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:  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: 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

Shots: FILSPARI received conditional marketing authorization (CMA) from European Commission for treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (Urine Protein: Creatinine > 0.75g/g) The approval is based on PROTECT (P-III) study, evaluating safety and efficacy of sparsentan (400 mg) vs irbesartan (300 mg). Study met 1EPs: statistical significance at pre specified interim analysis; mean reduction in proteinuria with Sparsentan (49.8%) and Irbesartan (15.1%) after 36wks First EU market launch of FILSPARI, a non-immunosuppressive therapy is expected in H2’24 Ref ..read more

Shots: Neurocrine reports results from SAVITRI, a P-II study (n=183), evaluating safety and efficacy of NBI-1065845 (AMPA) in adults with MDD who had improper response to other MDD treatment Study met both 1EP and 2EP, showing significant reduction in MADRS score at D28 (Dose 1: -4.3; Other dose: -3) and D56 (Dose 1: -7.5; Other dose: -3.6), respectively. Common AE observed is headache, no deaths or SAEs; low discontinuation rate. Based on P-II data, company to discuss P-III studies path at FDA meeting Ref: Neurocrine Biosciences | Image: Neurocrine Biosciences Related News ..read more

Shots: Astellas received label extension approval of Xtandi as monothx or in combo with ADT to treat unsuitable salvage-radiotherapy, adult men with high-risk BCR nmHSPC The approval was based on EMBARK (P-III) study (n=1,068). Xtandi (160 mg) in combo with leuprolide (n=355) reduced cancer spreading risk or death by 57.6% and Xtandi alone (160 mg) (n=355) reduced risk by 36.9% vs PBO with 22.5 mg leuprolide (n=358) at every 12wks. Study met its both 1EP (MFS) and 2EP (reduction in risk of metastasis or death) Revised guidelines of EAU in Apr’24, recommends Xtandi in high-risk BCR nm ..read more

Shots: Incyte to acquire Escient Pharmaceuticals for $750 M plus Escient’s remaining net cash at closing of transaction (based on customary adjustments). Closing of acquisition is anticipated in Q3’24 Acquisition will enhance Incyte’s R&D activities in Inflammation and Autoimmunity (IAI) by addition of Escient's MRGPR antagonists, EP262 and EP547; possible launch begins in 2029 Moreover, EP262 in the P-I study showed safety and tolerability at all doses tested with no AEs & SAEs, vital signs, or ECG parameters, whereas TEAEs were mild having incidence lesser than PBO (33.3% vs. 62.5 ..read more