Bio Pharma Dive
SEPTEMBER 11, 2023
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
ACRP blog
SEPTEMBER 13, 2023
With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00
Advertisement
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.
Bio Pharma Dive
SEPTEMBER 12, 2023
Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
SEPTEMBER 13, 2023
For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.
Bio Pharma Dive
SEPTEMBER 14, 2023
Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.
Pharmaceutical Technology
SEPTEMBER 15, 2023
The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.
Antidote
SEPTEMBER 14, 2023
Alzheimer’s disease, the most prevalent type of dementia , is diagnosed in more than 6 million Americans. Estimates project that by 2050, 13 million individuals will be diagnosed with Alzheimer’s disease. This condition ranks among the top 10 causes of death in the United States, profoundly impacting those diagnosed, their loved ones, and their caregivers.
Advertisement
There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Fierce Pharma
SEPTEMBER 13, 2023
Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). | Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing.
Bio Pharma Dive
SEPTEMBER 13, 2023
The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.
Pharmaceutical Technology
SEPTEMBER 15, 2023
Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.
Drug Discovery World
SEPTEMBER 15, 2023
Advanced Therapies Europe took place from 9-12 September 2023 in Portugal. DDW’s Megan Thomas asked attendees: What is most important to scale from discovery to commercialisation of cell and gene therapies (CGTs)? Joel Eichmann, Co-Founder, Green Elephant Biotech It always comes down to time-to-market and risk minimisation. To cover these, it is critical to choose [.
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.
Fierce Pharma
SEPTEMBER 12, 2023
The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.
Bio Pharma Dive
SEPTEMBER 14, 2023
The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.
BioSpace
SEPTEMBER 11, 2023
With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.
Advertiser: FourKites
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.
Fierce Pharma
SEPTEMBER 15, 2023
Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.
Bio Pharma Dive
SEPTEMBER 12, 2023
The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.
Pharmaceutical Technology
SEPTEMBER 12, 2023
BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.
Drug Discovery World
SEPTEMBER 14, 2023
Ernesto Staroswiecki, Senior Manager, R&D, at Beckman Coulter Life Sciences takes readers through common lab automation myths. Many clinical and research laboratories today are having to do more with less: faced with ongoing staffing shortages, increased workloads, and budgetary constraints, many laboratory managers are feeling the stress, which is where the benefits of automation can be truly realised for labs in both academia and industry.
Advertisement
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Fierce Pharma
SEPTEMBER 11, 2023
Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.
Bio Pharma Dive
SEPTEMBER 11, 2023
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
Pharmaceutical Technology
SEPTEMBER 13, 2023
The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.
BioSpace
SEPTEMBER 13, 2023
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
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
Fierce Pharma
SEPTEMBER 11, 2023
Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).
Bio Pharma Dive
SEPTEMBER 13, 2023
“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.
Pharmaceutical Technology
SEPTEMBER 12, 2023
CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.
BioSpace
SEPTEMBER 14, 2023
Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study.
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
Expert insights. Personalized for you.
318 
Let's personalize your content