Mon.Feb 26, 2024

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Obesity drug from Boehringer, Zealand succeeds in MASH trial

Bio Pharma Dive

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.

Drugs 286
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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

Trials 331
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Simple Experiment Reveals Why Your Next Antibiotics May Prove Useless

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Bacteria 187
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Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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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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Panel asks govt to persuade private insurance companies to cover Ayush treatments

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Medicine 166
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SK bioscience’s typhoid vaccine receives WHO prequalification

Pharmaceutical Technology

SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.

More Trending

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February 26, 2024: In PRIM-ER Qualitative Study, EM Talk Program Improved Serious Illness Conversation Skills

Rethinking Clinical Trials

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.

Trials 130
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Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

Bio Pharma Dive

The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S. market.

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Streamlining supply chain operations in focus at Clinical Trial Supply Europe 2024 

Pharmaceutical Technology

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.

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Choosing laboratory equipment with workplace experience in mind

Bio Pharma Dive

Making equipment choices with employee experience in mind can help researchers build top-performing teams while enhancing operational efficiencies.

Research 141
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA approves Alvotech-Teva’s SIMLANDI jab for multiple conditions

Pharmaceutical Technology

The US FDA has granted approval for Alvotech and Teva Pharmaceuticals’ SIMLANDI injection, which is an interchangeable biosimilar to Humira.

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NGM to go private through deal with investment firm

Bio Pharma Dive

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.

Trials 161
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FDA clears PK Med to streamline gout injectable to Phase II

Pharmaceutical Technology

The Phase II prospective, randomised trial will evaluate three doses of PKM-01 to select the optimal dosage for a Phase III study.

Trials 130
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GSK drug meets goal in late-stage gonorrhea study

Bio Pharma Dive

The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections.

Bacteria 152
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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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Biogen receives EMA CHMP recommendation for ALS drug Qalsody

Pharmaceutical Technology

The EMA's decision on the marketing authorisation application for Biogen Qalsody is expected in Q2 of this year.

Drugs 130
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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

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.

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Moderna concludes construction at new mRNA vaccine facility in Canada

Pharmaceutical Technology

Moderna has announced the conclusion of construction works at its new mRNA manufacturing facility in Canada.

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Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

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.

Drugs 117
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The New Age of Decentralized Clinical Trials

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.

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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

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.

Trials 115
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With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

Fierce Pharma

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.

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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

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.

Drugs 115
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BeiGene grows global workforce by 1,000+ as Brukinsa surges, Tevimbra launches outside China

Fierce Pharma

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.

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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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Neuraxpharm launches new multiple sclerosis treatment in Europe

BioPharma Reporter

Neuraxpharm Group, a European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, has announced the first launch of BRIUMVI (ublituximab) in Europe for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease.

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Sanofi CEO Hudson takes another small dip in pay to €10.57M

Fierce Pharma

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.

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Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma

Drug Patent Watch

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.

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CHMP backs AZ’s danicopan for anaemia in patients with PNH

pharmaphorum

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).

Medicine 105
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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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Jacobio Pharmaceuticals Group sees highest patent filings and grants during October in Q4 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Jacobio Pharmaceuticals Group here.

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Shionogi takes Akili’s ADHD digital therapy to Japan

pharmaphorum

Digital health company Akili expands beyond the US as partner Shionogi files for approval for its ADHD digital therapeutic (DTx) in Japan

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Praxis Precision Medicines sees highest patent filings and grants during November in Q4 2023

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Praxis Precision Medicines here.

Medicine 100
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Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies

XTalks

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.

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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.