Bayer wins FDA breakthrough therapy designation for NSCLC candidate
Pharmaceutical Technology
FEBRUARY 26, 2024
Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.
Mon.Feb 26, 2024
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Obesity drug from Boehringer, Zealand succeeds in MASH trial
Bio Pharma Dive
FEBRUARY 26, 2024
Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.
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Merck’s Keytruda regimen gains positive EMA CHMP opinion
Pharmaceutical Technology
FEBRUARY 26, 2024
Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.
Simple Experiment Reveals Why Your Next Antibiotics May Prove Useless
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 26, 2024
Do bacteria mutate randomly, or do they mutate for a purpose? Researchers have been puzzling over this conundrum for over a century. In 1943, microbiologist Salvador Luria and physicist turned biologist Max Delbrück invented an experiment to argue that bacteria mutated aimlessly.
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
SK bioscience’s typhoid vaccine receives WHO prequalification
Pharmaceutical Technology
FEBRUARY 26, 2024
SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.
Panel asks govt to persuade private insurance companies to cover Ayush treatments
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 26, 2024
The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended to the government to persuade private insurance companies to include Ayurveda, Yoga, Unani, Siddha and Homoeopathy (Ayush) treatments in their products and look at global acceptance for these systems of medicines through legalisation and insurance support in other countries.
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PhaSER Biomedical receives $2.3m drug discovery grant from the Gates Foundation
Pharma Times
FEBRUARY 26, 2024
Every year, tuberculosis, malaria and HIV cause over five million deaths worldwide
Choosing laboratory equipment with workplace experience in mind
Bio Pharma Dive
FEBRUARY 26, 2024
Making equipment choices with employee experience in mind can help researchers build top-performing teams while enhancing operational efficiencies.
Biogen receives EMA CHMP recommendation for ALS drug Qalsody
Pharmaceutical Technology
FEBRUARY 26, 2024
The EMA's decision on the marketing authorisation application for Biogen Qalsody is expected in Q2 of this year.
NGM to go private through deal with investment firm
Bio Pharma Dive
FEBRUARY 26, 2024
The deal would mark a retreat from public markets for the once notable biotech, which was forced to cut staff last year to save cash after trial setbacks.
FDA clears PK Med to streamline gout injectable to Phase II
Pharmaceutical Technology
FEBRUARY 26, 2024
The Phase II prospective, randomised trial will evaluate three doses of PKM-01 to select the optimal dosage for a Phase III study.
February 26, 2024: In PRIM-ER Qualitative Study, EM Talk Program Improved Serious Illness Conversation Skills
Rethinking Clinical Trials
FEBRUARY 26, 2024
Dr. Oluwaseun Adeyemi, lead author of the report Communication skills training using the EM Talk model reached a high proportion of clinicians in participating emergency departments and improved their serious illness conversation skills, according to a qualitative study conducted as part of the PRIM-ER trial. The observed reach and effectiveness of the training program has the potential to improve use of these skills in clinical practice.
Streamlining supply chain operations in focus at Clinical Trial Supply Europe 2024
Pharmaceutical Technology
FEBRUARY 26, 2024
The upcoming Clinical Trial Supply Europe 2024 conference will round-up pharma and biotech delegates to discuss the trends and challenges in clinical trial supply industry.
Researchers develop terahertz biosensor to detect skin cancer for early diagnosis
Pharma Times
FEBRUARY 26, 2024
Results from the study could also be used for other forms of cancer and diseases
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
FDA approves Alvotech-Teva’s SIMLANDI jab for multiple conditions
Pharmaceutical Technology
FEBRUARY 26, 2024
The US FDA has granted approval for Alvotech and Teva Pharmaceuticals’ SIMLANDI injection, which is an interchangeable biosimilar to Humira.
Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too
Fierce Pharma
FEBRUARY 26, 2024
Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.
Moderna concludes construction at new mRNA vaccine facility in Canada
Pharmaceutical Technology
FEBRUARY 26, 2024
Moderna has announced the conclusion of construction works at its new mRNA manufacturing facility in Canada.
Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350
Fierce Pharma
FEBRUARY 26, 2024
Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.
GSK drug meets goal in late-stage gonorrhea study
Bio Pharma Dive
FEBRUARY 26, 2024
The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections.
With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy
Fierce Pharma
FEBRUARY 26, 2024
Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.
Shionogi takes Akili’s ADHD digital therapy to Japan
pharmaphorum
FEBRUARY 26, 2024
Digital health company Akili expands beyond the US as partner Shionogi files for approval for its ADHD digital therapeutic (DTx) in Japan
BeiGene grows global workforce by 1,000+ as Brukinsa surges, Tevimbra launches outside China
Fierce Pharma
FEBRUARY 26, 2024
The chilling wind of the biotech winter has apparently spared BeiGene. | The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.
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.
Sanofi trumpets win for oral BTK drug in chronic hives
pharmaphorum
FEBRUARY 26, 2024
Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.
Sanofi CEO Hudson takes another small dip in pay to €10.57M
Fierce Pharma
FEBRUARY 26, 2024
For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. | For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. For 2023, Hudson will receive 10.57 million euros ($11.44 million) in total pay, according to the company’s annual filing.
GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial
pharmaphorum
FEBRUARY 26, 2024
GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.
Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma
Drug Patent Watch
FEBRUARY 26, 2024
Switching pharmaceutical excipients, the inactive components used in drug formulations, can have significant implications for both production costs and market appeal. These components, while not contributing directly to the therapeutic… The post Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma appeared first on DrugPatentWatch - Make Better Decisions.
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
Boehringer’s survodutide shows monster MASH potential
pharmaphorum
FEBRUARY 26, 2024
Boehringer Ingelheim and Zealand Pharma report stellar top-line results for GLP-1/glucagon agonist survodutide in liver disease MASH.
Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies
XTalks
FEBRUARY 26, 2024
The US Food and Drug Administration (FDA) has granted expanded approval to Genentech’s (part of Roche) Xolair (omalizumab) to help reduce allergic reactions to various foods after accidental exposure. The approval is indicated for reducing Type 1 allergic reactions, known as immediate reactions mediated by immunoglobulin E (IgE), in certain adults and children one year of age or older after accidental exposure to one or more foods.
CHMP backs AZ’s danicopan for anaemia in patients with PNH
pharmaphorum
FEBRUARY 26, 2024
AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).
Vir Biotechnology sees highest patent filings and grants during November in Q4 2023
Pharmaceutical Technology
FEBRUARY 26, 2024
Access and buy GlobalData’s databook on the latest filings and grants activity for Vir Biotechnology here.
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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