Lilly drug for Alzheimer’s approved by FDA
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.
Tue.Jul 02, 2024
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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid
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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Cartesian data add to progress, questions for CAR-T in autoimmune disease
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.
Eli Lilly’s donanemab wins FDA approval for Alzheimer’s disease
Pharmaceutical Technology
JULY 2, 2024
Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Moderna gets US funding for bird flu vaccine development
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.
Eisai and Bristol Myers Squibb terminate ADC development deal
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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The pathway to preventative health: How pharma can support the NHS Long Term Plan
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.
Sobi starts rolling FDA filing for chronic gout drug
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.
Researchers find whole genome sequencing improves care for paediatric cancer
Pharma Times
JULY 2, 2024
Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children
Eli Lilly continues radiopharma push with $140m Radionetics partnership
Pharmaceutical Technology
JULY 2, 2024
The deal also gives Eli Lilly exclusive rights to acquire Radionetics for $1bn after the exercise period is over.
The power and potential of regenerative medicine
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.
Aerovate slashes workforce after failed Phase IIb trial
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.
FTC launches probe of Teva over ‘improper’ patents; report
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
FTC investigates Teva over contested product patents
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.
The New Age of Decentralized Clinical Trials
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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
Biden joins Sanders' campaign targeting Novo Nordisk, Eli Lilly's diabetes and obesity drug prices
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.
Tracon mulls strategic options after sarcoma drug fails Phase II trial
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.
Female cancer survivors at low risk of developing obstetric complications
Pharma Times
JULY 2, 2024
According to WHO, around 15% of pregnant women will develop an obstetric complication
EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world
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.
China-made injectable PD-L1 drug flunks pivotal trial, forcing US partner to seek strategic options
Fierce Pharma
JULY 2, 2024
The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.
FDA grants priority review for Neurocrine’s crinecerfont NDAs
Pharmaceutical Technology
JULY 2, 2024
The US FDA has accepted Neurocrine Biosciences’ NDAs for crinecerfont to treat congenital adrenal hyperplasia, and granted priority review.
Changing Faces: Pharma and biotech hires from April 2024
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.
Samsung Bioepis’ PYZCHIVA gains FDA approval as Stelara biosimilar
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.
The New Age of Decentralized Clinical Trials
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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.
Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures
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.
Which pharmaceutical drugs have the most drug patents in Slovakia?
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.
BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey
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.
The Power of Patience: Delaying Patents to Enhance Pharma Market Exclusivity
Drug Patent Watch
JULY 2, 2024
The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma
Fierce Pharma
JULY 2, 2024
In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.
Apellis will appeal CHMP’s rejection of pegcetacoplan
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.
High-flying Samsung Biologics inks $1B production pact with unnamed US pharma
Fierce Pharma
JULY 2, 2024
As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. | As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.
Skipping Informed Consent for In Vitro Diagnostic (IVD) Trials: Understanding the Exceptions
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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