March, 2024

article thumbnail

BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

343
343
article thumbnail

Should the DOJ Break Up UnitedHealth Group?

MedCity News

The U.S. Department of Justice has reportedly recently launched an antitrust investigation of UnitedHealth Group, which begs the question of whether the healthcare giant should be broken up. Experts have varying opinions.

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

Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

FDA 120
article thumbnail

Who’s getting left behind in the weight loss bonanza?

PharmaVoice

As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.

Medical 111
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

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.

119
119
article thumbnail

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.

More Trending

article thumbnail

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.

article thumbnail

Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

145
145
article thumbnail

Former U.S. patent head on why federal march-in rights for drugs would be a ‘devastating’ mistake

PharmaVoice

A Biden administration proposal to seize patents for drugs deemed too pricey would have a ripple effect that cuts into the heart of innovation, says former U.S. PTO head Andrei Iancu.

109
109
article thumbnail

Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

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

PAP 2024: John Hoffman Discusses the Health Equity Spotlight Panel

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, John Hoffman, Principal, Advocate for Success, LLC talks about his 'Health Equity Spotlight' panel and advocacy accomplishments.

Pharma 105
article thumbnail

BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

Sales 333
article thumbnail

AbbVie Gets Another Ulcerative Colitis Contender via $137M Landos Acquisition

MedCity News

AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

Biopharma 121
article thumbnail

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.

FDA 123
article thumbnail

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

article thumbnail

Cellares Innovates With Automated Cell and Gene Therapy Platform

PharmaTech

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

105
105
article thumbnail

Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 111
article thumbnail

Reading the Tea Leaves on Recent Surge in Pharma Dealmaking

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the positive signs from rising activity levels in biopharma M&A— and what the momentum may mean for industry dealmaking and partnership efforts in the months ahead.

Biopharma 105
article thumbnail

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.

FDA 349
article thumbnail

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.

article thumbnail

Health Execs Applaud Biden’s Executive Order on Women’s Health

MedCity News

President Joe Biden has signed an executive order that aims to improve women’s health research, among other things. Several women’s health executives came out in support.

126
126
article thumbnail

FDA turns down Regeneron bispecific blood cancer antibody

pharmaphorum

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

FDA 109
article thumbnail

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.

Marketing 119
article thumbnail

Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

FDA 105
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.

article thumbnail

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.

article thumbnail

With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

Fierce Pharma

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

FDA 304
article thumbnail

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

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.

FDA 130
article thumbnail

Clasp emerges with $150m for safer T cell engagers

pharmaphorum

Clasp Therapeutics has burst onto the T-cell engager (TCE) scene with $150 million in funding for a platform that aims to improve the safety of the class, which is currently gaining traction in cancer immunotherapy.

Safety 109
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

article thumbnail

Why a pharmacist was tapped to spearhead ‘patient excellence’ at Boehringer Ingelheim

PharmaVoice

Deborah Reardon is leading a new pillar that asks, ‘Are we looking at this from a patient lens and not from a Boehringer lens?

article thumbnail

AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

119
119
article thumbnail

Are Adults With Diabetes Who Switch to High-Deductible Health Plans at Greater Risk for Complications?

Pharmaceutical Commerce

A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.

article thumbnail

AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ

Fierce Pharma

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

340
340
article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.