HI-Bio: A Biogen Company’s Post

One Life, One Liver Under the theme, “One Life, One Liver,” this year's World Hepatitis Day will highlight the importance of the liver for a healthy life, and the need to scale up viral hepatitis prevention, testing and treatment to optimize liver health, prevent liver disease and achieve the 2030 hepatitis elimination goals.   At AXIS Clinicals, we are committed to support the Clinical Development related to Hepatitis treatment. Our collective efforts with Pharma and Biotech companies will ensure a real impact in creating a healthier future.   #OneLifeOneLiver #axisclinicals #Clinicaltrials #Clinicalstudies #worldhepatitisday #AXISClinicals #AXISINDIA #AXISUSA #AXISMEXICO #ClinicalTrials #Bioequivalence #Biostudies #CDM #Clinicaldatamanagement #Clinicalresearch #505B2 #VCStudies #PhaseI #PhaseII #PhaseIII #PhaseTrials #PhaseItoIV #FirstInHuman #Regulatory #clinicaldevelopment #AXISHyderabad #AXISAhmedabad #CRO #PatientPK #ClinicalEndPoint #Clinicaltrials 

Drug repurposing has often been suggested as a logical solution for targeting rare disease therapies. This strategy is a particularly attractive method to develop therapies in a more efficient and cost-effective way. The International Rare Diseases Research Consortium (IRDiRC) has developed a new guidebook to invigorate drug repurposing for rare diseases. #drugdiscovery #repurposing #drugdevelopment

🚀 Exciting news for the rare disease community! 🚀 The FDA has launched the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program, aimed at accelerating the development of therapies for rare diseases. As part of START, participants will receive invaluable guidance and support from FDA experts, addressing key challenges in clinical trial design and patient population identification. However, challenges still persist. Many in the industry have raised concerns about the Inflation Reduction Act (IRA), which some view as a barrier to orphan drug developers. While orphan drugs are exempt from IRA negotiations, this exemption only applies to drugs approved for one specific indication. Looking ahead, there's hope for positive change. Advocates are urging governmental regulators to enhance incentives for rare disease drug development in the coming year, paving the way for more treatments to reach the market. Let's work together to bring hope and healing to those affected by rare diseases. Together, we can make a difference. 💪 #RareDisease #FDA #ClinicalTrials #OrphanDrugs #HealthcareInnovation #citeline

“Rather than protect orphan drug development, the single- indication exemption “has slowed and in some cases stopped drug development in the rare disease space” -Christina Hochul While well intentioned, the IRA has created additional barriers to the development of rare disease treatments and ultimately hampered rare disease patients to access life saving medications. To learn more about the IRA’s impact on orphan drugs please check out this article by BioCentury Inc. or watch the full panel below! https://lnkd.in/eZMJJFTJ https://lnkd.in/esz3TKjH

Exciting news from Amgen as Uplizna proves its worth in another rare disease setting! Learn more about the regulatory filings in the US and EU. #RareDisease #Amgen #Uplizna

Exciting news from Amgen as Uplizna proves its worth in another rare disease setting! Learn more about the regulatory filings in the US and EU. #RareDisease #Amgen #Uplizna

Etrasimod is a new generation of oral S1P receptor modulator, which can specifically bind to S1P receptors 1, 4, and 5. It is being studied for a range of immune inflammatory diseases, including ulcerative colitis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata. At present, the highest stage of research and development of the drug is to apply for marketing, which is used to treat ulcerative colitis and is expected to be approved by FDA in this month. Chemenu has been working to develop more compounds for drug discovery. Here come the related building blocks we can provide: https://lnkd.in/gckhBZS9 Etrasimod.html 👇 #Chemenu #Etrasimod #S1Preceptor #immuneinflammatorydiseases #ulcerativecolitis #Crohn'sdisease #atopicdermatitis #eosinophilicesophagitis #alopeciaareata #FDA #buildingblocks

Exciting news from Amgen as Uplizna proves its worth in another rare disease setting! Learn more about the regulatory filings in the US and EU. #RareDisease #Amgen #Uplizna

Exciting news from Amgen as Uplizna proves its worth in another rare disease setting! Learn more about the regulatory filings in the US and EU. #RareDisease #Amgen #Uplizna

Exciting news from Amgen as Uplizna proves its worth in another rare disease setting! Learn more about the regulatory filings in the US and EU. #RareDisease #Amgen #Uplizna