MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine
Pharmaceutical Technology
FEBRUARY 12, 2024
The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.
Mon.Feb 12, 2024
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Chart a course for sustainable growth
Bio Pharma Dive
FEBRUARY 12, 2024
Explore how companies are optimizing efficiency, enhancing customer experiences and embracing AI.
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Disc wins orphan drug tag for rare blood cancer
Pharmaceutical Technology
FEBRUARY 12, 2024
The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.
Gilead to buy CymaBay in $4.3B deal for liver disease drug
Bio Pharma Dive
FEBRUARY 12, 2024
The proposed acquisition is a bet on CymaBay’s drug seladelpar, which is now under FDA review in a chronic liver disease called primary biliary cholangitis.
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
ICMR issues comprehensive guidance on ethical requirements for laboratory validation testing
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 12, 2024
In a significant move aimed at upholding ethical standards in the realm of medical research, the Indian Council of Medical Research (ICMR) has recently released detailed guidelines on the ethical requirements for laboratory validation testing.
The opioid crisis: Different delivery systems tackle treatment needs
Pharmaceutical Technology
FEBRUARY 12, 2024
What is the outlook for existing approaches and other pharmaceuticals in managing the opioid crisis?
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Innovate UK grants funds for breast cancer therapy project
Pharmaceutical Technology
FEBRUARY 12, 2024
Innovate UK has awarded £1m grant for a collaborative initiative called AI-VISION to aid in adopting treatment decisions for breast cancer.
First UK patients receive experimental mRNA therapy for cancer in global trial
Pharma Times
FEBRUARY 12, 2024
The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359
CSL heart drug misses goal in large study
Bio Pharma Dive
FEBRUARY 12, 2024
The failure of CSL’s plasma-derived infusion, which contains a protein in “good” cholesterol, follows a similar path as pills from Lilly, Merck, Pfizer and Roche.
NIHR awards over £20m to eight new global health research projects
Pharma Times
FEBRUARY 12, 2024
The projects will focus on healthcare in LMICs in the event of extreme weather
First targeted alpha therapy wins FDA breakthrough device designation
Pharmaceutical Technology
FEBRUARY 12, 2024
RadioMedix and Orano Med’s radioligand therapy AlphaMedix (lead-212-Dotamtate) is currently in a Phase II trial.
Scientists develop micofluidic chip to make cell therapy safer
Pharma Times
FEBRUARY 12, 2024
The chip removes cells, which could become tumours, before they are implanted in a patient
Science and menopause under the spotlight during the Super Bowl
Pharmaceutical Technology
FEBRUARY 12, 2024
Super Bowl LVIII saw Astellas run awareness for hot flashes and Pfizer touchdown with the history of science.
Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients
Pharma Times
FEBRUARY 12, 2024
The platform delivers digitalised patient data to improve clinical trials and development
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
CSL’s ‘big’ post-heart attack drug fails in Phase III trial
Pharmaceutical Technology
FEBRUARY 12, 2024
CSL’s post-MI drug failed to meet its primary endpoint of reducing the risk of major adverse cardiovascular events.
February 12, 2024: New Chapter of Living Textbook Highlights Value of Patient Engagement and Provides Practical Strategies
Rethinking Clinical Trials
FEBRUARY 12, 2024
Dr. Steven George The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement , describes principles and strategies for effectively engaging patient partners. Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials.
Alys Pharmaceuticals announces launch with $100m funding
Pharmaceutical Technology
FEBRUARY 12, 2024
Alys Pharmaceuticals has announced its launch with a R&D pipeline, backed by a $100m financing from Medicxi.
Women’s health is a priority not a charity
pharmaphorum
FEBRUARY 12, 2024
Investing in women's health research and funding is not a charity, but a priority. Discover the importance of allocating resources and supporting initiatives that promote women's health and well-being.
FDA grants breakthrough status to J&J’s nipocalimab for HDFN
Pharmaceutical Technology
FEBRUARY 12, 2024
The FDA granted breakthrough therapy status for J&J's nipocalimab for pregnant people at risk of haemolytic disease of the foetus and newborn.
Dermatology pharma Alys launches with $100m from Medicxi
pharmaphorum
FEBRUARY 12, 2024
Medicxi has combined six biotechs with dermatology medicines in development in a single drugmaker, called Alys Pharma, which starts life with $100 million in financing.
After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel
Fierce Pharma
FEBRUARY 12, 2024
With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. | Following a rejection in 2023, the FDA has accepted the resubmission of Xspray’s application for its leukemia candidate Dasynoc, which is seeking to dethrone Bristol Myers Squibb’s entrenched cancer blockbuster Sprycel (dasatinib).
Apple devices enrich patent data in arthritis trial
pharmaphorum
FEBRUARY 12, 2024
Study finds that monitoring of rheumatoid arthritis patients with an Apple Watch and iPhone and AI algorithm improves on standard practices.
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.
In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’
Fierce Pharma
FEBRUARY 12, 2024
Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection. But the first FDA-approved oral eosinophilic esophagitis therapy comes with a limitation.
FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen
pharmaphorum
FEBRUARY 12, 2024
GSK’s antisense-based drug for chronic hepatitis B, bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval
PTC's Emflaza to face generics this month after Aurobindo's final FDA nod
Fierce Pharma
FEBRUARY 12, 2024
After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S. | After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.
Changing Faces: Agency, consultancy, and investor hires from January 2024
pharmaphorum
FEBRUARY 12, 2024
Changing Faces: Agency, consultancy, and investor hires from January 2024 highlights the recent hires and movements in prominent companies such as Permira, Cuttsy+Cuttsy, SV Health Investors, and Cure Ventures. Stay updated with the latest talent appointments in the industry.
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
Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records
Fierce Pharma
FEBRUARY 12, 2024
When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by f | When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list.
Gilead to buy liver disease specialist CymaBay for $4.3bn
pharmaphorum
FEBRUARY 12, 2024
Gilead Sciences has beefed up its pipeline with an agreement to buy CymaBay Therapeutics and its seladelpar drug for primary biliary cholangitis (PBC) for $4.
In wake of Reata buyout, Biogen's key launch Skyclarys passes muster in EU
Fierce Pharma
FEBRUARY 12, 2024
Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starti | Roughly half a year after Biogen’s $7.3 billion buyout of rare disease specialist Reata Pharmaceuticals, the companies’ blockbuster bid for Reata’s Friedreich’s ataxia (FA) drug Skyclarys is starting to take shape.
CSL’s post-heart attack therapy flunks big phase 3 test
pharmaphorum
FEBRUARY 12, 2024
Biotech giant CSL has seen almost 5% wiped off the value of its shares after one of its most anticipated pipeline products failed a phase 3 trial in heart attack patients
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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