July, 2024

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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

Pharma 342
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CCC Pioneers Collective Licensing Solution for Content Usage in Internal AI Systems

Copyright Clearance Center

July 16, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced the availability of artificial intelligence (AI) re-use rights within its Annual Copyright License s (ACL), an enterprise-wide content licensing solution offering rights from millions of works to businesses that subscribe.

Education 133
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The FTC Released a Scathing Interim Report on PBMs. What’s Next?

MedCity News

The Federal Trade Commission recently released an interim report that details how the practices of pharmacy benefit managers negatively impact patients and pharmacies. Some experts hope for legislative action based on the report. The post The FTC Released a Scathing Interim Report on PBMs. What’s Next? appeared first on MedCity News.

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Clarivate launches Academia AI Advisory Council

Clarivate

“AI Everywhere All at Once.” This year’s theme from Outsell, Inc. perfectly captures the expansion of artificial intelligence across all facets of our lives. In academia, this rapid advancement raises more questions than answers. How do we ensure ethical AI use? How can we advance research and drive research integrity? How do we use AI to advance student learning skills?

Ethics 122
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Bill that would cut down ‘patent thickets’ clears Senate

pharmaphorum

The US Senate has come together to pass a bill that aims to prevent pharma companies from filing multiple patents around biologic drugs as a way to delay biosimilar competitors.Lawmakers unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150), which is part of a lengthening list of measures being taken by Congress to curb the prices of medicines in the US.

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Endo Recalls Clonazepam Because of Mislabeling

PharmaTech

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

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More Trending

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‘Accidental’ media switch leads to CAR T therapy discovery

European Pharmaceutical Review

Altering the conditions that T cells are grown in can improve CAR T-cell therapy, US researchers have found. Discovered by chance, their new method has potential to treat solid cancer tumours more efficiently, according to the findings. Putting T cells on a keto diet [putting our T cells on a three-day ‘keto’ diet] showed reduced maturity at the end of the manufacturing process.

Media 109
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Health Leaders Applaud HHS’ Action Giving Some Incarcerated Individuals Medicaid Coverage Before Release

MedCity News

Illinois, Kentucky, Oregon, Utah and Vermont have been authorized by HHS to provide Medicaid/Children’s Health Insurance Program coverage to those transitioning out of incarceration up to 90 days before they’re released. Several healthcare leaders called the action a necessary step. The post Health Leaders Applaud HHS’ Action Giving Some Incarcerated Individuals Medicaid Coverage Before Release appeared first on MedCity News.

Insurance 124
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Agios Pharmaceuticals’ “Do You See It?” Campaign Featured in MM+M

Eversana Intouch

MM+M recently named Agios Pharmaceuticals’ “Do You See It?” campaign as their Campaign of the Week! The campaign focuses on the hidden dangers of thalassemia, a rare genetic condition affecting an estimated 8,000 Americans. The disease can result in anemia-like symptoms, with severe cases requiring regular blood transfusions, while milder cases often go untreated.

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PBMs will face House committee grilling next week

pharmaphorum

The House Committee on Oversight and Accountability will quiz leaders of pharmacy benefit managers (PBMs) at a hearing next week, amid scrutiny of the sector's role in rising healthcare costs in the US.The hearing – scheduled for 23rd July – is part of an ongoing investigation by the committee into PBMs' alleged anticompetitive practices launched last year and spearheaded by chairman James Comer (R-Ky).

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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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CCC Launches Collective Licensing for AI

Copyright Clearance Center

Copyright Clearance Center has launched a collective licensing solution for the internal use of copyrighted materials in artificial intelligence systems, with the aim of providing streamlined, legal means to use content and compensate creators.

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FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

Marketing 119
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With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

MedCity News

A uniQure gene therapy for Huntington’s disease has interim clinical data showing an 80% slowing of disease progression. An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. The post With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA appeared first on MedCity News.

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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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AbbVie appoints new Chief Scientific Officer

European Pharmaceutical Review

Dr Roopal Thakkar has been appointed as Executive Vice President, Research & Development and Chief Scientific Officer of AbbVie. He is the company ’s current Senior Vice President, Chief Medical Officer, Global Therapeutics. “As AbbVie’s Chief Scientific Officer, Dr Thakkar will continue to build momentum across discovery and all stages of development to fully realise the potential of our diverse pipeline.

Medicine 100
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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

Marketing 114
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Has pharma emerged from the ‘age of uncertainty’?

PharmaVoice

An industry reeling from a precarious market is showing signs of stabilizing as the future becomes a little less cloudy, an Evaluate report suggests.

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Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

Fierce Pharma

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

FDA 341
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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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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

Patients 116
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Report: Cost Reduction Is Less of a Priority for Health CFOs Compared to Past Years

MedCity News

Cost reduction is no longer a top priority for healthcare finance leaders, a new Deloitte survey found. In past years, cost reduction was among the top three priorities. The post Report: Cost Reduction Is Less of a Priority for Health CFOs Compared to Past Years appeared first on MedCity News.

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CCC Announces a Collective Licensing Subscription for AI Systems

Copyright Clearance Center

Copyright Clearance Center's AI re-use rights offer stands in its Annual Copyright Licenses subscription program for 'millions of works.

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FTC said to be planning legal action against PBMs

pharmaphorum

The FTC is said to be gearing up to file lawsuits against the top three pharmacy benefit managers in the wake of its damning report on the sector.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The 12 Best Sales Methodologies You Need To Know

Spotio

Every sales department wants to close more deals. Fortunately, there’s an easy way to make this happen: implement a proven sales methodology that will enable your sales team to be more effective. Don’t believe us? Try this stat on for size: 90% of companies that follow a guided sales process rank as high performing. In other words, you’ll find more success if there’s a method to your madness.

Sales 97
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Lilly's Mounjao triggers more weight loss than Novo Nordisk's Ozempic: study

Fierce Pharma

Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? | Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? While a head-to-head trial pitting the two treatments remains ongoing, new evidence shows that Lilly’s tirzepatide may be the superior weight loss product.

Patients 329
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AstraZeneca’s Tagrisso gains approval in Canada for NSCLC

Pharmaceutical Technology

AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.

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Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi 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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BMS’ long-standing leukemia blockbuster stares down its first generic

PharmaVoice

Patent disputes in the U.S. and abroad have opened the door to new generics ready for launch as soon as September for BMS’ Sprycel.

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Sobi starts rolling FDA filing for chronic gout drug

pharmaphorum

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

FDA 130
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Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water

European Pharmaceutical Review

Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceutical products. The team tested various samples two ion chromatography analytical methods. This included a range of water types eg, purified and potable water, according to the paper. Kumar et al. explained that “accurate determination of nitrite content in process water will support an understanding of the potential for nitrosamine formation from nitrite in process water

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Novo Nordisk's Ozempic cuts dementia risk compared with Merck's Januvia: Oxford study

Fierce Pharma

Trials have already shown that Novo Nordisk’s semaglutide | Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.

Medicine 315
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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.