April, 2024

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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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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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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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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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EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

PharmaTech

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

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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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Report: How MA Plan Design Affects Utilization, Health Equity

MedCity News

A new study found that enrollees with zero-premium MA plans are three times as likely to be non-White compared to other MA enrollees and traditional Medicare enrollees. The post Report: How MA Plan Design Affects Utilization, Health Equity appeared first on MedCity News.

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The 7 Ps of Marketing

Healthcare Success

As an engineering undergrad, I took a Marketing 101 class on a lark, seeking to better understand the psychology behind consumer behavior and developing products with a competitive edge. On the first day of class, we learned the fundamental concept of the 4 Ps of marketing. However, today, I like to use an expanded “7 Ps” definition. In any event, this marketing mix remains essential for any successful marketing strategy.

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NHS trust bids to take license for abandoned gene therapy

pharmaphorum

Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.

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FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

PharmaTech

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

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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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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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Number of ongoing US drug shortages reaches new high, pharmacist group says

Fierce Pharma

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

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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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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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UK calls time-out on post-Brexit rules opposed by industry

pharmaphorum

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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Next-gen menopause treatments have blockbuster potential. Can women, doctors and payers be convinced?

PharmaVoice

The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?

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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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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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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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Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem

MedCity News

Nurse managers being too busy to train and support their team members is one of the biggest reasons nurses are exiting the healthcare industry, according to a new report. The post Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem appeared first on MedCity News.

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Ed Schoonveld Discusses Drug Pricing in the US and Upcoming Articles

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.

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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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Unlocking growth: How GenAI can help pharma companies convert new clients

PharmaVoice

GenAI is profoundly reshaping various facets of the pharmaceutical industry. Projections indicate that the global GenAI market in pharma will soar to USD 2258.1 million by 2032.

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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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Microbial burden assessment of solid pharmaceutical products

European Pharmaceutical Review

The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden , stated Prada-Ramírez et al.

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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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AHA Urges Labor Department to Investigate MultiPlan’s ‘Unconscionable Practices’

MedCity News

Following an extensive investigative report from the New York Times, the AHA is calling for the Labor Department to probe into the business practices of data analytics firm MultiPlan. The report revealed that MultiPlan works with major payers to negotiate reduced reimbursements for out-of-network medical providers — and this that practice ends up costing patients and employers.

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Ed Schoonveld Discusses List Prices for Pharmaceuticals in the US Compared to Other Countries

Pharmaceutical Commerce

In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.

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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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Sage drops dalzanemdor for Parkinson’s after trial flop

pharmaphorum

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

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Women want to participate in clinical trials. Lack of flexibility is still a problem.

PharmaVoice

Underrepresentation of women in clinical trials affects the resulting drugs that are available down the line. Encouraging more women to partake is a critical step in promoting more equitable healthcare.

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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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AstraZeneca, Daiichi Sankyo's Enhertu wins historic HER2 tumor-agnostic FDA nod

Fierce Pharma

With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.

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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.