Wed.Sep 27, 2023

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Former Novartis executive Tsai to lead UK heart drug startup

Bio Pharma Dive

John Tsai, previously Novartis’ chief medical officer, has been named CEO of Forcefield Therapeutics, an 18-month-old biotech working on a treatment for heart attacks.

Drugs 272
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Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

Licensing 264
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ProQR sale of eye drugs comes undone over employment contracts

Bio Pharma Dive

Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.

Sales 280
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Glenmark to market Winlevi in Europe and South Africa after Cosmo deal

Pharmaceutical Technology

The popular acne treatment will soon be available in 15 EU countries in addition to UK and South Africa.

Marketing 245
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BrainStorm’s ALS therapy not effective, FDA panel finds

Bio Pharma Dive

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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September 27, 2023: This Friday’s PCT Grand Rounds to Highlight PROTEUS Consortium

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Claire Snyder of Johns Hopkins University and Norah Crossnohere and Anne Schuster, both of Ohio State University, will present “Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium.” The Grand Rounds session will be held on Friday, September 29, 2023, at 1:00 pm eastern.

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Mobile health strategies: Should you build or partner for success?

Pharmaceutical Technology

With GlobalData figures showing the value of pharma’s 2023 digital therapeutics-related deals to have grown by 129% since 2018, and the year still not out, it is clear that projects such as companion apps are becoming an increasing priority for life science firms. Here, we debate the benefits of building versus partnering, and share some important considerations for a successful project.

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BrainStorm’s ALS therapy not effective, FDA panel finds

Bio Pharma Dive

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Arcturus Therapeutics extends cystic fibrosis treatment deal

Pharmaceutical Technology

Arcturus Therapeutics has extended an existing agreement in place with the Cystic Fibrosis Foundation (CF Foundation) for advancing ARCT-032.

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Inside Bavarian Nordic’s late-stage stumbles — and drive to become a vaccine giant

Bio Pharma Dive

Despite the company's recent Phase 3 setbacks in RSV and COVID, CEO Paul Chaplin sees a path forward for the Dutch biotech in the travel vaccine market.

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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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Avalyn raises $175m in funding to develop inhaled IPF drugs

Pharmaceutical Technology

The funding was part of an oversubscribed Series C financing that will be used to advance its lead IPF therapies into Phase II trials.

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Women in Science: ScaleReady’s Jenny Stjernberg and her fervent passion for cell and gene therapies

BioPharma Reporter

At Advanced Therapies Europe 2023, BioPharma Reporter caught up with ScaleReady's Jenny Stjernberg to discuss her work at the biotech company, her journey from academia to commercial and female representation in the cell and gene therapies industry.

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Alfasigma to buy Intercept Pharmaceuticals for $794m

Pharmaceutical Technology

Alfasigma has signed a definitive agreement for the acquisition of Intercept Pharmaceuticals in an all-cash deal valued at $794m.

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The epigenetic edge: Harnessing precision medicine’s potential 

Drug Discovery World

HKG Epitherapeutics is a biotechnology company developing novel tools for the early detection of cancer and promoting healthy aging. Founder Dr Moshe Szyf Founder shares the potential of harnessing precision medicine. Embarking on a new era of medicine The advent of genomics has ushered in the era of personalised medicine, enabling us to analyse the genetic makeup of individuals with unprecedented accuracy.

DNA 115
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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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Novo Nordisk and Evotec launch translational drug discovery accelerator

Pharmaceutical Technology

The partnership will help advance preclinical concept in the cardiometabolic disorder space from four academic institutions.

Drugs 130
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Patient Death Likely from Virus Used to Deliver Gene-Editing Therapy: NEJM Study

BioSpace

The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.

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Galecto downsizes by 70% following Phase II trial failure

Pharmaceutical Technology

Apart from the workforce cuts, the company is also considering asset divestment and mergers as part of a strategic review.

Trials 130
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NHS Confederation research supports investment in NHS services

Pharma Times

Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes

Research 131
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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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UKHSA signs influenza vaccine deal with CSL Seqirus

Pharmaceutical Technology

UKHSA has signed an advance purchase agreement (APA) with healthcare company CSL Seqirus for influenza pandemic vaccines.

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Colorectal Cancer Clinical Trials & Patient Participation: Bridging the Gap

XTalks

Colorectal cancer, the third most frequently diagnosed cancer for both women and men in the US, continues to be a significant area of focus for the medical community. As advancements in research forge ahead, it is imperative to ensure patients are informed about and can access potentially life-saving clinical trials. Enter the Colorectal Cancer Alliance.

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MilliporeSigma opens two new mRNA manufacturing facilities in Germany

Pharmaceutical Technology

MilliporeSigma has opened two new messenger ribonucleic acid (mRNA) drug substance manufacturing facilities in Germany.

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Portsmouth NHS Trust maternity team enhances patient experience

Pharma Times

Patient waiting times to receive an appointment have reduced from 6-8 weeks to just 24 hours - News - PharmaTimes

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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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Roche Doubles Down on Alzheimer’s, Huntington’s with $60M Ionis Partnership

BioSpace

The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.

RNA 98
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As Viatris seeks growth in eye care, its Ocuphire-partnered dilation drop Ryzumvi wins FDA nod

Fierce Pharma

Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S. in the first half of 2024.

Sales 94
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FDA Approves Viatris, Ocuphire’s Eye Drops to Reverse Pupil Dilation

BioSpace

The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.

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NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer

Fierce Pharma

NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer aliu Wed, 09/27/2023 - 10:40

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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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Karuna Submits Highly Anticipated NDA for KarXT in Schizophrenia

BioSpace

If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.

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'We can't forget about this': As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions

Fierce Pharma

It’s been about 10 months since FDA inspectors rebuked a | As some cancer centers struggle to secure access to key platinum-based chemotherapies, a national spotlight gives the issue newfound political importance. But will this be a turning point for the recurrent shortage issue? ASCO's Julie Gralow, M.D., certainly hopes so.

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Ahmed Mousa: From the Hill to the C-Suite

BioSpace

As the incoming CEO of Vicore, Mousa is ready to rally for fresh investment to advance cures for respiratory conditions.

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In Emgality patent case against Teva, Lilly wins reversal of $177M verdict

Fierce Pharma

A U.S. judge has sided with Lilly, overturning a $176.5M jury verdict awarded to Teva in a patent infringement squabble over competing migraine drugs.

Drugs 97
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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.