Skip to content

First Patient Enrolled in SELUTION SLR IDE BTK Study

By asianet

The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR(TM), MedAlliance’s novel sirolimus-eluting balloon, just one week after receiving IDE approval. “I am excited to begin an important trial which will establish the evidence that this novel technology benefit patients suffering from CLTI,” commented Dr. Michael Lichtenberg, … Continued

Menarini Group and Radius Health, Inc. present a subgroup analysis from the elacestrant pivotal phase 3 EMERALD clinical trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

By asianet

Subgroup analysis of patients with no prior chemotherapy in EMERALD: A phase 3 trial evaluating elacestrant, an investigational oral selective estrogen receptor degrader (SERD), vs. investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC) The Menarini Group (“Menarini”) and Radius Health, Inc. (“Radius”) (NASDAQ: RDUS) (collectively, the “Companies”) today announced the presentation at … Continued

Medison Pharma Announces Multi-Regional Partnership Agreement with argenx to Commercialize Efgartigimod Across Europe and Israel

By asianet

Medison Pharma [http://www.medisonpharma.com/] (“Medison”), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today an exclusive multi-regional agreement with argenx [https://www.argenx.com/] to commercialize efgartigimod in 14 countries, including Poland, Hungary, Slovenia, Czech Republic, Romania, Bulgaria, Lithuania, Croatia, Slovakia, Estonia, Latvia, Greece, Cyprus, and Israel, for the … Continued

CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer

By asianet

* The National Medical Products Administration approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy * Sugemalimab became the first anti-PD-1/PD-L1 monoclonal antibody approved for stage III NSCLC following concurrent or sequential chemoradiotherapy. It’s also the only anti-PD-(L)1 … Continued

Vazyme Releases 2021 Annual Report: Announces More Efforts in Technology innovation and Together with Partners for a Better Future

By asianet

Vazyme, China’s leading biotechnology company, has recently released its 2021 annual report, revealing that the company has maintained a steady and solid growth throughout the past year. The report shows that it has achieved $289 million in operating income with an increase of 19.44% year-on-year. The company’s R&D investment reached $36 million, up 83.47%, representing … Continued

Cambrex Acquires Leading EU Stability Storage Company Q1 Scientific

By asianet

Cambrex, a leading global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced the acquisition of Q1 Scientific – a leading provider of environmentally-controlled cGMP stability storage services for the pharmaceutical, medical device and life science industries, strategically located in Waterford, Ireland. “Stability … Continued

PMB Announces EIT Health Supported FLASHKNiFE Consortium Towards the Clinical Application of FLASH Radiation Therapy

By asianet

PMB announces the launch of the FLASHKNiFE Consortium, supported by the European Institute of Innovation & Technology for Health (EIT Health). This European public-private partnership aims at advancing radiation therapy by introducing a new radiotherapy device into clinical practice. More than 10 million patients receive radiation therapy each year worldwide, making it an essential tool … Continued

Tau-targeting Alzheimer’s treatment, HMTM, moving toward regulatory submission based on initial data from TauRx’s LUCIDITY trial

By asianet

– LUCIDITY data suggest that participants receiving hydromethylthionine mesylate (HMTM) decline at a rate substantially less than is typical in Alzheimer’s based on published research – Safety profile is favourable and consistent with previous HMTM studies – TauRx will now pursue regulatory submission and coverage for HMTM TauRx Pharmaceuticals Ltd, the global leader in tau-based … Continued

MedAlliance’s SELUTION SLR Drug-Eluting Balloon (DEB) Receives FDA Investigational Device Exemption (IDE) Approval, Making it the First Limus DEB to be Available to US Patients

By asianet

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted “breakthrough device designation” by the FDA on March 4, 2019 and further in September 25, 2019 for below-the-knee (BTK) indications … Continued