PharmaFocus Today – Page 20 – media

Milepost! The first RNA editing therapy releases clinical data

On October 16th, Wave Life Sciences released positive mechanistic evidence data from the Ib/IIa RestorAATion-2 study of RNA editing therapy WVE-006 for the treatment of alpha-1 antitrypsin deficiency (AATD). This is the first RNA editing therapy to release clinical data. AATD is a genetic disease caused by mutations in the SERPINA1 gene, which encodes alpha-1 antitrypsin (AAT), the most abundant protease inhibitor in human serum. Patients with homozygous protease inhibitor gene mutation type (Pi * ZZ) AATD are unable to naturally produce wild-type alpha-1 antitrypsin (M-AAT) protein. Therefore, after receiving WVE-006 treatment, patients can produce M-AAT protein in their bodies, which confirms the successful editing of mutant Z-AAT mRNA. In addition, restoring 50% of M-AAT levels will be consistent with the heterozygous “MZ” genotype, resulting in a lower risk of AATD lung disease and liver disease. The data released this time comes from the 200mg single dose cohort of RestorAATion-2 ...
- Source: drugdu
- 79
- October 22, 2024
90%! Pfizer’s RSV vaccine has significant efficacy in treating severe respiratory diseases

The new data released on Thursday at IDWeek provides a clearer picture of Abrysvo’s performance in preventing severe illness and hospitalization. The results came from Kaiser Permanente in Southern California, although the trial was funded by Pfizer and included co authors from Pfizer. This retrospective study observed patients aged 60 and above who were hospitalized or visited the emergency room due to severe acute respiratory disease. In this group, the effectiveness of the vaccine in preventing the most severe respiratory cases was 90%, with only one positive case found among patients who received the Abrysvo vaccine. The confidence interval is wide, ranging from 24% to 99% in preliminary analysis. Although the results were not significantly different from those shown by the company in previous trials, this study is the first to review individuals with compromised immune function as they were not included in the Phase 3 study. Despite the introduction ...
- Source: drugdu
- 86
- October 22, 2024
BeiGene PD-1 inhibitor BaiZeAn ® Approved for the 14th indication in China

Beijing, China – October 21, 2024- BeiGene Limited (NASDAQ: BGNE; Hong Kong Stock Exchange code: 06160; Shanghai Stock Exchange code: 688235), a global cancer treatment innovation company, announced today that its PD-1 inhibitor BeiGene An ® Teralizumab has been officially approved by the China National Medical Products Administration (hereinafter referred to as “NMPA”) for use in combination with platinum based chemotherapy as neoadjuvant therapy, and continues to be used as monotherapy for resectable stage II or IIIA non-small cell lung cancer patients after surgery. As the first PD-1 drug approved for neoadjuvant and adjuvant immunotherapy of stage II-III non-small cell lung cancer (NSCLC) in China, Trastuzumab provides a new option for perioperative treatment of operable lung cancer patients, helping them achieve longer survival benefits. This approval is based on clinical trial data of RATIONALE 315 (NCT04379635). This study is a multicenter, randomized, placebo-controlled, double-blind phase 3 study evaluating the efficacy ...
- Source: drugdu
- 65
- October 22, 2024
Innovative ophthalmic anti VEGF/complement drug clinical latest results announced

Biopharmaceutical Era October 21, 2024 10:04 Zhejiang Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On October 21, 2024, Xinda Biotechnology announced the Phase II clinical data of its recombinant human vascular endothelial growth factor receptor (VEGFR) – antibody human complement receptor 1 (CR1) fusion protein Efdamrofusp alfa injection (R&D code: IBI302) in neovascular age-related macular degeneration (nAMD) at the 2024 American Academy of Ophthalmology (AAO) Annual Meeting. This presentation attracted the attention of many attending experts and scholars. Phase II clinical study of IBI302 (anti VEGF and anti complement dual target drug) administered at long intervals in subjects with neovascular age-related macular degeneration The data released ...
- Source: drugdu
- 68
- October 22, 2024
Zhengda Tianqing’s Anlotinib Application for Ninth Indication Accepted by CDE

According to a report from Zhengda Tianqing, the company has recently submitted a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its self-developed Class I innovative drug, anlotinib hydrochloride capsules, in combination with chemotherapy for treating advanced unresectable or metastatic soft tissue sarcoma. This application has been accepted. Zhengda Tianqing noted that there are currently no officially approved combination therapies for first-line treatment of advanced soft tissue sarcoma globally. The Phase III clinical study (ALTN-III-04) evaluating the use of anlotinib hydrochloride capsules in combination with chemotherapy for first-line treatment of advanced unresectable or metastatic soft tissue sarcoma has achieved its pre-specified primary efficacy endpoint, as assessed by an Independent Data Monitoring Committee (IDMC). This study is the first key Phase III research globally to utilize an anti-angiogenic drug in combination with chemotherapy. At present, anlotinib hydrochloride capsules have received approval for six ...
- Source: drugdu
- 82
- October 22, 2024
Folagliptin benzoate tablets

According to the authoritative forecast of the International Diabetes Federation, the number of diabetes patients in China may increase to 174 million in 2045! This number really shocked the Chinese people. Are there really so many? You know, the number of diabetes patients in China in 2023 will reach 141 million, with an incidence rate of 12.8%. The number of diabetes patients in China ranks first in the world! In recent years, diabetes has become younger in China. According to a report in 2020, the prevalence of diabetes among residents aged 18 and above in China has reached 11.9%. This set of data once again sounded the alarm for the health of the Chinese people! You should know that diabetes is a chronic disease, and its typical symptoms are “three more and one less”. “Three more” means drinking more, eating more, and urinating more; “one less” mainly refers to weight ...
- Source: drugdu
- 61
- October 22, 2024
Abbott joins the PFA melee

Recently, Abbott announced its latest progress in electrophysiology pulsed field ablation (PFA). Specifically, the global IDE registration of the Volt™ PFA system was completed ahead of schedule; the tactical flex™ Duo ablation catheter Sensor Enabled™ is undergoing the global FOCALFLEX trial; the Advisor™ HD Grid X mapping catheter Sensor Enabled™ has been approved by the US Food and Drug Administration and has begun commercial release. According to Abbott’s official website, the above two catheters are being developed as important tools for doctors to treat patients with abnormal heart rhythms such as atrial fibrillation (AFib). Among them, the mapping catheter will further support the mapping of PFA and radiofrequency ablation cases, and the visualization of cardiac anatomy is crucial for patients undergoing ablation surgery to achieve the best results. It is reported that the enrollment of the US VOLT-AF IDE study was completed 4 months ahead of schedule, and nearly 400 ...
- Source: drugdu
- 89
- October 22, 2024
The state has issued documents many times, and the anti-corruption crackdown in the pharmaceutical industry has been launched frequently.

Recently, the National Medical Insurance Administration reported on the unannounced inspection of Wuxi Hongqiao Hospital in Jiangsu Province, and made it clear that the next step will be to guide the Jiangsu Provincial Medical Insurance Administration to conduct a comprehensive investigation in the local area. At the same time, it will organize a special action to severely crack down on fraud and insurance fraud across the country to focus on rectifying the unhealthy trends and corruption problems around the people in the medical insurance field. On October 10, the State Drug Administration issued the “Notice on Rewarding Internal Whistleblowers on Drug and Medical Device Quality and Safety (Draft for Comments)” (hereinafter referred to as the “Reward for Reporting”) for public comments. The “Reward for Reporting” clearly states that the announcement applies to reporting major violations of drug and medical device quality and safety to the drug supervision and management department, ...
- Source: drugdu
- 72
- October 22, 2024
Four consecutive A! Prolo Pharmaceutical received the highest evaluation for its information disclosure work on the Shenzhen Stock Exchange again

Recently, the Shanghai and Shenzhen Stock Exchanges released the evaluation results of information disclosure for the years 2023-2024, and Prolo Pharmaceutical (stock code: 000739) received the highest rating of A in the annual information disclosure evaluation of listed companies on the Shenzhen Stock Exchange. Prolo Pharmaceutical has won this honor for four consecutive years, fully reflecting the high recognition of the securities regulatory authorities for the company’s standardized operation level, information disclosure quality, and investor relations management.The evaluation of information disclosure work on the Shenzhen Stock Exchange is a comprehensive assessment of multiple dimensions such as internal governance, information disclosure quality, investor relations management, and social responsibility fulfillment of listed companies. It is an important indicator for measuring the level of governance and information disclosure quality of listed companies. Listed companies that receive A-level evaluations can not only enhance the recognition of the capital market, but also enjoy policy support ...
- Source: drugdu
- 72
- October 21, 2024
2.5 billion+2.3 billion! Sanofi adds more nuclear weapons

Original Xie Ling Arterial New Medicine October 18, 2024 08:27 Chongqing Yesterday (October 17th), Sanofi announced that it has reached an agreement with Orano Med, a subsidiary of the Orano Group, to further accelerate the development of next-generation radioligand therapy (RLT) by leveraging their expertise in combating rare cancers. According to the agreement, Sanofi and Oueno will jointly invest in a new entity operated under the Oueno Medical brand, focusing on the discovery, design, and clinical development of next-generation radioligand therapy (RLT) based on lead-212 (①¹² Pb) alpha emitting isotopes. Sanofi will make an equity investment of 300 million euros (approximately 2.313 billion yuan), accounting for approximately 16% of the equity of the new entity Orano Medical, with a valuation of 1.9 billion euros (approximately 14.648 billion yuan). At the beginning of last month, Sanofi announced a licensing agreement with RadioMedix and Orano Med for RLT, focusing on AlphaMedix, a ...
- Source: drugdu
- 85
- October 21, 2024

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