Wed.Apr 10, 2024

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Can $12 Billion Jumpstart Women’s Health?

BioSpace

Federal funding and legislation spotlight women’s health opportunities and challenges.

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New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

Bio Pharma Dive

The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.

Medicine 316
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Fasting-Style Diet Seems to Result in Dynamic Changes to Human Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists looking to tackle our ongoing obesity crisis have made an important discovery: Intermittent calorie restriction leads to significant changes both in the gut and the brain, which may open up new options for maintaining a healthy weight.

Scientist 192
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Bio Pharma Dive

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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April 10, 2024: Primary Results of PRIM-ER Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Corita Grudzen, principal investigator of PRIM-ER In this Friday’s PCT Grand Rounds, Corita Grudzen of the Memorial Sloan Kettering Cancer Center will present “Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments,” including the results of the PRIM-ER trial. The Grand Rounds session will be held on Friday, April 12, 2024, at 1:00 pm eastern.

Trials 179
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Vertex to buy kidney disease drugmaker Alpine for $4.9B

Bio Pharma Dive

The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.

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More Trending

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DTAB recommends various amendments in Medical Devices Rules, 2017

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Technical Advisory Board (DTAB) has recommended various amendments to the Medical Devices Rules (MDR), 2017, for inclusion of disinfectants under the definition and applicability clauses and to bring in changes for quality management rules in line with the updated ISO standards for the devices.

Drugs 154
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Aerie Pharmaceuticals gets grant for ocular disorder treatment using amino isoquinolinyl amide compounds

Pharmaceutical Technology

Discover how Aerie Pharmaceuticals' patented compounds target kinases and proteins to treat eye diseases, inflammation, and more. Explore the groundbreaking method for treating ocular disorders with Formula (I) compound.

Protein 130
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J&J, Rallybio partner on drug development for rare fetal condition

Bio Pharma Dive

The biotech is working on a preventive therapy for the immune disorder, known as FNAIT for short, while J&J is studying its drug nipocalimab as a treatment.

Drugs 141
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Kyowa Kirin gets grant for monoclonal antibody inhibiting ccr1 activation by ccl15

Pharmaceutical Technology

Discover the groundbreaking patent by Kyowa Kirin Co Ltd for a monoclonal antibody targeting CCR1, inhibiting its activation by CCL15. Explore the therapeutic and diagnostic potential for CCR1-related diseases.

Antibody 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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Birth Control Market Evolves as OTC Opill Hits US Stores

BioSpace

Thousands of retail outlets are now receiving shipments of the first over-the-counter birth control pill approved in the U.S., but effects on the overall contraception market are unclear.

Marketing 123
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MorphoSys gets grant for novel compounds for treating diseases associated with methyl modifying enzymes

Pharmaceutical Technology

Discover a groundbreaking patent by MorphoSys AG for novel compounds targeting methyl modifying enzymes in cancer treatment. Learn about Formula (I) compounds and their potential impact on various types of cancer.

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Sunshine transparency reporting for emerging pharma: Simplify, streamline, and secure

pharmaphorum

Discover how Sunshine transparency reporting can be simplified, streamlined, and secured for emerging pharmaceutical companies with a focus on Healthcare Professionals (HCP) and Healthcare Organisations (HCO).

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Acceleron Pharma gets grant for treatment of spinal muscular atrophy using ALK4:ACTIRiib antagonists

Pharmaceutical Technology

Discover how Acceleron Pharma's patent for treating spinal muscular atrophy with ALK4:ActRIIB antagonists aims to increase muscle mass, strength, and bone density in patients.

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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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FDA appears receptive to surrogate endpoint supporting accelerated approval of multiple myeloma drugs

Fierce Pharma

New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. | New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions.

Drugs 113
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ADMA Biologics gets grant for treatment of upper respiratory tract infection with immunotherapeutic composition

Pharmaceutical Technology

ADMA Biologics Inc's innovative method for treating upper respiratory infections caused by S. pneumonia with hyperimmune globulin composition.

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GLP-1s Like Novo Nordisk’s Ozempic Do Not Increase Thyroid Cancer Risk: Study

BioSpace

A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.

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Lisata wins FDA orphan drug status for bone cancer candidate

Pharmaceutical Technology

The FDA has granted orphan drug designation for Lisata Therapeutics’s LSTA1 (certepetide) to treat osteosarcoma, a rare type of blood cancer.

Drugs 130
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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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AACR: Merck, Kelun’s Anti-TROP2 ADC Shows Early Promise in Gastric Cancer

BioSpace

Merck and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.

Antibody 113
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Pharmaceutical cleanrooms and cleanroom flooring suppliers

Pharmaceutical Technology

Pharmaceutical Technology has listed the leading suppliers of pharmaceutical cleanrooms and cleanroom flooring. Download the free guide here.

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Women in Science: Elisa Cascade on why women should never be afraid to ask

BioPharma Reporter

Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome, how to avoid suffering in silence and her 'just do it' mantra.

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TORL scores $158m in Series B2 to advance ADC cancer therapies

Pharmaceutical Technology

TORL plans to use the funds to advance the clinical development of its antibody-drug conjugate (ADC) pipeline.

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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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UK calls time-out on post-Brexit rules opposed by industry

pharmaphorum

The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.

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Innate Pharma plans IND of ADC candidate after positive preclinical data

Pharmaceutical Technology

Innate Pharma plans to advance IPH45 towards clinical trials, with an investigational new drug (IND) application planned in 2024.

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FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S. FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses.

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Novartis plans to axe 680 employees

Pharmaceutical Technology

Novartis lays off 680 staff members in the US and Switzerland following a successful 2023 financial year.

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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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YS Biopharma’s Rabies Vaccine Outperforms Commercial Competitor in Phase III Trial

BioSpace

Late-stage study results released Tuesday show YS Biopharma’s rabies vaccine candidate can induce twice the seroconversion rate at seven days versus a standard, globally marketed comparator.

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MHRA approves TMC Pharma’s fosdenopterin for MoCD type A

Pharmaceutical Technology

The UK MHRA has approved TMC Pharma's fosdenopterin (Nulibry) for the treatment of molybdenum cofactor deficiency (MoCD) type A.

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AACR: Study Suggests Accelerated Approval Doesn’t Always Lead to Clinical Benefit

BioSpace

Less than half of cancer drugs approved via the FDA's accelerated approval pathway between 2013 and 2017 showed clinical benefit in confirmatory trials in terms of overall survival or quality of life, according to the paper.

Trials 107
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Vertex wagers $4.9bn on Alpine kidney disease therapy

pharmaphorum

In another departure from its focus on genetic medicines, Vertex Pharma has agreed a $4.9 billion purchase of Alpine Immune Sciences, adding a mid-stage drug candidate for kidney disease IgA nephropathy (IgAN). The $65-per-share deal is due to close within the next three months, said Vertex, which plans to fund the acquisition with cash in hand. It is the largest acquisition in the biopharma sector so far in 2024.

Genetics 105
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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.