Wed.Mar 20, 2024

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BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

Sales 332
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Why Are Most Provider-Sponsored Health Plans Unprofitable?

MedCity News

The “vast majority” of provider-sponsored health plans are unprofitable, Flare Capital Partners Principal Parth Desai pointed out during a recent interview. He said most of these plans aren’t able to cover the large number of lives required to ensure a viable risk pool and maintain a healthy operating margin.

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Johnson & Johnson accuses former employee of taking thousands of files to new role at Pfizer

Fierce Pharma

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. | The company is accusing former employee Andrew Brackbill of downloading thousands of confidential strategy-related files before leaving for rival Pfizer.

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What Are the Challenges Facing the Pharmacy Industry Right Now?

MedCity News

The regulatory environment and workforce shortages are plaguing the pharmacy industry, one Walgreens exec shared at the Abarca Forward conference on Tuesday.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension

Fierce Pharma

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

FDA 266
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Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

MedCity News

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein.

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Lonza to acquire major biologics manufacturing facility

European Pharmaceutical Review

Lonza has agreed to acquire one of the world’s largest biologics manufacturing sites (by volume), for a total of $1.2 billion from Roche. The acquisition of the manufacturing facility will significantly increase Lonza’s capacity of the manufacture of large-scale biologics, to meet demand for commercial mammalian contract manufacturing. At present, the Genentech Vacaville facility in the US has a total bioreactor capacity of around 330,000 litres.

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After Opdivo flop in liver cancer, Bristol Myers finds Yervoy combo could save lives

Fierce Pharma

Bristol Myers Squibb is gunning for newly diagnosed unresectable liver cancer—again—after an immunotherapy setback five years ago. | Bristol Myers Squibb is gunning for newly diagnosed unresectable liver cancer—again—after its Opdivo monotherapy setback five years ago and a subsequent market withdrawal.

Marketing 246
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Germany largest revenue contributor in Europe’s LIMS market

European Pharmaceutical Review

According to a report by Arizton, the Europe laboratory information management system (LIMS) market is expected to reach $912.47 million by 2028. The market is growing at a CAGR of 10.16 percent between 2022-2028, the research found. Factors shaping the market partnerships and collaborations “promise huge demand and growth opportunities for small and medium-sized firms to enter the [European LIMS] market” With pharmaceutical and biotechnological industries making large R&D investments, the

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With exec appointments and new pharma unit, Bayer's overhaul takes shape

Fierce Pharma

Early this month at an investor event, Bayer CEO Bill Anderson—the agent for reform of the troubled company—declared that employees “are ready for change. They’re saying bring it on.” | Early this month at an investor event, Bayer CEO Bill Anderson declared that employees “are ready for change." On Wednesday, Anderson answered the call with changes to the company’s leadership.

Pharma 234
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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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Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval

Pharmaceutical Technology

Johnson & Johnson has received approval from the FDA for EDURANT PED to treat human immunodeficiency virus-1 (HIV-1) in children.

FDA 110
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Vicore’s lung disease digital therapy gets breakthrough tag

pharmaphorum

Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis

FDA 101
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Researchers suggest treatments for rare diseases could reduce burden of kidney disease

PharmaTimes

Rare kidney diseases are a group of conditions which account for over 5% of people living with chronic kidney disease

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Breaking Down Barriers to Obesity Care

MedCity News

How targeted outreach and heightened engagement can help companies achieve better outcomes

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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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Hubs East 2024: Leveraging Digital Hubs

Pharmaceutical Commerce

Presentation offers insight on this aforementioned model that assists retail and specialty-lite brands.

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Orchard’s MLD gene therapy becomes costliest US medicine

pharmaphorum

Orchard Therapeutics has revealed the US price of Lenmeldy, its gene therapy for rare disease MLD, placing a $4.

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Unlocking U.K. research excellence: Key insights from the Research Professional News Live summit

Clarivate

Discover pivotal insights shaping the landscape of U.K. research shared at the second Research Professional News Live summit. From discussions on REF2029 to the imperatives of fostering diversity, innovation and research integrity, we explored the future of research amidst financial challenges and evolving policies. On March 14, the Research Professional News Live summit brought together a stellar group of speakers, panelists and delegates including keynotes from Professor Dame Jessica Corner, E

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EU pharma legislation reforms inch closer to fruition

pharmaphorum

EU pharma legislation gets closer to fruition as European Parliament's ENVI committee votes in favour of amendments, but industry remains concerned

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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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ebook: A practical guide to single-use filtration in biopharma

European Pharmaceutical Review

Single-use filtration systems can help streamline processes and enhance efficiency of biopharma production. In this practical guide readers will embark on a journey through pre-filtration and sterile filtration stages, gaining insight into diverse membrane technologies. Download this ebook to: Uncover how pore size and membrane material can be used to tailor filtration processes Learn how to optimise flow rates to balance efficiency and quality Discover how single-use filtration systems can boos

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Lonza adds biologics capacity with $1.2bn Roche deal

pharmaphorum

Swiss CDMO Lonza pays $1.2bn for Roche's biologics manufacturing facility in Vacaville, US, safeguarding around 750 jobs.

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New study reveals neurological conditions as leading cause of ill health worldwide

PharmaTimes

In 2021, neurological conditions, including Alzheimer's disease, affected approximately 3.

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Gates, Wellcome-backed TB vaccine starts phase 3 trial

pharmaphorum

A highly anticipated phase 3 trial of a new tuberculosis vaccine developed by GSK has started in Africa, funded by the Gates MRI and Wellcome.

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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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FDA approves Boehringer’s SPEVIGO for psoriasis treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim's SPEVIGO injection to treat generalised pustular psoriasis (GPP).

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Iclusig gets FDA nod as frontline therapy for rare leukaemia

pharmaphorum

Takeda’s Iclusig is first targeted therapy approved by the FDA for use alongside chemo as a first-line therapy for acute lymphoblastic leukaemia

FDA 74
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Why Traditional Sales Role Play Falls Short

Quantified

The internet is full of statistics that demonstrate how vital sales training is. Whether you’re measuring the productivity of each agent, the total ROI of training initiatives, or the percentage increase of closed-won deals, training makes a sizeable difference. The trick is identifying which training methods are contributing to increases and, whenever possible, which training exercises contribute the most to sales success.

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Phosgene at Valsynthese: An Atom-Economic Reagent That Demonstrates Exceptional Versatility (March 2024)

PharmaTech

Dr. Luca Mantilli, an R&D chemist at Valsynthese, shares his insights into the company’s journey with phosgene, an exceptionally versatile reagent that offers various synthetic possibilities.

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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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Orchard sets out to sell world’s priciest gene therapy

PharmaVoice

Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25 million list price, the highest of any genetic medicine to come to market.

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PAP 2024: Amy Niles Discusses Moderating the State of Patient Access and Affordability Breakout Session

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, PAN Foundation offers her thoughts on the session and feedback from the audience at PAP 2024 in Philadelphia.

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What is Neurosurgery Device Sales? with Eddie Cortez

Evolve Your Success

Unlock the secrets of thriving in the competitive world of medical sales with Eddie Cortez of Integra Life Sciences’ Neurosurgery West Division. Join us as Eddy, with his 14 years of experience, shares the journey from the front lines in the operating room to leading a sales team, providing a rare glimpse into the dynamic space of neurosurgical product sales.

Sales 52
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PAP 2024: Monique French Discusses Effective Ways to Engage Patients, Caregivers, and Advocacy Groups

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Monique French, MPH, Senior Director, Patient Advocacy, Health Policy & Communications, Rx4Good provides insight on engaging multiple healthcare groups.

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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.