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Announcement of Hengrui Pharmaceuticals on the Notification of Approval for Clinical Trial of Drugs by Subsidiary Company

Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the “Company”), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Ltd. has received the “Notice of Approval for Clinical Trial” from the State Drug Administration (hereinafter referred to as “SDA”) for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows: I. Basic information of the drug Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to ...
- Source: drugdu
- 111
- January 22, 2024
Announcement of Tasly Bioharma on the Notification of Approval of Drug Clinical Trial

Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
- Source: drugdu
- 107
- January 22, 2024
Merck’s Keytruda again bags industry-first cervical cancer nod—with limitation

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
- Source: drugdu
- 88
- January 21, 2024
Across 25 industries, pharma staffers most satisfied with compensation

2023 was riddled with labor strikes across industries as workers lobbied for higher pay amid economic headwinds that shook up the global economy. As for the biopharma industry, employees are more content with their income compared with workers in other fields, a new report suggests. USA Today recently analyzed more than 3 million reviews on the employee review service Glassdoor, focusing on 500 large companies in 25 industries and seeking to identify the industries with the highest number of pay-related complaints. Employees in the pharma and biotechnology sector reported the fewest number of pay complaints, according to the report. On the flip side, the healthcare field took the second-highest position for pay frustration, second only to education. Some drugmakers in particular rose above their peers and others in terms of pay. Novartis, GSK, AstraZeneca and Genentech made the list of the top-10 companies overall where employees are most satisfied with ...
- Source: drugdu
- 92
- January 21, 2024
Emergent snares contract worth up to $236M to supply anthrax vaccine to Defense Department

Emergent BioSolutions was awarded a 5-year, $235.8 million contract with the U.S. Department of Defense to supply the anthrax vaccine BioThrax to the various branches of the military. Under the terms of the deal, Emergent is guaranteed a purchase minimum of $20.1 million, with future orders estimated to be worth at least $20 million for each following year. Beyond the initial 5-year term, the contract has a 5-year option that could extend the deal to 2033. In all, the procurement pact could be worth up to $235.8 million, the company said in a Jan. 11 release. “Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” Paul Williams, senior vice president, products head at Emergent, said in the release. Founded in 1998, Emergent has been a long-time supplier of anthrax countermeasures to the U.S. ...
- Source: drugdu
- 78
- January 21, 2024
Zhengda Tianqing Etrazepam Ethanolamine Tablets (Tepsin) Approved for Market Listing

On January 16th, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration (NMPA), approving the registration and marketing of Eltrombopag olamine tablets (trade name: Tepsin) for the following indications: for use in patients with chronic immune thrombocytopenia (ITP) who have had a poor response to previous treatments of glucocorticosteroids and immunoglobulins, as well as in children aged 6 years and above. ) patients to raise platelet counts and reduce or prevent bleeding. This product is intended for use only in patients with ITP who are at increased risk of bleeding due to thrombocytopenia and clinical conditions. Eltrombopag olamine tablets are an oral, small-molecule, nonpeptide thrombopoietin receptor agonist (TPO-RA) that works by increasing platelet counts. In the Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition), Eltrombopag is the only drug with the highest level (1a) of evidence and A ...
- Source: drugdu
- 82
- January 21, 2024
After 17-year courtship, Sun and Taro finally agree on $348M buyout

It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. On Thursday, the companies revealed their long-awaited merger, with Sun of Mumbai, India, agreeing to purchase outstanding shares in the Israeli drugmaker for $43 each. The deal nets out to $348 million for a 48% premium on Taro’s share price of $29. Taro, which manufactures generics, over-the-counter drugs and APIs, will be delisted on the New York Stock Exchange and become a privately held subsidiary within Sun, which already had a 78.5% stake in the company. The companies expect the deal to close in the first half of this year. In its most recent financial report, Taro posted revenue of $593 million for the 12 months ending on Sept. 30, 2023, for a 4% increase year over year. Taro’s annual revenue has generally been in decline since maxing out in 2016 at $951 million. Sun ...
- Source: drugdu
- 153
- January 20, 2024
Bayer CEO Bill Anderson makes his mark with major restructuring, ‘significant’ job cuts

Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” Bayer on Wednesday unveiled a restructuring of its organization that will “come at the expense of many managerial employees,” according to chairwoman of the executives committee on Bayer’s supervisory board, Barbara Gansewend. The job cuts will begin in the coming months and will end in 2025, the company said without providing a specific number for the jobs impacted. But the reductions will be “significant” at the group in Germany, the company said. Bayer declined to comment on the scale of the layoff or the functions involved. Reducing bureaucracy is the “central component” of the adjustments, a Bayer spokesperson told Fierce Pharma. The company’s new operating models are developed with customers at the center. “For this reason, there are no top-down targets and we will only gradually know what scale is really realistic here,” the spokesperson ...
- Source: drugdu
- 183
- January 20, 2024
Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith

Taiwan-based CDMO Bora Pharmaceuticals is expanding its business in the United States, acquiring Minnesota generics manufacturer Upsher-Smith Laboratories for $210 million. Upsher-Smith, which was established in 1919, brings two manufacturing facilities that are five miles apart in the suburbs of Minneapolis. These become Bora’s first facilities in the U.S. Bora also has a 170,000 square meter plant in Mississauga, Ontario, which acts as its North America headquarters. Upsher-Smith produces a portfolio of 48 generic products. Its plants can handle packaging and a range of formulations including oral solids, liquids and topical powders. The sites have a total annual capacity of 3.5 billion doses. “This is a significant milestone for Bora Group, marking the most critical expansion of Bora’s presence in the U.S. market and significantly enhancing Bora’s position as a global competitor,” Bora CEO Bobby Sheng said in a release. The acquisition also supports Bora’s commercial prescription business, TWi, which ...
- Source: drugdu
- 97
- January 20, 2024
Bayer’s Cost-Cutting Plans Take Aim at Multiple Layers of Management

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
- Source: drugdu
- 115
- January 20, 2024

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