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.
Wed.Oct 23, 2024
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Merck acquires cancer drug startup; Elevidys ex-US sales rise
Bio Pharma Dive
OCTOBER 23, 2024
Yale spinout Modifi agreed to sell to Merck for $30 million upfront. Elsewhere, Sangamo plotted a much faster path to market for its Fabry gene therapy.
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J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe
Pharmaceutical Technology
OCTOBER 23, 2024
Darzalex will now be available to patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant.
Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
Bio Pharma Dive
OCTOBER 23, 2024
Approval of Pfizer's Abrysvo in certain adults aged 18 to 59 years old will expand the number of people eligible for vaccination with the shot.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva 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
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
Alto hits new low as depression drug flunks key test
Bio Pharma Dive
OCTOBER 23, 2024
While analysts still see value in Alto’s approach to brain drugmaking, investors may have lost some faith, as the biotech’s shares were down by two-thirds Wednesday morning.
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Amgen plans launch of Eylea biosimilar after court ruling
Bio Pharma Dive
OCTOBER 23, 2024
With “nerves of steel,” Amgen is getting ready to sell a copycat of Regeneron’s top-selling eye drug Eylea, even as litigation continues.
FDA approves Alvotech and Teva’s SELARSDI for new indications
Pharmaceutical Technology
OCTOBER 23, 2024
The FDA has approved a new presentation of Alvotech and Teva’s SELARSDI, for the treatment of ulcerative colitis and Crohn's disease.
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.
Health Canada approves Servier’s VORANIGO for IDH-mutant glioma
Pharmaceutical Technology
OCTOBER 23, 2024
Servier Canada has announced Health Canada's approval of VORANIGO for Grade 2 IDH-mutant glioma in adults and paediatric patients.
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.
Ocuphire and Opus Genetics merge to develop IRD gene therapy
Pharmaceutical Technology
OCTOBER 23, 2024
Ocuphire Pharma has announced the acquisition of Opus Genetics to develop gene therapies for inherited retinal diseases (IRDs).
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.
AAO 2024: NMA reveals Vabysmo’s superior CST improvement over Eylea HD
Pharmaceutical Technology
OCTOBER 23, 2024
This NMA serves to bridge the gap between trials for both therapies and compare them to one another based on existing data.
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
Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide
Fierce Pharma
OCTOBER 23, 2024
The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.
FDA expands Pfizer’s RSV vaccine label to include all high-risk adults
Pharmaceutical Technology
OCTOBER 23, 2024
Abrysvo is now approved to prevent lower respiratory tract disease caused by RSV in high-risk adults over 18 years of age.
Lawmakers seek answers on Pfizer, Lilly telehealth moves
pharmaphorum
OCTOBER 23, 2024
US lawmakers fear Pfizer and Lilly's recent forays into direct-to-consumer distribution of medicines via telehealth could violate anti-kickback laws.
Roche's Vabysmo will rise above Eylea biosim threat, exec says, as DMD gene therapy Elevidys delivers sales surprise
Fierce Pharma
OCTOBER 23, 2024
By squeezing Regeneron’s Eylea, eye disease drug Vabysmo has become one of the biggest growth drivers for Roche. | Despite the potential imminent launch of a biosimilar to Regeneron's Eylea, Roche expects the market potential will remain stable for Vabysmo. Meanwhile, Sarepta-partnered Elevidys delivered a big surprise in the third quarter.
Pfizer gets a leg up in RSV as FDA clears jab for all adults
pharmaphorum
OCTOBER 23, 2024
A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference in the battle for market share.The US regulator has cleared Abrysvo for use in adults aged 18 to 59 at risk of RSV-related disease, extending its earlier label which covered the 60 and over age bracket.
New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data
XTalks
OCTOBER 23, 2024
Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. The pill, called Sirona, is actually a device that presents a new, non-pharmacological approach to managing weight. Sirona is designed as a non-invasive solution for individuals struggling with obesity, offering a safer alternative to traditional weight-loss medications and surgeries.
Roche CEO says Novo's Catalent buyout 'could be a problem' for smaller drugmakers
Fierce Pharma
OCTOBER 23, 2024
While Novo Holdings and Catalent continue to voice confidence that their planned $16.5 billion merger will go through before the year is out, the deal has received near-constant criticism over the | While Novo Holdings and Catalent continue to voice confidence that their planned $16.5 billion merger will go through before the year is out, the deal has received near-constant criticism over the past several weeks.
Using Google Patents to Find Drug Patents? Here’s 15 Reasons Why You Shouldn’t
Drug Patent Watch
OCTOBER 23, 2024
When it comes to patent searches, especially in the pharmaceutical industry, accuracy and comprehensiveness are crucial. While Google Patents is a popular tool due to its accessibility and user-friendly interface, it may not be the best resource for finding drug patents. Let’s explore why.
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.
Creating True Value with GenAI
pharmaphorum
OCTOBER 23, 2024
Unlock the true value of GenAI technology with Axtria's innovative solutions. Learn how to leverage GenAI for your business success.
Mira’s New Menopause Transitions Kit Allows for At-Home Hormone Monitoring
XTalks
OCTOBER 23, 2024
Mira, a California-based women’s health technology company, has introduced its Menopause Transitions Kit, a new hormone monitoring kit designed for menopausal women. The at-home device enables women to track key hormone levels, offering real-time insights into the complex hormonal fluctuations associated with perimenopause and menopause. The product is an AI-powered hormone monitoring device designed for women aged 35 to 60.
Amgen pledges to launch Eylea biosim after legal win—but Regeneron stresses the fight's not over yet
Fierce Pharma
OCTOBER 23, 2024
While Regeneron may have lost its latest bid to block the launch of Amgen’s Eylea biosimilar Pavblu, the New York-based pharma isn’t throwing in the towel just yet. | Amgen is preparing to launch its Eylea biosimilar, Pavblu, after another victory over Regeneron in court. That said, Regeneron is appealing the decision and stressed that it continues to believe Amgen's copycat infringes multiple Eylea patents.
UK 'should abolish clock changes on health grounds'
pharmaphorum
OCTOBER 23, 2024
On Sunday, the clocks in the UK will be set back by an hour as British Summer Time ends, and some believe the practice of twice-yearly changes could impact our health.Many will celebrate having an extra hour in bed – perhaps forgetting how they lost an hour at the end of March when the clocks went forward – but the British Sleep Society (BSS) is advocating for the changes to be abolished altogether and for the UK to return to Standard or Greenwich Mean Time (GMT).
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
With expanded FDA nod for RSV shot Abrysvo, Pfizer gains edge on GSK's Arexvy. But will it amount to much?
Fierce Pharma
OCTOBER 23, 2024
With expanded FDA nod for RSV shot Abrysvo, Pfizer gains edge on GSK's Arexvy. But will it amount to much?
Darzalex subcutaneous regimen approved by European Commission
Pharma Times
OCTOBER 23, 2024
New treatment option for patients with newly diagnosed multiple myeloma
Red light, green light: England's NICE not sold on Lilly's Kisunla despite UK approval
Fierce Pharma
OCTOBER 23, 2024
Eli Lilly’s Alzheimer’s disease offering Kinsunla is poised to face a tough road ahead in the U.K. | Lilly's Alzheimer treatment fell to the same fate as Biogen and Eisai's rival Leqembi in the U.K., with the region's cost watchdog declining to support reimbursement through its National Health Service.
NICE rejects Donanemab for NHS use despite MHRA approval
Outsourcing Pharma
OCTOBER 23, 2024
Donanemab marks a significant advancement in Alzheimer’s treatment, but NHS patients face a setback with NICE's rejection of its cost-effectiveness.
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.
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