Can $12 Billion Jumpstart Women’s Health?
BioSpace
APRIL 10, 2024
Federal funding and legislation spotlight women’s health opportunities and challenges.
Wed.Apr 10, 2024
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New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
Bio Pharma Dive
APRIL 10, 2024
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.
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Fasting-Style Diet Seems to Result in Dynamic Changes to Human Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 10, 2024
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.
Vertex to buy kidney disease drugmaker Alpine for $4.9B
Bio Pharma Dive
APRIL 10, 2024
The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.
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
Bayer and Google Cloud to develop AI solutions for radiologists
Pharmaceutical Technology
APRIL 10, 2024
Bayer has partnered with Google Cloud to develop AI-powered solutions for radiologists, creating scalable and compliant imaging software.
Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
Bio Pharma Dive
APRIL 10, 2024
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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April 10, 2024: Primary Results of PRIM-ER Trial to Be Featured in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
APRIL 10, 2024
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.
J&J, Rallybio partner on drug development for rare fetal condition
Bio Pharma Dive
APRIL 10, 2024
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.
TORL scores $158m in Series B2 to advance ADC cancer therapies
Pharmaceutical Technology
APRIL 10, 2024
TORL plans to use the funds to advance the clinical development of its antibody-drug conjugate (ADC) pipeline.
Bio-Rad and Alleghany Health Network partner for patients with solid tumour cancer
Pharma Times
APRIL 10, 2024
Solid tumour cancers account for 90% of adult human cancers and 50% of childhood malignancies
UK calls time-out on post-Brexit rules opposed by industry
pharmaphorum
APRIL 10, 2024
The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.
Aerie Pharmaceuticals gets grant for ocular disorder treatment using amino isoquinolinyl amide compounds
Pharmaceutical Technology
APRIL 10, 2024
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.
FDA appears receptive to surrogate endpoint supporting accelerated approval of multiple myeloma drugs
Fierce Pharma
APRIL 10, 2024
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.
Kyowa Kirin gets grant for monoclonal antibody inhibiting ccr1 activation by ccl15
Pharmaceutical Technology
APRIL 10, 2024
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.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Sunshine transparency reporting for emerging pharma: Simplify, streamline, and secure
pharmaphorum
APRIL 10, 2024
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).
ADMA Biologics gets grant for treatment of upper respiratory tract infection with immunotherapeutic composition
Pharmaceutical Technology
APRIL 10, 2024
ADMA Biologics Inc's innovative method for treating upper respiratory infections caused by S. pneumonia with hyperimmune globulin composition.
Essential adds neuroblastoma drug with Renaissance buy
pharmaphorum
APRIL 10, 2024
Essential Pharma has bought Renaissance Pharma, adding its first developmental drug candidate, a therapy for rare cancer neuroblastoma.
MorphoSys gets grant for novel compounds for treating diseases associated with methyl modifying enzymes
Pharmaceutical Technology
APRIL 10, 2024
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.
Study reveals shorter scans for prostate cancer could improve diagnosis
Pharma Times
APRIL 10, 2024
The most common form of cancer in men is responsible for 12,000 deaths every year in the UK
Acceleron Pharma gets grant for treatment of spinal muscular atrophy using ALK4:ACTIRiib antagonists
Pharmaceutical Technology
APRIL 10, 2024
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.
FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too
Fierce Pharma
APRIL 10, 2024
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.
Lisata wins FDA orphan drug status for bone cancer candidate
Pharmaceutical Technology
APRIL 10, 2024
The FDA has granted orphan drug designation for Lisata Therapeutics’s LSTA1 (certepetide) to treat osteosarcoma, a rare type of blood cancer.
The New Age of Decentralized Clinical Trials
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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.
Novartis halts recruitment of Kisqali trials as it adjusts production methods
Fierce Pharma
APRIL 10, 2024
In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kisqali (ribociclib) as it makes adjustments to its manufacturing processes for the drug.
Novartis plans to axe 680 employees
Pharmaceutical Technology
APRIL 10, 2024
Novartis lays off 680 staff members in the US and Switzerland following a successful 2023 financial year.
Changing Faces: Digital and supplier hires from March 2024
pharmaphorum
APRIL 10, 2024
Discover the latest trends in leadership appointments and C-suite hires in the digital and supplier space from March 2024 in our in-depth analysis.
Innate Pharma plans IND of ADC candidate after positive preclinical data
Pharmaceutical Technology
APRIL 10, 2024
Innate Pharma plans to advance IPH45 towards clinical trials, with an investigational new drug (IND) application planned in 2024.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
How Efficient Logistics Can Change the Lives of Rare Disease Patients
Pharmaceutical Commerce
APRIL 10, 2024
If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.
Pharmaceutical cleanrooms and cleanroom flooring suppliers
Pharmaceutical Technology
APRIL 10, 2024
Pharmaceutical Technology has listed the leading suppliers of pharmaceutical cleanrooms and cleanroom flooring. Download the free guide here.
e-therapeutics is latest UK biotech to seek AIM de-listing
pharmaphorum
APRIL 10, 2024
e-therapeutics is the latest UK biotech to say it plans to delist from the AIM, citing a lack of interest from institutional investors.
AACR: Merck, Kelun’s Anti-TROP2 ADC Shows Early Promise in Gastric Cancer
BioSpace
APRIL 10, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
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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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