PharmaFocus Today – Page 208 – media

Imperative Care begins first-in-human study of neurovascular stent

BY SEAN WHOOLEY Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as director of neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan. All three patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms. Imperative Care reported all three patient discharges from the hospital within 48 hours on an aspirin-only antiplatelet regimen. The company reported no device- or procedure-related complications, including clot formation. “The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” said Sakai said in a news release. “I am encouraged ...
- Source: drugdu
- 124
- December 18, 2023
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial

BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
- Source: drugdu
- 590
- December 18, 2023
Fosun Pharma’s Global Multicenter Phase III Clinical Program for New Anti-malarial Drugs Receives USD 3.3 Million Investment from GHIT Fund Jointly Enhancing Global Accessibility of Anti-malarial Drugs

(Shanghai, China, December 14, 2023) Japan’s Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen) in a global multicenter Phase III clinical trial project in Africa and Southeast Asia for a new anti-malarial drug, artemether benfluorex amodiaquine triple combination formulation, led by Fosun Pharmaceuticals (“the project “) invests approximately US$3.3 million (approximately JPY500 million1 ) to advance the development and launch of this new drug. The Project will be jointly conducted by Fosun Pharma, Marubeni Corporation of Japan, the Mahidol-Oxford Research Center for Tropical Medicine in Thailand, a division of the University of Oxford (“MORU”), and the Medicines for Malaria Foundation (“MMV”), and this is the first time that the GHIT Fund has invested in a research project led by a According to GHIT, the drug candidate could address the widespread Plasmodium artemisinin partial resistance (ART-R) problem in the ...
- Source: drugdu
- 102
- December 17, 2023
BeiGene’s new commercial products and multiple indications have been included in the new version of the National Medical Insurance Drug Catalog

Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
- Source: drugdu
- 97
- December 17, 2023
Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib(ABSK021)

Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
- Source: drugdu
- 102
- December 17, 2023
In $92.5M deal, Alkermes hands the keys to Ireland manufacturing plant to Novo Nordisk

As high-flying Novo Nordisk continues its global manufacturing expansion, the GLP-1 maker has expanded its reach with a $92.5 million plant buy from Alkermes. The deal, which is expected to close in mid-2024, gives Novo the keys to Alkermes’ development and manufacturing site and its approximately 400 employees in Athlone, Ireland, the companies said in a press release. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” Novo’s senior vice president of product supply emerging technologies, Thilde G. Hummel Bøgebjerg, said in a statement. The 400 employees Novo will bring on board have “valuable capabilities within oral drug development and manufacturing,” Bøgebjerg added. The staff switchover marks an “exciting opportunity for growth” for the employees, Alkermes CEO Richard Pops added. For now, the companies will ink subcontracting ...
- Source: drugdu
- 99
- December 17, 2023
Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns

Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its FDA approval. The outcomes-based agreement bluebird reached for Lyfgenia is with an organization that covers about 100 million people in the U.S., the gene therapy specialist said in a securities filing (PDF) Thursday. That’s nearly a third of the country’s entire population, which is estimated at 335 million. For Lyfgenia, bluebird is offering an outcomes-based framework that tracks treatment results for three years and offers rebates if a patient is hospitalized because of a painful episode of vaso-occlusion, which is a common complication of SCD. The deal marks Lyfgenia’s first coverage agreement. A bluebird spokesperson declined to disclose more details of the contract for competitive reasons. Meanwhile, the speed of this deal underscores that payers recognize the value of the therapy and ...
- Source: drugdu
- 88
- December 17, 2023
MHRA supports launch of Innovate UK’s first-of-its-kind initiative to fund new Regulatory Science and Innovation Networks

Launched yesterday (Wednesday 13 December) by Innovate UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has joined partners across government including the Office for Life Sciences to provide support and invite academic institutions in the UK to apply to become a member of an RSIN. In a drive to proactively deliver agile and robust regulatory pathways and guidance to support the innovators of today and tomorrow, the MHRA has helped shape the design of this programme with partners across government, which will enable research informing the future of UK regulatory practice. Applications can be made through UKRI’s Innovation Funding Service. Dr June Raine, MHRA Chief Executive, said: As a forward-thinking, agile, and enabling regulator in today’s fast-paced environment, we must get ready for the innovations of tomorrow. This initiative, the first-of-its-kind, is a fantastic opportunity for academic institutions in the UK to be at the cutting edge of life ...
- Source: drugdu
- 100
- December 16, 2023
Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree. According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace. “When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA plays an important role in protecting consumers, ...
- Source: drugdu
- 101
- December 16, 2023
St. Jude decks out more celebs in t-shirts for seasonal donation drive

St. Jude Children’s Research Hospital has brought together another busload of celebrities, artists and influencers for its annual #ThisShirtSavesLives campaign, decking them out in a new-look t-shirt in a push to persuade people to make monthly donations to its cause. The campaign, which began in 2017, has a simple premise. Famous people wear a t-shirt displaying the text “this shirt saves lives.” The only way to get an official version of the t-shirt is to donate $19 a month, or $228 once, to St. Jude. That proposition seems to have found plenty of takers, with the hospital reporting that it has distributed nearly 1 million shirts so far. St. Jude has redesigned the t-shirt for the latest campaign, replacing the large text used in years gone by with five repeating lines of smaller text. The shirt represents the first redesign in the history of the campaign, with previous years using ...
- Source: drugdu
- 100
- December 16, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.