Fierce Pharma
NOVEMBER 7, 2023
Pfizer’s $3.5 billion cost-savings drive has made its way overseas. | The layoffs at Pfizer's Newbridge, Kildare, manufacturing site are the latest in the company's effort to save $3.5 billion by 2024 amid declining demand for its COVID-19 products.
MedCity News
NOVEMBER 7, 2023
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
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Fierce Pharma
NOVEMBER 7, 2023
Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.
MedCity News
NOVEMBER 7, 2023
My phone chimed with a notification, signaling the availability of a new CT test result in my online health portal. “Multiple bilateral pulmonary nodules measuring up to 8mm. May represent metastatic disease.” This was several weeks after my very first mammogram–which I underwent shortly after my 40th birthday–detected an anomaly on my left breast. I soon learned I had what are called “dense” breasts, which means I have compact breast tissue and typical imaging isn’t the best screening for me.
Fierce Pharma
NOVEMBER 7, 2023
There might just be a silver lining for Johnson & Johnson in the FDA's recent approval of Amgen’s Stelara biosimilar. | There might just be a silver lining for Johnson & Jonhson in the FDA's recent approval of Amgen’s Stelara biosimilar. That’s because the coming entry of a cheaper copycat presents J&J with an opportunity to elude Medicare price negotiations outlined in the Inflation Reduction Act.
MedCity News
NOVEMBER 7, 2023
Ventyx Biosciences is stopping work on its lead drug candidate in plaque psoriasis and psoriatic arthritis. Despite achieving the goals of its Phase 2 test in psoriasis, the results are short of those achieved by big pharmaceutical companies with molecules that address the same target.
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Copyright Clearance Center
NOVEMBER 7, 2023
November 7, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, announces Clinical Trial Registries, a new data connector for customers of the cloud-based software solution RightFind Navigate. The new data connector provides access to aggregated data from seven global clinical trial registries within a single personalized discovery tool that enables knowledge workers to find the latest clinical trial dat
Fierce Pharma
NOVEMBER 7, 2023
Since launching the Regeneron-partnered antibody Dupixent in 2017, Sanofi has relied on the star medicine for sales growth. Now, though, an investigation in France calls into question some of the c | France's Parquet National Financier opened a preliminary investigation into Sanofi's financial communications during Dupixent's 2017 launch, according to press reports.
MedCity News
NOVEMBER 7, 2023
Perhaps more of us would find greater joy and fulfillment at work, if we embraced the idea of being a beginner and starting anew. The most fulfilling path in the 21st century isn’t necessarily a straight line.
Fierce Pharma
NOVEMBER 7, 2023
Armed with dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin Pharmaceutical recently turned a corner into profitability after many years operating at a loss. | Armed with dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin recently turned a corner into profitability after many years operating at a loss. Now, the drugmaker has reportedly garnered the attention of activist investor Elliott Management.
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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.
PharmExec
NOVEMBER 7, 2023
Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.
Fierce Pharma
NOVEMBER 7, 2023
Before Sage and Biogen’s Zurzuvae (zuranolone) won approval from the FDA for postpartum depression (PPD) in August, the companies had said that the highly anticipated first-in-class treatment would | Before Sage and Biogen’s Zurvuvae was approved by the FDA for postpartum depression in August, the companies had said that the highly anticipated treatment would be available for less than $10,000.
MedCity News
NOVEMBER 7, 2023
Baylor Medicine teamed up with Luna to launch a program expanding access to in-home physical therapy for patients in the Houston area. Luna, a provider of in-home physical therapy, has similar partnerships with more than two dozen health systems. These partnerships help health systems expand access to care and increase their geographic coverage across their markets, said Palak Shah, Luna’s co-founder.
Fierce Pharma
NOVEMBER 7, 2023
WuXi's bioconjugation spinoff is set to break free onto the Hong Kong Stock Exchange this month, with plans to funnel hundreds of millions of dollars in proceeds back into its Asian manufacturing n | WuXi's bioconjugation spinoff is set to break free onto the Hong Kong Stock Exchange this month, with plans to funnel hundreds of millions of dollars in proceeds back into its Asian manufacturing network.
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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
Medgadget
NOVEMBER 7, 2023
Researchers at North Carolina State University have developed a robotic prosthetic ankle that can provide stability for lower limb amputees. The ankle uses electromyographic sensors placed on the sites of muscles in the residual limb that then convey the intentions of the wearer with regard to movement. So far, the system has been shown to assist with postural control, which in this context refers to the many complex and unconscious movements that the muscles in our legs make to maintain balance
MedCity News
NOVEMBER 7, 2023
CMS proposed a new rule that would set a flat amount — $632 — that MA plans can pay agents and brokers when they help enroll a person into any MA plan. The proposed rule also addresses behavioral health access and prior authorization.
PharmaTech
NOVEMBER 7, 2023
Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation discusses the analytical and downstream purification challenges of oligonucleotides.
MedCity News
NOVEMBER 7, 2023
Covera Health has finalized its acquisition of CoRead, the companies announced last week but did not disclose the terms of the deal. Covera also announced that it raised up to $50 million in additional Series C funding led by Insight Partners.
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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.
European Pharmaceutical Review
NOVEMBER 7, 2023
Positive results for a combination treatment using the first Fc-silent investigational monoclonal antibody in pivotal clinical trials that is designed to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), have been announced. The treatment is being evaluated in patients with upper GI adenocarcinomas. Domvanalimab plus the antibody zimberelimab and chemotherapy showed encouraging overall response rate and six-month progression-free survival (PFS) rate results in a preli
Pharmaceutical Commerce
NOVEMBER 7, 2023
Conference session discusses the drivers, practical considerations, success factors, and landscape for next-generation pharmacy innovation.
PharmExec
NOVEMBER 7, 2023
Exagamglogene autotemcel (Exa-Cel) was assigned a Prescription Drug User Fee Act action date of December 8, 2023, for the treatment of sickle cell disease.
Pharmaceutical Commerce
NOVEMBER 7, 2023
Bill Roth provides insight as to how where chief commercial officers and access leaders can plan for a profitable product lifecycle.
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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.
Medgadget
NOVEMBER 7, 2023
Charco Neurotech , a medtech company based in the United Kingdom, has developed CUE1, a non-invasive wearable that is intended to assist those with Parkinson’s disease to manage their motor symptoms. The device is typically affixed to the sternum, and provides vibratory action in a focused region of the body. The technology is based on the observation of a doctor in the early 1800s, who noticed that their patients’ motor symptoms were significantly reduced when they traveled to their appoi
PharmExec
NOVEMBER 7, 2023
House Committee on Oversight and Accountability request documents on agency’s drug shortage mitigation strategies.
Clarivate
NOVEMBER 7, 2023
What is the impact when IP departments are regularly asked to “do more with less”? Employees may feel that they are paying the price and burnout is on the rise. Instead, with thoughtful evaluation, IP legal teams can find areas of efficiency to work smarter with less. IP legal teams continue to face a universal business challenge: how to do more with less.
PharmaTimes
NOVEMBER 7, 2023
Doctors will use the service to track signs of deterioration in paediatric patients - News - PharmaTimes
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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
pharmaphorum
NOVEMBER 7, 2023
BioNTech flashes the cash, adding tumour drug in $1bn deal Phil.
PharmaTimes
NOVEMBER 7, 2023
Lung cancer is currently the leading cause of cancer deaths in the UK - News - PharmaTimes
pharmaphorum
NOVEMBER 7, 2023
Generic breast cancer drug cleared for prevention in England Phil.
PharmaTech
NOVEMBER 7, 2023
Chris Spivey, editorial director for Pharmaceutical Technology®, discusses mRNA advances and the background for the leading scientific conference for the field, with host and co-organizer CureVac CEO Dr. Alexander Zehnder.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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