Nobel laureates ‘strongly urge’ Senate to oppose confirmation of RFK Jr
Pharmaceutical Technology
DECEMBER 12, 2024
In the letter, 77 Nobel Prize winners argue that appointing RFK as Secretary of HHS would put the US publics health in jeopardy.
Thu.Dec 12, 2024
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December 12, 2024: Another Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
Rethinking Clinical Trials
DECEMBER 12, 2024
In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups , and results from the NIH Collaboratory Trials.
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Sanofi’s combo vaccines gain FDA fast track designation
Pharmaceutical Technology
DECEMBER 12, 2024
Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.
Bayer begins inhibitor study treating advanced KRAS-mutated tumours
Pharma Times
DECEMBER 12, 2024
Trial explores potential of therapy in treating multiple cancer types
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
UK indefinitely bans puberty blockers for teenagers due to “unacceptable risk”
Pharmaceutical Technology
DECEMBER 12, 2024
Puberty blockers for people aged under 18 with gender dysphoria will be indefinitely banned by the UK Government.
Leriglitazone meets primary endpoint in pivotal cALD trial
Pharma Times
DECEMBER 12, 2024
Promising trial results support marketing authorisation application
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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
China NMPA approves Santhera’s DMD treatment therapy
Pharmaceutical Technology
DECEMBER 12, 2024
Chinas NMPA has granted approval to Santhera Pharmaceuticals AGAMREE, used in treating DMD in individuals aged four years and above.
What Influence Do CROs Have on Improving DEI Across the Healthcare Industry?
XTalks
DECEMBER 12, 2024
Equal opportunity to healthcare is not just a topic of discussion it must be intentionally implemented and built into every aspect of healthcare. In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products.
Meitheal gains US commercial rights for CABP treatment therapy
Pharmaceutical Technology
DECEMBER 12, 2024
Meitheal Pharmaceuticals has gained exclusive US commercial rights for XENLETA for treating CABP in the adult population.
Addressing Generic Drug Market Challenges: Strategies for Stability and Affordability
Drug Patent Watch
DECEMBER 12, 2024
The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. These challenges can lead to drug shortages, price spikes, and reduced affordability for patients and payers. To address these issues, several market-based proposals and regulatory reforms have been suggested.
Building up the infrastructure for future pandemic preparedness: Frontiers in rapid raw material production
Pharmaceutical Technology
DECEMBER 12, 2024
Strengthening domestic production capabilities is essential in ensuring health security.
Noema Pharma raises $147 million to develop drugs for neurological conditions
Outsourcing Pharma
DECEMBER 12, 2024
Noema Pharma extends its series B funding to $147M, advancing phase 2 trials for CNS disorders like Tourette syndrome, menopause symptoms, and neuropathic pain.
Transforming preventative care in the NHS
Pharmaceutical Technology
DECEMBER 12, 2024
In a new webinar, industry experts explain how innovative technology is reshaping healthcare delivery, enabling proactive interventions that improve patient outcomes, relieve NHS pressures, and pave the way for a more sustainable healthcare system.
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
MeMed’s Sepsis Severity Test Gets FDA Breakthrough Device Designation
XTalks
DECEMBER 12, 2024
MeMed has received Breakthrough Device designation for its MeMed Severity sepsis test from the US Food and Drug Administration (FDA). MeMeds test is designed to advance the management of individuals with suspected acute infections and sepsis. MeMed says the test helps empower clinicians with timely, data-driven clinical insights, allowing for rapid risk stratification and predicting disease progression, along with clinical assessments and other laboratory findings.
Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Inaxaplin?
Pharmaceutical Technology
DECEMBER 12, 2024
Inaxaplin is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Focal Segmental Glomerulosclerosis (FSGS).
Eli Lilly Powers Investor Confidence with New $15B Share Buyback Program
XTalks
DECEMBER 12, 2024
In a move that underscores its soaring market performance and investor confidence, Eli Lilly announced a massive $15 billion share buyback program. The share repurchase program was approved by Lillys board of directors. The companys previous $5 billion share repurchase program was completed in the fourth quarter of 2024. Stock buybacks, which involve a company repurchasing its own shares from the market, typically result in a reduction of outstanding shares, thereby increasing earnings per share
Risk adjusted net present value: What is the current valuation of Pfizer’s (Clesacostat tromethamine + Ervogastat)?
Pharmaceutical Technology
DECEMBER 12, 2024
(Clesacostat tromethamine + Ervogastat) is a small molecule commercialized by Pfizer, with a leading Phase II program in Metabolic Dysfunction-Associated Steatohepatitis (MASH).
Immune-Based Intratumoral Cancer Therapies ft. Intensity Therapeutics Founder and CEO Lewis Bender
XTalks
DECEMBER 12, 2024
In this episode, Ayesha had a conversation with Lewis Bender, MBA, Founder, Chairman and CEO of Intensity Therapeutics , a biotech company developing first-in-class immune-based intratumorally injected cancer therapies. Intensitys lead product candidate, INT230-6, is currently in human clinical studies for the treatment of refractory solid tumors, including metastatic soft tissue sarcoma and breast cancer.
Risk adjusted net present value: What is the current valuation of I-Mab’s Lemzoparlimab?
Pharmaceutical Technology
DECEMBER 12, 2024
Lemzoparlimab is a monoclonal antibody commercialized by I-Mab, with a leading Phase II program in Solid Tumor.
How to Evaluate CDMO Performance: Key Considerations and Best Practices
Drug Patent Watch
DECEMBER 12, 2024
The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial. Evaluating CDMO performance is a critical step in this process, ensuring that the chosen partner can meet the required standards and deliver high-quality products.
Risk adjusted net present value: What is the current valuation of Novartis’s Rapcabtagene autoleucel?
Pharmaceutical Technology
DECEMBER 12, 2024
Rapcabtagene autoleucel is a gene-modified cell therapy commercialized by Novartis, with a leading Phase II program in Diffuse Large B-Cell Lymphoma.
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.
Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules
FDA Law Blog
DECEMBER 12, 2024
By Larry K. Houck Administrative Law Judge (ALJ) John Mulrooney conducted a prehearing conference hearing on Monday, December 2nd, to kick off the public hearing on the Department of Justices (DOJs) notice of proposed rulemaking (NPRM) to reschedule marijuana. The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III.
Risk adjusted net present value: What is the current valuation of Adicet Bio’s ADI-001?
Pharmaceutical Technology
DECEMBER 12, 2024
ADI-001 is a gene-modified cell therapy commercialized by Adicet Bio, with a leading Phase I program in Lupus Nephritis.
Trade & Channel Strategies 2024: Key Challenges of Implementing Direct-to-Patient Models
Pharmaceutical Commerce
DECEMBER 12, 2024
Kevin OMeara discusses Patient-Cetric 3.0 breakout session and the challenges of drug manufactures implementing Direct-to-Patient models.
Risk adjusted net present value: What is the current valuation of Eli Lilly and Co’s Imlunestrant tosylate?
Pharmaceutical Technology
DECEMBER 12, 2024
Imlunestrant tosylate is a small molecule commercialized by Eli Lilly and Co, with a leading Phase III program in Metastatic Breast Cancer.
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
Pharma Pulse 12/12/24: AI Skepticism to Adoption in Pharma Marketing, Biologic Treatments Transforming Severe Asthma Management & more
Pharmaceutical Commerce
DECEMBER 12, 2024
The latest news for pharma industry insiders.
Risk adjusted net present value: What is the current valuation of Plus Therapeutics’s Rhenium (186Re) Obisbemeda?
Pharmaceutical Technology
DECEMBER 12, 2024
Rhenium (186Re) Obisbemeda is a small molecule commercialized by Plus Therapeutics, with a leading Phase II program in Recurrent Glioblastoma Multiforme (GBM).
Trade & Channel Strategies 2024: A Deep Dive into Drug Shortages
Pharmaceutical Commerce
DECEMBER 12, 2024
A session investigates the drivers of these shortages and ways to mitigate them.
Risk adjusted net present value: What is the current valuation of Eli Lilly and Co’s Retatrutide?
Pharmaceutical Technology
DECEMBER 12, 2024
Retatrutide is a synthetic peptide commercialized by Eli Lilly and Co, with a leading Phase III program in Type 2 Diabetes.
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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