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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
- 100
- 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
- 104
- 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
- 101
- 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
- 90
- 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
- 103
- 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
- 103
- 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
- 102
- December 16, 2023
US WorldMeds’ Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. This week, the U.S. FDA approved US WorldMeds’ (USWM) Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior multiagent, multimodality treatment, USWM said in a press release. Between 700 and 800 cases of neuroblastoma are diagnosed in the U.S. each year, according to the American Cancer Society. Ninety percent of diagnoses occur before a patient is 5 years old and more than 50% of neuroblastoma cases are classified as high-risk. Approximately half of children with high-risk neuroblastoma don’t live more than five years past their diagnosis, USWM added. Avoiding relapse is ...
- Source: drugdu
- 90
- December 16, 2023
Study Highlights Need for Pharma Industry to Address Stigmatization of Acne

Don Tracy, Associate Editor JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas. Currently, little is known about the magnitude of stigmatizing attitudes toward individuals with acne. In a recent study published by the JAMA Network, researchers aimed to explore the degree of stigma toward individuals with acne and whether these attitudes vary based on characteristics of the individuals with acne or of the survey participants. In order to find an efficient answer, the authors employed a cross-sectional internet survey using digitally enhanced portraits to assess stigmatizing attitudes, recruiting a total of 1357 respondents in the US, with a focus on acne-related attitudes. To perform the survey, the authors provided four stock portraits of adults who varied in sex and skin tone and who were digitally enhanced to have acne, with one of 12 ...
- Source: drugdu
- 96
- December 16, 2023
Atropos Health, Seqster Team Up to Reduce Disparities in Clinical Trials

Atropos Health and Seqster joined forces to address historical diversity and inclusion challenges in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. By KATIE ADAMS Two healthcare data companies joined forces on Thursday to address historical diversity and inclusion challenges in clinical trials. Atropos Health, a Palo Alto-based company that delivers clinical data to physicians at the point of care, formed a strategic partnership with Seqster, a San Diego-based company that aggregates patient data from various sources. Together, they plan to remove barriers that perpetuate the lack of diversity in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. These registries encompass real time updates to medical records, patient reported outcomes and tools for querying ...
- Source: drugdu
- 89
- December 16, 2023

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