Bayer's Pan-Cancer Drug Vitrakvi Rejected in UK and Germany
Bayer
Pharmaceutical Product R&D Developer
[2020.01.15/R&D NEWS]Tide Pharmaceutical’s application for the marketing approval of pregabalin extended-release tablets has been accepted; Chia Tai Tianqing’s capsule of anlotinib hydrochloride for a new indication is proposed for priority review; New lymphoma drug umbralisib applied for marketing approval in the United States; Special proteins related to ovarian cancer may promote the occurrence of Alzheimer's disease...
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[Drug Approval]
Modern Pharmaceutical's Diclofenac Sodium Sustained-Release Tablets Pass Consistency Evaluation
On the 19th, Modern Pharmaceutical announced that its controlled subsidiary, Zhijun Pingshan, received the "Drug Supplemental Application Approval" issued and signed by the National Medical Products Administration (NMPA), approving the drug Diclofenac Sodium Sustained-Release Tablets (0.1g) to pass the consistency evaluation of quality and efficacy for generic drugs.
On the 19th, Beijing Tide Pharmaceutical Co., Ltd. submitted a marketing application for its new Class 3 drug “Pregabalin Extended-Release Tablets,” which was accepted by the NMPA (Acceptance Number: CYHS2000085).
Roche’s Trastuzumab Emtansine to Be Approved!
Recently, the marketing application for Roche’s trastuzumab emtansine for injection (Acceptance Numbers: JXSS1900012/13) is currently “under review” by the NMPA. Following the submission of supplementary materials, it is expected to be approved imminently as the first ADC drug to be marketed in China.
Roche’s Kadcyla Poised for Approval
Recently, the National Medical Products Administration updated the review status of Roche’s HER2-ADC drug ado-trastuzumab emtansine for injection (brand name: Kadcyla®) to “under approval,” with market authorization expected in the near future.
Bayer’s Anti-Cancer Drug Vitrakvi Rejected for Market Approval in the UK and Germany
Recently, the cost-effectiveness regulators in England and Germany rejected Bayer's application for market approval of its targeted anticancer drug Vitrakvi (larotrectinib), primarily due to the drug's high price and limitations in clinical data.
Chia Tai Tianqing’s Anlotinib Hydrochloride Capsules Proposed for Priority Review for New Indication
On the 17th, the CDE announced a new batch of drugs proposed for inclusion in the priority review and approval list, which includes the marketing application for the fourth new indication of Chia Tai Tianqing’s Anlotinib Hydrochloride Capsules.
BCMA-Targeted Allogeneic CAR-T Therapy Receives Approval
Recently, Precision BioSciences announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the PBCAR269A therapy and granted orphan drug designation to the therapy.
New Lymphoma Drug Umbralisib Applies for Market Approval in the United States
TG Therapeutics Announces Initiation of Rolling Submission of New Drug Application to FDA for Accelerated Approval of Umbralisib, an Oral, Once-Daily Dual Inhibitor of Phosphoinositide 3-Kinase Delta and CK1-ε, for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
First Nasal Spray Treatment Drug Valtoco Approved by FDA
Recently, Neurelis announced that the FDA has approved Valtoco as an acute treatment for intermittent, stereotyped episodes of frequent seizure activity in patients aged 6 years and older with epilepsy, which differ from the patient’s usual seizure pattern.
Zesheng Pharmaceutical’s Recombinant Neuregulin Poised for Market Approval in China
On the 16th, the marketing application for Zesheng Pharmaceutical’s investigational Class 1 new drug, Recombinant Human Neuregulin-1 for Injection, was updated to “under review,” signaling that this internationally pioneering gene-engineered biologic innovative drug for the treatment of chronic heart failure is poised for approval and market launch in China.
[Latest Research]
Ovarian Cancer-Associated Special Proteins May Promote the Development of Alzheimer's Disease
Recently, a research report published in the international journal EBioMedicine identified a specific protein in ovarian cancer by scientists from institutions including Houston Methodist Cancer Center, which may promote cognitive decline and the development of Alzheimer's disease.
Scientists Poised to Develop Novel Targeted Therapies for Cholangiocarcinoma
Recently, a research report published in the international journal Molecular Cancer Therapeutics revealed how cholangiocarcinoma patients develop resistance to potential targeted therapies. Scientists from The Ohio State University Wexner Medical Center found that adding another drug, an FGFR inhibitor, during cancer progression could effectively restore the sensitivity of cancer cells to the initial treatment.
*Disclaimer: This article was written by an author contributing to Sina Pharmaceutical News. The views expressed are solely those of the author and do not represent the position of Sina Pharmaceutical News.