Sat.Mar 09, 2024 - Fri.Mar 15, 2024

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Amylyx plummets as confirmatory trial of ALS drug fails

pharmaphorum

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.

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With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

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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Google Cloud Releases New Clinical Generative AI Tools at HIMSS24

MedCity News

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.

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What’s next for AAV gene therapies in 2024?

Pharmaceutical Technology

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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm

pharmaphorum

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.

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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

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.

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Older Adults’ Experience with Opioid Use, Deprescribing

Pharmaceutical Commerce

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.

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After Amylyx drug failure, what’s next for ALS?

PharmaVoice

The company’s combo treatment Relyvrio was approved in 2022, but after failing a phase 3 trial, may be pulled from the market.

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Despite early death concerns, FDA advisers back J&J and Legend's Carvykti for earlier myeloma

Fierce Pharma

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.

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How Marketing Fueled the Opioid Overdose Crisis and What We Can Learn From It

MedCity News

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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The Case for Domestic Sourcing to Establish Reliable Pharmaceutical Supply Chains in the United States

Pharmaceutical Commerce

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.

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Lilly adds Amazon Pharmacy to LillyDirect DTC channel

pharmaphorum

Amazon Pharmacy will provide dispensing for Eli Lilly’s recently launched direct-to-consumer LillyDirect channel, covering obesity, diabetes, and migraine drugs.

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Novartis lays out $256M for antibody plant expansion in Singapore, plots 100 hires

Fierce Pharma

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.

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AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

MedCity News

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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How to Stay Competitive in the Evolving State of Martech

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

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Adopting New Manufacturing Technologies

Pharmaceutical Commerce

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.

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Deep learning model ‘detects 90% of lymphatic cancer cases’

pharmaphorum

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.

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Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec

Fierce Pharma

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.

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GE HealthCare & Mass General Brigham Have a Plan to Accelerate Their AI Research

MedCity News

At HIMSS, GE HealthCare and Mass General Brigham announced that they are integrating foundation models into their collaborative AI research and development. Foundation models could help developers create healthcare AI tools “10 times faster than in the past,” according to Parminder Bhatia, GE HealthCare’s chief AI officer.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Software Advances Mass Customization for Cell and Gene Therapies

PharmaTech

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.

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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

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).

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Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia

Fierce Pharma

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.

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GLP-1s Alone Are Not the Answer to America’s Obesity and Chronic Illness Crises

MedCity News

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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Roles and Responsibilities of Specialized Clinical Supply Experts

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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AstraZeneca buys rare disease firm Amolyt for $1.05bn

pharmaphorum

AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.

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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

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).

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J&J's Duato nets major raise to $28.4M, jumps to top of pharma CEO pay rankings

Fierce Pharma

It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. | It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. After paying Duato $13.1 million in his first year as CEO, the pharma giant more than doubled his compensation to $28.4 million last year, according to a regulatory filing.

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Novartis Pays $90M for Molecules That Could Take STING Out of Inflammation

MedCity News

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.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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EMA pins lack of long-term data as rationale for Novartis’ failed Vijoice bid

Pharmaceutical Technology

The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.

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ALS body takes digital approach to clinical trials access

pharmaphorum

The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.

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FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma

Fierce Pharma

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.

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Mount Sinai CEO: Hospitals Will Start Seeing ROI from Their AI Investments in a Couple Years

MedCity News

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.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.