Thu.Dec 12, 2024

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Nobel laureates ‘strongly urge’ Senate to oppose confirmation of RFK Jr

Pharmaceutical Technology

In the letter, 77 Nobel Prize winners argue that appointing RFK as Secretary of HHS would put the US publics health in jeopardy.

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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

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.

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UK indefinitely bans puberty blockers for teenagers due to “unacceptable risk”

Pharmaceutical Technology

Puberty blockers for people aged under 18 with gender dysphoria will be indefinitely banned by the UK Government.

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What Influence Do CROs Have on Improving DEI Across the Healthcare Industry?

XTalks

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.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Sanofi’s combo vaccines gain FDA fast track designation

Pharmaceutical Technology

Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.

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Leriglitazone meets primary endpoint in pivotal cALD trial

Pharma Times

Promising trial results support marketing authorisation application

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Bayer begins inhibitor study treating advanced KRAS-mutated tumours

Pharma Times

Trial explores potential of therapy in treating multiple cancer types

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China NMPA approves Santhera’s DMD treatment therapy

Pharmaceutical Technology

Chinas NMPA has granted approval to Santhera Pharmaceuticals AGAMREE, used in treating DMD in individuals aged four years and above.

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How to Evaluate CDMO Performance: Key Considerations and Best Practices

Drug Patent Watch

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.

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Meitheal gains US commercial rights for CABP treatment therapy

Pharmaceutical Technology

Meitheal Pharmaceuticals has gained exclusive US commercial rights for XENLETA for treating CABP in the adult population.

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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

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New ways of looking at effective cancer treatment

Drug Discovery World podcast

This is the latest episode of the free DDW narrated podcast, titled New ways of looking at effective cancer treatment, which covers three articles written for DDW Volume 24 Issue 2, Spring 2023 of DDW. They are called: 3D Genomics and targeted cancer therapies , Democratising proteomics for cancer and beyond, and Meet the Researcher: John Maher In the first article, Anthony Schmitt, PhD, Senior Vice President, Science at Arima Genomics, discusses the applications of 3D genomics in cancer res

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Building up the infrastructure for future pandemic preparedness: Frontiers in rapid raw material production

Pharmaceutical Technology

Strengthening domestic production capabilities is essential in ensuring health security.

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Eli Lilly Powers Investor Confidence with New $15B Share Buyback Program

XTalks

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

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Transforming preventative care in the NHS

Pharmaceutical Technology

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.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novo Nordisk’s chief scientific officer looks to the future of GLP-1s

Fierce Pharma

GLP-1 agonists have taken the pharma world by storm, and Novo Nordisk has been at the forefront of it all thanks to blockbuster drug semaglutide, which it sells as Ozempic, Wegovy and Rybelsus. | This week on The Top Line, we hear from Novo Nordisk CSO Marcus Schindler about his role at the Danish pharma and whats next for the GLP-1 drug class.

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Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Inaxaplin?

Pharmaceutical Technology

Inaxaplin is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Focal Segmental Glomerulosclerosis (FSGS).

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ICER calls out Gilead, J&J, Novartis and more in latest report on 'unsupported' price increases

Fierce Pharma

In the Institute for Clinical and Economic Reviews (ICERs) annual price-hike report, the U.S. | The U.S. watchdog is taking several pharma majors to task over what it says are "unsupported" price increases. But many of the companies have been quick to hit back against ICERs findings.

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Risk adjusted net present value: What is the current valuation of Pfizer’s (Clesacostat tromethamine + Ervogastat)?

Pharmaceutical Technology

(Clesacostat tromethamine + Ervogastat) is a small molecule commercialized by Pfizer, with a leading Phase II program in Metabolic Dysfunction-Associated Steatohepatitis (MASH).

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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After M&A rumors sparked stock volatility, Bausch + Lomb confirms it's exploring a sale

Fierce Pharma

Twenty-one months into his second tenure as CEO of Bausch + Lomb, serial dealmaker Brent Saunders has so far come up empty in his latest attempt to sell the company. | Bausch + Lomb has issued a statement saying that its board had authorized management and its advisors to explore a potential sale, which is one of several options being explored to complete a full separation from its parent, Bausch Health Companies.

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Risk adjusted net present value: What is the current valuation of I-Mab’s Lemzoparlimab?

Pharmaceutical Technology

Lemzoparlimab is a monoclonal antibody commercialized by I-Mab, with a leading Phase II program in Solid Tumor.

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Noema Pharma raises $147 million to develop drugs for neurological conditions

Outsourcing Pharma

Noema Pharma extends its series B funding to $147M, advancing phase 2 trials for CNS disorders like Tourette syndrome, menopause symptoms, and neuropathic pain.

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Risk adjusted net present value: What is the current valuation of Novartis’s Rapcabtagene autoleucel?

Pharmaceutical Technology

Rapcabtagene autoleucel is a gene-modified cell therapy commercialized by Novartis, with a leading Phase II program in Diffuse Large B-Cell Lymphoma.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lonza plans to shed capsules business, simplify operating structure in push to become 'pure-play' CDMO

Fierce Pharma

With a new CEO at the helm, Swiss CDMO Lonza is looking to revivify its business by doubling down on contract manufacturing and jettisoning less profitable areas of its operations. | Lonza unveiled a restructuring strategy under which the company will reorganize its CDMO business. Notably, Lonza aims to hive off its capsules and health ingredients business at the appropriate time," the company said.

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Risk adjusted net present value: What is the current valuation of Adicet Bio’s ADI-001?

Pharmaceutical Technology

ADI-001 is a gene-modified cell therapy commercialized by Adicet Bio, with a leading Phase I program in Lupus Nephritis.

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Sodium lauroyllactylate (Koplactylate Na)

Pharma Tutor

Sodium lauroyllactylate (Koplactylate Na) admin Fri, 12/13/2024 - 11:00 Vinay Kumar Singh. Head-Formulation Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru Email : formulation_krc@kopresearchcentre.

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Risk adjusted net present value: What is the current valuation of Eli Lilly and Co’s Imlunestrant tosylate?

Pharmaceutical Technology

Imlunestrant tosylate is a small molecule commercialized by Eli Lilly and Co, with a leading Phase III program in Metastatic Breast Cancer.

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The New Age of Decentralized Clinical Trials

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.

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Fierce Pharma Asia—AZ, Daiichi's Dato-DXd rethink; BIOSECURE's setback; Amgen China's makeover

Fierce Pharma

AstraZeneca and Daiichi Sankyo shared the pooled analysis behind the refiling of their TROP2 antibody-drug conjugate (ADC) with the FDA. The BIOSECURE Act missed a key opportunity to become U.S. | AstraZeneca and Daiichi Sankyo shared the pooled analysis behind the refiling of their TROP2 ADC with the FDA. The BIOSECURE Act missed a key opportunity to become U.S. law.

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Risk adjusted net present value: What is the current valuation of Plus Therapeutics’s Rhenium (186Re) Obisbemeda?

Pharmaceutical Technology

Rhenium (186Re) Obisbemeda is a small molecule commercialized by Plus Therapeutics, with a leading Phase II program in Recurrent Glioblastoma Multiforme (GBM).

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Building upon a decade of CDx development for global commercialization

Fierce Pharma

| Discover how a decade of CDx innovation is expanding access to targeted therapies globally, paving the way for scalable precision oncology solutions

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Risk adjusted net present value: What is the current valuation of Eli Lilly and Co’s Retatrutide?

Pharmaceutical Technology

Retatrutide is a synthetic peptide commercialized by Eli Lilly and Co, with a leading Phase III program in Type 2 Diabetes.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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