10 clinical trials to watch in the second half of 2024
Bio Pharma Dive
JULY 1, 2024
Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
Mon.Jul 01, 2024
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July 1, 2024: Latest Podcast Features Michael Pencina and Brian Anderson of Coalition for Health AI
Rethinking Clinical Trials
JULY 1, 2024
In a new episode of our Rethinking Clinical Trials podcast, Drs. Michael Pencina and Brian Anderson of the Coalition for Health AI speak with host Dr. Adrian Hernandez about public-private partnerships in a trustworthy health AI ecosystem. Pencina and Anderson presented on their experiences during the March 8 session of PCT Grand Rounds. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts , and view the full March 8 PCT Grand Rounds webinar.
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Eisai and Bristol Myers cancel cancer ADC deal
Bio Pharma Dive
JULY 1, 2024
The Japan-based drugmaker said its U.S. partner’s “portfolio prioritization efforts” led to the termination. It will refund part of an upfront payment.
Risk adjusted net present value: What is the current valuation of AstraZeneca’s Rilvegostomig?
Pharmaceutical Technology
JULY 1, 2024
Rilvegostomig is a monoclonal antibody commercialized by AstraZeneca, with a leading Phase III program in Non-Small Cell Lung Cancer.
With new IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease
Bio Pharma Dive
JULY 1, 2024
Like many of its cell therapy peers, Artiva, which originally sought an IPO in 2021, has shifted its strategy in hopes of riding a recent wave of investor interest in autoimmune disease research.
Risk adjusted net present value: What is the current valuation of Atai Life Sciences’s RL-007?
Pharmaceutical Technology
JULY 1, 2024
RL-007 is a small molecule commercialized by Atai Life Sciences, with a leading Phase II program in Diabetic Neuropathic Pain.
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Risk adjusted net present value: What is the current valuation of Pfizer’s Osivelotor?
Pharmaceutical Technology
JULY 1, 2024
Osivelotor is a small molecule commercialized by Pfizer, with a leading Phase III program in Sickle Cell Disease.
Eli Lilly inks another radiopharma deal, gaining option to buy startup
Bio Pharma Dive
JULY 1, 2024
Under an arrangement with Radionetics, Lilly will have rights to acquire the San Diego biotechnology company for $1 billion.
Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?
Pharmaceutical Technology
JULY 1, 2024
Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).
The right viral safety program can guard against costly bioburden incidents in biopharma development
Bio Pharma Dive
JULY 1, 2024
Viral contamination threatens biopharmaceutical development, making viral clearance and safety essential for risk mitigation.
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
TauRx seeks UK MHRA approval for Alzheimer’s treatment
Pharmaceutical Technology
JULY 1, 2024
TauRx Pharmaceuticals has filed an application with the UK MHRA seeking approval for hydromethylthionine mesylate (HMTM) to treat Alzheimer’s.
Are you meeting safety standards for residual host cell DNA?
Bio Pharma Dive
JULY 1, 2024
Ensure the safety of gene therapies with accurate HEK293 DNA measurement using Vericheck ddPCR kits.
Risk adjusted net present value: What is the current valuation of Pfizer’s Idrebormilast?
Pharmaceutical Technology
JULY 1, 2024
Idrebormilast is a small molecule commercialized by Pfizer, with a leading Phase II program in Rosacea.
GSK takes another Zantac personal injury case off its plate with settlement in Illinois
Fierce Pharma
JULY 1, 2024
GSK scratched another Zantac lawsuit off the list with a confidential settlement in Illinois as it continues to work through the mountain of personal injury litigation related to the heartburn pill | Following a win and a separate dismissal in Illinois, GSK agreed to a confidential settlement to resolve prostate cancer claims put forward by plaintiff Martin Gross.
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.
UK’s antibiotic subscription funding model – a route to market sustainability?
Pharmaceutical Technology
JULY 1, 2024
On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.
Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara
Fierce Pharma
JULY 1, 2024
Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.
Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Suzetrigine?
Pharmaceutical Technology
JULY 1, 2024
Suzetrigine is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Post-Operative Pain.
Talc claimants denied in effort to block Johnson & Johnson's latest Texas two-step bankruptcy
Fierce Pharma
JULY 1, 2024
Less than three weeks after a group of cancer victims filed a motion against Johnson & Johnson attempting to block the company’s latest bankruptcy plan—which comes with a $6.5 billion class-act | Less than three weeks after a group of cancer victims filed a motion attempting to block Johnson & Johnson's latest talc litigation bankruptcy plan—which comes with a $6.5 billion class-action settlement offer—a New Jersey federal court has quashed the effort.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma sector votes for post-Brexit clarity under new government
Pharmaceutical Technology
JULY 1, 2024
As the 4 July election approaches, the UK pharmaceutical sector wants the new government to prioritise the UK’s commercial clinical landscape.
France agrees to fund experimental glioblastoma therapy
pharmaphorum
JULY 1, 2024
France's HAS agrees to fund treatment with Carthera's ultrasound device for French subjects enrolled in a glioblastoma trial.
Risk adjusted net present value: What is the current valuation of Pfizer’s Idrebormilast?
Pharmaceutical Technology
JULY 1, 2024
Idrebormilast is a small molecule commercialized by Pfizer, with a leading Phase II program in Rosacea.
NeuroSense says ALS drug extends survival
pharmaphorum
JULY 1, 2024
NeuroSense Tx reports 12-month data with its amyotrophic lateral sclerosis therapy PrimeC, including a 43% improvement in survival
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
FDA approves Shorla Oncology’s TEPYLUTE for cancer treatment
Pharmaceutical Technology
JULY 1, 2024
The US FDA has approved speciality pharmaceutical company Shorla Oncology’s NDA for TEPYLUTE to treat breast and ovarian cancer.
Lilly builds in radiopharma with $140m Radionetics deal
pharmaphorum
JULY 1, 2024
Eli Lilly has lined up another deal in the radiopharmaceutical sector, paying $140 million to partner drugs developed by Radionetics Oncology and taking an option on buying the company outright for $1 billion.Radionetics is working on small-molecule drugs that target G protein-coupled receptors (GPCRs), a fertile source of drug targets for the pharma industry and the target of around a third of all marketed drugs but according to the company is a “largely unexplored” class for radiopharma.
Orion to hand over exclusive rights to MSD for prostate cancer therapy
Pharmaceutical Technology
JULY 1, 2024
Opevesostat will now be globally developed and commercialised exclusively by MSD, with Orion set to receive milestone payments.
As former BMS CEO Giovanni Caforio plots move to Novartis, will noncompete issues come into play?
Fierce Pharma
JULY 1, 2024
Fierce Pharma explored the status of the industry's noncompete clauses with experts to learn whether an intercompany transition at the highest levels can proceed without a hitch.
EMA CHMP recommends approval for Roche’s PNH therapy
Pharmaceutical Technology
JULY 1, 2024
The EMA CHMP has recommended granting approval for Roche's PiaSky to treat paroxysmal nocturnal haemoglobinuria (PNH).
After Gilead and J&J lawsuits, distributor Safe Chain sees its owners charged with wire fraud, conspiracy
Fierce Pharma
JULY 1, 2024
In yet another legal development surrounding counterfeit HIV drugs, a Florida court has handed down an indictment for the owners of a wholesale distributor that allegedly bought and redistribu | The wholesaler Safe Chain allegedly purchased $90 million of misbranded, diverted and adulterated HIV meds, according to U.S. authorities. The indictment of the company's three owners follows separate lawsuits from Gilead and Johnson & Johnson.
J&J looks to challenge argenx’s Vyvgart with positive Phase III data
Pharmaceutical Technology
JULY 1, 2024
The Phase III data for J&J’s nipocalimab shows the antibody's efficacy in improving symptoms of myasthenia gravis.
J&J adds another string to nipocalimab bow with gMG data
pharmaphorum
JULY 1, 2024
Johnson & Johnson has reported new phase 3 data with its FcRn blocker nipocalimab in generalised myasthenia gravis (gMG), pointing to data that it says differentiates it from other drugs in the class.The results from the Vivacity-MG3 study, presented at the European Academy of Neurology (EAN), show an improvement with nipocalimab compared to placebo on activities of daily living scores that have not been seen with other FcRn inhibitors, according to J&J.
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.
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