Pharmaceutical Technology
JUNE 20, 2023
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.
Bio Pharma Dive
JUNE 5, 2023
The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.
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Fierce Pharma
JUNE 9, 2023
After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
BioSpace
JUNE 12, 2023
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
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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.
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Incorrect billing can result in federal and state violations as well as financial penalties. “To ensure billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better,” said Kelly Willenber
Pharma Times
JUNE 21, 2023
Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 29, 2023
After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.
Fierce Pharma
JUNE 12, 2023
Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.
BioSpace
JUNE 14, 2023
Two children with relapsed T cell acute lymphoblastic leukemia were cleared of cancer while a third died from fungal infection, according to research published Wednesday in The New England Journal of Medicine.
JAMA Internal Medicine
JUNE 4, 2023
This quality improvement study examines the association between the discontinuation of universal admission testing for SARS-CoV-2 infections and hospital-onset SARS-CoV-2 infections in England and Scotland.
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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.
Drug Patent Watch
JUNE 8, 2023
17th Edition Project Portfolio and Resource Management Excellence for Pharma July 11-13, 2023 | Sheraton Philadelphia University City Hotel | Philadelphia, PA Mastering Resource and Project Prioritization, Operational Excellence, and People Development… The post 17th Edition Project Portfolio and Resource Management Excellence for Pharma appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JUNE 6, 2023
Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.
Bio Pharma Dive
JUNE 22, 2023
The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.
Fierce Pharma
JUNE 29, 2023
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.
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.
BioSpace
JUNE 9, 2023
Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
BioPharma Reporter
JUNE 28, 2023
Dr. Theresa Heah is the CEO of Intergalactic Therapeutics, bringing over two decades of global leadership experience in ophthalmology drug development along with commercialization in early-stage, private-staged companies. We spoke to her about her background, overcoming adversity and unlocking the power of science. Losing her father at 5 years old due to a lack of medical advancement in her native Malaysia is what, she says, drove and determined her career.
Drug Patent Watch
JUNE 8, 2023
DrugChatter recently launched as an experimental AI chat-based business intelligence tool. Here’s some of the more interesting questions it’s been asked: Cost savings for bulk lipitor Who Invented Advil? What… The post DrugChatter Featured Questions appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.
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.
Bio Pharma Dive
JUNE 8, 2023
Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.
Fierce Pharma
JUNE 12, 2023
Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.
BioSpace
JUNE 29, 2023
After an initial rejection, BioMarin has finally secured the FDA’s approval for Roctavian, the first gene therapy in the U.S. for the most common form of the bleeding disorder.
XTalks
JUNE 30, 2023
It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The US Food and Drug Administration (FDA) approved BioMarin’s Roctavian, an adeno-associated virus (AAV) vector-based gene therapy, for the treatment of adults with severe hemophilia A.
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
pharmaphorum
JUNE 30, 2023
Editor in Chief Jonah Comstock speaks with Mark Reisenauer, president, US Commercial at Astellas. Mark gives an update on some of Astellas’s abstracts at the show, including the trials in gastric cancer, bladder cancer, and head and neck cancer.
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
Bio Pharma Dive
JUNE 9, 2023
The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.
Fierce Pharma
JUNE 22, 2023
Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.
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!
BioSpace
JUNE 15, 2023
The data for Reproxalap, Aldeyra Therapeutics’ drug for treating allergic conjunctivitis and dry-eye disease, could potentially pave the way for an alternative to over-the-counter eye drops.
Antidote
JUNE 29, 2023
In order to connect people with medical research opportunities, it is important to understand what motivates patients to participate in clinical trials. We asked 4,000 volunteers and caregivers to gain insight into their motivation for clinical trial participation. Here’s what we learned.
XTalks
JUNE 30, 2023
Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM). This approval distinguishes Ultravist as the singular contrast agent in the US specifically indicated for visualizing confirmed or suspected breast lesions in adults in conjunction with mammography and/or ultrasound.
Pharmaceutical Technology
JUNE 20, 2023
Teenagers and adults under the age of 25 at higher risk of sexually transmitted disease transmission will receive a single dose of the human papillomavirus (HPV) vaccine from September 2023. Whilst teenagers and eligible gay, bisexual, and other men who have sex with men (GBMSM) under the age of 25 will shift from two doses to one, immunosuppressed individuals (or those known to be HIV positive) will continue a 3-dose schedule.
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