Search Results for “EC” – Page 67 – media

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
- 179
- 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
- 213
- 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
- 189
- 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
- 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
- 229
- December 27, 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
- 216
- 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
- 174
- 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
- 97
- December 26, 2023
Previously unrecognized class of antibodies can broadly neutralize multiple virus strains

Researchers have identified a previously unrecognized class of antibodies-;immune system proteins that protect against disease-;that appear capable of neutralizing multiple forms of flu virus. These findings, which could contribute to development of more broadly protective flu vaccines, will publish December 21st by Holly Simmons of the University of Pittsburgh School of Medicine, US, and colleagues in the open access journal PLOS Biology. A flu vaccine prompts the immune system to make antibodies that can bind to a viral protein called hemagglutinin on the outside of an invading flu virus, blocking it from entering a person’s cells. Different antibodies bind to different parts of hemagglutinin in different ways, and hemagglutinin itself evolves over time, resulting in the emergence of new flu strains that can evade old antibodies. New flu vaccines are offered each year based on predictions of whatever the most dominant strains will be. Extensive research efforts are paving the ...
- Source: drugdu
- 211
- December 25, 2023
Glass specialist Schott Pharma touts 2023 sales growth, Serbia expansion and hiring plans

Following an IPO and ahead of its fiscal 2023 earnings release next month, German drug containment and delivery specialist Schott Pharma is trumpeting its recent momentum. Over the course of its 2023 fiscal year, Schott Pharma charted a 9% year-over-year revenue boost to €899 million (about $986 million), the company said Tuesday. For comparison, the company pulled down €821 million in fiscal year 2022. Schott credited the gains to the expansion of its production capabilities, especially as they pertain to drug delivery systems and new production lines for prefillable polymer syringes in Germany. Schott partners with a range of drugmakers in the biopharma industry. The company and its products are involved in several significant trends, such as the GLP-1 treatments from Novo Nordisk and Eli Lilly, plus mRNA vaccines from Moderna. Schott’s revenue win comes more than a year after the company set out on its own. Back in August ...
- Source: drugdu
- 128
- December 25, 2023

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