Trending Articles

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Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group

Fierce Pharma

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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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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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

MedCity News

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?

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Levo Health Sponsors Tampa Bay Wave’s HealthTech|X Accelerator Program

LEVO Health

At Levo Health, we’re always on the lookout for opportunities to push the boundaries of healthcare marketing and support innovations that can transform the industry. This year, we’re thrilled to take our commitment a step further by sponsoring the 2024 HealthTech|X Accelerator program hosted by Tampa Bay Wave. Tampa Bay Wave has a proven track record of fostering startup success, having supported 527 startups, collectively raising over $900 million in capital and creating more than 5

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Metsera lands with $290m to take on obesity giants

pharmaphorum

New obesity biotech Metsera formally launches, led by Clive Meanwell and with a $290m warchest to take on the likes of Novo Nordisk and Eli Lilly.

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Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

Fierce Pharma

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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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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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

MedCity News

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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At Princeton University Press, The Mission is “Our Compass”

Copyright Clearance Center

In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.

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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today!

MedCity News

In addition to panel discussions around some of the hottest topics in healthcare transformation, there is also a startup pitch contest, a presentation on government funding for startups and networking opportunities. The post Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today! appeared first on MedCity News.

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Estetrol by Mithra Pharmaceuticals for Genitourinary Syndrome of Menopause (GSM): Likelihood of Approval

Pharmaceutical Technology

Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).

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Technology advancement driving growth of rapid sterility testing market

European Pharmaceutical Review

A report by Market Research Future has predicted that the rapid sterility testing market will increase in value from $2.3 billion in 2023 to $4.3 billion by 2032. It is expected hold a compound annual growth rate (CAGR) of 8.20 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to t

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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‘Stiffness’ of cells could give early warning of cancer

pharmaphorum

Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.

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Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN

Fierce Pharma

A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.

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Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

MedCity News

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. The post Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too appeared first on MedCity News.

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Inflammation among current dementia research focus, says Alchemab CSO

Pharmaceutical Technology

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

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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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Novartis releases new data for innovative rare kidney disease treatment

European Pharmaceutical Review

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN).

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Heart disease risk ‘calculator’ could save lives

pharmaphorum

UK researchers describe an algorithm that is more accurate than current tools at predicting an individual’s risk of developing cardiovascular disease in the next 10 years.

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Pfizer, BioNTech win pause in patent infringement case from rival Moderna

Fierce Pharma

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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Guidance and Education For Employees Facing a Cancer Journey

MedCity News

In vulnerable moments when employees need it most, virtual specialty care delivers a human connection that offers empathy, support, and guidance. The post Guidance and Education For Employees Facing a Cancer Journey appeared first on MedCity News.

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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.

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Trial Findings for Minimally Invasive Parafascicular Technology Show Promise for Intracerebral Hemorrhage Treatment

Pharmaceutical Commerce

Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.

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Fujifilm plans $1.2 billion investment in major US manufacturing facility

European Pharmaceutical Review

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

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Activist hedge fund seeks big shake-up at Novavax

pharmaphorum

Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.

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Amgen CEO nabs pay raise thanks to Horizon deal. Does that incentivize aggressive M&A?

Fierce Pharma

Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company’s acquisition of Horizon Therapeutics. | Amgen CEO Robert Bradway scored a 5.8% increase in overall compensation last year mostly thanks to the company's acquisition of Horizon Therapeutics.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.