Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
Bio Pharma Dive
APRIL 9, 2024
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
Tue.Apr 09, 2024
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Alzheimer’s Is More Common in Women, And This May Help Explain Why
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 9, 2024
In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.
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PureTech launches Seaport, hoping to create Karuna 2.0
Bio Pharma Dive
APRIL 9, 2024
The startup is taking aim at anxiety with $100 million from high-profile biotech backers like ARCH, Sofinnova and Third Rock.
Export of Ayush and herbal products registers 1.65% growth in first 10 months
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 9, 2024
Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.
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
FDA gives nod to BrainStorm for ALS trial after Phase III flop
Pharmaceutical Technology
APRIL 9, 2024
BrainStorm Cell Therapeutics has faced a few hurdles along the way towards the development of its lead candidate, NurOwn for ALS.
Pfizer accused of 'bringing discredit' on industry with 'unnecessary' vaccine tweet
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
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US researchers reveal positive results of personalised vaccine for liver cancer
Pharma Times
APRIL 9, 2024
Hepatocellular carcinoma is one of the leading causes of cancer-related deaths worldwide
Basilea wins CARB-X grant for new antibody development
Pharmaceutical Technology
APRIL 9, 2024
The grant will support the preclinical development of the antibody acquired by Basilea from Spexis in January.
Has Pfizer brought discredit on the industry with misguided vaccine tweet? Industry weighs in
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
Seaport emerges after $100m raise with ex-Karuna team at helm
Pharmaceutical Technology
APRIL 9, 2024
Seaport is developing oral neuropsychiatric drugs that bypass first-pass metabolism.
As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake
Fierce Pharma
APRIL 9, 2024
About 15 years ago, Carl Ola Landgren, M.D. Ph.D., noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. | At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma. For this report, Fierce Pharma spoke with experts to learn about what's at stake, including the need to bring new treatments to patients earlier.
Oryzon wins FDA approval to begin SCLC treatment trial
Pharmaceutical Technology
APRIL 9, 2024
The Phase I/II trial will assess iadademstat in combination with immune checkpoint inhibitors in lung cancer patients.
Culmination Bio and BillionToOne partner to advance cancer diagnosis
Pharma Times
APRIL 9, 2024
Both will validate the clinical performance of two new diagnostic tests for regulatory submission
Prothea debuts with $13m to develop cancer diagnostics and treatment
Pharmaceutical Technology
APRIL 9, 2024
Prothea plans to use the funds to start clinical trial for cancer imaging, biopsy and laser ablation treatment in lung cancer patients.
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
Amid corporate restructuring, Novartis plots 680 layoffs in development group
Fierce Pharma
APRIL 9, 2024
Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational uni | Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational unit.
NHS trust bids to take license for abandoned gene therapy
pharmaphorum
APRIL 9, 2024
Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.
Advanced therapy CDMO Ascend nabs Florida manufacturing site and team from ocular gene therapy outfit Beacon
Fierce Pharma
APRIL 9, 2024
Though gene therapy manufacturing specialist Ascend Advanced Therapies just launched a little more than a year ago, the CDMO is already on the hunt to expand. | Ascend, which bills itself as a “total solutions gene therapy development partner,” has picked up the manufacturing team and site of Beacon Therapeutics in Alachua, Florida. As part of the deal, Ascend has also agreed to a long-term partnership with Beacon to produce its ocular gene therapies for clinical and commercial use.
Commercialising IVDs – The complex path towards access to early diagnosis
pharmaphorum
APRIL 9, 2024
Navigating the complex path towards commercialising In Vitro Diagnostics (IVDs) can be challenging. Learn more about the intricate process involved in bringing early diagnostic tools to market.
AACR: Detailed data spark glimmer of hope for Merck's Keytruda-Lynparza combo in lung cancer
Fierce Pharma
APRIL 9, 2024
Researchers plan to run biomarker analyses of patients in the KEYLYNK-008 trial to see whether any subsets may benefit from the addition of Lynparza.
Bayer, Google partner on AI for time-pressed radiologists
pharmaphorum
APRIL 9, 2024
Bayer enlists the aid of Google Cloud to develop its AI platform for radiologists, adding genAI capabilities
Too many patients aren’t filling their prescriptions. Here’s how the industry can change that.
Fierce Pharma
APRIL 9, 2024
Medication adherence is a large and growing challenge for pharma companies, healthcare providers and the patients they serve. In the U.S. | Research shows that 20% of patients have failed to fill a script in the past, and one-third aren’t confident managing their illness. Engaging patients from the moment a drug is prescribed can help.
Harnessing the velocity of biopharmaceutical advances
pharmaphorum
APRIL 9, 2024
On today's episode of the podcast CEO and co-founder of 908 Devices Kevin Knopp joins as guest, discussing how such acceleration is by virtue of technological advancements, including the buzzword artificial intelligence (AI) and machine learning when it comes to bioprocessing.
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.
AbbVie’s Humira Loses Only 4% of Market Share to Biosimilars: Report
BioSpace
APRIL 9, 2024
Even with discounts that reach as high as 86%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.
UK survey finds deep ethnic divisions in cancer diagnosis
pharmaphorum
APRIL 9, 2024
A UK report has found that people from minority ethnic backgrounds face an average delay of a year between first noticing symptoms and gaining a diagnosis, which is more than twice as long as white people.
The Top Pharmacy Benefit Managers of 2023: Market Share and Trends for the Biggest Companies—And What’s Ahead
Drug Channels
APRIL 9, 2024
Three is still the magic number for pharmacy benefit managers (PBMs). For 2023, nearly 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group. Read on for Drug Channels Institute’s (DCI’s) latest market share figures, along with a preview of the industry changes that will shift these shares over the next few years.
Ex-Karuna team launch Seaport with $100m for psychiatry meds
pharmaphorum
APRIL 9, 2024
The team that brought you Karuna, recently sold to Bristol-Myers Squibb for $14 billion, has set up a neuropsychiatry-focused biotech called Seaport Therapeutics
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Pfizer Eyes Broader Label for RSV Vaccine Abrysvo After Promising Phase III Data
BioSpace
APRIL 9, 2024
Pfizer’s respiratory syncytial virus vaccine Abrysvo is just as effective in younger adults aged 18 to 59 years as it is in the shot’s currently approved population of 60 years of age and older.
Ubie AI aims to improve diagnosis of rare disease Cushing’s
pharmaphorum
APRIL 9, 2024
People with Cushing’s syndrome can sometimes take years to get a diagnosis, but a new project hopes to shorten that timeline with the help of artificial intelligence.
The IRA Is Already Curtailing Small Molecule Drug Development. Here’s How to.
BioSpace
APRIL 9, 2024
Many promising small molecules have lost significant investment appeal as a result of lopsided incentives favoring biologics in 2022’s Inflation Reduction Act.
The Challenges in Medical Device Safety Operations
Cloudbyz
APRIL 9, 2024
Medical devices play a critical role in healthcare, but ensuring their safety and reliability can be a complex and challenging task. The medical device industry is constantly evolving, and with that evolution come new and complex safety issues. In this article, we will explore some of the key challenges facing medical device safety operations and how they can be addressed. 1.
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.
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