Wed.Jul 10, 2024

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Amylyx, with GLP-1 buy, doubles down on blood sugar drugs

Bio Pharma Dive

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

Drugs 188
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Ozempic And Similar Drugs Lower Cancer Risks, Study Suggests

AuroBlog - Aurous Healthcare Clinical Trials blog

A class of diabetes medications, which include the best-selling drug Ozempic, are associated with a reduced risk of certain obesity-related cancers, according to a study released Friday.

Insulin 226
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NICE recommends Ebglyss for atopic dermatitis patients

Pharmaceutical Technology

Almirall’s Ebglyss is predicted to hit blockbuster status in two years in the crowded atopic dermatitis market.

Marketing 264
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July 10, 2024: Asking Different Causal Questions in Randomized Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Miguel Hernán In this Friday’s PCT Grand Rounds, Miguel Hernán of Harvard University will present “Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them?” The Grand Rounds session will be held on Friday, July 12, 2024, at 1:00 pm eastern. Hernán is the Kolokotrones Professor of Biostatistics and Epidemiology and the director of the CAUSALab at Harvard T.H.

Trials 182
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Evotec and Pfizer announce drug discovery collaboration

Pharmaceutical Technology

Evotec and Pfizer have entered a multi-year partnership that will focus initially on early discovery research.

Drugs 246
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FTC to sue three largest PBMs over drug price practices: WSJ

Bio Pharma Dive

Antitrust regulators are set to file suit against CVS Caremark, Express Scripts and Optum Rx over how they negotiate discounts for drugs, including insulin, per the report.

Insulin 164

More Trending

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As GLP-1 drugs boom, other healthcare companies are cashing in

Bio Pharma Dive

With more Americans taking obesity medications, adjacent businesses are offering supportive services to offset side effects, collect data and document new health benefits.

Drugs 148
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IntegriChain acquires pharma advisory services company FCS

Pharmaceutical Technology

IntegriChain, a provider of data-driven commercialisation solutions for the pharma industry, has acquired Federal Compliance Solutions (FCS).

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Flagship raises $3.6B for biotech investing

Bio Pharma Dive

The latest round of funding comes as biotech company creator adds executives and prepares to grow more life sciences startups.

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Longeveron scores RMAT designation for Alzheimer’s cell therapy

Pharmaceutical Technology

Lomecel-B is also being investigated for treating hypoplastic left heart syndrome, and ageing-related frailty, in addition to Alzheimer’s.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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AbbVie names new R&D head; Arcutis eczema cream approved

Bio Pharma Dive

Roopal Thakkar will succeed Tom Hudson as AbbVie’s top scientist. Elsewhere, Skyhawk is advancing its Huntington’s drug and Zevra is preparing for an FDA advisory committee meeting.

Scientist 126
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ORLADEYO gains approval in Peru for HAE prevention

Pharmaceutical Technology

Pint Pharma has announced the approval of Orladeyo (berotralstat) in Peru to prevent hereditary angioedema (HAE) attacks.

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Why Is Antimicrobial Resistance Not Getting Much Attention from Biopharma?

BioSpace

Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.

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Arcutis bags FDA approval for atopic dermatitis cream after delay

Pharmaceutical Technology

The FDA has approved the once-daily topical cream for mild to moderate atopic dermatitis in patients aged six and older.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Move over, oncology: Obesity, diabetes meds will take over 2030's top drug rankings, Evaluate forecasts

Fierce Pharma

It’s well known that obesity drugs from Novo Nordisk and Eli Lilly are on a high-flying growth trajectory that doesn’t look to be letting up anytime soon. | Novo Nordisk's Ozempic is slated to take over No.1, while Merck's Keytruda falls to No.9 on Evaluate's predicted rankings of top drugs by 2030 sales.

Drugs 122
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Vistagen secures new patents for PH80 migraine treatment

Pharmaceutical Technology

Vistagen has expanded its global intellectual property portfolio with the receipt of multiple new patents for its PH80 for migraine.

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Turning pilots into production: How to create, scale, and succeed with GenAI

pharmaphorum

Learn how to successfully transition pilots into production with GenAI in the pharmaceutical industry. Discover strategies to create, scale, and achieve success with this innovative technology.

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UK DRI and NHS collaborate on digitally enabled dementia care platform

Pharma Times

Around one in five dementia hospitalisations are due to potentially preventable causes

Research 149
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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After FDA delay, Arcutis gets Zoryve OK in atopic dermatitis

pharmaphorum

After short but worrying delay, Arcutis gets FDA approval for flagship drug Zoryve in atopic dermatitis, which could further unlock sales growth

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Amid GLP-1 boom, Novo Nordisk strikes up insulin partnership in Indonesia

Fierce Pharma

While much of the attention on Novo Nordisk these days revolves around the company’s wildly popular GLP-1 drugs Ozempic and Wegovy, insulin remains a critical backbone for the drugmaker. | As Novo Nordisk steadily ups its commitments in Asia, the company is teaming up with Indonesia’s state-owned pharmaceutical firm Bio Farma to bolster insulin packaging in the southeast Asian nation.

Insulin 102
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The Current Landscape of Drug Shortages

Pharmaceutical Commerce

In an interview with Pharma Commerce editor Nicholas Saraceno, Peter Ax, UpScriptHealth, founder and CEO, offers his thoughts surrounding the lack of supply.

Drugs 105
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Alnylam Could Challenge Pfizer in ATTR-CM But Experts Want Full Data

BioSpace

Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong, but details expected later this summer are critical.

Trials 92
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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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uniQure rockets on Huntington’s gene therapy result

pharmaphorum

Shares in Dutch biotech uniQure shoot up after Huntington’s candidate AMT-130 slows disease progression by 80% two years after dosing.

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Institutions to lead £1.7m-funded network to support people at risk of dementia

Pharma Times

The neurodegenerative condition currently affects more than 944,000 people in the UK

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Eli Lilly names company vet Gordon Brooks as its interim CFO

Fierce Pharma

Editor's note: This story was corrected to note that Brooks will be Eli Lilly's interim CFO. | Gordon Brooks, currently Eli Lilly's group vice president, controller and corporate strategy, will take the interim role after 29 years at the drugmaker.

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Overcoming barriers to opioid treatment: Challenges and innovations in methadone and buprenorphine

Outsourcing Pharma

The growing opioid crisis in the US has been exacerbated by various systems and biases, preventing individuals from accessing critical treatments like methadone and buprenorphine.

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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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Viagra’s Resilience in the Face of Generic Competition: A Pharmaceutical Market Analysis

Drug Patent Watch

This is an example from the DrugPatentWatch AI Research Assistant, which is available with DrugPatentWatch subscriptions.

Marketing 105
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VC Firm Flagship Raises $3.6B to Create, Support 25 ‘Breakthrough’ Companies

BioSpace

Biotech venture capital firm Flagship Pioneering is looking to fund companies focused on artificial intelligence, human health and sustainability, bringing the total raised since 2021 to $6.4 billion.

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ASCO 2024 - Chris Haqq

pharmaphorum

Get insights from an exclusive interview with Chris Haqq, a prominent figure at Elicio Therapeutics, on his thoughts and updates regarding ASCO 2024.

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Amylyx Pivots to GLP-1 Space, Acquires Phase III-Ready Asset from Eiger

BioSpace

After pulling its ALS drug Relyvrio from the market, Amylyx Pharmaceuticals has purchased Eiger BioPharmaceuticals’ GLP-1 avexitide, which has been studied for the treatment of hyperinsulinemic hypoglycemia.

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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.