Mon.Apr 08, 2024

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Psychiatry drugs finally have pharma’s attention. Can they keep it?

Bio Pharma Dive

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

Medicine 344
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FDA accepts Shorla’s oral liquid leukaemia drug NDA

Pharmaceutical Technology

The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.

Drugs 264
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Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

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J&J and Legend’s Carvykti scores early line approval for MM by FDA

Pharmaceutical Technology

J&J and Legend’s CAR-T cell therapy has been approved as a second-line therapy for patients with multiple myeloma (MM).

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Scientists Accidentally Made a Mouse Grow Legs in Place of Genitals

AuroBlog - Aurous Healthcare Clinical Trials blog

Turning off a gene early in mouse development led researchers to end up with an accidental six-legged embryonic mammal. This strange result took the spinal cord research of developmental biologists Anastasiia Lozovska and Moisés Mallo and their colleagues at Portugal’s Gulbenkian Science Institute in a new direction.

Scientist 246
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Trial shows Wegovy can ease heart failure symptoms

Bio Pharma Dive

The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.

Trials 245

More Trending

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Private biotech funding ticks up as venture firms deploy cash

Bio Pharma Dive

Twenty-six drugmakers closed private fundraising rounds worth more than $100 million, according to HSBC data shared with BioPharma Dive.

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Enhancing Sponsor Outcomes: The Power of In-House Clinical Assessment Support

Worldwide Clinical Trials

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success. Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research.

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DTAB asks health ministry to approach corporate ministry to mandate free medicine from pharma as part of CSR

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Technical Advisory Board (DTAB) has suggested to the ministry of health and family welfare (MoHFW) to write to the ministry of corporate affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR).

Medicine 185
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Unitaid funds over £6m to Liverpool researchers to treat major diseases

Pharma Times

The project aims to advance therapeutics for tuberculosis, malaria and hepatitis C in LMICs

Research 153
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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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FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for solid tumours

Pharmaceutical Technology

The US FDA has approved Daiichi Sankyo and AstraZeneca’s Enhertu for adults with HER2-positive solid tumours.

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Alliance Healthcare launches cancer symptom referral scheme in UK pharmacies

Pharma Times

Around three million people in the UK were estimated to be living with cancer in 2022

Pharmacy 146
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Sensorion raises $16m for gene therapies to treat deafness

Pharmaceutical Technology

Sensorion expects results from a Phase I/II trial of its lead candidate SENS-501 in the second half of 2025.

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Women’s health and digital tech empowerment

pharmaphorum

Empower women's health with digital tools and technology. Learn about the latest advancements and resources to promote wellness and empowerment in women's health.

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

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Pluri launches manufacturing division as cell therapy pipeline progresses

Pharmaceutical Technology

In an interview with Pharmaceutical Technology, Pluri’s CEO discussed its recent launch as a CDMO as well as its cell therapy pipeline.

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Jardiance doesn’t cut it in post-heart attack trial

pharmaphorum

SGLT2 inhibitors have transformed the treatment of heart failure in the last few years, but an attempt to extend their use into the setting of post-heart attack patients has suffered a setback.

Trials 118
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Medicxi and Starpharma to develop dendrimer-based cancer treatments

Pharmaceutical Technology

Medicxi has partnered with Starpharma for the formation of Petalion Therapeutics to develop dendrimer-based oncology treatments.

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Merck Snaps Up Small Startup in $208M Deal, Seeks to Improve Safety of ADCs

BioSpace

As the antibody-drug conjugate space continues to heat up, Merck has acquired preclinical startup Abceutics—spun out of the University at Buffalo—and its novel platform that aims to make ADC therapeutics safer.

Antibody 116
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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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AdAlta and SYNthesis to form AdCella for advanced cancer treatments

Pharmaceutical Technology

AdAlta has signed an MOU with SYNthesis to explore the creation of a jointly owned special purpose entity, AdCella.

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Changing Faces: Pharma and biotech hires from March 2024

pharmaphorum

Stay up to date with the latest pharma and biotech hires from March 2024, including notable companies like Sitryx, Oxford, and MaaT Pharma.

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Navigating post-approval research and reimbursement for orphan therapies

Pharmaceutical Technology

In the second part of this series, F. Randy Vogenberg talks about how planning early can positively impact insurance coverage for new therapies, especially in the case of orphan drugs.

Research 130
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AstraZeneca, Daiichi Sankyo's Enhertu wins historic HER2 tumor-agnostic FDA nod

Fierce Pharma

With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.

Antibody 115
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Creating a winning playbook for consistent digital product success

pharmaphorum

Creating a winning playbook for consistent digital product success involves strategic planning, execution, and continuous improvement. Discover key strategies and practices to ensure your digital products achieve lasting success.

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Ed Schoonveld Discusses Drug Pricing in the US and Upcoming Articles

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.

Drugs 105
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Ionis, Arrowhead hail data with triglyceride drugs at ACC

pharmaphorum

Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress. The two companies are racing to bring their apoC-III inhibitors to market for severe hypertriglyceridaemia (HTG) and ultra-rare disorder familial chylomicronaemia syndrome (FCS).

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Digital Humans: Where Technology and Humanity Converge for a Healthier Future

Intouch Solutions

In the dynamic realm where technology meets humanity, digital humans emerge as catalysts for a healthier future. With endless opportunities for innovation and advancement, these AI-driven entities are reshaping education, research and training in the life sciences industry. What are digital humans? Also known as digital twins or synthetic clones, digital humans blend cutting-edge innovation with human-like charm, surpassing traditional avatars or chatbots by emulating human behavior, expressions

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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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Enhertu gets FDA nod for tumour-agnostic HER2 cancers

pharmaphorum

FDA approves AstraZeneca and Daiichi Sankyo’s Enhertu for all HER2-positive solid tumours, in a first for both the HER2 inhibitor and ADC category.

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Breakthrough UTI vaccine could prevent infections for nine years

BioPharma Reporter

Recurring urinary tract infections (UTIs) can be prevented for up to nine years with a simple oral spray vaccine, a âbreakthroughâ British trial has shown.

Vaccine 105
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Study points to weaknesses in FDA accelerated approval path

pharmaphorum

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

Trials 110
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BMS Sees Early ROI for $14B Karuna Buy with Phase III Schizophrenia Win

BioSpace

Fresh off of its $14 billion acquisition of Karuna Therapeutics, Bristol Myers Squibb on Saturday reported promising late-stage data for Karuna’s antipsychotic KarXT, which elicited significant symptomatic improvement in schizophrenia symptoms.

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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