Radius Health, Inc.的动态

??? Update on Novo Nordisk's Patents for Semaglutide ?? Novo Nordisk has faced setbacks as two of its key patents for semaglutide, a key ingredient in diabetes and weight-loss drugs like Ozempic, Wegovy, and Rybelsus, were recently revoked by the European Patent Office (EPO). These patents protected the tablet form of semaglutide, which is used in Rybelsus. Several generic drug companies, including Teva and Hexal, successfully challenged the patents. However, Novo Nordisk remains confident, highlighting that other divisional patents are still in force, ensuring protection for its tablet formulation. While the legal battle continues, the administration of semaglutide via injection, as seen in the blockbuster drugs Ozempic and Wegovy, remains unaffected. This situation is one to watch as it could pave the way for more affordable generic alternatives in the market! #IntellectualProperty #Generics #NovoNordisk #DiabetesTreatment #WeightLoss #EPO

?? ???????????????? ???????????????????? ?????????? ???????? €??????.?? ?????????????? ?????? ?????????????? ???????????? ?????????????????? ???? ???????????????? ?????????????????? ???????? The European Commission has imposed a significant €462.6 million fine ??on????????? ?????????????????????????????? for abusing its dominant position to ?????????? ???????????????????????for Copaxone, a leading treatment for multiple sclerosis ??. According to the Commission, Teva leveraged divisional patents to prolong exclusivity on Copaxone, ???????????????? ?????????? ???????????????? that delayed the entry of more affordable generics. Additionally, Teva systematically ???????? ???????????? ???? ?????? ???????????? ?????? ???????????????? ???? ?? ????????????????????'?? ?????????????? ??????????????, further hindering its adoption across the EU. ?? This case and earlier actions involving H. Lundbeck, Servier, Aspen Pharmacare, and Teva & Cephalon reflect the EU’s increasing vigilance on antitrust practices within the healthcare sector. ??Press release: https://lnkd.in/dvkjwyWk ?#Antitrust #EUCompetition #Pharma #Teva #MultipleSclerosis #PatentAbuse #Healthcare #TrojanEconomics

Fascinating, fascinating case! Beijing IP Court REVERSES the Chinese patent office's invalidation of Novo Nordisk's semaglutide (Ozempic?, Wegovy?) patent, upholding the validity of the patent for this blockbuster drug. Even more interesting? It's because of post filing supplemental data that Novo Nordisk submitted. Any patent attorney who has experience prosecuting biopharma patents in China will agree that China's strict stance on accepting post-filing supplemental data has always been a sore spot. This decision analyzes and really teases apart the reasons why certain post-filing data (submitted by Novo Nordisk) were acceptable, while others were not. The nuanced differences are quite subtle, and it's worth reading the whole article to understand (and apply) it. I gave a talk about this case at #LSPN2024 in #Boston earlier this year. I'm glad I finally found the time to write up the article (together with the help of my colleagues Yolanda Wang and Audrey Cheung). Enjoy! https://lnkd.in/gScYh9kg #semaglutide #ozempic #wegovy #chinapatentlaw #chinapatentstrategy #patentattorney #patentlaw #intellectualproperty #pharmaceuticals #generics #innovators #novonordisk #obesity #cnipa #beijingipcourt

READ NOW: NAVLIN Last Week in Review https://ow.ly/onCg50SVLRe This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world:Policy: NHS England’s consultation on CMF and BIT threshold revisions is now open, aligning with the 2024 VPAG promises. #HealthPolicy Pricing & Reimbursement: China expands its NRDL shortlist to 440 drugs, up from last year’s 344. #DrugPricing HTA: New study in IJTAHC explores HTA and decision-making connections to inform access models in Latin America. #HealthTechAssessment Drug Approval: FDA grants accelerated approval to Novartis’ Fabhalta (iptacopan) for IgAN patients at risk of rapid progression. #DrugApproval C&G Therapy: BioMarin realigns Roctavian business to focus on the U.S., Germany, and Italy, aiming to cut annual expenses by USD 60M by 2025. #GeneTherapy Managed Entry Agreements: HAS grants early access to BMS’ Abecma for relapsed and refractory multiple myeloma patients in France. #ManagedEntry Supply Issues: FDA confirms availability of Novo Nordisk’s Wegovy and Ozempic doses in the U.S. #DrugSupply Other: Charles River Laboratories sees reduced demand due to pharma R&D budget cuts, influenced by the U.S. IRA and patent cliffs. #PharmaR&D And much more...

This review in BioDrugs provides an overview of the general mechanisms of action and design features of antisense oligonucleotides (ASOs), as well specific information on each of the FDA-approved ASO drugs. #Antisense #mRNA https://lnkd.in/gaf8wXZn

Recently, PresVu eye drops, developed by Entod Pharmaceuticals, claimed to have received final approval from the Drug Controller General of India (DCGI) on September 3, marking what was initially hailed as a breakthrough in the treatment of presbyopia. However, on September 5, the DCGI raised serious concerns about the company's claims, labeling the statements regarding PresVu being a “revolutionary treatment” as unethical and a misrepresentation of facts. In response, the DCGI requested an official explanation from Entod Pharmaceuticals. As of yesterday, the DCGI has suspended regulatory approval for PresVu. It will be interesting to see how this situation unfolds, and I hope that Entod Pharmaceuticals takes swift and responsible actions to address these concerns and provide clarity. #PharmaNews #DrugSafety #Presbyopia #RegulatoryAffairs #HealthcareEthics #eyecareprofessional

Shield Therapeutics plc (AIM:STX, OTCQX:SHIEF), the commercial-stage pharma company, has entered into a $5.7 million monetisation agreement with AOP Health International Management, its biggest shareholder. Under the terms of the agreement, AOP will provide Shield with the funds in return for the right to the $11.4 million China approval milestone payment. This payment is to be made by Jiangsu Aosaikang Pharmaceutica (ASK Pharma), Shield's commercial partner, on the successful Chinese sign-off for Shield's lead asset, Ferracru. Ferracru is a breakthrough treatment?for iron deficiency. The phase III trial is expected to begin recruitment later this year, meaning the milestone payment could fall due by the end of 2026. As part of the transaction,?Dr Rudolf Widmann, the founder of AOP, which owns just under 40% of Shield, would join the UK group's board as a non-exec. Greg Madison said?$5.7 million (along with the $8... More at #Proactive #ProactiveInvestors https://ow.ly/cbO2105z7q6

Zai Lab and Pfizer announced a strategic collaboration for Xacduro (sulbactam-durlobactam) in mainland China - Zai Lab + Pfizer https://lnkd.in/eTrcXSf8

Prof. Peter Yuen Interviewed by “News Magazine” on the Issue of Expensive Self-financed Drugs In Hong Kong, self-financed new drugs for rare diseases and cancer are prohibitively expensive, while the same drugs are more affordable in mainland China. This has led many Hong Kong residents to seek medical treatment and purchase medication across the border in recent years. Prof. Peter Yuen, Dean of PolyU CPCE, was interviewed on the TVB programme #News_Magazine aired on 10 August 2024 to share his insight into the issue. Prof. Yuen, a renowned health economist, pointed out that if Hong Kong patients go to the mainland to buy drugs, the Hong Kong branches of pharmaceutical companies make no profit. Therefore, the HKSAR government should proactively negotiate with pharmaceutical companies to lower drug prices, which would encourage patients to stay in Hong Kong and seek treatment, benefiting both sides. Watch the “News Magazine” episode 「同藥不同命」at https://lnkd.in/euf53Z43 #peteryuen #selffinanceddrugs #自費藥物 #hksargovernment #PolyUHKCC #PolyUSPEED #理大專業及持續教育學院

UPDATE ? To all PHARMA, BIOTECH & MEDICAL DEVICE companies interested in the Hong Kong and/or Greater Bay Area (GBA) marketplace. As of November 1, 2024, a New Hong Kong SAR Policy was announced regarding new drugs, new vaccines, new advanced therapies and new medical devices. Under the "1+ mechanism", once a new drug, a new vaccine, a new advanced therapy product and a new medical device are approved and registered in Hong Kong and in-use at Hong Kong public hospitals, these new drugs, new therapies and new medical devices shall have a 'Green Channel' to access the 86 million population residing in the Greater Bay Area {GBA = Guangdong Province}. #2024policyaddress #InvestHK #HongKong https://lnkd.in/g7hViW32 https://lnkd.in/gtCPkD46 Hong Kong Where Business Goes to Grow!