Drug Patent Watch
SEPTEMBER 26, 2024
The generic drug market is a complex and dynamic environment where multiple factors influence the availability, quality, and pricing of generic drugs. Conducting an effective market analysis is crucial for pharmaceutical companies, policymakers, and healthcare professionals to understand the market dynamics and make informed decisions.
Bio Pharma Dive
SEPTEMBER 26, 2024
In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.
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AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2024
(juanma hache/Getty Images) A new study has investigated whether drinking coffee or tea can reduce the risk of developing dementia, and the findings help explain some murky past results. Researchers at Ningxia Medical University in China have found that some coffee or tea drinkers are lowering their risk of dementia.
Bio Pharma Dive
SEPTEMBER 26, 2024
Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.
Pharmaceutical Technology
SEPTEMBER 26, 2024
West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.
Bio Pharma Dive
SEPTEMBER 26, 2024
The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
SEPTEMBER 26, 2024
The letter follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.
Pharmaceutical Technology
SEPTEMBER 26, 2024
The company has also reported positive data for PDE4 inhibitor, orismilast, in psoriasis, hidradenitis suppurativa, and ulcerative colitis.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 26, 2024
Healthcare technology company MCura is transforming outpatient department (OPD) services across India through its innovative digital solutions aimed at improving patient safety, medication adherence, and overall treatment transparency.
Pharmaceutical Technology
SEPTEMBER 26, 2024
Orion has entered a partnership with Aitia to leverage artificial intelligence in drug discovery and simulation in the oncology field.
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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
pharmaphorum
SEPTEMBER 26, 2024
Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.
Pharmaceutical Technology
SEPTEMBER 26, 2024
Pfizer has announced the withdrawal of all lots of OXBRYTA approved for treating sickle cell disease (SCD) from worldwide markets.
pharmaphorum
SEPTEMBER 26, 2024
Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.
Pharmaceutical Technology
SEPTEMBER 26, 2024
AskBio has entered a strategic partnership with China-based Belief BioMed (BBM) to advance the development of new gene therapies.
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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.
pharmaphorum
SEPTEMBER 26, 2024
BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.
Pharmaceutical Technology
SEPTEMBER 26, 2024
The Japanese MHLW has granted approval for MSD’s KEYTRUDA (pembrolizumab) for lung and urothelial cancer indications.
pharmaphorum
SEPTEMBER 26, 2024
AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.
Pharmaceutical Technology
SEPTEMBER 26, 2024
The Angelika Amon research building will house 150 employees across 11 floors researching cancer therapies.
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.
Fierce Pharma
SEPTEMBER 26, 2024
After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur
pharmaphorum
SEPTEMBER 26, 2024
MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac
Fierce Pharma
SEPTEMBER 26, 2024
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.
pharmaphorum
SEPTEMBER 26, 2024
IntraBio claims FDA approval for its Aqneursa therapy for Niemann-Pick type C, the second new drug for the disease in four days
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.
Fierce Pharma
SEPTEMBER 26, 2024
In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tag | In June at the ASCO conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer blockbuster Tagrisso, the presentation received a standing ovation.
Outsourcing Pharma
SEPTEMBER 26, 2024
The US big pharma company Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinical trials of the drug as data indicate a high risk of severe adverse events.
Drug Discovery World
SEPTEMBER 26, 2024
Researchers at the Francis Crick Institute, in collaboration with Revolution Medicines, have shown that a combination of treatments in mice with lung cancer allow immunotherapies to target non-responsive tumours. Their findings show that targeting tumours in different ways simultaneously might increase response to treatments. The researchers combined a newly identified KRAS G12C inhibitor, with a compound that blocks a protein called SHP, which inhibits cancer cells and can also activate tumour
FDA Law Blog
SEPTEMBER 26, 2024
By Jennifer D. Newberger — We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock.
Drug Discovery World
SEPTEMBER 26, 2024
Dr Rita Bottino Director of Islet Programs at Imagine Pharma, discusses the need for regulatory reform in islet allotransplantation for type 1 diabetes. Islet allotransplantation – the transplantation of isolated pancreatic islets from a deceased donor to a living recipient with type 1 diabetes – has emerged as a promising therapy for patients with type 1 diabetes, particularly those experiencing hypoglycemia unawareness.
Pharma Times
SEPTEMBER 26, 2024
New government scheme to offer routine opt-out blood tests
Drug Channels
SEPTEMBER 26, 2024
Today’s guest post comes from George Moore, Chief Information Technology Officer at CareMetx. As George explains using novel survey data, manufacturers view new technologies as crucial for patient services. He then explains how digital technology, artificial intelligence (AI), and machine learning (ML) can be used to improve patient adherence and increase hub efficiencies.
pharmaphorum
SEPTEMBER 26, 2024
Explore the future of oncology in 2024, including advancements in CAR-T therapies, support for cancer survivors, and the latest in radiopharmaceuticals. Stay ahead of the curve with this in-depth analysis.
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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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