Search Results for “EU” – Page 15 – media

Virtual Therapeutics, Akili Interactive Strike Definitive Merger Agreement Seeking to Improve Mental Health Through Immersive Video Games

Don Tracy, Associate Editor Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.Virtual Therapeutics and Akili, Inc. announced that they have agreed to terms on a definitive merger agreement, aiming to establish a digital health company that creates engaging and immersive games to improve mental health. Under terms of the merger, Akili will now work as a wholly owned company of Virtual Therapeutics, Akili shareholders will receive $0.4340 per share of common stock in cash, representing a 4% premium to the closing stock price.1 “In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan ...
- Source: drugdu
- 95
- June 5, 2024
BIO-THERA Receives Positive CHMP Opinion for Bevacizumab Avzivi® in Europe

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer. The CHMP’s opinion on ...
- Source: drugdu
- 64
- June 5, 2024
Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Don Tracy, Associate Editor Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis announced promising results from the Phase III ASC4FIRST trial of Scemblix (asciminib), which showed superiority over standard-of-care tyrosine kinase inhibitors (TKIs) in treating newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). “Patients living with CML need efficacious and well-tolerated treatment options that help them achieve meaningful outcomes as they manage their chronic condition,” said Shreeram Aradhye, MD, president, development, chief medical officer, Novartis, in a press release. “The compelling ASC4FIRST data highlight the potential of Scemblix to achieve better results than standard-of-care in newly diagnosed adults, while maintaining a favorable safety and tolerability profile. These results reinforce Scemblix as a proven treatment in Ph+CML-CP, as we continue to build on ...
- Source: drugdu
- 115
- June 4, 2024
AstraZeneca actively promotes Shanghai to become the “home port” for the export of pharmaceutical innovation achievements

What is the significance of the Chinese market to leading biopharmaceutical companies? Pablo Soriot, global CEO of AstraZeneca, one of the leading international biopharmaceutical companies, told reporters in an interview on the 26th: “China plays a vital role in the global healthcare industry. It is not only a leader in innovation, but also plays a key role in the global research and development and production of important drugs. For AstraZeneca, the Chinese market is crucial.”Biopharmaceutical Industry International Development Conference” held on the same day , AstraZeneca officially announced that Shanghai would become its fifth global strategic center. The “Shanghai Biopharmaceutical Innovation Enterprise 2024 Overseas Cooperation Plan” was officially released on the same day, enabling local innovative drugs to reach a new level and helping Chinese innovation lead global pharmaceutical innovation. It is reported that in the future, Shanghai, China will become another global strategic center integrating R&D, commercial and production ...
- Source: drugdu
- 97
- June 3, 2024
The University of Macau and Sinopharm Group signed a cooperation agreement to carry out biopharmaceutical cooperation

According to the University of Macau (UM) on the 4th, in order to cooperate with the Macao Special Administrative Region Government’s “1+4” moderate economic diversification development strategy and promote the development of Macao’s big health industry, UM and China National Pharmaceutical Group Co., Ltd. (Sinopharm Group) recently signed a strategic cooperation agreement in the field of big health. Both parties hope to promote the transformation of Australia’s scientific research results through closer industry-university-research cooperation, and help enhance the scientific and technological strength of the biomedicine and health strategy. Liu Jingzhen, Chairman of China National Pharmaceutical Group Co., Ltd., led a delegation to visit the University of Adelaide on February 26. The delegation members included leaders of Sinopharm Group and representatives of subsidiaries in different fields such as traditional Chinese medicine , biopharmaceuticals, chemical pharmaceuticals, and medical aesthetics. UM Rector Yonghua Song briefed the delegation on UM’s recent development, strengths and ...
- Source: drugdu
- 111
- June 3, 2024
FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer

Don Tracy, Associate Editor Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Jazz Pharmaceuticals announced that the FDA has granted Priority Review to zanidatamab, a bispecific antibody being evaluated for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). According to the company, the submission was based on positive results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which showed a confirmed objective response rate (cORR) of 41.3%. The FDA assigned the application with a Prescription Drug User Fee Act target action date of November 29, 2024. A Phase III trial, HERIZON-BTC-302, is evaluating zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC.1 “The priority review designation for zanidatamab underscores the critical ...
- Source: drugdu
- 108
- June 3, 2024
FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

Don Tracy, Associate Editor Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Merck has announced that the FDA granted Priority Review designation to its application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. According to the company, the application was a based on positive data from the Phase II/III IND.227/KEYNOTE-483 trial, which found that Keytruda in combination with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Further, death was reduced by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. After a year of treatment, the estimated PFS ...
- Source: drugdu
- 139
- June 1, 2024
Gerresheimer to acquire Blitz LuxCo Sarl, for EUR 800 million

Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
- Source: drugdu
- 84
- May 30, 2024
With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
- Source: drugdu
- 73
- May 29, 2024
Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Don Tracy, Associate Editor Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders. Degron Therapeutics announced that it has agreed to terms on a collaboration with Takeda, which will utilize its GlueXplorer to develop molecular glue degraders targeting oncology, neuroscience, and inflammation. Upon completion of the initial stages, Takeda will take over for further development and commercialization. Under terms of the deal, Degron will receive an upfront payment, with the opportunity to receive up to $1.2 billion in milestone payments and tiered royalties on sales. The deal also includes an equity investment by Takeda in Degron and the option to expand to additional targets.1 “We are excited to collaborate with Takeda, expanding the use of our platform into new therapeutic areas,” said Lily Zou, PhD, co-founder, CEO, Degron Therapeutics, in a press release. “Degron’s differentiated and powerful GlueXplorer platform has been validated by ...
- Source: drugdu
- 76
- May 28, 2024

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