PharmaFocus Today – Page 202 – media

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
- 170
- 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
- 103
- 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
- 101
- 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
- 235
- 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
- 151
- 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
- 200
- December 26, 2023
M&A saw an uptick in 2023. Analysts expect the trend to continue

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
- Source: drugdu
- 221
- December 26, 2023
HuidaGene Announces Rare Pediatric Drug Designation Granted to HG302, A Novel CRISPR DNA-editing Therapy, for the Treatment of Duchenne Muscular Dystrophy

SHANGHAI and CLINTON (NJ), December 19, 2023 – HuidaGene Therapeutics (辉大基因“HuidaGene”) today announced the U.S. FDA granted Rare Pediatric Drug Designation (RPDD) to HG302, a novel CRISPR-Cas12 DNA-editing therapy, to treat Duchenne muscular dystrophy (DMD), affecting 1 in ~5,000 newborn boys. Unlike the in-vivo use of Cas9 system with limited genome-editing efficiency, high occurrence of off-targeting modifications, viral delivery packaging limitations, and complicated CRISPR-Cas9 patent dispute, HuidaGene identified novel Cas12i proteins using AI and deep machine-learning of DNA sequencing through the proprietary HG-PRECISE® platform to develop high-fidelity Cas12i variant (hfCas12Max®). This hfCas12Max® is smaller in size than Cas9, thereby packaging it using one viral vector with the lowest off-targeting activity and highest editing efficiency in mammalian cells when compared to SpCas9 and LbCas12a. Furthermore, Cas12i was granted a patent by USPTO with a cleaner commercial landscape. “This is Company’s third program receiving RPDD, suggesting the recognition of the importance of ...
- Source: drugdu
- 149
- December 26, 2023
Anke Biotechnology’s Joint Venture Company, Yuan Song Biotechnology, Receives FDA Approval for the First Oncolytic Virus National Class I New Drug IND Application

According to the announcement from Anke Biotechnology’s joint venture company, Yuan Song Biotechnology: Shanghai Yuan Song Biotechnology Co., Ltd. (hereinafter referred to as “Yuan Song Biotech”) announced that its independently developed oncolytic virus anticancer drug, “Recombinant L-IFN Adenovirus Injection,” obtained the Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) on December 21, 2023. Dr. Zhang Kangjian, Co-founder and General Manager of Yuan Song Biotech, stated that the successful completion of the IND in the United States is a significant milestone for Yuan Song Biotech, a company dedicated to the development of oncolytic virus anticancer clinical drugs. This achievement not only validates our research and development strategy and technological platform for industrialization but also demonstrates Yuan Song Biotech’s clinical development capabilities in the field of targeted gene-virus therapy. This includes oncolytic adenovirus process development, quality method research, high-quality preclinical studies, and clinical research. With the ...
- Source: drugdu
- 176
- December 26, 2023
Henlius Passes Its Second EU GMP Inspection

Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards. The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ...
- Source: drugdu
- 98
- December 26, 2023

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