May, 2022

article thumbnail

Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

article thumbnail

Mental health apps and services may be doing more harm than good

World of DTC Marketing

Cerebral will stop writing prescriptions for Adderall, Ritalin, and other controlled substances to new ADHD patients as concerns grow about telehealth companies’ prescribing practices. To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs.

Licensing 252
Insiders

Sign Up for our Newsletter

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

article thumbnail

Moderna’s HIV vaccine prepped for trials in Africa

pharmaphorum

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.

article thumbnail

Artificial intelligence stands to transform precision medicine: AiCure

Outsourcing Pharma

An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.

Medicine 140
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

DrugPatentWatch named “Best of the Web” by Genetic Engineering News

Drug Patent Watch

DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.

article thumbnail

PTC Therapeutic’s Upstaza has been recommended by both the EMA and CHMP

Pharma Times

It is the first gene therapy to be directly administered into the brain to treat aromatic L-amino acid decarboxylase (AADC) deficiency

More Trending

article thumbnail

Oramed hits oral insulin clinical trial milestone

BioPharma Reporter

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

Insulin 124
article thumbnail

The antimicrobial pipeline is ‘dry’ and that’s a problem

pharmaphorum

Antimicrobial resistance is a growing problem and one that is already claiming over a million lives per year. The situation is urgent but finding a sustainable solution is a difficult prospect, finds Ben Hargreaves. Alexander Fleming discovered the world’s first antibiotic, penicillin, in 1928. However, the difficulty in developing a method to adequately produce sufficient levels of the product meant that the age of the antibiotic did not truly begin until the 1940s.

Bacteria 144
article thumbnail

Machine learning can unlock potential of EEG data: Beacon Biosignals

Outsourcing Pharma

A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.

article thumbnail

NeuroMetrix’s Quell Device Gets FDA Approval as First Non-Drug Treatment for Fibromyalgia

XTalks

Fibromyalgia is a chronic condition that causes widespread pain, difficulty concentrating, sleep problems, fatigue, mood disorders and other symptoms. People with fibromyalgia have abnormal pain perception processing, so they may be more sensitive to pain compared to people without the condition. Fibromyalgia affects approximately 4 million adults in the US, which is about 2 percent of the US adult population.

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

Simple blood test could save thousands from bowel cancer

Pharma Times

Comparisons with other tests available have shown that blood test has greater sensitivity for the detection of bowel cancer

132
132
article thumbnail

BioMarin delays planned FDA filing for hemophilia gene therapy

Bio Pharma Dive

BioMarin now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for the company's closely watched treatment.

article thumbnail

“Growing end” of inflammation discovered

Scienmag

Redness, swelling, pain – these are signs of inflammation. It serves to protect the body from pathogens or foreign substances. Researchers from the Universities of Bonn and Cologne were able to show that inflammatory reactions of an important sensor protein proceed in a specific spatial direction. This finding has the potential to conceivably stop inflammation […].

Protein 104
article thumbnail

How patient-on-a-chip tech could be the future of drug discovery

pharmaphorum

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves discovers how the technology could provide more accurate safety predictions and even discover new treatments. The limits of animal models in drug discovery are well known.

Drugs 143
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

NIH awards $577m to antiviral drug developers

BioPharma Reporter

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

Allergies 105
article thumbnail

Clinical Scientist Jobs: The Steps to Succeed in This Role

XTalks

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform. Who is a Clinical Scientist?

Scientist 105
article thumbnail

New patent for Ironwood Pharms drug DUZALLO

Drug Patent Watch

Annual Drug Patent Expirations for DUZALLO Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. DUZALLO drug…. The post New patent for Ironwood Pharms drug DUZALLO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
article thumbnail

In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too.

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

Modifying the body’s immune system to help treat Type 1 diabetes

Scienmag

In a new study, a team of researchers from the University of Missouri, Georgia Tech and Harvard University has demonstrated the successful use of a novel Type 1 diabetes treatment in a large animal model. Their approach involves transplanting insulin-producing pancreas cells — called pancreatic islets — from a donor to a recipient, without the […].

Insulin 102
article thumbnail

Google gives ex-FDA digital health head Bakul Patel strategic role

pharmaphorum

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig

Radiology 136
article thumbnail

Bacteriophage producer Locus Biosciences raises $35m in financing

BioPharma Reporter

Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.

article thumbnail

World Hunger Day 2022: History, Theme and Ways to Support the Movement

XTalks

World Hunger Day is observed each year on May 28 to raise awareness about the dramatic rise in hunger in recent years. While the day was created prior to the COVID-19 pandemic, the unprecedented global crisis has forced hundreds of millions of people into chronic hunger, escalating the need for change. Here’s everything you need to know about World Hunger Day 2022.

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

The GoodRx-Kroger Blowup: Spread Pricing, Pharmacy Margins, and the Future of Discount Cards

Drug Channels

A few weeks ago, GoodRx surprised investors with the unpleasant news that a major grocery chain had stopped accepting its discount card for an unspecified number of prescriptions. As I explain below, the unnamed chain appears to be Kroger— the sixth-largest U.S. pharmacy. What’s more, GoodRx disclosed that Kroger accounts for an unexpected one-quarter of its prescription business.

article thumbnail

Biogen CEO to step down as company pulls back from Alzheimer's drug

Bio Pharma Dive

Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors.

Doctors 337
article thumbnail

Scripps Research scientists explain what makes COVID-19 antibody “J08” so potent

Scienmag

LA JOLLA, CA—Last year, scientists at Scripps Research and Toscana Life Sciences studied the blood of 14 COVID-19 survivors to find the most potent antibodies against the SARS-CoV-2 virus. One of the leading molecules that emerged—now in stage II/III trials in Italy—was an antibody dubbed J08, which seemed to be capable of both preventing and […].

Antibody 100
article thumbnail

Oracle co-founder Larry Ellison leads $21.5m round for Imagene AI

pharmaphorum

Israeli cancer diagnosis startup Imagene AI has raised $21.5 million in first-round financing for its cancer diagnosis platform based digitised imaging of biopsy samples. The Series A – led by Oracle co-founder Larry Ellison and fellow investors Dr David Ahus and Zebra Medical Vision founder Eyal Gura – includes $3 million in seed funding from venture capital firm Blumberg Capital.

Genome 137
article thumbnail

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

article thumbnail

Cytiva opens Swiss manufacturing facility and Center of Excellence for cell and gene therapies

BioPharma Reporter

Cytiva is opening a new 7,400m manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the companyâs cell and gene therapy business as well as a being a base for European customer training programs.

article thumbnail

Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer

XTalks

Researchers at the University of Manchester have developed a new blood test that can help diagnose ovarian cancer faster and more accurately in women, particularly those under the age of 50, using a newer ovarian cancer biomarker. The blood test can be administered by general practitioners/physicians. The test includes the use of the emerging ovarian cancer biomarker, human epididymis protein 4 (HE4).

Research 105
article thumbnail

Time to Benefit of Intensive Blood Pressure Control in Older Adults

JAMA Internal Medicine

This secondary analysis of randomized clinical trials estimates the time needed to potentially derive clinical benefit from intensive blood pressure treatment in patients 60 years and older.

article thumbnail

Responding to outbreak, Moderna starts early work on monkeypox vaccine

Bio Pharma Dive

One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.

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.