PharmaFocus Today – Page 193 – media

Treatment of Orthopedic Postoperative Pain, Hengrui Pharmaceuticals’ New Drug Application for Tegretol Fumarate Injection Accepted

Postoperative pain is acute pain that occurs immediately after surgery. Inadequate management of postoperative pain may lead to a variety of psychological and physiological negative effects, such as persistent pain and the possibility of turning into a chronic state. Opioids are the most commonly used drugs for the treatment of moderate to severe acute and chronic pain. Classical μ-opioid receptor (MOR) agonists, including morphine and fentanyl, are among the more potent analgesic classes of opioids and can activate both the G protein-coupled pathway and the β-arrestin2 signaling pathway.Activation of the G protein-coupled pathway is conducive to a potent central analgesic effect, whereas activation of the β-arrestin2 signaling pathway causes gastrointestinal side effects, such as gastrointestinal dysphoria. Side effects. Currently, there are no biased MOR agonists with good analgesic effects and low incidence of adverse effects on the market in China, and there is an unmet clinical need. In December 2023, ...
- Source: drugdu
- 90
- January 7, 2024
HANSIZHUANG Combined with Chemotherapy for the First-line Treatment of sqNSCLC

Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
- Source: drugdu
- 85
- January 7, 2024
Rapid Bedside Test to Protect Newborns from Life-Threatening Illnesses

Group B Streptococcus (GBS), a bacterial strain, is the leading cause of severe infections in newborns in the UK. Around one in four pregnant women in the UK are carriers of GBS, often unknowingly, and during childbirth, there’s a 50% chance of transmitting the bacteria to the baby. While most exposed infants remain healthy, approximately one in 1,750 will develop early-onset GBS infections, including sepsis, pneumonia, or meningitis, which can have severe consequences. The UK currently employs a ‘risk factor-based screening’ approach, providing antibiotics during labor to women identified with GBS during pregnancy or those with a previous baby affected by GBS. However, this strategy fails to detect many GBS carriers, with about 65% of early-onset GBS infections in newborns occurring in babies whose mothers had no identified risk factors. Now, a research project is examining the potential of a rapid bedside test for safeguarding newborns from life-threatening illnesses transmitted ...
- Source: drugdu
- 163
- January 6, 2024
Machine Learning Model Calculates Chemotherapy Success in Patients with Bone Cancer

The calculation of Percent Necrosis (PN) — the proportion of a tumor considered inactive or “dead” following chemotherapy — serves as a vital predictor of survival outcomes in osteosarcoma, a type of bone cancer. For instance, a PN of 99% signifies that 99% that the tumor is dead, indicating the patient’s positive response to chemotherapy and potentially better survival prospects. Pathologists typically assess PN by meticulously examining, interpreting, and marking up whole-slide images (WSIs), which are detailed cross-sections of specimens (like bone tissue) prepared for microscopic examination. Nevertheless, this traditional method is not only time-consuming and demands specialized expertise but also suffers from significant variability among observers. This means two pathologists might report differing PN estimates from the same WSI. Now, a machine learning model created and trained to calculate PN has shown that its calculation was 85% correct when compared to the results of a musculoskeletal pathologist, with the ...
- Source: drugdu
- 95
- January 6, 2024
Nalu Medical raises $65M for neurostim tech

BY SEAN WHOOLEY Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture Partners — participated, too. Nalu plans to use the proceeds to accelerate commercial growth and expand clinical and health-economic evidence. It also wants to use the funds to continue product development and scale operations. The company’s FDA-cleared spinal cord stimulation and peripheral nerve stimulation technology treats patients with chronic neuropathic pain. It delivers gentle electrical pulses to the nervous system to modulate pain signals before they reach the brain. Nalu system includes a fully featured, battery-free, miniaturized implantable pulse generator (IPG). An externally worn therapy disc wirelessly powers the IPG and ...
- Source: drugdu
- 174
- January 6, 2024
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec

Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
- Source: drugdu
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- January 6, 2024
Lilly makes website to simplify access to obesity drug Zepbound, plus diabetes and migraine meds

Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
- Source: drugdu
- 158
- January 6, 2024
Thermo Fisher to cut the lights at California plastics plant, lay off 74

After pumping millions into its manufacturing capacity to keep up with COVID-related demand and bolster longer-term efforts during the pandemic, Thermo Fisher is winding down operations for good at its Petaluma, California, plant and letting go of 74 employees in the process. The 74 layoffs will take effect on February 1, according to the state’s recent Worker Adjustment and Retraining Notification (WARN) update. The site itself will close its doors in July, a company spokesperson confirmed over email. Thermo Fisher’s ten-year lease on the property ends that month, according to the North Bay Business Journal. The decision to not renew the lease aligns with the company’s “ongoing effort” to “continuously evaluate its global operations to identify opportunities to improve efficiency and effectiveness in meeting our customers’ needs,” the spokesperson said. “Decisions that impact colleagues and their families are never taken lightly,” Thermo Fisher’s spokesperson added. “All impacted colleagues will receive ...
- Source: drugdu
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- January 6, 2024
Inbound HCP communication channels double digital engagement, Veeva finds

Biopharma companies that provide healthcare professionals (HCPs) with compliant chat channels benefit from increased engagement, according (PDF) to Veeva Systems. Analyzing interactions captured in its customer relationship management platform, Veeva found HCPs start 30% of conversations with reps when a compliant chat channel is available. The software provider framed the use of the channels by HCPs in light of the rise of precision therapies, saying the focus on smaller patient populations means physicians have questions when they come to start patients on drugs. Inbound channels offer HCPs a way to get answers to questions about reimbursement, site certification and more. Veeva found that, on average, reps can respond to queries in compliant chat channels in less than five minutes and use the medium to arrange samples for new patient starts and schedule meetings. Text messaging and standalone chat apps may also support timely responses but in the view of Veeva, ...
- Source: drugdu
- 91
- January 6, 2024
Bluebird bio’s Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. The Massachusetts biotech has signed a second outcomes-based reimbursement agreement for Lyfgenia, according to a securities filing. The deal pushes Lyfgenia’s coverage range to nearly 200 million people in the U.S., up from the previous 100 million when bluebird signed the first agreement three weeks ago. Bluebird pulled off the feat within a month of winning FDA approval for Lyfgenia in SCD patients who have a history of the painful blood flow blockade episodes known as vaso-occlusive events. And it comes despite the company pricing Lyfgenia at a wholesale acquisition cost that’s about 40% higher than Vertex and CRISPR Therapeutics’ rival gene therapy Casgevy. Under these outcomes-based agreements, bluebird is offering a discount if a patient is hospitalized because of vaso-occlusion events within three years after treatment. In addition ...
- Source: drugdu
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- January 6, 2024

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