Trending Articles

article thumbnail

Amgen shares soar as executives outline obesity drug push

Bio Pharma Dive

The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

Drugs 253
article thumbnail

AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Common Blood Pressure Drug Increases Lifespan And Slows Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.

Drugs 166
article thumbnail

May 1, 2024: PKIDS Pragmatic Trial to Be Featured in PCT Grand Rounds

Rethinking Clinical Trials

Dr. Gregory Tasian In this Friday’s PCT Grand Rounds, Gregory Tasian of the Children’s Hospital of Philadelphia will present “Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial.” The Grand Rounds session will be held on Friday, May 3, 2024, at 1:00 pm eastern. The Pediatric Kidney Stone (PKIDS) Care Improvement Network Trial is a patient-centered, pragmatic clinical trial comparing the effectiveness of stone clearance for 3 surgical m

Trials 141
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Funding Rehab: Knowing Your Options

Pharma Mirror

Addiction is affecting a large portion of people’s lives at the minute, but one of the things people often struggle with is knowing how to afford rehab. There’s a common misconception that it costs thousands upon thousands of pounds and is entirely unattainable for people in some circles of society. However, that’s precisely what it is, a misconception, and many options can help people, no matter how wealthy or poor they are.

130
130
article thumbnail

ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

299
299

More Trending

article thumbnail

CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro 176
article thumbnail

5 Mid-Stage ALS Drugs to Watch

BioSpace

As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.

Drugs 121
article thumbnail

Insights from the 18th Annual Canadian Summit on Food Safety in 2024

XTalks

The 18th Annual Canadian Summit on Food Safety , held last week, brought together industry leaders, regulatory experts and innovators to discuss the current state and future of food safety. The event spanned two days packed with keynote speeches, panel discussions and networking opportunities aimed at enhancing food safety practices across the country.

article thumbnail

The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.

275
275
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

Reunion raises over $100M to build a better psychedelic drug

Bio Pharma Dive

The funding will help Reunion pay for a mid-stage study testing its most advanced medicine — essentially a synthetic version of the hallucinogenic psilocin — in women with postpartum depression.

Medicine 255
article thumbnail

Breakthrough: Rare Gene Mutation Offers Clues to Preventing Type 1 Diabetes

AuroBlog - Aurous Healthcare Clinical Trials blog

A unique genetic mutation in two siblings – that has never been seen in anyone else – has been discovered by UK researchers at the University of Exeter, pointing the way towards new treatment options for type 1 diabetes.

Gene 182
article thumbnail

Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits

Fierce Pharma

Biopharma companies and industry lobbying groups are striking out in their legal efforts to challenge price-cutting measures in the Inflation Reduction Act. | A federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on drug pricing.

Drugs 112
article thumbnail

Walmart retreats from healthcare, closing clinics across US

pharmaphorum

For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.

107
107
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

FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy 

Pharmaceutical Technology

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

article thumbnail

Enlaza gets JP Morgan, Regeneron backing for covalent biologics

Bio Pharma Dive

The funds will help the cancer-focused startup Enlaza bring “several development candidates” towards human testing in the next few years, its CEO said.

article thumbnail

Florida Man’s Mystery Migraine Traced to Rare Case of Parasite in His Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

A 52-year-old Florida man presented to hospital with complaints that his usual migraines had worsened over the past four months. On closer inspection using a CT scan, the doctors discovered his severe headaches were the result of several cysts throughout his brain.

Doctors 172
article thumbnail

Pfizer sets up DTC marketing platform as Q1 sales beat expectations

Fierce Pharma

Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. | Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. The company plans to sell products such as its COVID treatment Paxlovid and a migraine nasal spray in this way, it told the Financial Times.

Sales 108
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

Jacobio plans bid for China’s KRAS market with safety edge

pharmaphorum

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

article thumbnail

ESCMID 2024: The infectious consequences of climate change

Pharmaceutical Technology

Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.

245
245
article thumbnail

Pfizer’s strong Vyndaqel sales draw attention to rare disease drug’s patent life

Bio Pharma Dive

Sales of the transthyretin amyloidosis treatment widely beat Wall Street forecasts in the first quarter. The company aims to extend its patent exclusivity.

Sales 281
article thumbnail

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

AuroBlog - Aurous Healthcare Clinical Trials blog

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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

Emergent BioSolutions to cut 300 employees, shutter 2 facilities in restructuring launched under new CEO

Fierce Pharma

Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. | Merely about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring.

106
106
article thumbnail

From banking to biotech - Renée Aguiar-Lucander's unique path in science

BioPharma Reporter

RenÃe Aguiar-Lucander, CEO of Calliditas, is driving the advancement and launch of TARPEYO â the companyâs medication targeting rare disease IgA nephropathy. We spoke with RenÃe about her journey from investment banking to science and the joy of bringing therapies to patients.

article thumbnail

Eli Lilly reports 67% increase in Q1 2024 net income

Pharmaceutical Technology

Eli Lilly has announced that its net income rose to $2.24bn in Q1 2024, a 67% increase from $1.34bn in the same period of 2023.

246
246
article thumbnail

Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb

Bio Pharma Dive

Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.

Sales 281
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

CDSCO empowers regulators & boosts exports through comprehensive training programmes

AuroBlog - Aurous Healthcare Clinical Trials blog

In a concerted effort to fortify regulatory capabilities and enhance pharmaceutical exports, the Central Drugs Standard Control Organisation (CDSCO) has orchestrated a series of impactful training initiatives in the fiscal year 2023-24.

article thumbnail

Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

Drugs 127
article thumbnail

Merck, Huma alliance bears fruit with UK bladder cancer app

pharmaphorum

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

article thumbnail

Xyphos and Poseida to develop allogeneic cell therapies for cancer

Pharmaceutical Technology

Xyphos Biosciences and Poseida Therapeutics have signed a deal to develop new allogeneic cell therapies for treating cancer.

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.