Bio Pharma Dive

JULY 2, 2024

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

Drugs 340

Drugs 340

Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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Bio Pharma Dive

JULY 2, 2024

The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.

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Pharmaceutical Technology

JULY 2, 2024

Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.

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FDA Approval Branding Marketing 264

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Bio Pharma Dive

JULY 2, 2024

BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.

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Development Vaccination Vaccine 299

Pharmaceutical Technology

JULY 2, 2024

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

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Development 246

Pharmaceutical Technology

JULY 2, 2024

Utilising innovative digital tools and access to real-time data, the pharmaceutical industry could offer invaluable support to the NHS’s preventative care mission.

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Pharma Times

JULY 2, 2024

According to WHO, around 15% of pregnant women will develop an obstetric complication

Development 144

Development 144

pharmaphorum

JULY 2, 2024

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

Drugs 135

Drugs Marketing 135

Pharmaceutical Technology

JULY 2, 2024

The deal also gives Eli Lilly exclusive rights to acquire Radionetics for $1bn after the exercise period is over.

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Clinical Supply

Fierce Pharma

JULY 2, 2024

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

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Drugs 124

Pharmaceutical Technology

JULY 2, 2024

The company has announced plans to lay off 39 employees, with most of the workforce cuts expected in coming months.

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Trials 130

pharmaphorum

JULY 2, 2024

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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Medicine Development Research 118

Pharmaceutical Technology

JULY 2, 2024

Teva’s asthma and COPD patents listed in the FDA’s Orange Book are under scrutiny and the company has until 24 July to adhere to the demands.

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Production 130

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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

Clinical Trials

pharmaphorum

JULY 2, 2024

The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book

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Pharmaceutical Technology

JULY 2, 2024

The company scrapped the envafolimab trial, after an independent review found the study was unlikely to meet its primary endpoint.

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Trials Drugs 130

pharmaphorum

JULY 2, 2024

Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.

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Pharmaceutical Technology

JULY 2, 2024

On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin gene-related proteins (anti-CGRP mAbs) to onabotulinumtoxinA (BoNT-A) for chronic migraine prevention.

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Protein Antibody Gene 130

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Clinical Supply

Drug Patent Watch

JULY 2, 2024

This chart shows the drugs with the most patents in Slovakia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

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Drugs 105

Pharmaceutical Technology

JULY 2, 2024

The US FDA has accepted Neurocrine Biosciences’ NDAs for crinecerfont to treat congenital adrenal hyperplasia, and granted priority review.

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Drug Patent Watch

JULY 2, 2024

The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.

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Marketing 105

Pharmaceutical Technology

JULY 2, 2024

Samsung Bioepis has received US FDA approval for PYZCHIVA (ustekinumab-ttwe / SB17) as a biosimilar to Stelara for various indications.

FDA Approval 130

FDA Approval 130

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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.

Clinical Trials

pharmaphorum

JULY 2, 2024

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.

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Medicine Marketing 105

Cloudbyz

JULY 2, 2024

Understanding the exceptions in Informed consent is an essential aspect of ethical clinical research because it concerns full awareness of risks and benefits related to research, as well as procedures. There is a need for conditions in which informed consent can be legitimately waived in IVD trials; hence, knowledge of those exceptions is significant for researchers to remember in ensuring regulatory standards are followed and participant rights safeguarded.

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In-Vitro Trials Clinical Trials Clinical Trials 99

Fierce Pharma

JULY 2, 2024

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

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Vaccine Vaccination Drugs 99

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 95

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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

Clinical Research

Fierce Pharma

JULY 2, 2024

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

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Life Science 95

Outsourcing Pharma

JULY 2, 2024

The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).

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Manufacturing Production Contract Manufacturing 93

Fierce Pharma

JULY 2, 2024

In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.

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Drugs 89

Outsourcing Pharma

JULY 2, 2024

NeuroSense Therapeutics has announced positive phase 2b results for a drug combination designed to treat amyotrophic lateral sclerosis (ALS).

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Trials Drugs Clinical Development Development 85

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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.

Clinical Trials