Search Results for “Takeda” – Page 6 – media

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. By Frank Vinluan on April 24, 2024 One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals. “Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of ...
- Source: drugdu
- 80
- April 26, 2024
GlobalData

In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
- Source: drugdu
- 83
- April 3, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 89
- March 22, 2024
FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
- Source: drugdu
- 98
- February 6, 2024
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
- Source: drugdu
- 114
- February 1, 2024
Pfizer’s eye for China ADC deals; Astellas’ gastric cancer rejection

Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
- Source: drugdu
- 141
- January 17, 2024
A Monthly Summary of Hires and Layoffs

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
- Source: drugdu
- 231
- January 3, 2024
National Resilience lines up 440 new jobs at former AstraZeneca plant in Ohio

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a recently purchased plant in Ohio. Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. The project represents a partnership between Resilience, JobsOhio and Cincinnati’s Regional Economic Development Initiative (REDI), the company noted. All told, the plan is set to nearly double Resilience’s current presence in West Chester, according to JobsOhio president and CEO J.P. Nauseef. In the company’s press release, Resilience’s CEO Rahul Singhvi pointed out that the West Chester site serves as the CDMO’s global center of excellence for commercial ...
- Source: drugdu
- 105
- December 14, 2023
Sanofi’s quiet Sarclisa chalks up a first-in-class win with eyes on a first-line multiple myeloma nod

In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. Using Sarclisa on top of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), significantly reduced the risk of disease progression or death versus VRd alone in patients with newly diagnosed multiple myeloma not eligible for transplant, Sanofi said Thursday. Sanofi’s phase 3 IMROZ readout comes as Sarclisa’s in-class rival, Johnson & Johnson’s Darzalex, is sharing a positive phase 3 for its VRd combo in transplant-eligible patients at the upcoming American Society of Hematology annual meeting. Still, the J&J data don’t prevent Sanofi from claiming the first phase 3 win for an anti-CD38 antibody with VRd in transplant-ineligible patients. Results from the IMROZ trial will be shared at a future medical meeting and will support a regulatory filing, Sanofi said. A ...
- Source: drugdu
- 105
- December 9, 2023
Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

US-based Generation Bio is cutting its workforce by 40%, becoming the latest company to announce lay-offs to save money this year. The restructuring includes the departure of key personnel, with medical chief Douglass Kerr and development leader Tracy Zimmerman among those leaving. The 29 November announcement adds to a series of setbacks in the field, with the cell therapy startup NexImmune reducing its workforce by over half this year, halting the development of its three adoptive T cell therapies. Generation anticipates that the downsizing and streamlining of its research and development focus will result in a cost-saving of $120m over the next three years, as outlined in a 27 November SEC filing. In April, Takeda announced that it was moving away from the adeno-associated virus (AAV) gene therapies sector amidst difficulties associated with gene therapy research development at the preclinical stage, highlighting that it is unlikely that many current AAV ...
- Source: drugdu
- 97
- December 4, 2023

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