Bio Pharma Dive
FEBRUARY 23, 2024
The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.
Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
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Bio Pharma Dive
FEBRUARY 23, 2024
European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.
Pharmaceutical Technology
FEBRUARY 23, 2024
The UK NICE has recommended Pfizer's Ritlecitinib as a new treatment option for individuals suffering from alopecia areata.
pharmaphorum
FEBRUARY 23, 2024
Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.
Pharmaceutical Technology
FEBRUARY 23, 2024
AstraZeneca has announced the conclusion of its acquisition of Gracell Biotechnologies for approximately $1.2bn.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 23, 2024
Sanofi and Regeneron’s Dupixent has received priority review by the US FDA, with a target action date of 27 June.
Fierce Pharma
FEBRUARY 23, 2024
Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.
Pharmaceutical Technology
FEBRUARY 23, 2024
The EMA has granted an accelerated review of CHIKV VLP as Bavarian Nordic attempts to catch Valneva’s Ixchiq.
Fierce Pharma
FEBRUARY 23, 2024
A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
FEBRUARY 23, 2024
The positive opinion is based on findings from the Phase III COMMANDS trial which met its primary endpoint.
pharmaphorum
FEBRUARY 23, 2024
Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva. The Danish pharma group said it is planning to file for approval of its vaccine in the first half of this year, adding the EU regulator’s human medicine committee, the CHMP, has said it will cut the review time from 210 to 150 days under its accelerated assessment procedure.
Pharmaceutical Technology
FEBRUARY 23, 2024
Moderna has reported a net loss of $4.7bn for the full year 2023 as against a net income of $8.4bn in 2022.
XTalks
FEBRUARY 23, 2024
Rare Disease Day is a global observance held on the last day of February each year that is aimed at raising awareness among the general public and decision-makers about rare diseases and their impact on patients’ lives. Rare Disease Day 2024 falls on February 29 this year as this year is a leap year, making the day even more rare and special. Despite varying definitions across different countries and regions, a disease is generally deemed to be rare if it affects less than one in 2,000 people.
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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
Pharmaceutical Technology
FEBRUARY 23, 2024
Following major successes in the RSV landscape over the last few years, experts debate rollout plans.
Outsourcing Pharma
FEBRUARY 23, 2024
In the fast-evolving landscape of healthcare and pharmaceuticals, the role of technology, particularly artificial intelligence (AI), is becoming increasingly prominent.
pharmaphorum
FEBRUARY 23, 2024
The FDA has started a priority review of Sanofi and Regeneron’s Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), which could become the first new treatment for the widespread and life-threatening disease in over a decade.
Fierce Pharma
FEBRUARY 23, 2024
As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission (FTC), a group of lawmakers on both sides of the aisle have war | As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission, a small group of lawmakers on both sides of the aisle have warned the approach could “hamstring” U.S. innovation.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
pharmaphorum
FEBRUARY 23, 2024
AI software developed by Israeli medtech Magentiq-Eye has been shown to improve detection rates for adenoma, a precursor to colorectal cancer, in colonoscopy procedures
Fierce Pharma
FEBRUARY 23, 2024
Teva and Alvotech have braved a long and winding road on the quest to win approval for their biosimilar to AbbVie’s Humira. | Teva and Alvotech have braved a long and winding road on the quest to win approval for their biosimilar to AbbVie’s Humira. Now, after multiple manufacturing setbacks, the partners have finally scored their inaugural regulatory nod in the United States.
Pharmaceutical Commerce
FEBRUARY 23, 2024
A cross-sectional study investigates how this supply chain link helps increase Medicare Part D spending on self-administered specialty drugs.
Fierce Pharma
FEBRUARY 23, 2024
Following a contentious advisory committee meeting and an FDA request for the withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. | Following a contentious advisory committee meeting and an FDA request for withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. market in late 2022, the other shoe has dropped.
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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
FEBRUARY 23, 2024
After losing Roche as a partner, Blueprint Medicines has sold US commercial rights to RET inhibitor Gavreto to Rigel Pharma in a deal worth up to $117.
Pharma Times
FEBRUARY 23, 2024
In England, around 1,100 cases of bowel cancer are caused by the inherited condition every year
Drug Channels
FEBRUARY 23, 2024
Today’s guest post comes from Nicole Grycan, VP of Commercialization at Phil, Inc. Nicole discusses how hubs can improve access and adherence. She outlines four success factors for manufacturers that use a digital hub partner. To learn more, register for Phil's upcoming webinar: Improving Access, Coverage, and GTN with a Digital Hub. Read on for Nicole’s insights.
Pharma Times
FEBRUARY 23, 2024
The immunosuppressant reduced inflammation in patients with the skin condition after three days
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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.
pharmaphorum
FEBRUARY 23, 2024
Travere and partner CSL Vifor close on EU approval of sparsentan for rare kidney disease IgA nephropathy, after CHMP's positive opinion on the drug.
Fierce Pharma
FEBRUARY 23, 2024
This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry. | This week on "The Top Line," we explore the impact of environmental, social, and governance measures, commonly known as ESG, on the pharmaceutical industry. Fierce Pharma's Fraiser Kansteiner engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights and discuss Lilly's specific ESG
pharmaphorum
FEBRUARY 23, 2024
In search of the legendary tricorder using cutting-edge AI and MedTech. Discover the future of healthcare technology today.
Drug Patent Watch
FEBRUARY 23, 2024
Annual Drug Patent Expirations for ANJESO Anjeso is a drug marketed by Baudax and is included in one NDA. There are seven patents protecting this drug. Drug patent litigation for… The post New patent expiration for Baudax drug ANJESO appeared first on DrugPatentWatch - Make Better Decisions.
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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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