PharmaFocus Today – Page 230 – media

Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
- 274
- December 27, 2023
Orthofix has positive spine stimulation tech data

BY SEAN WHOOLEY rthofix Medical (Nasadaq: OFIX)+ today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion. Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis. SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site. Orthofix says its system has an overall success rate of 92% in treating spinal fusion surgery patients. Researchers published their data evaluating the SpinalStim system in the International Journal of Spine Surgery. Lead author Dr. ...
- Source: drugdu
- 197
- December 27, 2023
With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. More specifically, the agency signed off on the ligand-conjugated antisense oligonucleotide (LICA) drug to treat polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (ATTRv-PN), a rare and often fatal disease that affects 40,000 people globally, the companies said in a press release. The nod was backed by phase 3 data showing Wainua’s ability to provide “consistent and sustained” benefit in outcomes measures, including serum transthyretin concentration and neuropathy impairment, as well as improvements in quality of life. Crucially, Wainua comes in an auto-injector form that patients can administer themselves once a month. That gives the treatment a convenience edge against the competition, including Alnylam’s Onpattro, which is delivered subcutaneously at treatment centers. Despite the Alnylam option, the unmet need for the genetic disease remains ...
- Source: drugdu
- 235
- December 27, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 207
- December 27, 2023
Hengrui Biopharmaceutical’s JAK1 Inhibitor SHR0302 Approved for Clinical Use in Systemic Lupus Erythematosus

Recently, Hengrui Biopharmaceuticals received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, granting approval for the company’s JAK1 inhibitor and innovative drug SHR0302 sustained-release tablets to conduct clinical trials for the indication of systemic lupus erythematosus (SLE). Currently, there is no globally approved medication targeting the same pathway for treating systemic lupus erythematosus. Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease with a complex etiology involving various factors such as genetics, sex hormones, and environmental factors like viral and bacterial infections. The prevalence of SLE in China is estimated to be around 30-70 per 100,000, with an estimated affected population of approximately one million. SLE manifests with complex clinical presentations, affecting multiple organ systems, including joints, skin, kidneys, lungs, blood systems, nervous systems, and blood vessels, potentially leading to severe complications and even death. The situation of SLE in China is characterized by a ...
- Source: drugdu
- 198
- December 27, 2023
da Vinci Innovation & Training Center Celebrates its Second Anniversary

The da Vinci Innovation & Training Center marks its second anniversary. Over the past two years, the center has provided more than 1,300 training sessions for healthcare professionals and conducted training operations related to da Vinci technology and surgeries for over 3,000 clinical nursing staff. Equipped with various series of da Vinci surgical robots and the Ion Bronchoscope Operation Control System (not yet launched in China), the da Vinci Innovation & Training Center features a surgical operating room capable of simultaneous training and operations for six da Vinci surgeries, an Ion simulation operating room, a training classroom for 40 people, and cutting-edge simulation training equipment, linked surgical beds, energy platforms, anesthesia machines, and other medical devices. Additionally, it includes multimedia conference rooms, a restaurant, a refreshment area, a maternity room, and changing rooms. Medical professionals can learn cutting-edge minimally invasive instruments and diagnostic techniques in such a simulated clinical environment. ...
- Source: drugdu
- 112
- December 27, 2023
NHS trials home testing for chronic kidney disease

Tens of thousands of patients at risk of kidney disease will be able to get tested from the comfort of their own homes as part of a £30 million tech and AI innovation fund this winter. The Healthy.io early detection device will initially be sent to 30,000 patients who are considered most at risk for kidney disease. Analysis suggests the device could help detect 1,300 cases of undiagnosed chronic kidney disease (CKD) over the coming months, as well as stopping some patients from developing end-stage renal disease – improving outcomes for individuals and reducing pressure on the NHS by preventing unplanned hospital admissions. Patients place a small device in a urine sample before scanning the device into an app which gives immediate results on whether a patient may have a kidney condition. The test results are immediately uploaded to the patient’s electronic medical record for clinical review. The National CKD ...
- Source: drugdu
- 120
- December 27, 2023
RemeGen Receives FDA Approval to Conduct a Global Multicenter Phase III Clinical Trial of Telitacicept for Adults with pSS

On Oct 17, RemeGen Co., Ltd. (688331.SH/09995.HK) announced that the global multicenter Phase III clinical IND of Telitacicept for the treatment of adults with active primary Sjögren’s syndrome has been approved by the U.S. FDA. Clinical studies will be carried out in many countries and regions around the world. This is a multicenter, randomized, double-blind, placebo-controlled phase III trial to evaluate the efficacy and safety of Telitacicept in the treatment of adults with active primary Sjögren’s syndrome (pSS), and the evaluation of pharmacokinetic characteristics, pharmacodynamics and immunogenicity will also be conducted. In a series of previous non-clinical projects and clinical trials, the efficacy and safety of Telitacicept in adult patients with pSS have been confirmed. In a phase II study (18C012) involving 42 adult pSS patients in China, both the 240 mg and 160 mg dosage regimens of Telitacicept for Injection showed good efficacy and tolerability. This 48-week global phase ...
- Source: drugdu
- 253
- December 27, 2023
Arcutis Biotherapeutics, Inc’s Zoryve Gets FDA Approval for Seborrheic Dermatitis

Pharmaceutical Executive Editorial Staff Zoryve (roflumilast) topical foam, 0.3% is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades. The FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve (roflumilast) topical foam, 0.3% to treat seborrheic dermatitis in patients aged 9 years and older. The once-daily, steroid-free foam is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades, according to Arcutis Biotherapeutics. Zoryve (roflumilast) topical foam, 0.3%. Credit: Arcutis Biotherapeutics. “We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a press release. “Zoryve foam is a once-daily, ...
- Source: drugdu
- 166
- December 26, 2023
GSK’s Jemperli Plus Zejula Produces Significant Survival Improvement in Endometrial Cancer

Pharmaceutical Executive Editorial Staff Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial show that Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula (niraparib) as maintenance therapy, achieved the primary endpoint of progression-free survival (PFS). The combination led to a statistically significant and clinically meaningful benefit across the overall patient population and among a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors in those with primary advanced or recurrent endometrial cancer. “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” Hesham Abdullah, senior ...
- Source: drugdu
- 225
- December 26, 2023

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