Trending Articles

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CSL Seqirus scores 4th award from US government for bird flu pandemic preparedness

Fierce Pharma

The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist to

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How to Get Into Medical Device Sales: Ultimate Career Guide

David Bagga

How to Get Into Medical Device Sales: Ultimate Career Guide Home Blog How to Get Into Medical Device Sales: Ultimate Career Guide How to Get Into Medical Device Sales: Ultimate Career Guide If you are new to medical device sales and interested in getting a job in this field, here are some essential tips that […] The post How to Get Into Medical Device Sales: Ultimate Career Guide appeared first on.

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Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites

Fierce Pharma

A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.

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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Mental Health Inequities Could Cost $1.3 Trillion in 2040. How Can the Industry Prevent This?

MedCity News

Mental health inequities are costing the U.S. $477.5 billion annually. This could rise to $1.3 trillion in 2040 if left unaddressed. The post Mental Health Inequities Could Cost $1.3 Trillion in 2040. How Can the Industry Prevent This? appeared first on MedCity News.

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As Senate’s gaze lands on patents, a former US PTO chief calls the effort a ‘broad misunderstanding’

PharmaVoice

To lower drug prices, lawmakers are turning to the drug patent system to outlaw some common practices — but a former patent agency director says it’s the wrong way to go.

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Digital therapeutics firm Akili agrees $34 million takeover

pharmaphorum

More consolidation in the digital health sector as Akili agrees a $34m takeover by Virtual Therapeutics, returning to private hands.

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J.D. Power: Customer Experience Gap Grows Among Commercial Health Plans

MedCity News

A new J.D. Power ranking of commercial health plans found a major difference in customer satisfaction between the top and bottom-ranked health plans. The post J.D. Power: Customer Experience Gap Grows Among Commercial Health Plans appeared first on MedCity News.

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FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea

Pharmaceutical Technology

The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.

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BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa

Fierce Pharma

As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech | Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda.

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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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How to Become A Medical Device Sales Rep in 2024?

David Bagga

Medical device sales is a burgeoning market, with jobs that have an extremely high earning potential. In 2018, the average base salary of a medical sales representative was $92,698 How to Become A Medical Device Sales Rep in 2024? Home Blog How to Become A Medical Device Sales Rep in 2024? How to Become A […] The post How to Become A Medical Device Sales Rep in 2024?

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Novartis cues up filings for remibrutinib in chronic hives

pharmaphorum

Novartis is just months away from filing for approval of oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria – also known as chronic hives – after reporting long-term data from two phase 3 trials.

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With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better

MedCity News

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. The post With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better appeared first on MedCity News.

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FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Pharmaceutical Technology

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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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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With ruling, Pfizer can escape some claims in legal battle over Chantix carcinogen allegations

Fierce Pharma

Pfizer chalked up a key win in its legal battle surrounding the now-recalled smoking cessation drug Chantix after a New York judge narrowed the scope of the arguments in play. | The company still faces some claims in a class action lawsuit over the now-recalled smoking cessation med Chantix.

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How to Become A Medical Sales Rep With No Experience 2024?

David Bagga

Medical device sales is a burgeoning market, with jobs that have an extremely high earning potential. In 2018, the average base salary of a medical sales representative was $92,698 How to Become A Medical Sales Rep With No Experience 2024? Home Blog How to Become A Medical Sales Rep With No Experience 2024? How to […] The post How to Become A Medical Sales Rep With No Experience 2024?

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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

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The Top 3 Reasons That Hospitals’ Tech Pilots Fail

MedCity News

Justin Brueck, vice president of innovation and research at Endeavor Health, shared three main reasons that technology pilots end up being unsuccessful at health systems. The post The Top 3 Reasons That Hospitals’ Tech Pilots Fail appeared first on MedCity News.

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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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CG Oncology Reveals Promising Results from Phase II CORE-001 Clinical Trial for the Treatment of BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer

Pharmaceutical Commerce

Results from the CORE-001 clinical trial are expected to be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.

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Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma

Fierce Pharma

In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. | In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. For the third time in as many months, those efforts have yielded a label expansion at the FDA.

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How Much Do Medical Device Sales Reps Make in 2024?

David Bagga

How Much Do Medical Device Sales Reps Make in 2024? Home Blog How Much Do Medical Device Sales Reps Make in 2024? How Much Do Medical Device Sales Reps Make in 2024? When looking for a medical device sales rep job, a common question is, ‘How much does a medical device sales rep earn? It’s […] The post How Much Do Medical Device Sales Reps Make in 2024?

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Astellas refiles CLDN 18.2 cancer drug after FDA knockback

pharmaphorum

The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it down earlier this year.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Plenful Raises $17M to Help Curb Rising Levels of Pharmacy Burnout

MedCity News

Plenful has completed a $17 million Series A funding round, bringing its total fundraising amount to date to more than $25 million. The startup offers a software platform that automates the manual and administrative tasks that burden pharmacists and pharmacy technicians. The post Plenful Raises $17M to Help Curb Rising Levels of Pharmacy Burnout appeared first on MedCity News.

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As weight loss booms, drugmakers look for an edge with oral options

PharmaVoice

Supply of GLP-1 medications falls well short of demand, and oral versions of the drugs loom over Eli Lilly and Novo Nordisk’s dominance.

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Verona's ensifentrine will be a 'paradigm shift in COPD treatment,' GlobalData says

Fierce Pharma

With a target date for FDA approval less than a month away, Sanofi and Regeneron’s megablockbuster Dupixent has gained much attention as it is on the verge of becoming the first biologic to treat c | With Verona Pharmaceuticals' COPD candidate ensifentrine approaching its FDA decision date, GlobalData has referred to it as a “paradigm shift in COPD treatment.

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Lignin-based drug delivery system may improve chemotherapeutics

European Pharmaceutical Review

Researchers have defined the conditions to formulate novel polyelectrolyte complexes (PECs) based on a sustainable hemicellulose-rich lignosulphonate. Their findings suggest potential applications in drug delivery. Novel biomaterials based on PECs are being investigated in the industry as drug delivery systems, due to PECs being able to “to entrap drugs under mild conditions and control their release”.

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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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Nippon Shinyaku’s DMD drug fails confirmatory trial

pharmaphorum

The future of Nippon Shinyaku’s Duchenne muscular dystrophy (DMD) therapy Viltepso has been thrown into doubt after it failed a confirmatory clinical trial

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ONC Chief: New AI Transparency Rule Should Drive Higher Quality Tools & More AI Adoption

MedCity News

Micky Tripathi, head of The Office of the National Coordinator for Health Information Technology (ONC), thinks his office’s recent rule on AI transparency will spur greater adoption of AI tools in healthcare, as well as potentially drive higher quality AI-based products. The post ONC Chief: New AI Transparency Rule Should Drive Higher Quality Tools & More AI Adoption appeared first on MedCity News.

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The Impact of Serialization Technology: Ensuring Product Integrity and Regulatory Compliance

Pharmaceutical Commerce

These advancements continue to act as a key driver in helping to boost the security, efficiency, and innovation of global industries, include pharma.

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Gilead's Trodelvy suffers double whammy as failed bladder cancer trial raises flag over early deaths

Fierce Pharma

In the span of half a year, Gilead Sciences' Trodelvy has flopped a second phase 3 trial. | Following a high-profile lung cancer setback in January, Gilead said Thursday that Trodelvy also failed to move the needle in a bladder cancer study. The flop threatens the ADC's accelerated approval in the tumor type.

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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.