Fierce Pharma
AUGUST 21, 2024
As Biogen’s relentless patent defense for blockbuster multiple sclerosis med Tecfidera came up short in the U.S., the company separately worked to fend off competition through an anticompetitive ki | A multi-employer health benefit plan in Illinois accused the drugmaker of scheming with pharmacy benefit managers to keep its Tecfidera in a more favorable spot on their formularies.
MedCity News
AUGUST 21, 2024
Lifestyle is equally important for long-term success. A good behavior-change program can benefit many people with chronic conditions – whether by impacting clinical outcomes, improving quality of life, or helping to lower long-term health-care costs. The post GLP-1s Can Improve Many Common Health Issues, but They’re Not Magic appeared first on MedCity News.
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Fierce Pharma
AUGUST 21, 2024
A survey of 800 biopharma executives shows that sustainability is an increasingly important priority but that companies are struggling to achieve it.
MedCity News
AUGUST 21, 2024
Lowering patient out-of-pocket expenses through thoughtful plan design is not only beneficial for the patients but also for the healthcare system at large. By advocating for policies that reduce these financial barriers, we can ensure that more patients benefit from early PT intervention, leading to better health outcomes and lower long-term costs. The post Challenging Healthcare Norms: Early Access to Physical Therapy Transforms Musculoskeletal Care Delivery appeared first on MedCity News.
Fierce Pharma
AUGUST 21, 2024
A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. | A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgAN into a full approval but left a liver toxicity monitoring requirement in place.
MedCity News
AUGUST 21, 2024
Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
AUGUST 21, 2024
Debate over the safety of GLP-1 drugs resurfaces after study finds 'disproportional' risk of suicidal thinking adverse event reports with Novo Nordisk's semaglutide
Fierce Pharma
AUGUST 21, 2024
Aadi Bioscience’s Fyarro is on track to fail a phase 2 solid tumor trial, leading the biotech to halt the study and lay off 80% of its R&D workforce.
pharmaphorum
AUGUST 21, 2024
A class action suit has been filed in the US against Teva, claiming that the company illegally subsidised the copays for patients prescribed its multiple sclerosis therapy Copaxone to boost its sales.The suit filed on behalf of Medicare Advantage coverage providers accuses the company of "funnelling hundreds of millions of dollars" to Copaxone (glatiramer acetate) patients through third-party foundations and companies.
Fierce Pharma
AUGUST 21, 2024
Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. | Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But the San Diego drugmaker is now poised for an October launch and a “blue sky opportunity,” according to the team of analysts at Leerink Partners.
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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.
MedCity News
AUGUST 21, 2024
Prescriptions, GLP-1s and cancer are major contributors to employers’ healthcare costs, according to a new survey from the Business Group on Health. The post Business Group on Health: Healthcare Costs Expected to Surge at Highest Rate in 15 Years appeared first on MedCity News.
pharmaphorum
AUGUST 21, 2024
J&J's Rybrevant/Lazcluze combination is cleared by FDA for first-line EGFR+ NSCLC, giving AstraZeneca's top-seller Tagrisso its first direct competition
MedCity News
AUGUST 21, 2024
The theme of the Pitch Perfect contest at INVEST Digital Health in Dallas is pediatric mental health. Six companies will compete in the event at Pegasus Park on September 18. Register today! The post Who Will Compete in the INVEST Digital Health Pitch Perfect Contest? appeared first on MedCity News.
PharmaTimes
AUGUST 21, 2024
The new test takes an average of 13 hours to identify the correct treatment compared to several days with current methods
MedCity News
AUGUST 21, 2024
Clarium, a startup on a mission to transform hospital supply chain operations, closed a $10.5 million financing round this week. The round was led by General Catalyst and included three health system venture capital arms — those of Kaiser Permanente, Yale New Haven Health and Texas Medical Center. The post 3 Health Systems Invest In Supply Chain Startup appeared first on MedCity News.
Pharmaceutical Technology
AUGUST 21, 2024
Amgen has announced the availability of Otezla (apremilast) in the US for paediatric patients with moderate to severe plaque psoriasis.
PharmaTech
AUGUST 21, 2024
For a preview of what's to come at the AAPS PharmSci 360 show in October, Pharmaceutical Technology® spoke with Vivek Gupta, PhD, associate dean for Graduate Education and Research, associate professor, Pharmaceutical Sciences, St. John’s University, Queens, New York, about the formulation of inhalation dosage forms.
Pharmaceutical Technology
AUGUST 21, 2024
The China NMPA approved AstraZeneca's Fasenra for individuals aged 12 years and older with severe eosinophilic asthma (SEA).
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
PharmaTimes
AUGUST 21, 2024
Globally 400,000 children are impacted every year by cancers that include leukaemia and lymphoma
Pharmaceutical Technology
AUGUST 21, 2024
The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.
Pharmaceutical Commerce
AUGUST 21, 2024
Although it still has to undergo the preclinical and clinical trial process, the DNA vaccine—which could be created in as little as six weeks—does not require the cold chain storage that mRNA jabs often demand.
Pharmaceutical Technology
AUGUST 21, 2024
Dr Reddy's Laboratories, Aurigene Pharmaceutical and Kainomyx signed an MoU to co-develop and co-commercialise an anti-malarial drug.
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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
Evolve Your Success
AUGUST 21, 2024
Unlock the secrets to thriving in medical sales with our latest episode featuring Sheila Mallon, a standout graduate of the Medical Sales Career Builder program. Sheila shares her transformational journey from job-seeker to successful territory manager, offering firsthand insights into navigating an uncharted territory near Middletown, New York. Learn how she effectively balances a demanding career with family life while promoting opioid alternatives to a diverse range of medical professionals.
PharmaTech
AUGUST 21, 2024
The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe.
Pharmaceutical Commerce
AUGUST 21, 2024
Although it still has to undergo the preclinical and clinical trial process, the DNA vaccine—which could be created in as little as six weeks—does not require the cold chain storage that mRNA jabs often demand.
PharmExec
AUGUST 21, 2024
Breakthrough therapy designation for GSK5764227 based on preliminary data from the ongoing ARTEMIS-001 Phase I trial, which showed the novel therapy’s promise treating patients with relapsed or refractory extensive-stage small-cell lung cancer.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
InCrowd
AUGUST 21, 2024
Can you introduce yourself? My name is Harrison Smith and I am physician practicing in the coastal southeastern United States. I am married to an emergency medicine physician and we currently have two beautiful and busy toddlers. What is your specialty? I am a board certified pulmonary and critical care physician. I have been fortunate enough to incorporate all aspects of my clinical practice to include time in the ICU, inpatient pulmonary consults, ambulatory clinics, and procedures.
PharmExec
AUGUST 21, 2024
Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.
PharmaTech
AUGUST 21, 2024
This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them.
Pharmaceutical Commerce
AUGUST 21, 2024
In this part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, outlines the necessary qualities of a digital pharmacy that will allow it to be of greatest value to patients.
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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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