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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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.
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.
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 meets Phase III primary endpoints for RSV vaccine Abrysvo
Pharmaceutical Technology
APRIL 9, 2024
Pfizer intends to submit data from MONeT to regulatory agencies in a bid to expand the vaccine’s indicated treatment population.
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.
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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.
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.
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.
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.
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
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.
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.
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.
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.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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.
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.
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.
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.
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.
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
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.
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.
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.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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
FDA Backs BrainStorm’s Design for Phase IIIb Trial in Early-Stage ALS
BioSpace
APRIL 9, 2024
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.
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.
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
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.
Nvelop and Seaport Raise $100M in Rounds, Tap Bluebird and Karuna Execs
BioSpace
APRIL 9, 2024
A pair of biotechs burst onto the scene Tuesday, exiting stealth with $100 million in financing each and tapping executives who made their names at bluebird bio and Karuna Therapeutics.
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.
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
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.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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