Fierce Pharma
FEBRUARY 15, 2024
Even as Catalent moves toward a $16.5 billion sale to Novo Holdings, hundreds of the CDMO's former staffers won't be in the mix going forward. | A recent buyout announcement didn't spare Catalent staffers from layoffs after the company this week revealed it's trimmed hundreds of jobs over the last few months. The move forms part of an ongoing restructuring scheme at Catalent.
MedCity News
FEBRUARY 15, 2024
Through a new partnership, up to 12 million members of Cigna’s employer customers will gain access to HelloFresh’s meals at a discounted rate. Cigna and HelloFresh are also partnering to provide free meal kits to those battling food insecurity in local communities.
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Fierce Pharma
FEBRUARY 15, 2024
Changing a clinical trial’s statistical analysis plan on the cusp of a readout? | Changing a clinical trial’s statistical analysis plan on the cusp of a readout? That’s exactly what Alnylam just did for a closely watched study of its next-generation RNA interference therapy Amvuttra in a rare heart disease.
MedCity News
FEBRUARY 15, 2024
Providing a clear and unwavering roadmap of anticipated milestones will ensure that no matter the inevitable bumps or detours, your stakeholders can always see the path forward and track your progress.
Fierce Pharma
FEBRUARY 15, 2024
With a $93 million settlement, Pfizer can wash its hands of more than a decade's worth of antitrust litigation over the once-lucrative cholesterol med Lipitor. | Purchasers have long accused Pfizer—and Sun Pharma's Ranbaxy—of conspiring to keep Lipitor generics off the market with a "reverse payment" agreement. After the Pfizer settlement, the class action lawsuit against Ranbaxy will continue.
MedCity News
FEBRUARY 15, 2024
During a virtual panel, leaders from across the industry shared their advice on how health plans can do a better job of achieving their goals for chronic management. For example, one executive said health plans should utilize remote monitoring tools for centralized observation and be wary of using the wrong metrics.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 15, 2024
The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.
Fierce Pharma
FEBRUARY 15, 2024
Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. | Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. LianBio, a prominent player in bringing foreign meds to China, will wind down.
MedCity News
FEBRUARY 15, 2024
Versant Ventures-backed Firefly Bio is part of a growing group of companies developing degrader antibody conjugates, or DACs. These targeted cancer therapies combine properties of antibody drug conjugates and protein degraders in order to overcome limitations of both types of therapies.
Fierce Pharma
FEBRUARY 15, 2024
After picking up European rights to a pair of Eli Lilly migraine meds in December, Organon, the women’s health-focused spinoff of Merck & Co., is hungry to ink more deals. | After picking up European rights to a pair of Eli Lilly migraine meds in December, Organon is hungry to ink more deals.
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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
FEBRUARY 15, 2024
The rise of electronic patient-reported outcomes (ePRO) tools enables patients to report their symptoms from home, alleviating any concern about burdening the clinic through constant phone calls.
Pharmaceutical Commerce
FEBRUARY 15, 2024
Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.
European Pharmaceutical Review
FEBRUARY 15, 2024
A clinical trial in malignant pleural mesothelioma (MPM) has demonstrated the first successful combination of chemotherapy with a drug targeting cancer’s metabolism developed for the asbestos-induced disease in two decades. The anti-cancer treatment combines the new drug ADI-PEG20 and traditional chemotherapy. The Phase III ATOMIC-meso trial was led by Queen Mary University of London in the UK and studied 249 patients with the disease.
Pharmaceutical Technology
FEBRUARY 15, 2024
As the market is progressively becoming saturated by GLP-1 receptor agonists, companies are investigating alternative mechanisms of action.
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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
European Pharmaceutical Review
FEBRUARY 15, 2024
The investment… includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP [manufacturers]” Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries has announced its Itasca, Illinois laboratory in the US as a new Pharmaceutical Center of Excellence to serve the unique needs of parenteral and ophthalmic drug product (PODP) manufacturers.
pharmaphorum
FEBRUARY 15, 2024
Healthtech specialist Innsena has committed funding and expertise to CancerX, launched last year to encourage the use of digital health technologies to overcome challenges in cancer care.
MedCity News
FEBRUARY 15, 2024
The event will take place in Chicago at the Ritz Carlton from May 21-22. The startup tracks include: oncology, cardiology, women’s health and preventing burnout/supporting operational efficiency. The deadline to submit applications is February 29 so apply today!
pharmaphorum
FEBRUARY 15, 2024
Exercise matched psychotherapy and was more effective than medication as a treatment for #depression in a meta-analysis of randomised clinical trials
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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.
Pharmaceutical Technology
FEBRUARY 15, 2024
The US FDA has granted approval for Eicos Sciences' Aurlumyn for adults with severe frostbite to lower the risk of amputation.
pharmaphorum
FEBRUARY 15, 2024
Gene-editing biotech Prime Medicine has priced an initial public offering, hoping to raise $140 million to advance its pipeline of one-shot therapies for severe genetic disorders. The Cambridge, Massachusetts-based company is offering 19.2 million shares at $6.25 each and expects to start trading on the Nasdaq on 20th February under the PRME symbol.
Pharmaceutical Technology
FEBRUARY 15, 2024
GSK has exercised its option for a licence for Elsie Biotechnologies’ discovery platform to detect and develop new oligonucleotides.
Pharmatutor
FEBRUARY 15, 2024
Anti-Stress Skin Care admin Thu, 02/15/2024 - 16:12 Vinay Kumar Singh. Head-Formulation Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru Email : formulation_krc@kopresearchcentre.
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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.
Fierce Pharma
FEBRUARY 15, 2024
In the U.S.
pharmaphorum
FEBRUARY 15, 2024
The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines
PharmaTimes
FEBRUARY 15, 2024
CLM-HT01 improved blood pressure and minimised adverse reactions in patients
pharmaphorum
FEBRUARY 15, 2024
Grifols will file its fibrinogen concentrate BT524 later this year, aiming to provide an improved treatment for patients with acquired fibrinogen deficiency
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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
PharmaTimes
FEBRUARY 15, 2024
In Europe, stroke-related brain-bleed deaths are expected to increase by 8.
pharmaphorum
FEBRUARY 15, 2024
Gene-editing biotech Prime Medicine has priced its IPO, hoping to raise $140m to advance its pipeline of one-shot therapies for severe genetic disorders.
Pharmaceutical Commerce
FEBRUARY 15, 2024
The Federal Trade Commission and the Department of Health and Human Services are seeking public input to evaluate how policymakers can address chronic drug shortages and promote a resilient supply chain.
PharmExec
FEBRUARY 15, 2024
Lymphir is an immunotherapy under evaluation for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma following at least one previous line of systemic therapy.
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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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