The Genomic Medicine Revolution: Multi-Modality Approaches in Advanced Therapies
Pharmaceutical Technology
AUGUST 16, 2024
Genomic medicines offer new techniques for treating conditions once thought to be intractable - a world of opportunity awaits.
Fri.Aug 16, 2024
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Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot
Bio Pharma Dive
AUGUST 16, 2024
The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.
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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting
Pharmaceutical Technology
AUGUST 16, 2024
The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.
Medicare drug price cuts could have limited early impact, but grow with time
Bio Pharma Dive
AUGUST 16, 2024
Some industry watchers described the level of price discounts announced by Medicare as a "relief," though they warned of bigger future implications for drug research.
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
Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout
Pharmaceutical Technology
AUGUST 16, 2024
While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.
Zealand, Arrowhead advance obesity drugs; Bluebird narrows guidance
Bio Pharma Dive
AUGUST 16, 2024
Zealand is using a recent $1 billion equity raise to “accelerate” several would-be weight loss medicines. Meanwhile, Bluebird reworked a loan and Boundless Bio cut jobs only months after an IPO.
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New research reveals AI bowel cancer test can help patients avoid chemotherapy
Pharma Times
AUGUST 16, 2024
This form of cancer was responsible for 1.
Armed with Phase III win, Incyte eyes label expansion for Monjuvi
Pharmaceutical Technology
AUGUST 16, 2024
The Phase III inMIND trial evaluating Monjuvi as a combination treatment in relapsed/ refractory follicular lymphoma met its primary endpoint.
Fiercest Women in Life Sciences 2024: Nominations open now
Fierce Pharma
AUGUST 16, 2024
It’s time once again to nominate the fiercest women you know in the life science industry for our annual list. | It’s time once again to nominate the fiercest women you know in the life science industry for our annual list.
Clinical research in the UK must build on industry collaboration, says NIHR director
Pharmaceutical Technology
AUGUST 16, 2024
Professor Michael Lewis, the NIHR director of innovation, highlights the importance of UK pharma collaboration.
Researchers map interactions of 144 active substances to identify drug benefits
Pharma Times
AUGUST 16, 2024
The study yielded over one million dose-responsive curves for existing cancer drugs
AstraZeneca’s sBLA for LS-SCLC treatment gains FDA priority review
Pharmaceutical Technology
AUGUST 16, 2024
AstraZeneca has received priority review from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Imfinzi to treat limited-stage small cell lung cancer (LS-SCLC).
Novo Nordisk plans new $220M raw ingredients plant in Denmark
Fierce Pharma
AUGUST 16, 2024
Even as supplies of Novo Nordisk’s immensely popular GLP-1 drugs Ozempic and Wegovy start to stabilize, the Danish drugmaker continues to announce manufacturing and capacity upgrades at a rapid cli | Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5 billion Danish kroner ($220 million) to build a plant in Køge, Denmark, that will make raw materials, the company said Friday.
Nuntius partners with Taiho to develop mRNA cancer therapies
Pharmaceutical Technology
AUGUST 16, 2024
UK-based biotechnology company Nuntius Therapeutics has announced a strategic collaboration agreement with Japan’s Taiho Pharmaceutical to develop next-generation messenger ribonucleic acid (mRNA) cancer immunotherapies.
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
Not if, but when: Pandemic preparedness is crucial
pharmaphorum
AUGUST 16, 2024
On Wednesday, 14th August, the World Health Organization (WHO) announced the mpox outbreak in Africa as a public health emergency of international concern (PHEIC). By Thursday, 15th August, the first case of the severe variant was reported in Sweden, marking its emergence outside of Africa.
FDA accepts Deciphera’s vimseltinib NDA for priority review
Pharmaceutical Technology
AUGUST 16, 2024
The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals’ vimseltinib, a treatment for tenosynovial giant cell tumour (TGCT).
GSK notches another Zantac win as Florida court tosses expert testimony linking heartburn drug to cancer
Fierce Pharma
AUGUST 16, 2024
After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation. | After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation, thanks to a decision in Florida that put the kibosh on suspect expert testimony.
Hoth and Aronnax partner for HT-KIT cancer therapy development
Pharmaceutical Technology
AUGUST 16, 2024
Hoth Therapeutics has announced a master services agreement with Aronnax to advance the development of its HT-KIT cancer therapeutic.
FDA signs off on AZ's Imfinzi in NSCLC despite concerns about trial design
Fierce Pharma
AUGUST 16, 2024
AstraZeneca has scored an FDA approval in the advancement of its hi | AstraZeneca has scored an FDA approval in the advancement of its high-flying cancer therapy Imfinzi that comes with some controversy. The nod is for Imfinzi to treat patients with resectable non-small cell lung cancer perioperatively.
Lykos cuts team by 75%, vows to keep MDMA program despite FDA veto
Pharmaceutical Technology
AUGUST 16, 2024
The FDA rejected the therapy after the AdCom raised efficacy and ethical concerns in Lykos’ trials of its lead pipeline drug.
Overcoming regulatory hurdles to unleash breakthrough innovations: Cell and gene therapies and radiopharmaceuticals
pharmaphorum
AUGUST 16, 2024
Overcoming regulatory hurdles to unleash breakthrough innovations: Cell and gene therapies and radiopharmaceuticals Mike.
Pharma Pulse 8/16/24: The Future of Launch Excellence is GenAI, Will Negotiated Drug Prices Actually Save Money? & more
Pharmaceutical Commerce
AUGUST 16, 2024
The latest news for pharma industry insiders.
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.
With FDA okay, AZ takes on MSD in early-stage lung cancer
pharmaphorum
AUGUST 16, 2024
AstraZeneca has claimed FDA approval for its immunotherapy Imfinzi before and after surgery for non-small cell lung cancer, setting up a contest with MSD's rival Keytruda.PD-L1 inhibitor Imfinzi (durvalumab) has been cleared for use in adult patients who need surgery for early-stage (IIA-IIIB) NSCLC and have no ALK or EGFR mutations that would make them suitable for targeted therapies.
Fierce Pharma Asia—Merck-Curon bispecific deal; Legend's path forward; Missing adverse events in Amgen FDA filing
Fierce Pharma
AUGUST 16, 2024
Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option. | Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option.
As WHO calls mpox emergency, NIH says only drug ineffective
pharmaphorum
AUGUST 16, 2024
As WHO declares mpox an emergency, the only recognised drug treatment for the virus, Siga's tecovirimat, fails a clinical trial.
Keeping Counterfeit Goods Out of the Supply Chain
Pharmaceutical Commerce
AUGUST 16, 2024
In the final part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, comments on other ways to limit ‘bad actors’ attempts to sneak counterfeit drugs into the supply chain, aside from the DSCSA.
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
Lykos co-founder Doblin to step down after MDMA setback
pharmaphorum
AUGUST 16, 2024
Lykos Therapeutics is slashing staff after the FDA turned down its MDMA-assisted therapy for PTSD, while founder Rick Doblin is stepping down.
Incyte looks to widen Monjuvi's net with label expansion bid after phase 3 lymphoma win
Fierce Pharma
AUGUST 16, 2024
Months after securing the full rights to anti-CD19 antibody Monjuvi (tafasitamab) from partner MorphoSys, Incyte has the data to potentially back a label expansion into lymphoma. | The company looks to file its drug for a follicular lymphoma indication as part of a later-line triple combo therapy by the end of the year.
Medicare Unveils Results of First-Round Drug Price Negotiations
Pharmaceutical Commerce
AUGUST 16, 2024
By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.
The New Penal Processes in Pharmacy Act
Pharma Tutor
AUGUST 16, 2024
The New Penal Processes in Pharmacy Act admin Fri, 08/16/2024 - 15:29 ABOUT AUTHOR Dr. R. S. Thakur Former Secretary, Pharmacy Council of India. Email : drramsthakur@gmail.
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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