Bio Pharma Dive
OCTOBER 29, 2024
Crescent Biopharma is advancing a drug its CEO claims is “purpose-built” to be a perfected version of Summit Therapeutics’ ivonescimab, which recently beat Merck’s Keytruda in a Phase 3 trial.
Worldwide Clinical Trials
OCTOBER 29, 2024
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.
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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.
Pharmaceutical Technology
OCTOBER 25, 2024
At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.
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
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
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 22, 2024
The European Union's CHMP has recommended the approval of AstraZeneca and Ionis Pharmaceuticals’ Wainzua to treat ATTRv-PN.
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.
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.
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.
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.
Pharmaceutical Technology
OCTOBER 23, 2024
A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.
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.
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
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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
Fierce Pharma
OCTOBER 22, 2024
Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.
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.
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
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
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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.
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
Bio Pharma Dive
OCTOBER 29, 2024
Daniel Quirk, an immunology and neuroscience executive at Bristol Myers Squibb, will be Biogen’s next chief medical officer, while Robin Kramer will replace retiring CFO Michael McDonnell.
Pharmaceutical Technology
OCTOBER 23, 2024
Darzalex will now be available to patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant.
XTalks
OCTOBER 25, 2024
Shields Health Solutions, a specialty pharmacy owned by Walgreens, has partnered with Sutter Health to expand access to specialty medications across the US. This collaboration aims to support patients with chronic and complex conditions, particularly in oncology, rheumatology and dermatology. Nearly 3,000 healthcare providers will benefit, as Shields’ broad payer network and access to limited distribution drugs will offer patients more treatment options and cost-saving support.
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.
pharmaphorum
OCTOBER 24, 2024
UK scheme to tackle "historically low" numbers of people taking part in dementia trials launches with £20m in government funding
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.
Bio Pharma Dive
OCTOBER 29, 2024
The licensing deal with China’s Chimagen Biosciences is the latest example of drugmaker interest in exploring the potential of “T cell engagers” in autoimmune disease.
Pharmaceutical Technology
OCTOBER 22, 2024
Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Outsourcing Pharma
OCTOBER 29, 2024
Riccardo Butta, a leader at Stevanato Group, delves into how cutting-edge digital twin technology, advanced data management, and AI-driven systems are transforming manufacturing efficiency and quality in the pharmaceutical sector.
pharmaphorum
OCTOBER 29, 2024
An evaluation of digital health technologies for hypertension by the Peterson Health Technology Institute (PHTI) finds some provide a clinical benefit, while others are lacking.On the plus side, the health technology assessment (HTA) body has concluded that tools to help people manage their antihypertensive drug treatment can deliver benefits in reduced blood pressure.
Fierce Pharma
OCTOBER 25, 2024
Despite Merck & Co. | Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus antibody clesrovimab, Sanofi thinks Beyfortus can hold its own. On a Friday call with analysts, Sanofi execs pointed to an efficacy edge for its preventive and stressed that more competition in the space is a net positive.
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.
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