Wed.Nov 20, 2024

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Chasing new ‘checkpoints,’ startup Valora emerges from a Nobel winner’s lab

Bio Pharma Dive

Built around research by Stanford scientist Carolyn Bertozzi and MIT researcher Jessica Stark, Valora Therapeutics is designing drugs to target glyco-immune checkpoints.

Scientist 161
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Algae That Can Cause Memory Loss Found Lurking in Seafood

AuroBlog - Aurous Healthcare Clinical Trials blog

(encrier/Getty Images) The tropical waters that flow between the Philippines archipelago contribute more than four million tonnes of seafood to global markets, positioning the country as the 11th largest seafood producer in the world.

Scientist 203
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Flagship, Pfizer alliance yields two more startup deals

Bio Pharma Dive

Pfizer will work with Ampersand Biomedicines and Montai Therapeutics to find drugs for obesity and lung cancer, respectively, adding to collaborations it previously formed with other Flagship startups.

Drugs 169
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November 20, 2022: In This Week’s PCT Grand Rounds, the HeLiX Pragmatic Trial in Patients Undergoing Liver Resection

Rethinking Clinical Trials

Dr. Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif and Mary-Lou Hanna Chair in Surgical Oncology Research, a joint appointment at the Sunnybrook Research

Trials 148
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Sage’s string of research failures continues

Bio Pharma Dive

Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.

Research 152
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Dr. Nimmy VS of Vaidyaratnam Ayurveda College wins first prize in All India Ayurveda Thesis Competition 2024

AuroBlog - Aurous Healthcare Clinical Trials blog

Dr Nimmy VS, a faculty member of the Vaidyaratnam Ayurveda College in Thrissur, has won the first prize in the 56th All India Ayurveda Thesis Competition 2024, conducted by the Kottakkal Aryvaidyasala (KAVS) in Malappuram district in Kerala. The award carries a cash prize of Rs 60,000 and a memento. Dr.

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Pfizer, under pressure to change, names oncology head as new R&D chief

Bio Pharma Dive

Chris Boshoff will replace Mikael Dolsten, who’s stepping down after 15 years leading research at the drugmaker.

Research 117
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Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

Drugs 147
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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Veeva Commercial Summit: Increased investment in medical affairs by pharma companies

Pharmaceutical Technology

Veeva’s VP of global medical, Christoph Bug, emphasises the importance of scientific exchange between clinical experts and pharmaceutical companies.

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

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Caring for Yourself While Caring for Others: Practical Tips for Caregivers

Antidote

Being a caregiver is one of the most selfless and demanding roles you can take on. Whether you're looking after a parent, spouse, child, or loved one, juggling all of the daily responsibilities that come with it can quickly feel overwhelming. With so much focus on taking care of others, it’s easy to put yourself and your needs on the back burner. While your focus is understandably on your loved one, it’s important to remember that your own well-being matters too.

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UK life science startups have trouble “scaling up” says Lord Vallance

Pharmaceutical Technology

The UK Minister of State for Science praised the UK’s thriving startup scene at the annual Jefferies London Healthcare Conference held in November.

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Plasma specialist Grifols shrugs off private equity firm Brookfield's potential €6.5B takeover offer

Fierce Pharma

With Spanish plasma specialist Grifols turning down a potential multi-billion-dollar takeover bid, it’s likely back to the drawing board for Canadian private equity outfit Brookfield. | Grifols’ board of directors on Tuesday rebuffed private equity firm Brookfield’s potential 6.45 billion euro buyout offer, recommending management reject the deal that it argues “significantly undervalues the company’s fundamental prospects and its long-term potential.

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AHA 2024: Phase III BROOKLYN trial – safety and efficacy of obicetrapib in HeFH patients

Pharmaceutical Technology

The Phase III BROOKLYN trial saw HeFH patients randomly assigned in a 2:1 ratio to receive either obicetrapib or a placebo for 52 weeks.

Trials 130
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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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Respiratory Health Priorities are Changing Across Europe – What Role Do Clinical Trial Sites Have to Play?

Velocity Clinical Research

For decades, research into respiratory health has centered on conditions such as asthma and chronic obstructive pulmonary disease (COPD), predominantly because of their high prevalence. However, the incidence of respiratory diseases is increasing globally, with lesser-researched but equally debilitating conditions such as interstitial lung disease, pulmonary sarcoidosis, and pneumoconiosis affecting health statuses worldwide.

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Wes Streeting says patients should view data sharing ‘the same as taxes’

Pharmaceutical Technology

UK Health Secretary Wes Streeting outlaid the key shifts needed to fix a “fragmented” NHS at the Jefferies London Healthcare Conference.

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Rapid growth spurt for UCB's Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval

Fierce Pharma

It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. | The latest nod positions Bimzelx to go head-to-head with Novartis' Cosentyx in the hidradenitis suppurativa market.

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KM Biologics’ mpox vaccine approved for emergency use by WHO

Pharmaceutical Technology

The first mpox vaccine authorised for children will be shipped to DRC in a 3.05 million-dose donation by the Japanese Government.

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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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MSD says subcutaneous Keytruda matches IV form

pharmaphorum

MSD's subcutaneous formulation of top-selling cancer drug Keytruda was non-inferior to the current intravenous version in a head-to-head trial

Trials 101
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Parkinson’s disease cases to reach 3.15 million in 7MM by 2033

Pharmaceutical Technology

Diagnosed prevalent cases of Parkinson’s disease will grow at 1.94% annually in the seven major markets between 2023 and 2033.

Marketing 130
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Tran Pham: Breaking barriers and building biopharma solutions

BioPharma Reporter

From discovering her knack for chemistry in high school to proving her expertise in male-dominated spaces, Tran Pham has built a dynamic career in biopharma.

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FDA issues CRL to Astellas’ IZERVAY sNDA for geographic atrophy

Pharmaceutical Technology

The US FDA has issued a CRL for sNDA of Astellas Pharma’s IZERVAY, a treatment for geographic atrophy (GA) secondary to AMD.

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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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Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

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Pharmanovia signs license agreement for Lindis Biotech’s catumaxomab

Pharmaceutical Technology

Pharmanovia has signed a licensing agreement with Lindis Biotech to commercialise catumaxomab for malignant ascites.

Licensing 130
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NICE blames companies for breakdown in Enhertu talks

pharmaphorum

Discussions aimed at making AstraZeneca and Daiichi Sankyo's Enhertu available to breast cancer patients on the NHS have been abandoned

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Tris Pharma receives ex-US approvals for ADHD treatments

Pharmaceutical Technology

Tris Pharma has received additional ex-US approvals for its ADHD treatments, Quillivant XR and QuilliChew ER.

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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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Helen Harrington’s journey: Patience, passion, and problem-solving

BioPharma Reporter

From developing treatments for Ebola to mastering karate with her daughters, Dr. Helen Harringtonâs journey is one of resilience and curiosity.

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Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu

Fierce Pharma

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu | A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star ADC Enhertu.

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Pfizer bags EU okay for haemophilia drug Hympavzi

pharmaphorum

Pfizer's Hympavzi has become the first once-weekly subcutaneous treatment for people living with severe haemophilia B in the EU

Drugs 94
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Ardena’s expanded nanomedicine facility granted full GMP approval

Pharma Times

The Netherlands facility is designed to handle a wide range of nanomedicines, including lipid-based nanoparticles

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time