stanford University, a senior fellow of the Stanford Institute for Economic Policy Research (SIEPR), and the codirector of the Productivity, Innovation and Entrepreneurship pro
Novo joins Lilly in asking FDA for ban on GLP-1 compounding
pharmaphorum
OCTOBER 23, 2024
Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.
Starboard makes case for change at Pfizer, citing research, M&A missteps
Bio Pharma Dive
OCTOBER 22, 2024
The activist investor claims Pfizer failed to capitalize on the windfall earned from its COVID-19 vaccine and, in the process, destroyed tens of billions of dollars in market value.
Editas and Genevant team up to develop gene editing therapies
Pharmaceutical Technology
OCTOBER 22, 2024
Editas is partnering its CRISPR platform with Genevant’s LNP technology to develop novel gene editing medicines in a deal worth $283m.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Grand Rounds October 18, 2024: Rigorous Testing of Behavior Change Interventions: Lessons from the BE ACTIVE Randomized Clinical Trial (Alexander Fanaroff, MD, MHS)
Rethinking Clinical Trials
OCTOBER 23, 2024
Speaker Alexander Fanaroff, MD, MHS Assistant Professor of Medicine Perelman School of Medicine University of Pennsylvania Slides Keywords Gamification; Financial Incentives; Physical Activity; Behavioral Economics Key Points Observational studies have found an inverse association between steps per day and risk for all-cause mortality and cardiovascular events.
DOJ challenges Johnson & Johnson's talc bankruptcy attempt in Texas
Fierce Pharma
OCTOBER 22, 2024
With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had
Lyell, in search of a turnaround, to buy cell therapy startup ImmPact
Bio Pharma Dive
OCTOBER 24, 2024
The deal will give Lyell a dual-targeting CAR-T candidate for blood cancers. Relatedly, Lyell has opted to end development of two current pipeline programs.
Pharmacists “desperation” by Novo Nordisk over semaglutide copycat block
Pharmaceutical Technology
OCTOBER 24, 2024
Novo Nordisk has asked the FDA to add semaglutide to a list that would effectively block manufacturing of copycat versions of Wegovy and Ozempic.
GSK plans $800m US manufacturing investment
pharmaphorum
OCTOBER 25, 2024
GSK has made another investment in its manufacturing network, setting aside $800 million to build two plants at its Marietta site in the US.The programme represents the largest capital spend by the UK drugmaker on production capacity to date and will double the size and capacity of GSK's existing medicines and vaccines facility in Marietta, Pennsylvania, creating around 200 new jobs.
Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients
Fierce Pharma
OCTOBER 21, 2024
As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too. | As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too.
GPCR drugmaker Septerna amasses $288M in IPO
Bio Pharma Dive
OCTOBER 24, 2024
Septerna is the 23rd biotech to go public this year, raising funds to advance its lead candidate, a treatment for hypoparathyroidism now in Phase 1 testing.
GSK pumps up to $800m for US manufacturing site upgrade
Pharmaceutical Technology
OCTOBER 25, 2024
A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.
The New Age of Decentralized Clinical Trials
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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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