May, 2024

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Patient dies in Pfizer study of Duchenne gene therapy

Bio Pharma Dive

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

Drugs 143
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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Generative AI Finds Its Footing in Drug Development

BioSpace

Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.

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World Lupus Day 2024: The Importance of Advocacy to Make Lupus Visible

XTalks

According to the Lupus Foundation of America , approximately 1.5 million Americans, and at least 5 million people worldwide, suffer from a form of lupus. The disease predominantly affects women, particularly women of color, who are two to three times more likely to develop lupus than caucasian women. Despite its prevalence, lupus remains one of the world’s least recognizable diseases, often leading to significant delays in diagnosis and appropriate treatment.

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The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.

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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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Could Cancer Vaccines Be the Next Big Breakthrough in Immunotherapy?

BioSpace

The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.

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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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Obesity drug slashes risk of heart attack or stroke 'regardless of weight lost’

BioPharma Reporter

Anti-obesity jabs could reduce the risk of heart attacks, strokes or heart failure in obese people irrespective of the amount of weight they lose while using the medication, according to a new study.

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Drug patents protect pharma profits. Track when they’ll expire here.

Bio Pharma Dive

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

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AstraZeneca to withdraw Covid-19 vaccine globally

Pharmaceutical Technology

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint

Fierce Pharma

As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.

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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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Transforming clinical trials with open-source tech

pharmaphorum

Think open-source is just for software? Think again. Learn how clinical researchers are embracing open data and tools to overhaul the drug development process.

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Amgen Wins FDA Approval for Difficult-to-Treat Lung Cancer

BioSpace

Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.

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Eisai sets new revenue target for Alzheimer’s drug Leqembi

Bio Pharma Dive

The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.

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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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Docetaxel albumin bound by CSPC Pharmaceutical Group for Hypopharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.

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With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy

Fierce Pharma

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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BMS CAR-T Therapy Wins FDA Approval for Expanded Use in Follicular Lymphoma

BioSpace

Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

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Lilly’s once-weekly insulin matches daily shots in late-stage tests

Bio Pharma Dive

The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

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Tracking the opioid lawsuit settlements amidst calls for oversight

Pharmaceutical Technology

The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.

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House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Life sciences in Ireland: Nurturing talent, innovating excellence

pharmaphorum

The life sciences sector in Ireland is booming thanks to nurturing talent and fostering innovation. Companies like Eli Lilly and Regeneron have major operations driving excellence.

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ASGCT2024: FDA’s Marks on Accelerated Approval, Gene Therapy Costs and More

BioSpace

In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.

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The Promise of RFID for Improving Medication Inventory Management

Pharmaceutical Commerce

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

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AstraZeneca withdraws COVID-19 vaccine, citing declining demand

Bio Pharma Dive

The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects.

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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