Wed.Feb 21, 2024

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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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Novo Nordisk, Eli Lilly lead industrywide sales surge in Q4

Fierce Pharma

In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.

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HealthSnap Snags $25M to Help Providers Launch & Scale RPM Programs

MedCity News

HealthSnap closed a $25 million Series B funding round led by Sands Capital. The Miami-based company seeks to help providers better care for a rapidly aging and chronically ill population through its remote patient monitoring platform.

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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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Novo, Novartis, BMS and J&J win judge's blessing to combine arguments in upcoming IRA hearing

Fierce Pharma

Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

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At ViVE 2024, Get a Glimpse of the State of Cybersecurity in Healthcare [Sponsored]

MedCity News

Mari Savickis, Vice President of Public Policy with CHIME, will be moderating a panel discussion as part of the Cybersecurity Pavilion at the ViVE 2024 event in Los Angeles, scheduled for February 25-28. She said her organization anticipates several developments addressing cybersecurity this year.

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Joseph Papa, after leaving Bausch, begins another turnaround project as CEO of Emergent BioSolutions

Fierce Pharma

Joseph Papa has reemerged nearly a year after stepping down as head honcho of Bausch + Lomb. | Joseph Papa has re-emerged nearly a year after stepping down as head honcho of Bausch + Lomb. The former Valeant helmsman is now tasked with turning around Emergent BioSolutions as its new CEO.

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Mobile ADHD awareness game launches in Germany

pharmaphorum

Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.

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United Therapeutics challenges FDA on application process for rival drug from Liquidia

Fierce Pharma

Two months ago, when a federal appeals court rejected United Therapeutics’ attempt t | When a federal appeals court rejected United Therapeutics’ attempt to revive an invalidated patent on its aging pulmonary arterial hypertension drug Tyvaso, it cleared one hurdle for the FDA to approve a rival treatment from the North Carolina-based Liquidia Corporation.

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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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340B Program Preserves, Improves Access to Rural Health Care

MedCity News

To ensure that rural hospitals like ours can continue delivering high-quality, comprehensive health care, the federal government must support and protect the 340B Drug Pricing Program that enables us to do what we do best.

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Sanofi's planned consumer health spinoff picks up interest from multiple firms: Bloomberg

Fierce Pharma

As Sanofi continues to plot its planned separation from its consumer healthcare division, the business has reportedly attracted interest from multiple private equity firms. | Top buyout firms, including Advent International and Blackstone, have their eye on Sanofi's consumer health business, according to the news service. Sanofi previously announced plans to split during this year's fourth quarter "at the earliest.

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Behind the breakthrough cancer therapy that just won a historic FDA nod

PharmaVoice

The first-of-its-kind TIL therapy for solid tumors developed by Iovance Biotherapeutics won FDA approval last week.

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Bavarian Nordic Hones Infectious Disease Focus by Dropping Cancer Vaccine R&D

MedCity News

Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program.

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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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EGFR inhibitor could provide major advance in lung cancer

European Pharmaceutical Review

Small molecule treatment TAGRISSO ® (osimertinib) demonstrated a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) for Stage III lung cancer patients, AstraZeneca has confirmed. This was established from positive high-level results seen in the LAURA Phase III trial. The data was based on observations from patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemor

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Menopause Startup Raises $3.3M in Funding Led By UPMC

MedCity News

Elektra Health, a virtual provider for menopause care, has secured $3.3 million in financing. With the funding, the company is focused on two areas: partnering with more payers and expanding its footprint to provide clinical care to more patients.

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United sues FDA to try to block rival’s drug application

pharmaphorum

United sues FDA for allowing a marketing application for a competitor to its top-seller Tyvaso, filed by Liquidia, that sidesteps established procedures

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Will smart tech revolutionise drug delivery for ulcerative colitis patients?

Pharmaceutical Technology

Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis

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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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US, EU regulators start swift reviews of Servier glioma drug

pharmaphorum

FDA and EMA start speedy reviews of Servier’s vorasidenib for IDH-mutated low-grade glioma, hoping to end decades of stagnation in therapies for the brain cancer.

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UK manufacturing output expected to improve despite challenges

European Pharmaceutical Review

Based on data from the Confederation of British Industry (CBI)’s latest monthly Industrial Trends Survey on UK manufacturing, expectations for future selling price inflation rose in February, to their strongest since July 2023. Despite this, the survey noted that selling price expectations remained well below the multi-decade high observed in 2022 (+80 percent in March 2022).

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RAPT hit by FDA clinical hold on eczema, asthma drug

pharmaphorum

RAPT Therapeutics shares fell sharply after the FDA placed a clinical hold on oral CCR4 antagonist zelnecirnon in atopic dermatitis and asthma.

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4 biotechs to watch in 2024

PharmaVoice

A splashy IPO, first-in-class treatments and upcoming approval dates are a few reasons we’ve got our eyes on these biotechs this year.

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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.

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Digital health firms DarioHealth and Twill merge

pharmaphorum

DarioHealth has bought fellow digital health company Twill in a move that combines their chronic disease and mental health platforms.

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FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma

Pharmaceutical Commerce

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

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Elicio’s vaccine shows promise as potential cancer treatment in phase 1 trial

PharmaTimes

Results showed robust responses in patients with pancreatic and colorectal cancer

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Advancing Lipid-Based Formulations and Softgels in Drug Development (Feb 2024)

PharmaTech

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.

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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

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Researchers launch global iSPY network to research Strep A infections

PharmaTimes

A streptococcal bacterial infections are estimated to affect around 50 million people worldwide

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Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure

Pharmaceutical Commerce

A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets.

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Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 

Legacy MEDSearch

Sparrow BioAcoustics recently unveiled its Stethophone TM software, which transforms smartphones into medical-grade stethoscopes. This innovative tool enables users to capture, analyze, and share crucial heart health data with medical professionals from any location. In June 2023, Sparrow received FDA clearance for the downloadable application, making it the first FDA-cleared smartphone stethoscope software-as-a-medical-device (SaMD).

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Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

PharmExec

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

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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.