Mon.Apr 08, 2024

article thumbnail

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
article thumbnail

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
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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).

246
246
article thumbnail

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

article thumbnail

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
article thumbnail

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 242

More Trending

article thumbnail

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.

204
204
article thumbnail

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.

article thumbnail

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 175
article thumbnail

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.

article thumbnail

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

article thumbnail

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 142
article thumbnail

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.

article thumbnail

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 136
article thumbnail

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.

article thumbnail

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

article thumbnail

With wider approval, J&J and Legend's Carvykti quickly leaps ahead of BMS' rival myeloma CAR-T

Fierce Pharma

Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a simil | Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a similar go-ahead—but in an even earlier setting and with expanded manufacturing specifications.

article thumbnail

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.

article thumbnail

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 126
article thumbnail

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.

130
130
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. | Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

Medicine 119
article thumbnail

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
article thumbnail

FDA swats away Supernus’ Parkinson’s disease infusion pump for 3rd time

Fierce Pharma

The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The following year, the agency doled out a complete response letter, dashing Supernus' second try.

119
119
article thumbnail

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 118
article thumbnail

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.

article thumbnail

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.

118
118
article thumbnail

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
article thumbnail

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
article thumbnail

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

article thumbnail

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

article thumbnail

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.

115
115
article thumbnail

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.

105
105
article thumbnail

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.

article thumbnail

Pharma Pulse 4/8/24: Cannabis Use in Oncology, J&J to Acquire Shockwave Medical & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

101
101
article thumbnail

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.