Thu.Jul 11, 2024

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Senate unanimously endorses legislation targeting pharma 'patent thickets'

Fierce Pharma

Even as pharma companies have yet to feel the full effects of the Inflation Reduction Act, Senate lawmakers have turned their attention to another facet of drug pricing with a bill meant to cr | The bill looks to limit the number of patents that companies can assert in litigation on individual products. It's intended to crack down on "patent thickets," which can delay and thwart generic competition.

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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?

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The end of the beginning: Lilly execs eye top spot in burgeoning Alzheimer's market after Kisunla's FDA approval

Fierce Pharma

Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the t | On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, VP of U.S.

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

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After $185M asset buy, Merz Therapeutics plots US workforce expansion as CEO eyes more deals

Fierce Pharma

Freshly equipped with two approved meds from Acorda Therapeutics, Frankfurt, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear. | Equipped with two approved meds from Acorda Therapeutics, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear.

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Closing the Gap in Medications for the Treatment of Alcohol Use Disorder (AUD)

MedCity News

By understanding that AUD is a diagnosable and treatable medical condition with individualized impact, we can tailor treatments to meet patients’ specific needs. Effective treatment for AUD is multifaceted, involving medical, psychological, and social support. The post Closing the Gap in Medications for the Treatment of Alcohol Use Disorder (AUD) appeared first on MedCity News.

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Will A Divestiture Save the UnitedHealth Group-Amedisys Deal?

MedCity News

Amedisys and UnitedHealth Group plan to divest care centers to an affiliate of VitalCaring Group. Several experts said this will likely clear the way for the companies’ merger. The post Will A Divestiture Save the UnitedHealth Group-Amedisys Deal? appeared first on MedCity News.

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AbbVie asks Supreme Court to uphold attorney-client privilege in AndroGel lawsuit

Fierce Pharma

AbbVie is asking the U.S. | AbbVie is asking the U.S. Supreme Court to overrule a lower court's ruling that the company must turn over records of communications with its lawyers regarding a patent lawsuit it filed against a generic drug maker more than a decade ago.

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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.

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Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season

Fierce Pharma

The dog days of summer might be in full swing, but for flu vaccine makers, its a busy time prepping for this fall's influenza season. | The companies started distributing shipments of their respective vaccine options ahead of the fall flu season as the CDC recommends vaccination before the virus spreads.

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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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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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Akebia unveils IRA-driven price tag for kidney disease drug Vafseo, ends CSL collab

Fierce Pharma

After a rocky road to approval and two amendments to the original pact, Akebia Therapeutics and CSL Vifor have terminated their collaboration around the oral chronic kidney disease (CKD) anemia dru | As it ends a licensing agreement with CSL Vifor, Akebia has priced its chronic kidney disease anemia drug Vafseo by incorporating an uncertain future label expansion that it plans to discuss with the FDA later this year.

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Clinical trial trends and the rise of site networks

pharmaphorum

Tune in to Caroline Redecker and Jason Casarella as they discuss clinical trial trends and the rise of site networks in this insightful podcast episode brought to you by Advanced Clinical.

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Find out what to expect from the PDA/FDA Joint Regulatory Conference

Fierce Pharma

In this episode of "The Top Line", sponsored by the Parenteral Drug Association (PDA), we do a deep dive into the highly anticipated PDA/FDA Joint Regulatory Conference, set to take place from Sept | We sat down with industry expert Janeen Skutnik-Wilkinson, the PDA/FDA Joint Regulatory Conference 2024 Co-Chair to give us an exclusive behind-the-scenes look at this must-attend CGMP event, set to take place from September 9-11 in Washington D.C.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Ipsen Turns to China-Based Biotech to Get Another ADC Cancer Drug

MedCity News

Ipsen has acquired global rights to a Foreseen Biotechnology antibody drug conjugate developed for an undisclosed cancer target. This is Ipsen’s second ADC deal in three months, following its acquisition of rights to a ROR1-targeting ADC from Sutro Biophrama. The post Ipsen Turns to China-Based Biotech to Get Another ADC Cancer Drug appeared first on MedCity News.

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FDA rejects Novo Nordisk’s weekly basal insulin

pharmaphorum

FDA rejects Novo Nordisk’s once-weekly basal insulin for people with diabetes, which would reduce the number of injections needed

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The Opportunity for Digital Innovation in Oncology Drug Development

MedCity News

Solving three major challenges in the development of new oncology drugs The post The Opportunity for Digital Innovation in Oncology Drug Development appeared first on MedCity News.

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New policy review reveals ten cancer challenges facing new UK government

PharmaTimes

Macmillan Cancer Support estimates that cancer affects over three million people in the UK

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Ipsen forges another ADC alliance, this time with Foreseen

pharmaphorum

Ipsen places another bet on an antibody-drug conjugate for cancer, pledging up to $1bn for a preclinical candidate from Foreseen Bio

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Hospital M&A Activity Remained Strong In Q2, Kaufman Hall Says

MedCity News

The number of hospital M&A deals may have fallen from Q1 to Q2 of this year, but that doesn’t mean that the hospital M&A space is lacking vitality, according to a new Kaufman Hall report. Rather, it means that the hospital M&A is shifting its emphasis from scale to strategy. The post Hospital M&A Activity Remained Strong In Q2, Kaufman Hall Says appeared first on MedCity News.

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AbbVie lines up Thakkar to replace outgoing CSO Hudson

pharmaphorum

Change of R&D chiefs at AbbVie, as Thomas Hudson steps down as CSO and is replaced by Roopal Thakkar.

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Researchers awarded £1.5m for national dementia inequalities network

PharmaTimes

The ESRC EquaDem Network Plus aims to improve disparities in diagnosis and care

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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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Pharma Pulse 7/11/24: Thermo Fisher Scientific Completes Acquisition of Olink, 7 Takeaways From the FTC Interim Report on PBMs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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From Winnipeg to Brandon: Exploring Market Opportunities with Manitoba’s Top Doctors

Scott’s Directories

In Manitoba, the healthcare sector thrives, offering vast market opportunities. For businesses targeting this industry, access to a comprehensive physician directory in Manitoba is invaluable. Whether you’re a pharmaceutical company, a medical equipment supplier, or a healthcare recruiter, having a detailed Manitoba medical directory can significantly enhance your outreach efforts.

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Leveraging telemedicine for enhanced healthcare network efficiency

Clarify Health

As health plans seek innovative strategies to enhance their service offerings and improve financial performance, the integration of telemedicine into their networks emerges as a pivotal solution. By leveraging data analytics to optimize and expand telemedicine capabilities, payers can effectively address the critical challenge of extending quality healthcare to underserved areas while managing costs.

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The Generico Crusader

Contrarian Sales Techniques

Meet Wei Wei isn't your typical high-flying pharma rep. Forget fancy suits and briefcases overflowing with brochures for the latest wonder drug. This 50-year-old rolls up his sleeves and hits the dusty roads in his trusty Perodua Alza, a familiar sight in the rural areas he frequents. The truth is, Wei used to be that kind of rep. All charm and spiel, pushing expensive branded meds on busy doctors.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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The Relationship Between Patients and Drug Shortages

Pharmaceutical Commerce

In an interview with Pharma Commerce editor Nicholas Saraceno, Peter Ax, UpScriptHealth’s founder and CEO, discusses how patients are affected by these supply chain bottlenecks, along with ways to mitigate these complications.

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FDA Issues Complete Response Letter to Novo Nordisk for Icodec, a Once-Weekly Basal Insulin for the Treatment of Diabetes Mellitus

PharmExec

According to the Complete Response Letter, the FDA has requested additional information on the manufacturing process and the type 1 diabetes indication for insulin icodec before completing its review.

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FTC Intends to Sue Biggest Pharmacy Benefit Managers for Unfair Negotiating Tactics

Pharmacy Times

In a follow-up to the interim FTC report documenting the business practices of PBMs and the power they hold in the pharmaceutical industry, the Commission now seeks to sue the 3 largest PBMs in the country for driving up the price of insulin and other essential drugs.

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The Weight-Loss Gold Rush: Legal and Regulatory Implications

PharmExec

Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.

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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.