Wed.Oct 04, 2023

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In splitting from Novartis, Sandoz makes muted market debut

Fierce Pharma

After more than a year of preparation, Sandoz has officially parted ways with Swiss drug giant Novartis. But the company's day-one valuation lagged what some analysts had projected. | The generics and biosimilar maker debuted on the SIX Swiss Exchange at 24 Swiss francs ($26.16) for a total valuation of about $11.2 billion. Analysts had previously published ranges of $11 billion to $26 billion for the company, according to Reuters.

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Emerging Behavioral Health Technology: Keeping it Human-Centric

MedCity News

While it’s easy to be consumed by the latest technology and the potential influence it could have, it’s important to remember the ultimate role these platforms should play when it comes to improved patient outcomes.

Patients 122
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Merck's COVID antiviral Lagevrio to hit commercial market in November, HHS says

Fierce Pharma

As long expected, the U.S. government is winding down its distribution of COVID-19 countermeasures. | The government will wind down its Lagevrio distribution ahead of the transition, the Administration for Strategic Preparedness and Response said.

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Individuals Living with Kidney Disease Deserve More From Our Healthcare System

MedCity News

Policymakers must work to increase access to the Medicare Kidney Disease Education Benefit and expand the Medicare annual wellness benefit to include kidney disease screening. These reforms will catch disease at earlier stages and equip patients to better recognize their risk.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Boehringer Ingelheim embraces dual-pricing tactic with launch of unbranded Humira biosimilar

Fierce Pharma

Boehringer Ingelheim, which recently launched the first interchangeable biosimilar to AbbVie’s megablockbuster Humira, is getting in on the industry’s double-pricing trick. | After debuting its branded Humira biosim Cyltezo in July, Boehringer has launched an unbranded copycat of the inflammatory disease drug, simply called adalimumab-adbm injection, which will be sold at an 81% discount to Humira.

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ICHRAs Are Gaining Steam, But Employers are Still Out of the Know

MedCity News

ICHRAs provide employees with more choice on their health benefits. But many employers aren’t very familiar with the new insurance model, executives say.

Insurance 112

More Trending

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FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

PharmaVoice

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said the UltraGenyx CEO and a leading rare disease researcher.

FDA 111
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Colombia, pursuing healthcare savings, plots compulsory license for ViiV's HIV drug dolutegravir

Fierce Pharma

After sparring with GSK’s ViiV Healthcare over the price of its HIV medication dolutegravir, Colombia appears to be taking matters into its own hands. | Colombian authorities say they plan to issue a compulsory license for ViiV Healthcare's dolutegravir, which goes by the name Tivicay on its own or as Dovato when combined with other therapeutics.

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What Pharma Fears Most About AI

PharmExec

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

Pharma 105
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Amgen, AbbVie, Gilead, Merck and more form coalition to push back on FTC's M&A reforms

Fierce Pharma

The Federal Trade Commission (FTC) recently came up short in its attempt to derai | More than 30 companies and biopharma associations have introduced the Partnership for the US Life Science Ecosystem (PULSE) to increase awareness of the value of M&A. After successfully defending itself against the FTC lawsuit, Amgen is among the drugmakers who have signed on.

Biopharma 212
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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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WHO recommends second malaria vaccine

European Pharmaceutical Review

The World Health Organization ( WHO ) has recommended a new vaccine, R21/Matrix-M, to prevent malaria in children. The R21 vaccine is the second malaria vaccine recommended by WHO. This follows the WHO’s recommendation of the RTS,S/AS01 vaccine for the disease in 2021. Novavax’s President and Chief Executive Officer, John Jacobs, declared that the company is “proud” of the role of its saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine.

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Mitigating pharma’s losses from missed diagnoses and lost-to-follow-up: Does AI have a role?

Fierce Pharma

Every year, too many people with health problems fall through the cracks of a complex care continuum. | When patients fall through the cracks of a complex care continuum, drug companies absorb the opportunity costs. Here’s why experts think AI could help recapture those losses.

Patients 173
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Lilly agrees $1.4 billion radiopharma acquisition

European Pharmaceutical Review

Eli Lilly and Company has agreed to acquire the radiopharmaceutical firm POINT Biopharma Global for $1.4 billion. According to Eli Lilly, it will action a tender offer to acquire all outstanding shares of POINT for total purchase price of approximately $1.4 billion. This will be payable once the deal has completed. What radioligand therapies will be developed under the acquisition agreement?

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Sculpting Seamless Patient Experiences: Five hallmarks of a highly effective patient support program

Fierce Pharma

Treatment journeys — especially those involving specialty medications — can be complex and arduous. | Unlock the art of sculpting seamless patient experiences with these five hallmarks of highly effective patient support programs.

Patients 164
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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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Already Partnered With Nvidia and Eli Lilly, Iambic Adds $100M for AI Drug Discovery

MedCity News

Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024.

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Drugmakers face uphill battle in Medicare negotiation suits

PharmaVoice

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

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Providence Plans to Spin Out a New Patient Engagement Startup, Marking Its 4th Incubated Company

MedCity News

Providence announced that it will spin out its fourth digital health startup in the first quarter of next year. The company, called Praia Health, offers a platform designed to build stronger relationships with patients by personalizing their healthcare journeys and connecting them to relevant resources and services.

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Novartis completes Sandoz spin-off

European Pharmaceutical Review

Sandoz, a former division of Novartis, is now a standalone company. Going forward, the company will continue to focus on developing generic and biosimilar medicines for the European medicines market, with focus on sustainable access. The pharmaceutical firm originally announced the proposed departure from Novartis in August 2022. To prepare for the separation, Sandoz stated in June that its headquarters would transfer to Basel, Switzerland.

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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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Decreased Volume Variability & Declining Labor Expenses Are Helping Hospitals’ Finances Bounce Back

MedCity News

Hospitals’ operating margins are still in a worse place than they were before the pandemic, but 2023 is shaping up to be a much more stable year for hospital finance than 2022, according to a new report from Kaufman Hall. Because this year hasn’t had any large Covid-19 surges, hospitals have seen less variability in patient volumes. This has helped them allocate their resources more efficiently and decrease their reliance on expensive contract labor.

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2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19

PharmaTech

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

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Novavax gets green light for updated COVID vaccine

pharmaphorum

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus. The FDA has signed off on the new protein-based shot, which joins two XBB.1.5-directed mRNA-based vaccines from Pfizer/BioNTech and Moderna as options for the upcoming immunisation campaign in the US.

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Kate Therapeutics and Capsida Biotherapeutics collaborate on gene therapies

PharmaTimes

The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes

Patients 107
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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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Strides Pharma gets FDA greenlight to market HIV treatment

Pharmaceutical Technology

Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.

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King Faisal Specialist and Research Centre achieves world-first fully robotic liver transplant

PharmaTimes

The approach reduces recovery times and lowers rates of complications - News - PharmaTimes

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Syneos Health Appoints Colin Shannon as CEO

Pharmaceutical Commerce

Exec joins the organization with decades of biopharma experience.

Biopharma 105
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Sandoz separates from Novartis, valued at just over $11bn

pharmaphorum

Sandoz separates from Novartis, valued at just over $11bn Phil.

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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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How Royal Philips supports growing IP administration demands with integrated Clarivate services and technology [Customer Story]

Clarivate

Royal Philips is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions. To manage their extensive IP portfolio, Philips has a robust Intellectual Property & Standards (IP&S) organization.

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FDA grants EUA for Novavax’s updated Covid-19 vaccine 

Pharmaceutical Technology

The US FDA has amended the EUA of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023-2024 formula.

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Particle Measuring Systems Announce Acquisition of Environmental Monitoring Services Limited and EMS Particle Solutions

PharmaTech

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

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Pfizer’s Hospira issues recall after glass particles found in injectables

Pharmaceutical Technology

The voluntary recall issued by Hospira will affect three different injectables following the potential presence of glass particles.

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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.