Lilly drug for Alzheimer’s approved by FDA
Bio Pharma Dive
JULY 2, 2024
The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.
Sat.Jun 29, 2024 - Fri.Jul 05, 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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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
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.
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.
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.
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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.
Cartesian data add to progress, questions for CAR-T in autoimmune disease
Bio Pharma Dive
JULY 2, 2024
The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.
DrugPatentWatch Week in Review
Drug Patent Watch
JUNE 29, 2024
Patent Expirations and Generic Competition This week saw several major blockbuster drugs facing patent expirations, potentially opening the market for […] Source
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.
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
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.
Moderna gets US funding for bird flu vaccine development
Bio Pharma Dive
JULY 2, 2024
BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.
Apellis will appeal CHMP’s rejection of pegcetacoplan
pharmaphorum
JULY 2, 2024
Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
ICL granted £150,000 to explore link between breast cancer and breastfeeding
Pharma Times
JULY 1, 2024
Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers
UniQure, with sale of plant, outsources Hemgenix manufacturing
Bio Pharma Dive
JULY 1, 2024
The gene therapy developer, which cut jobs in October, expects the sale of a Lexington, Massachusetts, facility to Genezen to lower its cash burn.
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.
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.
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.
How can pharmaceutical marketing evolve with generic entry? The example of Lipitor
Drug Patent Watch
JULY 1, 2024
Lipitor’s marketing strategy underwent a significant evolution as generic competition emerged, employing aggressive tactics to retain market share and brand […] Source
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.
AstraZeneca files rival to Pemgarda for COVID PrEP
pharmaphorum
JULY 1, 2024
AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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