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 342
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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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BMS and 2seventy bio’s Abecma gains approval for multiple myeloma

Pharmaceutical Technology

Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma have received FDA approval for relapsed or refractory multiple myeloma (RRMM).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 239
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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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More Trending

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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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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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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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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 136
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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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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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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 131
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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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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 123
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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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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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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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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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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.

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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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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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Vodcast: Dr Adriano Flora, The Jackson Laboratory

Drug Discovery World

The latest sponsored DDW Sitting Down With vodcast features Dr Adriano Flora, Director of Business Development at The Jackson Laboratory (JAX). He discusses alternatives to non-human primates, the key benefits of this, and what impact will they have on the future of drug development. Moreover, he answers questions on the key breakthroughs in recent years in this field and how have these impacted future success, as well as challenges in the clinic that must be overcome to ensure this success is a

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'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 115
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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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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.

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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.

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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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AstraZeneca, Daiichi Sankyo Win First Tumor-Agnostic HER2 FDA Approval for Enhertu

BioSpace

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is the first FDA-approved tumor-agnostic HER2-targeted therapy authorized for the treatment of solid tumors in adults who have undergone prior systemic treatment.

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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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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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ACC24 Roundup: Novo, Ionis Tout Cardio Victories and Boehringer, Lilly Disappoint

BioSpace

Novo Nordisk and Ionis Pharmaceuticals unveiled promising respective data at the American College of Cardiology’s Annual Scientific Session, while Boehringer Ingelheim and Eli Lilly’s Jardiance missed the endpoint in a myocardial infarction study.

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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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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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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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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.