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【EXPERT Q&A】How should one start a business in pharmaceutical intermediates?

Drugdu.com expert’s response: Entering the business of pharmaceutical intermediates involves several key steps and considerations: 1.Industry Understanding Comprehensive Research: Understand the pharmaceutical industry, focusing on the role and demand for intermediates in drug production. Market Trends and Needs: Identify current trends, future projections, and specific needs within the market for pharmaceutical intermediates. 2.Regulatory Compliance Regulatory Knowledge: Familiarize yourself with the regulatory environment, including quality standards and certifications like Good Manufacturing Practice (GMP). Licensing and Permits: Obtain necessary licenses and permits required for manufacturing and trading pharmaceutical intermediates. 3.Business Plan and Strategy Business Model Development: Develop a clear business model, including target market, business scale (local, national, international), and value proposition. Financial Planning: Prepare a detailed financial plan covering startup costs, operational expenses, and revenue projections. 4.Supply Chain and Manufacturing Manufacturing Setup: Decide whether to manufacture in-house or outsource. If manufacturing, ensure the setup meets industry standards. Supplier and Customer ...
- Source: drugdu
- 170
- December 18, 2023
“Magnetic Wave Knife” technology is here! Fosun Pharma and Insightec to establish a joint venture in China

On December 13, 2023, Fosun Pharma announced that its medical device subsidiary has signed a cooperation agreement with Insightec on December 12, to establish a joint venture in China, Fosun Insightec Medical Technology Company Limited* (hereinafter referred to as “Fosun Insightec”). Fosun Insightec will focus on the commercialization, clinical application and research of the Magnetic Resonance Guided Focused Ultrasound (MRFU) Brain Therapy System (i.e. Magnetic Wave Knife Brain Therapy System) in China, which will help Parkinson’s Disease patients and patients with idiopathic tremor to regain a high quality of life. In addition, Fosun Meditech plans to establish strategic partnerships with a number of medical centers in China to further explore the potential application of the Magnetic Wave Knife in neurological diseases and benefit a wider range of patients. Mr. Liu Yi, Senior Vice President of Fosun Pharma and Chairman and CEO of the Medical Device Division, said that he is ...
- Source: drugdu
- 170
- December 17, 2023
Fosun Pharma’s Global Multicenter Phase III Clinical Program for New Anti-malarial Drugs Receives USD 3.3 Million Investment from GHIT Fund Jointly Enhancing Global Accessibility of Anti-malarial Drugs

(Shanghai, China, December 14, 2023) Japan’s Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen) in a global multicenter Phase III clinical trial project in Africa and Southeast Asia for a new anti-malarial drug, artemether benfluorex amodiaquine triple combination formulation, led by Fosun Pharmaceuticals (“the project “) invests approximately US$3.3 million (approximately JPY500 million1 ) to advance the development and launch of this new drug. The Project will be jointly conducted by Fosun Pharma, Marubeni Corporation of Japan, the Mahidol-Oxford Research Center for Tropical Medicine in Thailand, a division of the University of Oxford (“MORU”), and the Medicines for Malaria Foundation (“MMV”), and this is the first time that the GHIT Fund has invested in a research project led by a According to GHIT, the drug candidate could address the widespread Plasmodium artemisinin partial resistance (ART-R) problem in the ...
- Source: drugdu
- 100
- December 17, 2023
BeiGene’s new commercial products and multiple indications have been included in the new version of the National Medical Insurance Drug Catalog

Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
- Source: drugdu
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- December 17, 2023
Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib(ABSK021)

Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
- Source: drugdu
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- December 17, 2023
In $92.5M deal, Alkermes hands the keys to Ireland manufacturing plant to Novo Nordisk

As high-flying Novo Nordisk continues its global manufacturing expansion, the GLP-1 maker has expanded its reach with a $92.5 million plant buy from Alkermes. The deal, which is expected to close in mid-2024, gives Novo the keys to Alkermes’ development and manufacturing site and its approximately 400 employees in Athlone, Ireland, the companies said in a press release. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” Novo’s senior vice president of product supply emerging technologies, Thilde G. Hummel Bøgebjerg, said in a statement. The 400 employees Novo will bring on board have “valuable capabilities within oral drug development and manufacturing,” Bøgebjerg added. The staff switchover marks an “exciting opportunity for growth” for the employees, Alkermes CEO Richard Pops added. For now, the companies will ink subcontracting ...
- Source: drugdu
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- December 17, 2023
Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns

Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its FDA approval. The outcomes-based agreement bluebird reached for Lyfgenia is with an organization that covers about 100 million people in the U.S., the gene therapy specialist said in a securities filing (PDF) Thursday. That’s nearly a third of the country’s entire population, which is estimated at 335 million. For Lyfgenia, bluebird is offering an outcomes-based framework that tracks treatment results for three years and offers rebates if a patient is hospitalized because of a painful episode of vaso-occlusion, which is a common complication of SCD. The deal marks Lyfgenia’s first coverage agreement. A bluebird spokesperson declined to disclose more details of the contract for competitive reasons. Meanwhile, the speed of this deal underscores that payers recognize the value of the therapy and ...
- Source: drugdu
- 88
- December 17, 2023
MHRA supports launch of Innovate UK’s first-of-its-kind initiative to fund new Regulatory Science and Innovation Networks

Launched yesterday (Wednesday 13 December) by Innovate UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has joined partners across government including the Office for Life Sciences to provide support and invite academic institutions in the UK to apply to become a member of an RSIN. In a drive to proactively deliver agile and robust regulatory pathways and guidance to support the innovators of today and tomorrow, the MHRA has helped shape the design of this programme with partners across government, which will enable research informing the future of UK regulatory practice. Applications can be made through UKRI’s Innovation Funding Service. Dr June Raine, MHRA Chief Executive, said: As a forward-thinking, agile, and enabling regulator in today’s fast-paced environment, we must get ready for the innovations of tomorrow. This initiative, the first-of-its-kind, is a fantastic opportunity for academic institutions in the UK to be at the cutting edge of life ...
- Source: drugdu
- 99
- December 16, 2023
Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree. According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace. “When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA plays an important role in protecting consumers, ...
- Source: drugdu
- 100
- December 16, 2023
St. Jude decks out more celebs in t-shirts for seasonal donation drive

St. Jude Children’s Research Hospital has brought together another busload of celebrities, artists and influencers for its annual #ThisShirtSavesLives campaign, decking them out in a new-look t-shirt in a push to persuade people to make monthly donations to its cause. The campaign, which began in 2017, has a simple premise. Famous people wear a t-shirt displaying the text “this shirt saves lives.” The only way to get an official version of the t-shirt is to donate $19 a month, or $228 once, to St. Jude. That proposition seems to have found plenty of takers, with the hospital reporting that it has distributed nearly 1 million shirts so far. St. Jude has redesigned the t-shirt for the latest campaign, replacing the large text used in years gone by with five repeating lines of smaller text. The shirt represents the first redesign in the history of the campaign, with previous years using ...
- Source: drugdu
- 99
- December 16, 2023

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