PharmaShots
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Real-time summarized News in 3 shots from pharma, biotech, medtech, digital health, diagnostics and life sciences industry readable in 60 seconds.
PharmaShots
1h ago
Shots: Primrose Bio and Intravacc have entered into a strategic partnership to strengthen the development & supply of conjugate vaccines under which the third-party developers of conjugate vaccines gain access to a solution for vaccine conjugation, manufacturing, and supply The collaboration will leverage Primrose Bio’s ultra-pure production, supply chain management & regulatory support for PeliCRM197, a component required for conjugate vaccine development Intravacc will provide its technical knowledge, advanced facilities, expertise in antigen conjugation process development, scale-up ..read more
PharmaShots
1h ago
Shots: The P-III (METIS) study assesses stereotactic radiosurgery with/without TTFields therapy vs SoC in patients (n=298) with 1-10 brain metastases from NSCLC The study met the 1EP demonstrating a median time to intracranial progression of 21.9mos. vs 11.3mos. and median TTFields therapy treatment duration of 16wks. with a median usage of 67%. The tolerability of TTFields was consistent with the prior evaluations showing sustained quality of life & neurocognitive function The preliminary analysis of 2EPs incl. time to neurocognitive failure, OS & radiological response rate was not si ..read more
PharmaShots
3h ago
Shots: The US FDA has granted approval to Medtronic’s Evolut FX+ transcatheter aortic valve replacement (TAVR) system for treating symptomatic severe aortic stenosis patients at all risk categories incl. extreme, high, intermediate & low The Evolut FX+ TAVR system has a diamond-shaped frame design which increases coronary access windows providing greater catheter maneuverability required for accessing the coronary arteries across diverse patient anatomies The system’s early US commercialization is anticipated during spring 2024 with its full launch expected during summer 2024 Ref: Med ..read more
PharmaShots
3h ago
Shots: The NMPA has accepted the company’s sNDA of savolitinib for treatment-naïve or previously treated locally advanced or metastatic MET Exon 14 NSCLC patients The sNDA was supported by the P-IIIb clinical evaluation to assess the safety, effectiveness & tolerability of savolitinib to treat locally advanced or metastatic NSCLC patients having MET Exon 14 mutations The study showed an ORR of 62.1%, DCR of 92%, mDoR of 12.5mos. & mPFS of 13.7mos. with mOS not attained at a median follow-up of 20.8mos. in treatment-naïve patients while an ORR of 39.2%, DCR of 92.4%, mDoR of 11.1mos. &a ..read more
PharmaShots
23h ago
Shots: The P-IIa trial evaluates the safety, efficacy & tolerability of SLS009 + aza/ven in r/r AML patients (n=10 & 11) at 45 & 60 mg (QW) or 30mg (BIW). Targets include response rate (RR), median survival & identifying biomarkers As of Mar 15, 2024, the study depicted a 10% & 20% RR with 45 & 60mg & a 50% RR with 30mg (BIW). The study also showed ≥50% bone marrow blast reduction in 67% of patients across all dose levels whereas the median survival rate was not reached & the 1st patient achieving CR remained leukemia-free 9mos. post-enrollment Patients wi ..read more
PharmaShots
23h ago
Shots: ABVC BioPharma and its subsidiary BioFirst signed an agreement with FEYE to enhance the development ABVC's Ophthalmology pipeline which includes Vitargus, a medical device valued at $187M Under the terms of the agreement, FEYE received the rights to develop, manufacture, supply, and distribute the Licensed Products' from ABVC BioPharma whereas ABVC expects to receive an up front payment of $30M cash within 30 days post-signing of the agreement and is eligible to receive a milestone payment of $3.5M in cash post first useful fundraise, plus 5% royalties (up to $60M) on net sales after th ..read more
PharmaShots
23h ago
Shots: Juvisé acquired the rights to Ponvory from Actelion Pharmaceutical (Johnson & Johnson) for its global commercialization, excluding the US & Canada , for the 1L treatment of adults with active forms of relapsing multiple sclerosis (RMS) While the financial details remain undisclosed, the acquisition was funded by a series of capital increases, additional debt, shareholder loans & the acquisition of minority stakes in Juvisé by Bpifrance & Pemberton Ponvory has shown superior efficacy results vs teriflunomide under P-III (OPTIMUM) clinical evaluation of adult patients with ..read more
PharmaShots
23h ago
Shots: The approval was based on the results from the P-III clinical trial evaluating the safety, efficacy, tolerability & PK of Adzynma vs plasma-based therapies in patients aged ≥12yrs. incl .5 Japanese patients) with cTTP Moreover, the approval was also based on the results from a continuation study TAK-755-3002. In both trials, no patient experienced an acute TTP event with Adzynma (n=37) vs plasma-based therapies (n=38) Adzynma is a human recombinant ADAMTS13 (rADAMTS13) that is also approved by the US FDA for the prophylactic treatment of adult and pediatric patients with cTTP ..read more
PharmaShots
23h ago
Shots: In this reprise, we feature Qiming Venture Partners again, based on the investments in 2023. With more than 600 investments to date, Qiming boasts a strong portfolio of companies involved in Technology & Consumer and Healthcare In 2023, Qiming closed 38 funding rounds comprising 11 in the first quarter, 10 in the second, 11 in the third, and 6 in the fourth quarter respectively. The company’s highest investment in the seed stage was made to Brise Pharmaceuticals worth $140M For a detailed report on all the Qiming’s investments in 2023, reach out to us at connect@pharmashots.com with ..read more
PharmaShots
1d ago
Shots: The approval was granted based on the results from the P-III (CHAMPION-NMOSD) clinical trial evaluating the safety & efficacy of Ultomiris vs PBO (external; (PREVENT) trial) in patients (n=58) with AQP4 Ab+ NMOSD for a duration of 73wks. The 1EP of the study was time to first adjudicated, on-trial relapse The study met its 1EP as 0 vs 20 patients depicted adjudicated relapse during the 73.5wks. follow-up period thereby showing a significantly reduced relapse risk along with a safety profile consistent with those of eculizumab & ravulizumab Ultomiris is a long-acting C5 complemen ..read more