Tue.Nov 21, 2023

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Drugs 353
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Roche’s Genentech partners with Nvidia in AI drug deal

Bio Pharma Dive

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

Drugs 328
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FDA delays assessment of BMS and 2seventy’s CAR-T therapy

Pharmaceutical Technology

The FDA's decision on the sBLA for Abecma will be delayed beyond the set PDUFA target date of 16 December.

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Quotient emerges from Flagship with plan to explore somatic mutations

Bio Pharma Dive

Studying somatic mutations could be “the next wave of opportunity” to develop more precise medicines, said Mike Stratton, one of Quotient’s scientific co-founders.

Medicine 287
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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

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UK launches medicines scheme with £400m earmarked for clinical trials

Pharmaceutical Technology

The new scheme will launch in 2024 and aims to save the National Health Service (NHS) £14bn over five years.

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Medtronic CEO downplays impact of obesity drugs on procedures, devices

Bio Pharma Dive

Surging demand for GLP-1 agonists has put medtech firms like Medtronic under pressure, even as they argue the hit to their businesses will be minimal.

Drugs 278

More Trending

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Merck to buy private biotech Caraway in neuroscience deal

Bio Pharma Dive

In a deal worth up to $610 million, Merck will gain a pipeline of neuroscience and rare disease programs from a startup it previously backed.

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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

Vaccine 145
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Two charities co-fund £5.5m childhood cancer research programme

Pharma Times

SMPaeds2 aims to advance precision medicines for children with relapsed cancer - News - PharmaTimes

Research 143
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With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma's patent tactics

Fierce Pharma

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. | The U.S. Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process. And it's Sanofi’s turn to land in the crosshairs.

Insulin 136
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Lab-grown blood vessels could potentially treat strokes and vascular dementia

Pharma Times

Cerebral SVD contributes to 45% of dementia cases and 20% of ischaemic strokes - News - PharmaTimes

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Texas accuses Pfizer and contract manufacturer of providing ineffective ADHD drug to state's Medicaid program

Fierce Pharma

Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades.

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Ascendis’ parathyroid hormone replacement therapy wins European approval

Pharmaceutical Technology

Despite a US FDA rejection for the drug earlier this year, the European Commission has approved Yorvipath for chronic hypoparathyroidism.

Hormones 130
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GSK aims to slash carbon emissions with next-generation inhaler

Fierce Pharma

Joining drugmakers like AstraZeneca and Novo Nordisk, GSK is making big strides in its quest to clean up its carbon footprint. | GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%.

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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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BeiGene strikes deal worth $1.3bn with Ensem for CDK2 inhibitor 

Pharmaceutical Technology

Ensem will receive an upfront payment and will be eligible for additional payments upon the achievement of milestones, totalling up to $1.33bn.

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New NICE Advice service

pharmaphorum

New NICE Advice service Mike.

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Merck & Co bolsters neurogenerative portfolio with Caraway acquisition

Pharmaceutical Technology

Merck & Co will acquire all outstanding shares of Caraway, which has a preclinical-stage drug portfolio, through a subsidiary.

Drugs 130
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GSK says new inhaler will help slash its carbon footprint

pharmaphorum

GSK says new inhaler will help slash its carbon footprint Phil.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Janssen seeks FDA approval for lung cancer combination therapy

Pharmaceutical Technology

Janssen has sought US FDA approval for the Rybrevant combination regimen for locally advanced or metastatic non-small cell lung cancer.

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Bayer's trial flop, courtroom setback could restrict CEO's options amid strategic review: analyst

Fierce Pharma

After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. | After suffering setbacks in the clinic and in court this week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends.

Trials 116
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Zevra Therapeutics completes Acer acquisition in $91m deal

Pharmaceutical Technology

Zevra Therapeutics has concluded the takeover of complete outstanding shares of Acer Therapeutics in a deal valued at $91m.

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Digital measures for value-based healthcare: Current perspectives

pharmaphorum

Digital measures for value-based healthcare: Current perspectives Mike.

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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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The right tools: How in-house tooling streamlines autoinjector manufacturing

Pharmaceutical Technology

Tooling is a crucial aspect in manufacturing medical devices, and developing plastic injection moulds in-house offers many advantages.

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Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Rethinking Clinical Trials

       Speakers Michael Ho, MD, PhD University of Colorado Sheana Bull, PhD University of Colorado Slides Keywords Nudge, Demonstration Project, Cardiovascular, Adherence Key Points A nudge is a strategic reminder that can help people adopt healthy behaviors, using principles from behavioral economics and cognitive psychology to improve behavior commitments, communicate social norms, and narrative stories.

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MIRA Pharmaceuticals and MIRALOGX sign deal on depression therapy

Pharmaceutical Technology

MIRA Pharmaceuticals has signed a licencing agreement with MIRALOGX for the development and marketing of Ketamir-2 for depressive disorders.

Marketing 130
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Immunometabolism: Providing a new era of targeted medicine

pharmaphorum

In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Neil Weir, CEO of Sitryx Therapeutics, a smaller biotech that specialises in immunometabolism – a rapidly emerging and exciting area of investigation into the role of intracellular metabolic pathways in immune cells.

Medicine 113
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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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Flagship-Founded Microbiome Company Evelo Biosciences Throws in the Towel

BioSpace

In an SEC filing, the biotech launched by Flagship Pioneering said there was no viable alternative to dissolution as its cash ran out and anti-inflammatory assets failed to achieve clinical success.

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Abecma delay gives Carvykti a chance to catch up

pharmaphorum

Abecma delay gives Carvykti a chance to catch up Phil.

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First Rett Treatment Offers Hope to Morell Family at Thanksgiving

BioSpace

When twins Kenzie and Kaylie were diagnosed with Rett syndrome in 2016, there was no dedicated treatment for the neurodevelopmental disorder. That changed this year with the approval of Acadia Pharmaceuticals’ Daybue.

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MSD reaches $610m deal to buy lysosome biotech Caraway

pharmaphorum

MSD reaches $610m deal to buy lysosome biotech Caraway Phil.

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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.