Shares of San Diego-based Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) fell 51% to close Monday at 62 cents after the FDA issued a complete response letter regarding its high-dose naloxone injection candidate, Zimhi, for the treatment of opioid overdose. The agency raised questions about chemistry, manufacturing and controls (CMC), but not the candidate's safety or efficacy, the company said.
On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
Recro Pharma Inc. CEO Geraldine Henwood said the firm, in response to its appeal to the FDA on behalf of I.V. meloxicam for moderate to severe postoperative pain, got a “very lengthy letter” agreeing that safety and efficacy were sufficient for approval but “there was a need to negotiate labeling.”
Less than four months after accepting Alnylam Pharmaceuticals Inc.'s NDA for Givlaari (givosiran), the FDA has approved the new RNAi therapy for the treatment of adults with the rare genetic disorder acute hepatic porphyria (AHP). The condition is defined by a buildup of toxic porphyrin molecules formed during the production of heme. That buildup can cause incidents of severe pain and paralysis, respiratory failure, seizures and mental status changes, according to the agency.
HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) NDA for surufatinib as a treatment for patients with advanced non-pancreatic neuroendocrine tumors (NET) has been accepted for review by China’s National Medical Products Administration (NMPA).
LONDON – “Innovation only matters if patients benefit.” So said Guido Rasi, executive director of the EMA, as the agency embarks on the next phase of updating its regulatory science, both to tap into a torrent of new technologies and to ensure drug development generates evidence to demonstrate cost effectiveness and speed up access.
DUBLIN – Friday marked an important milestone for the EMA as its settles into its new home in Amsterdam. The Dutch authorities formally handed over to the agency the keys to its new building, which is located in the Zuidas district of the city.
About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD).
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