Fierce Pharma
NOVEMBER 2, 2023
The days of booming COVID-19 vaccine sales, which sent Moderna into the ranks of pharma's top companies, have | The company is focusing on scaling back its manufacturing efforts to cope with the lack of COVID-19 vaccine demand.
MedCity News
NOVEMBER 2, 2023
A webinar on December 5 will spotlight expert panelists from Praia Health and Providence, interviewed by AVIA, to discuss the benefits of adopting a hyperpersonal care model for patients, challenges that health systems face providing this care, and how they can overcome them.
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Fierce Pharma
NOVEMBER 2, 2023
Supply problems for Eli Lilly’s diabetes med Mounjaro were no secret. But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. | As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions.
PharmaTech
NOVEMBER 2, 2023
Pharmaceutical Technology Europe® speaks with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
Fierce Pharma
NOVEMBER 2, 2023
The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | Even before a potential label expansion, the gene therapy Elevidys has raked in around $69 million since its launch. Earlier this week, the company said that a pivotal trial on the medicine failed to reach its primary endpoint.
MedCity News
NOVEMBER 2, 2023
BioMarin Pharmaceutical CEO Jean-Jacques Bienaimé will retire in December, when he will be succeeded by Genentech CEO Alexander Hardy. The transition comes with BioMarin in the early stages of the commercial launch of Roctavian, the first FDA-approved hemophilia A gene therapy.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 2, 2023
BeMe Health, a digital mental health company for teens, is teaming up with Inland Empire Health Plan and Molina Healthcare of California to bring BeMe’s platform to 10 local educational agencies. The partnership will support more than 72,000 teens.
Fierce Pharma
NOVEMBER 2, 2023
In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna. The first came on Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection.
European Pharmaceutical Review
NOVEMBER 2, 2023
While unsolicited and burdensome, medicine shortages are an obstacle faced by the pharmaceutical industry. In 2023, a combination of factors, including increased demand (particularly for critical medicines), economic inflation, as well as international geopolitical unrest, has led to Europe’s supply chain being acutely affected. Consequently, regulators, trade groups and other organisations have worked to prevent and alleviate medicine shortages in the region.
Fierce Pharma
NOVEMBER 2, 2023
Roche’s surge in sales for its long-acting macular degeneration drug Vabysmo showed that patients in the market are open to switching to another treatment. | After gaining FDA approval for its high-dose Eylea, Regeneron racked up $43 million in sales in the U.S. over the final six weeks of the third quarter for the new formulation. Regeneron and partner Bayer are battling Roche's Vabysmo in the treatment of multiple eye diseases.
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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
NOVEMBER 2, 2023
Jona, a New York-based gut microbiome testing startup, emerged from stealth with $5 million in funding. The company’s at-home microbiome profiling kit educates users about how the community of microorganisms residing in their gut impacts their overall health. The platform also offers recommendations concerning diet and lifestyle modifications based on users’ personal health goals.
Fierce Pharma
NOVEMBER 2, 2023
Travere Therapeutics recently reported two pivotal trial flops for Filspari, with one threatening the drug’s accelerated approval in IgA nephropathy (IgAN) and the other raising doubts about its ch | Travere Therapeutics recently reported two pivotal trial flops for Filspari, with one threatening the drug’s accelerated approval in IgA nephropathy (IgAN) and the other raising doubts about its chances of tapping into another kidney disease.
MedCity News
NOVEMBER 2, 2023
Only 21% of primary care physicians feel they are fairly compensated, according to a new report from Pearl Health. However, primary care physicians who participate in an ACO were 56% more likely than non-ACO participants to believe they are paid fairly. ACO participants were also 15% more likely to believe that the way they generate revenue allows them to deliver holistic care.
Fierce Pharma
NOVEMBER 2, 2023
Merck KGaA is in-licensing a PARP1 inhibitor from Hengrui. Novartis said an ex-employee who recently jumped to Takeda took sensitive files. | Merck KGaA is in-licensing a PARP1 inhibitor from Hengrui. Novartis said an ex-employee who recently jumped to Takeda took sensitive files. The FDA approved Coherus and Junshi's China-made PD-1 inhibitor toripalimab.
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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
PharmExec
NOVEMBER 2, 2023
The rise in popularity of GLP-1 weight-loss drugs, such as Ozempic, Wegovy, and Mounjaro, has had a wide-reaching impact across the healthcare industry and beyond.
Pharmaceutical Technology
NOVEMBER 2, 2023
Memo’s fast track-designated candidate is currently in a Phase II trial for BKV infection, with a data readout expected in 2024.
MedCity News
NOVEMBER 2, 2023
Patients deserve agency over their own bodies and care, and clinicians, educators, and caregivers can be those catalysts needed to promote disability rights in healthcare practices across the industry.
European Pharmaceutical Review
NOVEMBER 2, 2023
The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Wezlana, like Stelara, is approved to treat: Adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; Patients six years and older with active psoriatic arthritis Adults with moderately to severely active Crohn’s disease Adults with moderately to severely active ulcerat
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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.
PharmaVoice
NOVEMBER 2, 2023
From Merck and J&J to AbbVie and Eisai, the oncology field has stayed consistently devoted to churning out important therapies.
European Pharmaceutical Review
NOVEMBER 2, 2023
Research led by the University of Sydney has found that many antibiotics recommended by the World Health Organization (WHO) had “less than 50 percent effectiveness” in treating childhood infections such as pneumonia, sepsis and meningitis. The study, published in Lancet South East Asia , analysed 6,648 bacterial isolates from 11 countries across 86 publications to review antibiotic susceptibility for common bacteria causing childhood infections.
Pharmaceutical Technology
NOVEMBER 2, 2023
Generate:Biomedicines has entered a strategic collaboration with Roswell Park to accelerate the development of new oncology therapies
PharmaTech
NOVEMBER 2, 2023
Predictive modeling facilitates the identification of coformers, cocrystal components, and complexing agents.
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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.
Pharmaceutical Technology
NOVEMBER 2, 2023
The UK MHRA authorises Pfizer’s Litfulo (ritlecitinib), to treat severe alopecia areata in people aged 12 years and above.
PM360
NOVEMBER 2, 2023
Don’t miss your chance to vote for the winners of the 2024 Pharma Choice Awards. Voting will remain open until Dec.
PharmaTimes
NOVEMBER 2, 2023
The NHS has already delivered over 20 million winter vaccines this year - News - PharmaTimes
PharmaTech
NOVEMBER 2, 2023
Pharmaceutical Technology Europe® spoke with Carlos Rial Calvo from FABRX, a pharmaceutical 3D printing company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
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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
NOVEMBER 2, 2023
The new AI model could potentially be applied to other cancers - News - PharmaTimes
PharmExec
NOVEMBER 2, 2023
Inpefa to be added on pharmacy benefit manager’s basic and high-performance formularies for commercially insured patients.
PharmaVoice
NOVEMBER 2, 2023
A challenging funding environment and lack of partnering deals have contributed to the market's ongoing troubles.
pharmaphorum
NOVEMBER 2, 2023
Novo Nordisk shrugs off supply issues with record sales Phil.
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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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