Trending Articles

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Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use

Fierce Pharma

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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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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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity

MedCity News

Achieving strong cybersecurity is a vast, interconnected web that must incorporate the correct software, procedures, and workflows and take into account the human element across an entire organization. The post In the World of Interoperability, How to Meaningfully Strengthen Cybersecurity appeared first on MedCity News.

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Microbial burden assessment of solid pharmaceutical products

European Pharmaceutical Review

The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden , stated Prada-Ramírez et al.

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Personalization In Sales Leads To Increased Loyalty and Repeat Business

Integrity Solutions

Mastering the human side of selling is key to sales success, but what does phrase that mean exactly? At its essence, humanizing the sales experience is really about personalization. It’s about asking questions from a place of genuine curiosity, listening, fully absorbing what you’re hearing and then being willing and able to pivot in whatever direction the customer’s answers take us.

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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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Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group

Fierce Pharma

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

MedCity News

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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Metsera lands with $290m to take on obesity giants

pharmaphorum

New obesity biotech Metsera formally launches, led by Clive Meanwell and with a $290m warchest to take on the likes of Novo Nordisk and Eli Lilly.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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At Princeton University Press, The Mission is “Our Compass”

Copyright Clearance Center

In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.

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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

MedCity News

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.

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Clearmind licenses psychedelic compounds for mental disorders

Pharmaceutical Technology

Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.

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Sage drops dalzanemdor for Parkinson’s after trial flop

pharmaphorum

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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A Work in Progress: CCC and Artificial Intelligence

Copyright Clearance Center

In a recent town hall webinar, The Heart of the Matter: Copy­right, AI Training and LLMs, CCC (Copyright Clearance Center) made the case that current artificial intelligence (AI) technology infringes copyrights, both in the way its underlying large language models (LLMs) are developed, or trained, and in the outputs it enables users to create.

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Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

Fierce Pharma

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today!

MedCity News

In addition to panel discussions around some of the hottest topics in healthcare transformation, there is also a startup pitch contest, a presentation on government funding for startups and networking opportunities. The post Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today! appeared first on MedCity News.

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Estetrol by Mithra Pharmaceuticals for Genitourinary Syndrome of Menopause (GSM): Likelihood of Approval

Pharmaceutical Technology

Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).

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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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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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Technology advancement driving growth of rapid sterility testing market

European Pharmaceutical Review

A report by Market Research Future has predicted that the rapid sterility testing market will increase in value from $2.3 billion in 2023 to $4.3 billion by 2032. It is expected hold a compound annual growth rate (CAGR) of 8.20 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to t

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With Vyvgart 'firing' in myasthenia gravis, argenx lays launch plans for next potential autoimmune approval: CEO

Fierce Pharma

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

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Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer

MedCity News

The FDA expanded the approval of Roche’s Alecensa to include adjuvant treatment of non-small cell lung cancer. The targeted therapy addresses cancers driven by the ALK genetic mutation. The post Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer appeared first on MedCity News.

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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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Inflammation among current dementia research focus, says Alchemab CSO

Pharmaceutical Technology

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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‘Stiffness’ of cells could give early warning of cancer

pharmaphorum

Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.

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Monitoring pharmaceuticals in the environment

European Pharmaceutical Review

What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). While pharmaceutical manufacturing’s overall contribution is small compared to patient use and inappropriate disposal of pharmaceuticals, inadequately managed manufacturing emissions can impact local environments and receiving waters.

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Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN

Fierce Pharma

A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.

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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.