Search Results for “cancer” – Page 63 – media

Hengrui Medicine’s PD-1 combination therapy is re-registered for listing in the United States

On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
- Source: drugdu
- 54
- October 17, 2024
Progress has been made in the construction of HSV-1 oncolytic virus where Wuhan virus is located

Recently, Hu Zhihong, Wang Manli, Luo Minhua and Zeng Wenbo from the Wuhan Institute of Virology, Chinese Academy of Sciences, jointly published a research paper entitled “Efficient Strategy for Synthesizing Vector Free and Oncolytic Herpes Simplex Type 1 Viruses” on the international academic journal ACS Synthetic Biology. This research carried out the construction and optimization of an artificial synthesis platform based on type I herpes simplex virus type F, and used this platform to transform oncolytic viruses. Type I herpes simplex virus (HSV-1) has important application prospects as an oncolytic virus in cancer treatment. In this study, the research team developed a new method for efficient synthesis and rescue of HSV-1 virus. Unlike traditional methods of synthesizing complete genomes containing vector sequences in vitro and transfecting them into mammalian cells to rescue viruses, the research team synthesized HSV-1 genome fragments containing homologous arms through transformation related homologous recombination (TAR) in ...
- Source: drugdu
- 58
- October 16, 2024
Yunnan Baiyao executive team adjustment

On October 11, Yunnan Baiyao issued the “Announcement on the Appointment of Senior Management Personnel”, appointing Li Shengli as its senior vice president. Li Shengli has held important positions in many pharmaceutical companies, including general manager, president, CEO, and chairman of Jiangsu Wanbang Pharmaceutical Marketing Biochemical Oncology Division, co-president, president, and chairman of Jiangsu Fosun Pharmaceutical Sales Co., Ltd., assistant to the president, vice president, senior vice president, executive president, and chief development officer of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. The joining of Li Shengli once again verified the change in Yunnan Baiyao’s talent training model, from internal talent training to the “internal training + external introduction” dual-channel talent model, to create a high-quality talent team that meets its future development needs. Pharmaceutical companies have established their own talent training and selection system, and the company and employees understand each other, have high loyalty, and there is almost no ...
- Source: drugdu
- 58
- October 16, 2024
After the 2024 Nobel Prize is announced, what is the commercial value?

The 2024 Nobel Prize in Physiology or Medicine has finally been announced, and surprisingly, the previously highly requested GLP-1 target and alphafold system have not been awarded, and the award-winning fields are similar to last year, which are pioneers in the field of RNA. Last year it was mRNA, this year it is microRNA. On October 7 at 5:30 p.m., the Sweden Carolinska Institutet announced that the 2024 Nobel Prize in Physiology or Medicine was awarded to Victor Ambros and Gary Ruvkun · · for their “discovery of microRNAs and their role in post-transcriptional gene regulation.” It is reported that the two are professors at the University of Massachusetts Medical School and Harvard Medical School, respectively. As we all know, the winner of the Nobel Prize needs to go through a long time from making relevant achievements to winning the Nobel Prize: the Nobel Prize needs time to test its ...
- Source: drugdu
- 69
- October 15, 2024
HUTCHMED’s Elunate ® (fruquintinib) was fully funded for inclusion in the Hong Kong Hospital Authority’s Drug Formulary

Chi-Med (China) Limited (“HUTCHMED”) today announced that Elunate ® (fruquintinib) has been added to the Drug Formulary of the Hong Kong Hospital Authority (“HA”) in the category of “Specialty Drugs”. Patients who are prescribed the new drug for specific clinical applications in public hospitals or clinics are only required to pay the standard fee. Elunate ® received approval from the Pharmacy and Poisons Board of Hong Kong in January 2024 for the treatment of adult patients with metastatic colorectal cancer who have been treated. The first innovative anti-oncology drug to be directly included in the HA’s Drug Formulary category, and the first new drug to be approved under the “1” mechanism of the HA’s Drug Formulary, which was quickly included in the Drug Matrix and the “1” mechanism, helping patients accelerate access to important treatment options. Elunate ® is the first oral targeted therapy approved in Hong Kong for the ...
- Source: drugdu
- 58
- October 15, 2024
$2.2 billion settlement, GSK pays for safety

Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
- Source: drugdu
- 66
- October 14, 2024
A tumultuous time for the king of orphan drugs

More than 20 years ago, research on rare diseases and the treatment of rare diseases were very rare in the medical community. The small market size of rare diseases and the huge difficulty in research and development have made pharmaceutical companies shy away from this field. In the past 25 years, BioMarin has launched eight rare disease drugs with strong R&D capabilities. Arguably, this record is unmatched by few companies in the biotech industry. However, with the failure of the commercialization of its highly-anticipated hemophilia A gene therapy, Roctavian, a strategic review began. Since the beginning of this year, BioMarin has been in turmoil. Over the past nine months, there have been layoffs, executive restructuring, spending cuts, and research projects on hold. With the reshuffle of the business structure and the arrival of new competition, it remains to be seen when BioMarin will be able to get out of this ...
- Source: drugdu
- 62
- October 14, 2024
intensified BD trading competition in the pharmaceutical market, pharmaceutical companies launch market competition war

Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received positive news regarding BD ...
- Source: drugdu
- 78
- October 12, 2024
intensified BD trading competition in the pharmaceutical market, pharmaceutical companies launch market competition war

October 11, 2024 09:03 Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received ...
- Source: drugdu
- 72
- October 11, 2024
Domestic PD-1 accelerates landing in Europe and America! Junshi and Baekje are rushing to the beach, and the next one is Hengrui?

Recently, BeiGene announced that its PD-1 inhibitor Trastuzumab (US trade name: TEVIMBRA) has been officially commercialized in the United States for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). Global pharmaceutical companies consider the US market as a battleground for going global. At the end of October 2023, Junshi Biotech’s trastuzumab (US trade name: LOQTORZI) obtained FDA approval, becoming the first nasopharyngeal carcinoma drug to be marketed in the United States, as well as the first biologically innovative drug and PD-1 inhibitor from China approved by the FDA. In March 2024, BeiGene’s Trastuzumab was approved for its first indication in the United States, following closely behind. After more than six months of FDA approval, Trastuzumab has finally been officially launched for sale in the United States. In the industry’s view, Chinese pharmaceutical companies such as ...
- Source: drugdu
- 59
- October 11, 2024

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