c-LEcta Reports Record Year With Significant Growth

Product line expanded to include NuCLEANase, an enzyme that has a wide range of potential applications in the food industry The course for future growth has been set: c-LEcta has secured over 10,000 m² of building space for its new headquarters at Alte Messe Leipzig LEIPZIG, Germany–(BUSINESS WIRE)–c-LEcta, a global biotechnology company with technology leadership … [Read more…]

Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

AWANS, Belgium–(BUSINESS WIRE)–#MVO–Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with … [Read more…]

Quizartinib Marketing Authorization Application Validated by EMA for Treatment of Adult Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone TOKYO & MUNICH–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and … [Read more…]

Alcon to Acquire Aerie Pharmaceuticals, Inc., Enhancing its Ophthalmic Pharmaceutical Portfolio

Builds on Alcon’s existing commercial expertise in the estimated $20 billion global ophthalmic pharmaceutical segment1 Adds Rocklatan® and Rhopressa®, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical product candidates Transaction values Aerie at approximately $770 million in equity value and is expected to be accretive to Alcon’s core diluted EPS in 2024 Ad … [Read more…]

Alcon to Acquire Aerie Pharmaceuticals, Inc., Enhancing its Ophthalmic Pharmaceutical Portfolio

Builds on Alcon’s existing commercial expertise in the estimated $20 billion global ophthalmic pharmaceutical segment1 Adds Rocklatan® and Rhopressa®, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical product candidates Transaction values Aerie at approximately $770 million in equity value and is expected to be accretive to Alcon’s core diluted EPS in 2024 Ad … [Read more…]

Afya Limited Announces Second-Quarter and First Half 2022 Financial Results

High and Predictable Growth Strong Net Income Results NOVA LIMA, Brazil–(BUSINESS WIRE)–Afya Limited (Nasdaq: AFYA) (“Afya” or the “Company”), the leading medical education group and digital health services provider in Brazil, reported today financial and operating results for the three and six-month period ended June 30, 2022 (second quarter 2022). Financial results are expressed in … [Read more…]

Prana Thoracic Announces That Its Subsidiary Receives $3 Million CPRIT Grant to Develop a Minimally Invasive Device for Early Interception of Lung Cancer

HOUSTON–(BUSINESS WIRE)–Prana Thoracic, Inc., today announced that Nucore Medical, Inc., the company’s wholly owned subsidiary has been awarded a $3M grant from the Cancer Prevention and Research Institute of Texas (“CPRIT”). Prana Thoracic is a medical device company developing the first minimally invasive lung tissue excision tool for early interception of lung cancer. The CPRIT … [Read more…]

Voran Group Obtains Health Canada Authorization on Disinfectant With 30-Second COVID Kill Claim

New label reflects a commitment to delivering an internationally recognized standard of cleanliness and efficacy EDMONTON, Alberta–(BUSINESS WIRE)–Today, Voran Group Ventures Ltd (“Voran Group”) announces the receipt of market authorization from Health Canada on new efficacy claims for its made-in-Canada disinfectant solution, Bacoban™ (106) Cleaner & Disinfectant. The new label reflects Voran’s commitment to supply … [Read more…]

Geron Announces First Patient Dosed in IMproveMF Phase 1 Combination Study in Frontline Myelofibrosis

– Preclinical data showed synergistic and additive effects of combination imetelstat and ruxolitinib – Study intended to explore potential for disease modification with imetelstat in earlier, frontline myelofibrosis setting – Single-agent imetelstat currently being studied in a separate Phase 3 trial designed to confirm clinically meaningful benefits observed in relapsed/refractory MF patients in Phase 2 … [Read more…]

Biocept Announces Receipt of Deficiency Notice from Nasdaq Regarding Requirement to Timely Quarterly Report on Form 10-Q

SAN DIEGO–(BUSINESS WIRE)–Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announces that it received a notice (the “Notice”) on August 17, 2022 from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) advising Biocept that it was not in compliance with Nasdaq’s continued listing requirements under the … [Read more…]