PharmaFocus Today – Page 216 – media

FDA Accepts New Drug Application for Shorla Oncology’s Novel Treatment for Breast, Ovarian Cancer

Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
- Source: drugdu
- 244
- January 13, 2024
Menstrual Blood Testing Technology Eliminates Need for Finger Prick or Lab Blood Draw

Traditional methods of blood testing require invasive procedures administered by medical professionals, and can be time-consuming as well as expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of women globally have their period every single month. Until now, menstrual samples had never previously been explored as a diagnostic source for health information. Now, for the first time, a safe and simple technology allows menstrual blood samples to be used as an alternative to traditionally collected venous blood draws. This breakthrough provides an opportunity for testing important biomarkers for millions of menstruating women across the world. Qvin (Menlo Park, CA, USA) has proved the clinical relevancy of menstrual blood for several important biomarkers. The company’s Q-Pad technology uses menstrual blood to gain health insights in a non-invasive, convenient manner and can be used for testing anywhere in the world. The ...
- Source: drugdu
- 110
- January 13, 2024
New Blood Test Identifies Neuroendocrine Subtype of Advanced Prostate Cancer

Roughly 10-15% of individuals with metastatic castration-resistant prostate cancer (CRPC) eventually develop neuroendocrine prostate cancer (NEPC), a challenging cancer subtype. This transformation is marked by a change from androgen-dependent cancer cells to those that no longer respond to androgens. Diagnosing NEPC typically involves a biopsy from a metastatic tumor, but this can be uncertain due to timing issues and the heterogeneous nature of metastatic tumors. Now, researchers have developed a blood test that can reliably detect NEPC and differentiate it from CRPC-adenocarcinoma (CRPC-adeno). In previous research, an international team of researchers from Dana-Farber Cancer Institute (Boston, MA, USA and the University of Trento (Trento, Italy) examined biopsy tissue samples to identify genetic and epigenetic shifts accompanying this shift from cancer cells that are dependent on hormones called androgens to cancer cells that no longer even recognize androgens. They discovered distinctive genome-wide epigenetic alterations, particularly in DNA methylation, that differentiate CRPC-adeno ...
- Source: drugdu
- 108
- January 13, 2024
Livanova to close loss-making circulatory support business

Dive Brief Livanova is closing its circulatory support unit to focus on larger, faster-growing cardiopulmonary and neuromodulation opportunities. The advanced circulatory support (ACS) business sells the Lifesparc device, which pumps blood during cardiovascular surgeries, but sales have fallen and then flatlined since peaking in 2021. In a note to investors, Stifel analysts said they supported the decision to wind down the unit by the end of 2024, predicting it will benefit revenue growth and profitability and increase focus at the company. Dive Insight Livanova expanded its circulatory support offering by acquiring Tandemlife for $200 million upfront in 2018 and received 510(k) clearance for Lifesparc the next year. ASC remained a small part of the broader business, though. Over the first nine months of last year, ASC brought in $30.2 million, almost exclusively in the U.S., and accounted for about 4% of total sales. The unit has contracted in recent years. ...
- Source: drugdu
- 105
- January 12, 2024
Multiplexed POC Testing IVD Solution Performs Molecular and Immunoassays from Various Body Fluids on Single Platform

A hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) can perform both molecular and immunoassays from several body fluids on a single platform. The hybrid and scalable technology aims to deliver lab-comparable test results in a single patient encounter, significantly reducing the diagnostic timeline. Picodya’s B-Matrix diagnostic system is the world’s first POC hybrid solution that can run IVD tests, both immunoassays and molecular assays on the same device at lab-comparable quality, on multiple patient samples, simultaneously within minutes. The B-Matrix is designed to minimize turnaround time, and deliver better outcomes while lowering costs. The B-Matrix is powered by Picodya’s proprietary PicoFluidic technology which enables the system to operate at high capacity testing for a panel of markers simultaneously, using just pico volumes of reagents and controls. This allows for ultra-fast results within as quickly as 15 minutes and at a fraction of the cost for comparable ...
- Source: drugdu
- 182
- January 12, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
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- January 12, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
- Source: drugdu
- 119
- January 12, 2024
AcelRx becomes Talphera, adopting new name to reflect pain pivot

AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy. The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022. Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and ...
- Source: drugdu
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- January 12, 2024
GSK

GSK has a lot of experience with its shingles vaccine Shingrix in getting the older population to take their shots; now, with the approval of the world’s first RSV vaccine last year, the U.K. Big Pharma is looking for a slow burn approach for its latest respiratory shot. During GSK’s official J.P. Morgan Healthcare Conference 2024 presentation, CEO Emma Walmsley and Chief Commercial Officer Luke Miels spoke on how the company is looking to carve out a RSV market with its new vax Arexvy. “Creating a market is absolutely fundamental,” Walmsley said during the JPM presentation. “Three years ago, I don’t know how broadly the awareness was of the general public about RSV for older adults, even though it’s a scale disease that hospitalizes tens of thousands of Americans that were on, sadly 15,000 died. “So, we’re at very early stages of penetration of the market. I think competition and ...
- Source: drugdu
- 204
- January 12, 2024
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority

Review Status Hong Kong, Shanghai & Florham Park, NJ — Thursday, January 11, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib ...
- Source: drugdu
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- January 12, 2024

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