Fierce Pharma

JANUARY 4, 2024

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. | Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

Side effects 333

Side effects FDA Patients 333

MedCity News

JANUARY 4, 2024

Contraline released promising data from the clinical trial it’s conducting to test the efficacy of Adam, its male birth control product. The nonhormonal gel seems to be doing a good job of blocking the flow of sperm to the vas deferens, and no serious adverse events have been reported.

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Fierce Pharma

JANUARY 4, 2024

Even after the heady highs of the COVID-19 era, the contract development and manufacturing organization (CDMO) realm remains one of biopharma's buzziest fields. | Even after the heady highs of the COVID era, the CDMO realm remains one of biopharma's buzziest fields. In 2024, CDMOs can advance their priorities on three fronts, a group of experts said during a recent Evaluate webinar on the state of the industry.

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Biopharma Manufacturing 257

MedCity News

JANUARY 4, 2024

Patient Reported Outcome Measures (PROM) scores should be the gold standard for how patients find their doctors, not viewing subjective online reviews of doctors’ ability to satisfy their patients.

Doctors 116

Doctors Patients Physicians 116

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Distribution

Fierce Pharma

JANUARY 4, 2024

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. | Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio has signed a second outcomes-based reimbursement agreement for its sickle cell gene therapy Lyfgenia.

Competition 245

Competition 245

MedCity News

JANUARY 4, 2024

Mount Sinai is out of network for UnitedHealthcare’s employer-sponsored and individual plans as of January 1 due to a payment dispute. Both parties are likely at fault for getting to this point, one expert declared.

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Networking 114

MedCity News

JANUARY 4, 2024

Hospitals markedly improved their compliance with price transparency regulations in 2023, according to a new report. It found that more than 90% of hospitals have posted a machine-readable file containing gross charges, negotiated charges and cash prices for the services and items they provide.

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Fierce Pharma

JANUARY 4, 2024

This year, CVS Health plans to employ the classic "out with the old, in with the new" mantra when it comes to AbbVie’s Humira. | The changes to major commercial formularies will take effect April 1 and favor Humira biosimilar options over the branded drug as part of CVS' efforts to ramp up U.S. biosimilar adoption.

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PharmExec

JANUARY 4, 2024

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

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FDA Patients 104

Fierce Pharma

JANUARY 4, 2024

As bankers predict a rise in private equity exits this year, one of 2024’s M&A moves could come from the drug manufacturing realm. | Investment giant Bain Capital is weighing a potential sale of its Dutch antibiotics and active pharmaceutical ingredients (API) specialist Centrient Pharmaceuticals, which could be valued as high as €1 billion ($1.09 billion), Bloomberg reported Wednesday, citing people close to the talks.

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Manufacturing Sales Pharmaceutical 214

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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.

Safety

MedCity News

JANUARY 4, 2024

NewSpring has closed on its fourth healthcare fund, which raised more than $180 million. It has already made six investments, including Healthworks and BetterNight.

Healthcare 108

Healthcare Healthcare 108

Fierce Pharma

JANUARY 4, 2024

Merck has reportedly settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017. | Merck has settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017, Bloomberg Law reports. With the settlement—terms of which were not disclosed—the insurance companies avoided a ruling that would have provided precedent for other cases involv

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Insurance Pharma 202

MedCity News

JANUARY 4, 2024

In aggregate, value based care has yet to produce the consistent, positive results that we seek. But VBC’s slow start is actually a reflection of the difficulty of transitioning away from our entrenched healthcare compensation system.

Healthcare 99

Healthcare Healthcare 99

Fierce Pharma

JANUARY 4, 2024

Article by Richard Pops, CEO of Alkermes | Alkermes, a pioneer in neuroscience therapeutics, is building on its foundation as it emerges as a pure neuroscience company.

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Leads Patients 198

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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

Distribution

MedCity News

JANUARY 4, 2024

The model will be challenging to implement since the expansive vision and cautious operational model don’t naturally align. But it could see positive reactions from the clinician community which – while seeing the need for change and technological innovation – is deterred by visions of disruption at the operational or at more granular, process levels.

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European Pharmaceutical Review

JANUARY 4, 2024

According to a paper recently published in the Biochemical Engineering Journal , challenges such as strict regulation and lack of industry awareness, limit the adoption of Industrial Internet of Things (IIoT) in bioprocessing and overall bioproduction. As a system that uses various technologies , such as data analytics and artificial intelligence (AI), to transfer data between each other autonomously in an industrial setting, IIoT “enables wide-scope data collection and utilisation, and reduces

Manufacturing 97

Manufacturing Biopharma Engineering Training 97

pharmaphorum

JANUARY 4, 2024

Scientists at Roche and Harvard University have discovered a new class of antibiotic that can kill carbapenem-resistant Acinetobacter baumannii (CRAB), a major public health threat

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Pharmaceutical Technology

JANUARY 4, 2024

Pfizer Canada has received Health Canada approval for gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of haemophilia B.

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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.

Safety

pharmaphorum

JANUARY 4, 2024

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

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FDA 90

Pharmaceutical Commerce

JANUARY 4, 2024

Electronic health record messaging network found to improve communication and lead to better medication adherence.

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Electronics Healthcare Provider Healthcare Healthcare 102

pharmaphorum

JANUARY 4, 2024

Novo Nordisk has reaped the first harvest from its wide-ranging alliance with life sciences investor Flagship Pioneering, buying rights to two programmes from the VC’s portfolio companies Omega Therapeutics and Cellarity.

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European Pharmaceutical Review

JANUARY 4, 2024

New research from the US indicates that a prophylactic treatment before immunotherapy can significantly reduce the rate of cytokine release syndrome (CRS) in multiple myeloma patients. Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). Prophylactic treatment as a preventative measure The new study, published in Blood Cancer Discovery , stated that in the future, this could eliminate the need

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Side effects Food and Drug Administration Patients Medicine 78

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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.

Specialization

pharmaphorum

JANUARY 4, 2024

CVS Health will remove AbbVie’s immunology blockbuster Humira from national lists of reimbursable products, and offer biosimilars of the drug instead

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PharmaTimes

JANUARY 4, 2024

Metastatic cancer is estimated to be responsible for 90% of cancer deaths

Patients 117

Patients 117

pharmaphorum

JANUARY 4, 2024

A digital therapeutic developed by Vicore Pharma and Alex Therapeutics has been shown to reduce anxiety in patients with pulmonary fibrosis in a pivotal trial

Pharma 83

Pharma Patients 83

European Pharmaceutical Review

JANUARY 4, 2024

US researchers have demonstrated the potential of a targeted drug delivery method that uses focused ultrasound in combination with anti-amyloid-beta monoclonal antibody treatment, as a way to accelerate brain amyloid-beta plaque clearance in Alzheimer’s. The paper, published in the New England Journal of Medicine , described that in the first-in-human study, the focused ultrasound system was able to safely and temporarily open the blood-brain barrier to allow the anti-amyloid-beta antibodies inc

Medicine 74

Medicine Leads Patients Pharmaceutical 74

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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

Leads

PharmaTimes

JANUARY 4, 2024

High amounts of disrupted sleep were found to affect memory and thinking performance

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pharmaphorum

JANUARY 4, 2024

German pharma Merck has paid $45m upfront to license a potential first-in-class therapy for colorectal cancer from New York biotech Inspirna

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Pharma 80

PharmaVoice

JANUARY 4, 2024

Key strategies for bringing more patients into the clinical trial fold.

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Recruitment Patients 105

pharmaphorum

JANUARY 4, 2024

Boehringer Ingelheim has signed a collaboration with China’s Ribo to develop treatments for NASH/MASH using siRNA drugs

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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.

Management