Trending Articles

article thumbnail

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.

300
300
article thumbnail

Alzheimer’s Is More Common in Women, And This May Help Explain Why

AuroBlog - Aurous Healthcare Clinical Trials blog

In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.

Hormones 224
Insiders

Sign Up for our Newsletter

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

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 342
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
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

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 169
article thumbnail

Pfizer accused of 'bringing discredit' on industry with 'unnecessary' vaccine tweet

BioPharma Reporter

Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.

More Trending

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

Vertex Buys Alpine for $4.9B to Bolster Autoimmune and Inflammatory Disease Pipeline

BioSpace

Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.

121
121
article thumbnail

Has Pfizer brought discredit on the industry with misguided vaccine tweet? Industry weighs in

BioPharma Reporter

Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.

article thumbnail

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.

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

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 199
article thumbnail

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).

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 132
article thumbnail

Number of ongoing US drug shortages reaches new high, pharmacist group says

Fierce Pharma

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

Drugs 118
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.

article thumbnail

Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59

Bio Pharma Dive

The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.

article thumbnail

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 153
article thumbnail

Bayer and Google Cloud to develop AI solutions for radiologists

Pharmaceutical Technology

Bayer has partnered with Google Cloud to develop AI-powered solutions for radiologists, creating scalable and compliant imaging software.

article thumbnail

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 120
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake

Fierce Pharma

About 15 years ago, Carl Ola Landgren, M.D. Ph.D., noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. | At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma. For this report, Fierce Pharma spoke with experts to learn about what's at stake, including the need to bring new treatments to patients earlier.

101
101
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

“This Is The First Time”: Drug Shows Signs of Slowing Parkinson’s Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A drug used to treat diabetes slowed the progression of motor issues associated with Parkinson’s disease, a study published in the New England Journal of Medicine said Wednesday. Parkinson’s is a devastating nervous system disorder affecting 10 million people worldwide, with no current cure.

Drugs 169
article thumbnail

Moderna pauses plans to build mRNA facility in Kenya

Pharmaceutical Technology

Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.

article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

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 115
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 122
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 220
article thumbnail

DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.

article thumbnail

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.

article thumbnail

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
article thumbnail

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.

113
113
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

US sues Regeneron, alleging false price reporting on Eylea

Bio Pharma Dive

The lawsuit claims the drugmaker didn’t disclose reimbursement to drug distributors for credit card fees, artificially inflating the reported price of the blockbuster eye drug.

Drugs 177
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.