pharmaphorum
MARCH 11, 2024
Shares in Amylyx have cratered after the company reported a confirmatory trial of its amyotrophic lateral sclerosis (ALS) therapy Relyvrio missed all its objectives, putting its accelerated approval in jeopardy.
Fierce Pharma
MARCH 15, 2024
Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.
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MedCity News
MARCH 12, 2024
At HIMSS, Google Cloud announced new AI features designed to assist providers, payers and any other healthcare organizations seeking to make better use of their clinical data.
Pharmaceutical Technology
MARCH 11, 2024
Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.
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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
pharmaphorum
MARCH 10, 2024
The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug. Lilly said the US regulator “wants to further understand topics related to evaluating the safety and efficacy of donanemab,” which includes the safety and efficacy results of its pivotal TRAILBLAZER-ALZ 2 study.
Fierce Pharma
MARCH 11, 2024
The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Commerce
MARCH 12, 2024
A qualitative study explores how these drugs are impacting these patients’ lives, while digging deeper into the possibility of deprescribing, with insight from primary care physicians.
pharmaphorum
MARCH 13, 2024
Amazon Pharmacy will provide dispensing for Eli Lilly’s recently launched direct-to-consumer LillyDirect channel, covering obesity, diabetes, and migraine drugs.
Fierce Pharma
MARCH 13, 2024
As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. | As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.
MedCity News
MARCH 14, 2024
The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.
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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.
Pharmaceutical Commerce
MARCH 15, 2024
Reliance on foreign imports means that disruptions in the supply chain can profoundly impact the ability of individuals in the United States to get access to the medications they need.
pharmaphorum
MARCH 14, 2024
Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.
Fierce Pharma
MARCH 15, 2024
Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee (ODAC) still believe that the drug | Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee still believe that the drug’s long-term benefits outweigh its risks.
MedCity News
MARCH 10, 2024
Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers.
Advertiser: ZoomInfo
Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Pharmaceutical Commerce
MARCH 12, 2024
A sit-down with Groovy Singh, CEO of Bright Green Corporation, who describes the waves in the global supply chain the company is making after being authorized to grow cannabis, along with cannabis-related products.
PharmaVoice
MARCH 15, 2024
The company’s combo treatment Relyvrio was approved in 2022, but after failing a phase 3 trial, may be pulled from the market.
Fierce Pharma
MARCH 15, 2024
Over the years, Singapore has attracted a suite of biopharma majors, and Novartis is no exception. | Novartis broke ground on a $256 million expansion of its biopharmaceutical production facility in Singapore. The project will introduce digitalization and automation at the site in a bid to boost manufacturing productivity and to help upskill the company’s workforce.
MedCity News
MARCH 10, 2024
Health systems aren’t seeing a ton of ROI when it comes to their AI investments quite yet, as use of the technology is still in an iterative stage. However, Mount Sinai CEO Brendan Carr thinks that is likely to change in the next couple years.
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.
PharmaTech
MARCH 12, 2024
In an interview, Fabian Gerlinghaus of Cellares outlines a paradigm change in both hardware and software, regulatory expansions, and some positive cost outcomes for the CGT field.
Impetus Digital
MARCH 15, 2024
This is a guest article and does not necessarily reflect the views and values of Impetus Digital. When it comes to artificial intelligence (AI), it feels like no industry has been left untouched. Even those that might not feel like a natural fit for computers are being shaped and influenced by this technology, with artists and writers utilizing it in new ways.
Fierce Pharma
MARCH 13, 2024
The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies. At the meeting, experts will discuss applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment.
MedCity News
MARCH 14, 2024
AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.
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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.
pharmaphorum
MARCH 14, 2024
AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.
European Pharmaceutical Review
MARCH 14, 2024
In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).
Fierce Pharma
MARCH 14, 2024
Just as BeiGene’s Brukinsa encroaches on C | Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.
MedCity News
MARCH 14, 2024
Obesity/overweight is a significant causal factor in chronic illness and cancer. Weight loss can help people with obesity/overweight avoid and/or manage chronic illness. GLP-1s cause weight loss. So, are GLP-1s the answer to America’s obesity and chronic illness crises? Not if we overlook a key problem at the heart of both challenges: lack of access to nutritious food in the land of plenty.
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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.
pharmaphorum
MARCH 13, 2024
Basecamp Research launches BaseFold, a deep learning model that it says surpasses benchmark tool AlphaFold2 and should accelerate AI-based drug discovery
European Pharmaceutical Review
MARCH 14, 2024
In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).
Fierce Pharma
MARCH 14, 2024
Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead. | Twenty months after the FDA's original target decision date, BeiGene has finally received the U.S. go-ahead for its PD-1 inhibitor Tevimbra.
MedCity News
MARCH 13, 2024
Placing research in the hands of a large pharmaceutical company is a goal of many biotech companies. IFM Therapeutics has now done it three times and its latest deal is the second time Novartis is the acquirer.
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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