ABBOTT INDIA LIMITED

Medtronic Plans to Separate Diabetes Business into Standalone Company

2 days ago

• Medtronic has announced plans to separate its Diabetes business into an independent, publicly traded company within the next 18 months, enabling both entities to focus on their core strengths and growth opportunities. • The separation is expected to improve Medtronic's financial metrics, with projected increases of approximately 50 basis points in adjusted gross margin and 100 basis points in adjusted operating margins. • The new Diabetes Company, to be led by current EVP Que Dallara, will be positioned as the only company offering a complete ecosystem for intensive insulin management, serving patients with diabetes globally.

Abbott's FreeStyle Libre CGM System Reduces Cardiovascular Hospitalization Risk in Diabetes Patients

8 days ago

• Abbott's FreeStyle Libre continuous glucose monitoring system is the first CGM shown to reduce cardiovascular complication severity in diabetes patients, with data showing a 78% reduction in heart-related hospitalizations for Type 1 diabetes patients. • The REFLECT program, comprising three real-world retrospective studies using Swedish registry data, demonstrated significant reductions in hospitalization risk for both Type 1 and insulin-treated Type 2 diabetes patients using the Libre technology compared to traditional blood glucose monitoring. • Patients with Type 1 diabetes who had no prior history of cardiovascular disease showed an 80% reduced risk of heart-related hospitalizations when using FreeStyle Libre, while those with prior cardiovascular disease history still saw a 49% reduction.

Critical Limb Ischemia Market Projected to Reach $2.5 Billion by 2035, Driven by Novel Therapies and Advanced Diagnostics

8 days ago

• The critical limb ischemia (CLI) market is expected to grow from $1.4 billion in 2024 to $2.5 billion by 2035, with a CAGR of 6.66%, fueled by advances in early detection technologies and personalized medicine approaches. • Novel therapies in development include oxygen carriers (YQ23), autologous stem cell treatments (ASCT-01, CLBS12, ACP-01), and cell-based therapies (REX-001), all aimed at promoting angiogenesis and improving tissue perfusion in ischemic limbs. • The United States represents the largest CLI market, with significant growth driven by FDA regulatory support through fast-track designations and regenerative medicine advanced therapy approvals for innovative treatments.

US Orphan Drug Market Set to Exceed $190 Billion by 2030 as FDA Designations Accelerate

9 days ago

• The US orphan drug market is projected to surpass $190 billion by 2030, with over 7,300 molecules receiving FDA Orphan Drug Designation to date, of which approximately 17.9% have gained approval. • Since 2020, more than half of all new drug approvals by the FDA's Center for Drug Evaluation and Research have been granted orphan status, highlighting the growing importance of rare disease treatments in pharmaceutical development. • Despite criticism over high pricing, exemplified by Abeona Therapeutics' Zevaskyn at $3.1 million per treatment, the orphan drug model has evolved into a sound business strategy offering fewer competitors, faster approvals, and seven-year market exclusivity.

FDA to Deploy AI Assistant Across All Centers by June 30 to Accelerate Scientific Reviews

15 days ago

• FDA Commissioner Martin Makary announced an agency-wide rollout of AI tools to assist with scientific reviews across all 11 FDA centers, with full deployment expected by June 30, 2025. • The AI assistant aims to handle repetitive aspects of regulatory reviews, allowing FDA scientists to focus on critical safety evaluations while potentially accelerating approval timelines for new therapies. • Implementation will be led by FDA's Chief AI Officer Jeremy Walsh and CDER's Strategic Programs Director Sridhar Mantha, with transparency measures including public release of user feedback and performance results.

Breakthrough in Diabetes Management: First One-Year CGM System Integrates with Automated Insulin Delivery

24 days ago

• Sequel Med Tech and Senseonics have partnered to integrate the twiist Automated Insulin Delivery System with Eversense 365, creating the first AID system compatible with a one-year continuous glucose monitor. • The integrated system, expected to launch in Q3 2025, aims to enhance diabetes management by offering improved glucose control, increased convenience, and greater flexibility for people with type 1 diabetes. • This collaboration represents a significant advancement in diabetes technology, allowing patients to benefit from both long-term glucose monitoring and automated insulin delivery without frequent sensor changes.

Roche and Regeneron Announce Multi-Billion Dollar Investments in US Manufacturing Amid Tariff Concerns

a month ago

• Roche has committed $50 billion to expand its US operations over five years, including new manufacturing facilities and R&D centers, with plans to create over 12,000 new jobs nationwide. • Regeneron is investing more than $3 billion in US operations through a partnership with Fujifilm Diosynth Biotechnologies, nearly doubling its large-scale manufacturing capacity in the country. • These pharmaceutical investments come as President Trump continues to threaten sector-specific tariffs, with Roche stating it will eventually export more medicines from the US than it imports.

SurVeil DCB Shows Comparable Efficacy to IN.PACT Admiral with 75% Lower Paclitaxel Dose in TRANSCEND Trial

a month ago

• The TRANSCEND trial demonstrated that Surmodics' SurVeil drug-coated balloon achieved non-inferior safety and efficacy outcomes compared to IN.PACT Admiral DCB despite using 75% less paclitaxel in patients with femoropopliteal arterial disease. • Results published in the European Journal of Vascular and Endovascular Surgery showed comparable 12-month primary patency (82.2% vs 85.9%) and primary safety endpoints (91.8% vs 89.9%) between the two devices. • The global randomized study, conducted across 65 sites in 9 countries with 446 patients, represents the first head-to-head comparison of drug-coated balloons for peripheral artery disease treatment.

Cadrenal Therapeutics Advances Towards Phase 3 Trial of Tecarfarin for LVAD Patients

2 months ago

• Cadrenal Therapeutics is preparing for a pivotal Phase 3 trial of tecarfarin specifically targeting patients with Left Ventricular Assist Devices (LVADs), addressing an important anticoagulation need in this population. • The company has secured Abbott as a strategic partner for the upcoming trial, leveraging Abbott's extensive experience with LVAD patients and clinical trials to strengthen the study design and execution. • Despite having approximately $7.3 million in cash as of March 2025, Cadrenal will need to raise additional capital to fully fund the planned Phase 3 trial while continuing to utilize its ATM facility for interim financing.

Ypsomed and CamDiab to Launch iOS Version of mylife Loop Automated Insulin Delivery System

2 months ago

• Ypsomed and CamDiab are launching an iOS version of the mylife CamAPS FX app, enabling people with type 1 diabetes to manage their automated insulin delivery system directly from iPhones. • The rollout will begin in Sweden on March 24, 2025, initially compatible with Abbott's FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, with Dexcom G6 integration to follow. • mylife Loop is the only algorithm in Europe and New Zealand approved for pregnant women with type 1 diabetes, and will expand across Europe, Australia, and Canada throughout 2025.

Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost

2 months ago

• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. • Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. • The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.

Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests

4 months ago

• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis. • Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology. • Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access. • These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.

Cadrenal Therapeutics Plans Phase 3 Trial for Tecarfarin in LVAD Patients

5 months ago

• Cadrenal Therapeutics aims to initiate a Phase 3 clinical trial for tecarfarin in LVAD patients in 2025, following discussions with the FDA. • Tecarfarin received FDA Orphan Drug Designation for preventing thromboembolism in LVAD patients and Fast Track designation for ESKD patients with AFib. • The company is exploring collaborations to advance tecarfarin's clinical trial and improve anticoagulation outcomes for patients with rare cardiovascular conditions. • Clinical data suggests tecarfarin may offer a safer alternative to warfarin for LVAD patients, addressing limitations of current anticoagulation treatments.