Fri.Aug 18, 2023

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Biogen kicks off 1,000 layoffs as part of CEO Viehbacher’s ‘complete redesign’

Fierce Pharma

It was only last spring that Biogen started a | It was only last spring that Biogen started layoffs that eventually shrank the company’s headcount by nearly 900 people last year. Now, a fresh round of job cuts targeting 1,000 positions has kicked off at the struggling drugmaker. At the same time, Biogen is spending $7.3 billion to buy rare disease specialist Reata Pharmaceuticals.

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Why Blue Shield of California Is Shaking Up its Prescription Drug Model

MedCity News

Blue Shield of California is cutting many of its ties with CVS Caremark (though not all) and adding four additional partners for its prescription drug benefits. These partners include Mark Cuban Cost Plus Drug Company and Amazon Pharmacy. The changes are needed to disrupt the current broken system, said Salina Wong, senior director of clinical pharmacy programs at Blue Shield of California.

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Moderna's updated COVID shot stands strong against new variants in first look at trial data, company says

Fierce Pharma

Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape, which includes a sh | Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape.

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Micro-Credentials Could Begin To Resolve the Nursing Shortage in as Little as One Month

MedCity News

We can begin to solve America’s nursing shortage in very short order with innovative educational and apprenticeship approaches that let young healthcare workers move up the skill ladder more quickly. Hospitals across the country are desperately struggling to find nurses. Traditional nursing programs take years of schooling with costs running to more than $100,000.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Fierce Pharma

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited im | Alongside a Friday approval for its ultra-rare disease medicine Veopoz, Regeneron now expects a high-dose Eyelea nod in the next few weeks after resolving inspection issues at third-party filler Catalent.

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Bruker to buy cell biology company PhenomeX for $108m

Pharmaceutical Technology

Bruker has entered into a definitive agreement to acquire functional cell biology company PhenomeX for a total equity value of $108m.

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AbbVie achieves win for migraine prevention drug Aquipta in Europe

Pharmaceutical Technology

The decision brings the first daily oral migraine prophylactic to Europe, with plans to rollout the treatment as soon as possible.

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On blockbuster mission, Merck says Welireg hit endpoint in renal cell carcinoma trial

Fierce Pharma

Two years after Welireg's original approval in the rare von Hippel-Lindau (VHL) disease, Merck is looking to expand its drug's reach and turn it into a blockbuster. | The drug, which was originally approved in rare von Hippel-Lindau (VHL) disease, showed improvements in progression-free survival in a phase 3 trial comparing the med with Novartis' Afinitor.

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Medtech Funding Expected to Pick Up In 2023 After Q1’s Low Point

MedCity News

Medtech funding reached its low point in the first quarter but will slowly pick back up over the rest of 2023, according to a new Pitchbook report. It noted that this year’s medtech funding total will not come close to the $19.7 billion the sector raised in 2021, and it might even come in below last year’s funding total of $13.5 billion.

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Publishers, Internet Archive Agree to Consented Judgment

Copyright Clearance Center

A stipulated permanent injunction prevents the Internet Archive from offering unauthorized copies of books to the global public.

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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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EMA accepts for review Iveric Bio’s MAA for geographic atrophy therapy

Pharmaceutical Technology

Astellas Pharma has announced that EMA has accepted the MAA from its subsidiary Iveric Bio for the review of ACP to treat GA.

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CHMP to review MAA for geographic atrophy treatment

European Pharmaceutical Review

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). “This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide.

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Boehringer Ingelheim advances weight loss drug to Phase III trials

Pharmaceutical Technology

Depending on Phase III results, survodutide could soon enter the weight loss market, which is expected to reach $37.1bn by 2031.

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Men with enlarged prostates offered robotic treatment by fourth University Hospital

PharmaTimes

Aquablation is a robotic method that uses a high-pressure saline solution to remove tissue - News - PharmaTimes

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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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InBody Hits Milestone: 100 Million Tests Recorded Globally on Their LookinBody Web Platform

Legacy MEDSearch

Highlighting a growing interest in body composition data, InBody is celebrating a long-anticipated milestone: 100 million tests taken globally on their body composition analyzers as of Friday, Aug. 4. “We’ve come a long way since InBody’s founding in 1996,” said Harry Yun, CEO of InBody USA. “The popularity of our tests is skyrocketing. Even the American Medical Association is changing their tune about BMI and recommending that body composition testing be used in clinical settings.

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Behind Flagship Pioneering’s triumphs and tribulations

PharmaVoice

With Flagship and Pfizer’s newly announced partnership to find the next big blockbuster, we’re examining some of the VC fund’s biggest successes and failures to date.

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EIP Pharma merges with CervoMed

PharmaTimes

The amalgamated company will focus on advancing neflamapimod for the treatment of dementia - News - PharmaTimes

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How competitive intelligence can give pharma companies an edge

Pharmaceutical Technology

Competitive intelligence is a vital tool of the research and analysis toolbox for firms wanting valuable data on their market, competitors and customers

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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How Breakthrough Technologies are Shaping Clinical Trials with Stuart Malcolm

PharmaTech

Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, speaks on how advancing technologies are shaping clinical trials.

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Coeptis licenses Deverra Therapeutics’ clinical stage assets

Pharmaceutical Technology

Coeptis Therapeutics has exclusively licensed allogeneic immuno-oncology platform and clinical stage assets from Deverra Therapeutics.

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EMA Reviews Data on Paternal Exposure to Valproate

PharmaTech

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

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Imugene licenses potential first-to-market allogeneic CAR T for blood cancers

Pharmaceutical Technology

Imugene's azercabtagene zarpreleucel (azer-cel) allo-CAR T cell therapy has shown a 58% ORR and 41% CR rate across all doses.

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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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Case Study: Positive HIV-1 Status Should Not Preclude Heart Transplant

Pharmacy Times

Previous studies have shown promising results with liver or kidney transplants in patients with HIV, but there was a lack of literature regarding heart transplants specifically.

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Nuvectis receives orphan drug designation for cholangiocarcinoma therapy

Pharmaceutical Technology

Nuvectis Pharma has received US Food and Drug Administration (FDA) orphan drug designation for NXP800 to treat cholangiocarcinoma.

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Use of First-Line Treatment for Insomnia Low Among Adults With Mental Health Conditions

Pharmacy Times

Although the rate of people with probable insomnia who discussed their sleep habits with a physician was relatively high, the number of people who went on to seek actual treatment was low.

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Signal: Abortion pill restriction may drive more patients to off-label drug

Pharmaceutical Technology

As restrictions on abortion drug mifepristone loom, doctors and patients are looking to off-label misoprostol as an alternative.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Data Show Durable Efficacy With Repotrectinib for Locally Advanced or Metastatic ROS1-Positive NSCLC

Pharmacy Times

Based on results from a trial of repotrectinib in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer, the FDA accepted the New Drug Application and set a Prescription Drug User Fee Act goal date of November 27, 2023.

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FDA Clears Ipsen’s Sohonos

PharmExec

Treatment indicated as the first and only for patients with fibrodysplasia ossificans progressiva.

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Precision Medicine Has Broadened the Application of Gene Therapy Testing, Further Specialization May Be Needed to Interpret Results

Pharmacy Times

Opportunities for an additional specialization in molecular pathology may be helpful to train professionals in the real-time interpretation of gene therapy test results.

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Payer Key Business Factors for Orphan Product Launches

Pharmaceutical Commerce

Supporting health plan clinical preparation and financial modeling.

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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.