Spanish plasma medicines producer Grifols is clapping back at Gotham City Research, filing a lawsuit that accuses the New York hedge fund of “knowingly making false and misleading statements” about the company “to manipulate the value of Grifols’ stock for their own monetary gain.” The complaint, filed in federal court in the Southern District of New York, comes in response to a report from Gotham on Jan. 9 which accused Grifols of wrongful accounting practices.Gotham called Grifols shares “uninvestable,” and over the next several days the report triggered a drop in Grifols shares of more than 30% and a freefall of its market cap from $7.6 billion to $4.6 billion. In reaction to the Gotham report, in a regulatory filing to Spain’s stock market watchdog CNMV, Grifols called it “false information” and “speculation.” The accounting questions raised by Gotham surround Grifols’ 2018 acquisitions of Haema AG and Biotest though its subsidiary Scranton Enterprises. In essence, Gotham said Grifols has underreported ...
Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
Don Tracy, Associate Editor Atypical antidepressant linked to severe adverse effects and death as a result of misuse. This week, the FDA released a statement warning consumers to stay away from Neptune Resources’ Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets. Citing potential adverse events (AEs) such as seizures, loss of consciousness, and death, the agency stated that they have continued to receive several reports of these AEs. After releasing an initial warning statement in November, the FDA sent a letter on January 11, 2024, to multiple retailers, stressing the need to pull Neptune’s Fix and any other tianeptine-containing products from their inventory. “Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label,” the agency said in the statement “These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or ...
Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
Currently, no artificial intelligence (AI) or machine-learning tools are available for investigating and interpreting the complete human genome, particularly for non-experts. Now, a first-of-its-kind software combines AI and machine-learning approaches to understand the importance of specific genomic biomarkers to predict diseases in individuals. The IntelliGenes software created by researchers at Rutgers Health (New Brunswick, NJ, USA) combines conventional statistical methods with cutting-edge machine learning algorithms to generate personalized patient predictions and provide a visual representation of the biomarkers significant to disease prediction. IntelliGenes has been designed in such as way that the platform can be used by anyone, including students or those lacking strong knowledge of bioinformatics techniques or access to high-performing computers. In a study, the researchers demonstrated how IntelliGenes can be deployed by a wide range of users to analyze multigenomic and clinical data. In another study, the researchers applied IntelliGenes to discover novel biomarkers and predict cardiovascular ...
CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
The National Institute for Health and Care Excellence (NICE) has recommended two artificial intelligence (AI)-powered software tools for use in the NHS for stroke diagnosis. The two softwares – e-Stroke and RapidAI – were selected after the health technology assessment agency found some evidence of faster and better access to treatment after using the software. Currently the leading cause of disability, responsible for more than 100,000 cases in the UK every year, a stroke is a life-threatening medical condition that occurs when the blood supply to parts of the brain is cut off. NICE advised that the software tools can be used within the NHS “while further evidence is generated to help better determine their cost-effectiveness”. The institute also noted that some form of AI was deployed in 99 out of 107 stroke units in England. e-Stroke, developed by Brainomix, was implemented in hundreds of hospitals in the UK, as ...
Xi’an Beilin Pharmaceutical Co., Ltd. (西安碑林药业股份有限公司, Xi’an Beilin), a subsidiary of Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK), recently entered into the second acquisition agreement with Chongqing Duoputai Pharmaceutical Co., Ltd. (重庆多普泰制药股份有限公司). Xi’an Beilin is to acquire 63% equity interest in Chongqing Duoputai Pharmaceutical Technology Co., Ltd. (重庆多普泰医药科技有限公司, Duoputai Pharmaceutical Technology) at a consideration of RMB442.26 million following the fulfillment of the relevant conditions. With the completion of the acquisition agreement, Xi’an Beilin will hold a 90% equity interest in Duoputai Pharmaceutical Technology, which will become a subsidiary of Grand Pharma to further consolidate the Group’s market position in the field of cerebro-cardiovascular disease treatment. https://www.grandpharm.com/en/news/grand-pharma-strategically-controls-duoputai-pharmaceutical-technology-strengthening-the-strategic-plan-in-field-of-cerebro-cardiovascular-disease-treatment
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