Search Results for “EC” – Page 57 – media

FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

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. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 136
- January 31, 2024
New Adjuvanted Recombinant Herpes Zoster Vaccine Phase I Clinical Study in China Completes Enrollment of First Batch of Subjects

At the kick-off meeting held at the Center for Disease Control and Prevention in Pu’er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial. REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline ...
- Source: drugdu
- 98
- January 31, 2024
Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

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 ...
- Source: drugdu
- 86
- January 27, 2024
With record year, Samsung Biologics bucks CDMO industry’s troublesome 2023

Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional” performance. In the fourth quarter, Samsung reeled in 1.07 trillion Korean won (about $802 million), growing sales 11% over the same period in 2022. For the full year, Samsung grew sales 23.1% to 3.69 trillion Korean won ($2.8 billion), the company said in an earnings release Wednesday. Also last year, Samsung Biologics became Korea’s first domestic biopharma firm to generate 1 trillion won in annual profit, Business Korea reports. The 2023 result marks another revenue record for the CDMO giant, which has enjoyed fast growth over the last 8 years, according to Companies Market Cap. Samsung Biologics credited the “exceptional” performance to the ramp-up of operations at its massive Plant 4 in Songdo, South Korea, plus a “robust” sales backlog. ...
- Source: drugdu
- 83
- January 27, 2024
Apotex, Heritage and Breckenridge settle with purchasers in generics price-fixing case

Over the years, myriad generic drugmakers have had to ante up fines and settlement fees for allegedly colluding on the prices of copycat drugs. Now, Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017. Apotex plans to settle with the group of direct purchaser plaintiffs for $30 million, while Heritage Pharmaceuticals and Breckenridge Pharmaceutical will hand over $10 million and $5 million, respectively, according to a trio of motions filed Tuesday in the multidistrict litigation in Pennsylvania federal court. Each of the settlement amounts has the potential to increase or decrease, depending on the outcome of the legal proceedings. Apotex, for instance, could have its settlement fund reduced by up to $3.6 million if certain parties opt out of the deal. The case stretches back to 2017, when direct purchasers ...
- Source: drugdu
- 98
- January 27, 2024
Announcement of Gan & Lee Pharmaceuticals Receiving Bolivian Drug Registration Approval for Menthol Insulin Injection

Recently, Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as “Gan & Lee”) received the registration approval for Menthol Insulin Injection (Cassette Vial) (Lot No. II-87550/2023) from the National Agency for Medicines and Technology for Health (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED) of Bolivia. Insulin Injection (Cassette Vial) (Lot No.: II-87550/2023). The relevant information is announced as follows: I. Basic information of the drug 1、Drug name: ASPARPEN 2、Generic Name of Drug: Mentholatum Insulin Injection 3、Indications: Diabetes mellitus 4、Dosage form: injection 5、Specifications: 3ml: 100U/ml (cassette bottle) 6、Batch No.: Ⅱ-87550/2023 7、Applicant: Gan & Lee Pharmaceutical Co. II. Other relevant information of the drug Mentholated insulin injection is a kind of rapid-acting insulin analog, which takes effect within 10~20 minutes after subcutaneous injection, the maximum action time is 1~3 hours after injection, and the duration of action is 3~5 hours, which can effectively control postprandial blood glucose. Mentholated insulin ...
- Source: drugdu
- 104
- January 27, 2024
IASO Bio’s IND application for new autoimmune indication of Equecabtagene Autoleucel Injection approved

January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
- Source: drugdu
- 86
- January 27, 2024
NICE recommends two AI-powered software tools for stroke diagnosis in NHS

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 ...
- Source: drugdu
- 82
- January 27, 2024
Grand Pharma Strategically Controls Duoputai Pharmaceutical Technology, Strengthening the Strategic Plan in Field of Cerebro-cardiovascular Disease Treatment

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
- Source: drugdu
- 81
- January 26, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 87
- January 26, 2024

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