PharmaFocus Today – Page 264 – media

CMS Is Getting More Serious About Penalizing Hospitals For Price Transparency Noncompliance

The Centers for Medicare & Medicaid Services (CMS) has fined two hospitals in September for alleged violations of its price transparency rule. This marks the third month in a row that the agency has issued fines against hospitals for price transparency noncompliance, following a yearslong period of light enforcement. The two fines issued on September 5 were the thirteenth and fourteenth penalties CMS has imposed on hospitals for price transparency violations. Saint Elizabeths Hospital in Washington, D.C. was fined $677,440, and Holy Cross Hospital in Silver Spring, Maryland was fined $325,710. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their websites in a machine-readable file. ...
- Source: drugdu
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- September 19, 2023
Novartis Shareholders Approve Sandoz Spin-Off as Product Plans Increase

By Connor Lynch Pictured: Novartis office in Germany/iStock, TBE Sandoz is finally nearing the end of its path towards independence. Over a year after Novartis finalized its plans to spin off its generics and biosimilars division, the Swiss pharma’s shareholders on Friday approved the move, which is expected to take effect on or around Oct. 4. The Novartis board of directors also approved the move back in July, paving the way for it to go ahead once the shareholders had signed off. The deal will see Novartis shareholders receive one Sandoz share for every five Novartis shares they hold, and the same ratio of American Depository Receipts (ADRs). Board of Directors Chair Joerg Reinhardt said in a statement that with “this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in ...
- Source: drugdu
- 124
- September 19, 2023
Anavex’s Blarcamesine Slows Cognitive Decline in Alzheimer’s Patients

By Tristan Manalac Pictured: Illustration of amyloid oligomers/iStock, selvanegra A follow-on analysis of a landmark Phase IIb/III study showed that Anavex Life Sciences’ investigational drug blarcamesine significantly slowed down cognitive decline in patients with Alzheimer’s disease, the company announced Thursday. At 48 weeks, the change in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale version 13 (ADAS-Cog13) scores in blarcamesine-treated patients was significantly better than placebo comparators. Blarcamesine was likewise significantly better than placebo when cognition was evaluated using the Clinical Dementia Rating scale Sum of Boxes (CDR-SB) scale, according to Anavex’s news release. The company bolstered these clinical findings with biomarker data, which showed that blarcamesine treatment resulted in a significant drop in pathological amyloid beta levels and a corresponding improvement in Aβ42/40 ratio, pointing to the molecule’s strong anti-amyloid potential. Anavex’s drug candidate also resulted in lower brain volume loss versus placebo. When it came to safety, the most common ...
- Source: drugdu
- 106
- September 19, 2023
Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
- Source: drugdu
- 153
- September 19, 2023
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
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- September 19, 2023
Bristol Myers Squibb reveals plans to double number of drugs in registrational trials

Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
- Source: drugdu
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- September 19, 2023
Sanofi and Ad Scientiam partner to assess MS disability progression

Sanofi and Ad Scientiam have partnered to launch an international, multicentre, longitudinal study to evaluate the ability of medical software, MSCopilot, to assess disability progression in people with multiple sclerosis (MS). The main objective of the MS-DETECT study, which explores digital biomarkers of MS, is to determine whether the MSCopilot software can effectively identify subtle and early signs of disability worsening. MS is a chronic immune-mediated, neurodegenerative disease of the central nervous system that currently affects 2.8 million people globally. The study will include 314 people with MS and will be conducted in the US, Canada, Germany, Italy, Spain, Denmark and France. Coordinating investigator and chairman of the study steering committee, professor Patrick Vermersch, believes that “these novel digital biomarkers are key to helping clinicians make appropriate treatment decisions and, ultimately, improve patients’ care.” As part of the agreement, the study will draw upon Ad Scientiam’s expertise in MS and ...
- Source: drugdu
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- September 19, 2023
Imported case of monkeypox leads to local transmission in China

Monkeypox (mpox) is a zoonotic disease caused by the mpox virus (MPXV) that has been primarily limited to Central and West African nations since its discovery. The recent spread of the West African lineage of MPXV in historically unaffected countries has raised concerns for global public health. Despite a significant decrease in global mpox cases, there is still a risk of a global resurgence. This study reports the first local case of mpox caused by an imported case in the Chinese mainland. Polymerase chain reaction (PCR) diagnosed the two cases, and the viral genomes were obtained by next-generation sequencing. Genomic analysis revealed that the two strains shared an identical genome sequence and belonged to the B.1.3 branch of the West African lineage, which is the first local case of mpox caused by an imported case in the Chinese mainland, highlighting the potential threat of mpox in China and the immediate ...
- Source: drugdu
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- September 18, 2023
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
- Source: drugdu
- 124
- September 18, 2023
FDA sends warning to CVS, Walgreens and other companies over unapproved eye products

By Jamie Gumbrecht, CNN CNN — The FDA sent warnings letters to eight companies for marketing and manufacturing of unapproved eye products. Sarah Silbiger/Getty Images The US Food and Drug Administration on Monday sent warning letters to CVS, Walgreens and other companies over manufacturing and marketing of unapproved eye products the agency says could pose a risk to people who use them. The agency said the products are illegally marketed to treat conditions including conjunctivitis — pink eye — glaucoma and cataracts, and some of the warnings cited sterility issues with the products. The agency issued warning letters to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc. Some companies have also been placed on import alert to stop products from entering the United States. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic ...
- Source: drugdu
- 114
- September 18, 2023

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