First nonprescription birth control pill approved by FDA
Bio Pharma Dive
JULY 13, 2023
The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.
Sat.Jul 08, 2023 - Fri.Jul 14, 2023
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Lonely People’s Brains Work Differently, New Evidence Shows
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2023
Being surrounded by people who don’t see the world quite like you do increases your risk of feeling lonely, even if you’re friends with them. Neuroimaging tests on 66 young adults discovered significant contrasts in the way lonely people’s brains process information compared to their peers.
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Cingulate prepares for FDA approval for its once-daily ADHD pill
Pharmaceutical Technology
JULY 12, 2023
To that end, the company presented positive top-line Phase III results for its once-daily stimulant for ADHD.
Actimed plans trials to treat muscle wasting syndrome in cancer patients
Pharmaceutical Technology
JULY 13, 2023
The company aims to start two trials in H1 2024 based on its current timeline, depending on if it closes its Series B round soon.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
AI May Have Found The Most Powerful Anti-Aging Molecule Ever Seen
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 9, 2023
Finding new drugs – called “drug discovery” – is an expensive and time-consuming task. But a type of artificial intelligence called machine learning can massively accelerate the process and do the job for a fraction of the price.
More convenient form of Roche MS drug succeeds in study
Bio Pharma Dive
JULY 13, 2023
The under-the-skin formulation of Ocrevus can be administered in 10 minutes, versus a longer period for the current intravenous version.
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Startup Tenpoint raises $70M to develop regenerative medicines for the eye
Bio Pharma Dive
JULY 12, 2023
Backed by F-Prime Capital and Sofinnova Partners, the company claims to have technology that could allow it replace eye cells destroyed in age-related and inherited ocular conditions.
NVIDIA invests $50m in AI-enabled drug discovery
Pharmaceutical Technology
JULY 13, 2023
NVIDIA signed an investment and collaboration agreement with Recursion to create AI models to accelerate drug discovery.
Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report
Fierce Pharma
JULY 11, 2023
Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.
Small Study Reveals How The Pandemic Impaired Babies’ Social Development And Behavior
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 13, 2023
The world changed for all of us when we were suddenly plunged into a pandemic in 2020. COVID sent us into a series of lockdowns in a bid to control the spread of the virus until a vaccine could be developed.
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
Bio Pharma Dive
JULY 10, 2023
Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.
Imperial spinout wins £1.6m Innovate UK grant for NK cell therapies
Pharmaceutical Technology
JULY 12, 2023
Innovate UK’s New Cancer Therapeutics programme awarded the grant to the Imperial College spinout to support pre-clinical development.
Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks
Fierce Pharma
JULY 10, 2023
Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbust | Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.
Karnataka budget gives big booster shot to health & lifesciences start-ups with focus on infrastructure & innovation
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 9, 2023
Karnataka government has given a booster shot to health & startups in lifesciences with focus on infrastructure and innovation. Announcing an allocation of Rs. 14,950,496 crore for healthcare, state has called for the re-introduction of Yashashwini scheme to provide medical facilities to rural farmers with a grant of Rs. 300 crore.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
RNA editing specialist Korro to go public via reverse merger
Bio Pharma Dive
JULY 14, 2023
The deal with Frequency Therapeutics is the latest biotech reverse merger as private drugmakers still face challenges going public via an IPO.
EMA concern stirs over suicide risk with weight loss GLP-1RA drugs
Pharmaceutical Technology
JULY 12, 2023
The EMA is reviewing data on the potential effects of high-profile GLP-1RAs in causing suicidal thoughts and thoughts of self-harm.
July 13, 2023: Adrian Hernandez Shares Insights Into Driving Change to Promote Data Sharing
Rethinking Clinical Trials
JULY 13, 2023
Dr. Adrian Hernandez At the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, we interviewed Dr. Adrian Hernandez about how to better promote data sharing. Hernandez is a co–principal investigator of the program’s Coordinating Center and the executive director of the Duke Clinical Research Institute. “We have to change the incentive structure because we still have barriers for sharing data.
Staying Up All Night May Actually Relieve Depression in Some People
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2023
As most new parents can attest, sleepless nights don’t exactly make for the most cheerful mornings. This is why it makes little sense that total sleep deprivation temporarily resets the mood of nearly half of people with a major depressive disorder.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Lilly to buy Versanis, adding to obesity drug pipeline
Bio Pharma Dive
JULY 14, 2023
The pharma will pay up to $1.9 billion to acquire the private biotech and its experimental antibody, which Lilly plans to pair with its own weight loss medicines.
Iovance looks to advance its non-small cell lung cancer therapy
Pharmaceutical Technology
JULY 11, 2023
Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.
July 24, 2023: Bioethics Research Project Explores Data Sharing and Respect for Trial Participants
Rethinking Clinical Trials
JULY 12, 2023
Dr. Stephanie Morain At the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in May, Dr. Stephanie Morain discussed the results of a recent bioethics initiative to explore ethical considerations for data sharing in the context of pragmatic clinical trials. The project was supported by a supplemental grant award from the NIH through the NIH HEAL Initiative.
Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2023
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June.
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.
Avrobio halts gene therapy research and considers a sale
Bio Pharma Dive
JULY 12, 2023
The decision to explore “strategic alternatives” comes about six weeks after the company sold its most advanced treatment to Novartis for nearly $90 million.
Covid-19: Anti-inflammatory drugs do not lead to a swifter hospital exit
Pharmaceutical Technology
JULY 11, 2023
Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.
July 12, 2023: Workshop Materials Now Available From ‘Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings’
Rethinking Clinical Trials
JULY 12, 2023
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings. “ The 2-day workshop, held in June at the 2023 AcademyHealth Annual Research Meeting in Seattle, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.
Quest and Proov collaborate to bring novel home fertility test to women through questhealth.com
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2023
Women seeking to start or expand a family can now access the Proov Confirm PdG home collection kit for assessing fertility through questhealth.com.
Takeda withdraws FDA approval application for dengue vaccine
Bio Pharma Dive
JULY 11, 2023
While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.
Causaly secures $60 Million in series B funding
Pharmaceutical Technology
JULY 14, 2023
Causaly serves 12 of the top 20 pharmaceutical companies with technology that aims to expedite the drug discovery process.
July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial
Rethinking Clinical Trials
JULY 12, 2023
Dr. Christopher Granger and Dr. Neha Pagidipati In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.” The Grand Rounds session will be held on Friday, July 14, 2023, at 1:00 pm eastern. The Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes (COORDINATE)–Diabetes was a cluster randomized trial assessing the effect of a multifaceted intervention of
ICMR issues list of technologies supported under ICMR- MDMS to foster indigenous manufacturing of medical devices
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 13, 2023
The Indian Council of Medical Research (ICMR) has issued list of technologies supported under ICMR-Medical Device and Diagnostics Mission (MDMS) Secretariat to foster indigenous manufacturing of medical devices and diagnostics. This will be implemented through different schemes which will strengthen the healthcare system in line with the ‘Make-in-India’ initiative of the Government of India (GoI).
The New Age of Decentralized Clinical Trials
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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.
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