Trending Articles

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With EU agency's ruling, Moderna tallies a win in vaccine patent war against Pfizer and BioNTech

Fierce Pharma

After Moderna last year suffered a loss in its heated patent fight against Pfizer and BioNTech, the mRNA drugmaker can now celebrate a win. | The win comes after a prior decision from the European Patent Office that invalidated Moderna's other asserted patent.

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It’s Past Time to Prevent Polypharmacy in U.S. Healthcare

MedCity News

The dangers of polypharmacy and its increasingly wide reach across the American population make it imperative that we enhance the accuracy and efficiency of medication reconciliation processes. The post It’s Past Time to Prevent Polypharmacy in U.S. Healthcare appeared first on MedCity News.

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With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy

Fierce Pharma

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue

MedCity News

SmarterDx — an AI startup that provides clinical review and quality audits for medical claims — closed a $50 million Series B funding round, bringing its total funding to date to $71 million. The post SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

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Another delay for Ascendis' hormone therapy as FDA extends review by 3 months

Fierce Pharma

It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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Pharma Pulse 5/17/24: Apple Watch's Afib App certified by FDA, Learning Telehealth Platforms Benefits Pharmacy Students & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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Docetaxel albumin bound by CSPC Pharmaceutical Group for Laryngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Laryngeal Cancer.

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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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Bayer slashed 1,500 roles in Q1 as simpler organization takes shape

Fierce Pharma

When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.

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Telehealth Is Far From Dead, Says Providence’s Virtual Care Chief

MedCity News

This year has been a messy one for virtual care companies, but that doesn’t mean that telehealth is dead, according to Eve Cunningham, Providence’s chief of virtual care and digital health. In her view, virtual care can definitely still be an important part of the care delivery model — but only if it is embedded into the greater healthcare delivery ecosystem.

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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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The Interplay Between Copyright Licensing and Exclusive Rights; AI Edition

Copyright Clearance Center

The post The Interplay Between Copyright Licensing and Exclusive Rights; AI Edition appeared first on Copyright Clearance Center.

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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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Docetaxel albumin bound by CSPC Pharmaceutical Group for Oropharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Oropharyngeal Cancer.

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With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide

Fierce Pharma

Though Galapagos has undergone plenty of staff shakeups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following | Galapagos has teamed up with the largest blood supply network in the U.S. to help establish decentralized CAR-T production on a national scale.

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Right-to-Repair Laws Could Threaten Healthcare Safety

MedCity News

Healthcare devices must be exempted from general right to repair legislation. The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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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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Sales Negotiation Skills That Deliver Success

Integrity Solutions

For many in sales, negotiation is one of the most challenging aspects of the job. More often than not, these salespeople approach negotiation as a win-or-lose endurance game, a contentious battle that pits two opposing sides against each other. “Winning” means convincing the customer to accept your point of view—even if the outcome isn’t necessarily in the customer’s best interest.

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Chenodiol by Leadiant Biosciences for Cerebrotendinous Xanthomatosis: Likelihood of Approval

Pharmaceutical Technology

Chenodiol is under clinical development by Leadiant Biosciences and currently in Phase II for Cerebrotendinous Xanthomatosis.

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Shionogi's antiviral comes up short in global COVID-19 trial

Fierce Pharma

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.

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DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference?

MedCity News

The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry. The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? 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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Updated BIOSECURE Act draft clears House committee

pharmaphorum

House Oversight Committee passes BIOSECURE Act, which would restrict US companies from contracting with Chinese biotechs including WuXi AppTec, MGI and BGI

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Ensuring sterility of a novel anti-VEGF bispecific antibody

European Pharmaceutical Review

Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”. Their study compared the stability, sterility, and binding affinity to VEGF and Ang-2 of faricimab.

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Tracking the opioid lawsuit settlements amidst calls for oversight

Pharmaceutical Technology

The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.

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Johnson & Johnson looks to offload remaining Kenvue stake in $3.75B deal

Fierce Pharma

After Johnson & Johnson's consumer healthcare spinoff last year—and its subsequent reduction in holdings in the new company—the healthcare conglomerate is once again cutting its stake in&n | Johnson & Johnson is again cutting its holdings in Kenvue. This time, it's pursuing a "debt-for-equity" offering that looks to be worth about $3.75 billion.

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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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Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model

MedCity News

As more hospitals across the country shut down their maternity wards, a Sutter Health-owned hospital in Berkeley has taken proactive steps to ensure it can continue providing care for the pregnant people in its community. The hospital partnered with Millie, a Berkeley-based startup offering hybrid maternal care from midwives and doulas. The post Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model appeared first on MedCity News.

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Lung disease imaging AI from Brainomix gets FDA nod

pharmaphorum

Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.

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Big Pharma’s most improved drugs: a new generation of blockbusters

PharmaVoice

The old guard of pharma bestsellers is seeing more competition, but newer drugs demonstrating sales and revenue growth can build up the coffers in years to come.

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FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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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.