Wed.Apr 24, 2024

article thumbnail

Roche's Vabysmo shows no sign of slowdown after Regeneron and Bayer's launch of Eylea HD

Fierce Pharma

It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. | How much impact has the approval of high-dose Eylea had on the upward trajectory of Roche’s Vabysmo? Not much, according to sales figures released by Roche.

Sales 245
article thumbnail

Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

130
130
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Biogen 'turning the corner' as Leqembi and Skyclarys launches advance, but much work remains to be done: CEO

Fierce Pharma

While Biogen’s Chris Viehbacher figures the company is “turning the corner” after several recent setbacks—thanks in large part to accelerating launches of new drugs like Leqembi and Skyclarys—the C | While Biogen’s Chris Viehbacher figures the company is “turning the corner” after several recent setbacks, the CEO admitted Wednesday that there’s still “a lot of work to do” as the biotech plugs ahead with its “Fit for Growth” savings initiative.

228
228
article thumbnail

Providence Ordered to Pay $200M for ‘Systemic Wage Violations’

MedCity News

More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

FDA 115
article thumbnail

It’s Time to Give Patients a Seat at the Table

MedCity News

Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. The post It’s Time to Give Patients a Seat at the Table appeared first on MedCity News.

Patients 109

More Trending

article thumbnail

When Investment Rhymes with Canada

MedCity News

Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception. The post When Investment Rhymes with Canada appeared first on MedCity News.

102
102
article thumbnail

NICE backs Novartis duo for NHS use in young glioma patients

pharmaphorum

An oral therapy that can allow children and adolescents with an aggressive form of brain cancer to be treated at home rather than in hospital has been recommended for use by the NHS in England and Wales.

article thumbnail

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

FDA 93
article thumbnail

Enter Xaira, with $1bn for its AI in drug discovery platform

pharmaphorum

New biotech Xaira Therapeutics emerges with $1bn in funding for its plan to apply AI to drug discovery in ways hard to achieve with conventional technologies

82
article thumbnail

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.

article thumbnail

Six Biopharma Companies to Watch at MedCity INVEST Pitch Perfect Contest

MedCity News

The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, The companies will offer a window into some of the promising treatments under development such as different types of cancers to muscular dystrophy. Space is limited so register today! The post Six Biopharma Companies to Watch at MedCity INVEST Pitch Perfect Contest appeared first on MedCity News.

article thumbnail

NICE recommends Novartis precision brain cancer treatment

European Pharmaceutical Review

in clinical trials [the combination treatment was shown] to halt tumour growth for low-grade gliomas for an average of more than two years” The National Institute for Health and Care Excellence (NICE) has recommended a new targeted drug combination treatment for young people with BRAF V600E mutation-positive glioma. Dabrafenib (Finlee) in combination with trametinib (Spexotras) is indicated for patients aged one and over, based on the agency’s proposal in its final draft guidance.

article thumbnail

Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients

PharmaTech

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

FDA 64
article thumbnail

To Further Impede the Progression of Heart Disease, We Must Treat Patients With Anti-Inflammatory Drugs in Combination With Statin Therapy

MedCity News

it is paramount that we address both cholesterol risk and inflammation to reduce the risk of a heart attack or stroke. The post To Further Impede the Progression of Heart Disease, We Must Treat Patients With Anti-Inflammatory Drugs in Combination With Statin Therapy appeared first on MedCity News.

article thumbnail

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

article thumbnail

Incyte signs deal to acquire Escient Pharmaceuticals

Pharmaceutical Technology

Incyte has agreed to acquire US-based Escient Pharmaceuticals and its assets including two first-in-class small molecule antagonists targeting Mas-related G protein-coupled receptor X2 (MRGPRX2) for the treatment of various mast cell-mediated disorders.

article thumbnail

New heart disease calculator more accurately predicts patients’ risk of CVDs

PharmaTimes

According to the World Health Organization, CVDs are responsible for an estimated 17.

article thumbnail

EU OK sets up first ex-China launches for BeiGene's Tevimbra

pharmaphorum

BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of the drug outside China. The new approval covers three separate indications for the drug, alone and in combination with chemotherapy for squamous and non-squamous forms of NSCLC, and covering first- and second-line therapy.

63
article thumbnail

FTC Chief Says Tech Advancements Risk Healthcare Price Fixing

MedCity News

Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF. The post FTC Chief Says Tech Advancements Risk Healthcare Price Fixing appeared first on MedCity News.

article thumbnail

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.

article thumbnail

Pharma Pulse 4/24/24: Migraine Treatment Comes in Different Forms, State Level Legislation Impacting Patient Services & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 104
article thumbnail

Patient Engagement Is Essential for Achieving the Goals of Value-Based Care

MedCity News

Success requires both novel VBC models as well as moving care beyond the clinic walls to meet patients where they are. The post Patient Engagement Is Essential for Achieving the Goals of Value-Based Care appeared first on MedCity News.

article thumbnail

UCL study to assess link between navigation and AD using virtual reality

PharmaTimes

The progressive neurodegenerative condition is the most common form of dementia

82
article thumbnail

Coya Therapeutics CEO Discusses Next Steps Amid Positive Results from Coya 302 Trial for ALS Treatment

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a preview on what the nexts steps are after presenting positive data on Coya 302 for the treatment of ALS.

52
article thumbnail

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.

article thumbnail

How Nurses Fit So Well In Medical Sales With Aaron Kravitz

Evolve Your Success

Amazing episode to celebrate the National Nurses Week! Unlock the secrets to a thrilling career leap from the frontlines of nursing to the cutting edge of medical sales with our guest, Aaron Kravitz, who brings firsthand insights on making this bold transition. This episode is a treasure trove of advice for nurses seeking to leverage their clinical expertise beyond bedside care, as Aaron outlines how he parlayed his background into a successful role as an Account Executive with 3M.

article thumbnail

On the Same Page for the Future

PharmExec

In this Pharmaceutical Executive video interview, Jon Hamrick, Partner, Curatio Scientia Advisors and Jon Rawlson, President & Founder, Armory Hill Advocates, speak about what kind of impact their survey's findings impact will be on the industry.

article thumbnail

MacroGenics gets grant for patent granted for compounds targeting IL23a and BAFF

Pharmaceutical Technology

Discover how MacroGenics Inc's patent for compounds targeting IL23A and BAFF can suppress inflammatory responses in subjects in need. Learn about the unique polypeptide compositions and methods outlined in the patent.

52
article thumbnail

FDA Grants Accelerated Approval to Day One’s Ojemda for Relapsed or Refractory Pediatric Low-Grade Glioma

PharmExec

Ojemda is the first systemic therapy approved by the FDA for the treatment of relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation.

FDA 52
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

article thumbnail

Seres Therapeutics gets grant for composition of isolated bacteria in capsule for dysbiosis treatment

Pharmaceutical Technology

Discover the groundbreaking patent by Seres Therapeutics Inc for a unique composition targeting dysbiosis in mammals. Learn how specific bacterial species in a capsule can inhibit pathogenic bacteria growth.

52
article thumbnail

Bristol Myers Squibb to Access Cellares' Cell Therapy Manufacturing Platform in New $380 Million CAR-T Cell Therapy Deal

PharmaTech

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb.

article thumbnail

Ipsen gets grant for treatment of diseases with specific benzothiazepine and benzothiadiazepine derivatives

Pharmaceutical Technology

Discover how Ipsen SA's patented compounds can treat cardiovascular, metabolic, gastrointestinal, and liver diseases. Learn about the method and specific compounds outlined in the recently granted patent.

52
article thumbnail

AAV gene therapy demonstrates positive activity in Duchenne muscular dystrophy

European Pharmaceutical Review

New trial data for a gene therapy presented at the International Myology 2024 Congress has revealed “good” tolerability in Duchenne muscular dystrophy, when combined with transient immunological prophylactic treatment, as well as efficacy data relating to microdystrophin expression and functional improvement. The gene therapy trial for GNT0004 enrolled ambulant (able to walk) boys six to 10 years old, Genethon stated.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.