This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials, Pharma, Animal Health & MedTech. Check out our full report below:    Health Canada Accepts Filling and Priority Review of Acadia’s TROFINETIDE for Rett Syndrome Read More: Health Canada                                                                                        &n ..read more

Shots: Vistagen reports P-IIa study (n=10) results, PH15 (1.6µg) shown statistically significant improvement in reaction time vs PBO & caffeine (p<0.001) in sleep-deprived participants at midnight and 3:00 a.m. (most fatigued) with no SAEs P-IIa study evaluating safety, efficacy & tolerability of intranasal PH15(1.6 µg multiple doses or 9.6 µg total dose) vs PBO (nasal spray or oral), or caffeine (single 400 mg oral dose 1 hr before session) in consecutive sleep deprivation sessions set apart 1wk, scheduled for 6:00 p.m., 9:00 p.m., midnight, and 3:00 a.m. Company to further explore ..read more

Shots: Regeneron and Mammoth signed a collaboration to develop and commercialize in vivo CRISPR-based gene editing therapies by using Regeneron’s AAV and antibody engineering and Mammoth’s ultracompact gene editing systems Under agreement, Mammoth will receive $100M includes $95M upfront cash and equity, $370M R&D and commercial milestones per target, plus single digits to mid-teens royalties, with an option to receive co-funding and profit-sharing on majority of collaborative initiatives in exchange of milestones and royalties Regeneron get access to Mammoth’s editing technologies, other ..read more

Shots: Onconic’s JAQBO (zastaprazan citrate) received Korea’s MFDS approval, based on comprehensive data of P-III study from 28 sites of Korea presented at UEG in Oct’23. Data shown effectiveness on erosive esophagitis with 97.9% healing rate, after 8wks Launch of JAQBO is expected in 2024, following its Korean National Healthcare Insurance Reimbursement listing. Jeil Pharmaceutical (Onconic’s parent company) will be responsible for JAQBO's domestic sales In Mar’23, Livzon Pharmaceutical acquired a license to use JAQBO in China for total transaction value of $127.5 million  Ref: Onco ..read more

Shots:  RNAi therapeutics are innovative medications that enable rapid identification of specific inhibitors of disease targets across a wide range of molecule classes. Several biopharma companies are investing in RNAi therapeutics extravagantly to maintain a healthy foothold in innovative medicines  In 2023, the global RNAi drug delivery market size was valued at $84.1B and is anticipated to register a market size of $410.3B by 2032 with a CAGR of 18.17 percent. Like the previous year, Roche retains the topmost position with an R&D expenditure of $15.73B followed by Novartis and ..read more

Shots: US FDA granted ODD and RPDD to Medivir’s MIV-711 for treatment of Legg-Calvé-Perthes Disease (LCPD) Animal model of LCPD shown the ability to prevent femoral head deformity and positive impact on bone degradation biomarker without affecting bone formation. Common consequences of LCPD in children includes Obesity, Depression, and Osteoarthritis With RPDD, MIV-711 is eligible for fast-track review and Priority review voucher post-FDA approval for LCPD Ref: Medivir | Image: Medivir Related News:- Medivir AB Reports the First Patient Dosing of Fostrox + Lenvima in P ..read more

Shots: Labcorp won Invitae’s auction bid, in the sale process under US Bankruptcy Code Section 363 Following the auction, LabCorp will acquire all assets for $239M in cash, plus other non-cash consideration The current hearing date of sale approval is May 6, 2024. Deal closing is expected by Q3’24, with court approval, customary regulatory clearances and closing conditions Ref: Labcorp  | Image: Labcorp  Related News:- Labcorp Launched Neurofilament Light Chain Blood Test to Identify Neurodegenerative Disease PharmaShots! Your go-to media platform for customi ..read more

Shots: Atom Bioscience initiated patient enrolment in the US for a P-IIb/III study of ABP-671 in oral formulation to treat Chronic Gout P-IIb/III study (n=580) evaluates ABP-671 in two parts; Part 1 for safety and efficacy at different doses and regimens vs PBO or allopurinol (SOC) in the US; Part 2 for comparing dose regimens selected from Part 1 with PBO in patients who were not enrolled in Part 1; identified 36 sites in 17 states ABP-671, an orally administered URAT1 inhibitor; preclinical data showed significant efficacy and good safety, whereas existing drugs showed poor efficacy and SAEs ..read more

Shots: The MHRA has granted marketing authorization to Ascendis’ Yorvipath (Palopegteriparatide) for the treatment of adults with chronic hypoparathyroidism, along with ODD (10 yrs. market exclusivity in Great Britain) MHRA approval is based on same dossier submitted for Yorvipath’s EU approval in Nov’23 Yorvipath (developed as TransCon PTH), a prodrug of parathyroid hormone (PTH 1-34) administered QD; also being developed in US, Japan and other countries for chronic hypoparathyroidism Ref: Ascendis Pharma | Image: Ascendis Pharma Related News:- Ascendis Enters into Collabo ..read more

Shots: An American investment firm, OrbiMed Advisor is a prominent name when it comes to healthcare investments. The company boasts a robust portfolio of more than 180 companies, including AbCellera, Acelyrin, Actus Medical, and Adaptive Biotechnologies, among others In 2023, OrbiMed invested in 38 funding rounds; 11, 6, 9 & 12 every quarter across 2023 respectively For a detailed report on all the investments, reach out to us at connect@pharmashots.com   OrbiMed Advisor Founded in 1989, Orbimed Advisor is a global healthcare investment firm, led by 21 partners. The company's investme ..read more