Tag Archives: Nemaura

Lilly to Acquire Versanis Bio; Brenzavvy Available by Prescription at Mark Cuban Cost Plus Drug Company; Abbott Initiates Libre 3 trial in T2DM and Basal Therapy; Nemaura FY ‘22 Earnings Update

Four cardiometabolic-related news items have been observed: Lilly and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis (view press release); TheracosBio announced Brenzavvy (bexagliflozin) is available by prescription through the Mark Cuban Cost Plus Drug Company (view press release); Abbott initiated a new trial evaluating its FreeStyle Libre 3 in adults with T2DM on basal therapy (view CT.gov record); and Nemaura Medical announced business updates and financial results for its FY ‘22 (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Nemaura Includes Insulin in EU DuoPack License Agreement; Sigilon Q4 ‘22 Earnings

Two CVRM-related news items have been observed: Neumara announced the inclusion of insulin on the list of eligible drugs for its EU DuoPack License Agreement; and Sigilon issued their Q4 ‘22 earnings and disclosed plans to advance its SIG-002 program into the IND-enabling stage (press release). Below, FENIX provides highlights and insights from the news items.

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Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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Biocon Completes Viatris Biosimilars Business Acquisition; Nemaura Launches Miboko Pilot Program in UK; BMS Terminates CV Partnership with uniQure

Three cardiometabolic-related news items have been observed: Biocon announced (view press release) the completed acquisition of Viatris’s biosimilar business (view press release); Nemaura announced the launch of its Miboko pilot program in the UK (view press release); and BMS reportedly terminated its research collaboration with uniQure (view article). Below, FENIX provides context and insight on the respective news items, including Nemaura’s challenged balance sheet.

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Sarissa Capital Challenges Amarin’s Management; Nemaura Receives Provisional Purchase Order from TPMENA

A series of cardiometabolic-related news items have been observed: Sarissa Capital Management LP announced plans to initiate the process of holding a special meeting of Amarin shareholders to reorganize the company’s Board; and Nemaura announced it received a provisional purchase order from its Middle East/North Africa licensee, TPMENA, for the non-invasive sugarBEAT CGM system. Below, FENIX provides highlights and insights for the respective new items.

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Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

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Novo Withdraws PIONEER START Trial; Onduo Partners with Sword Health; Nemaura and Movano Q2 ’22 Earnings Updates

A series of cardiometabolic updates have been observed: Novo’s PIONEER START trial (H2H oral sema vs. empa) has been withdrawn (CT.gov record); Onduo announced a partnership with Sword Health to integrate Sword Health’s musculoskeletal digital solution (press release); and Nemaura (press release) and Movano (press release; webcast) released their Q2 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.

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Teplizumab Delayed Even Further; Lexicon Wins with LX9211; Novartis Buys a PRV; Nemaura FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Provention Bio announced FDA extended the teplizumab PDUFA date by 3 months to November 17, 2022; Lexicon announced positive LX9211 results in Diabetic Neuropathic Pain and hosted an associated call with investors (view webcast); Novartis has reportedly purchased a PRV from Mallinckrodt (view SEC filing); and Nemaura announced its fiscal year 2021 financial results, including updates on its non-invasive CGM product launches (press release). Below, FENIX provides highlights and insights for the respective news items.

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Provention Hosts Teplizumab Commercial Launch Investor Event; Lifescan Initiates New RWE Study; Diamyd Enrolls First Patient in Ph3 T1DM Vaccine Trial; Dario Announces New Employer and Provider Contracts; MySugarWatch Expands DTC Marketing Campaign; Adocia Q1 ’22 Earnings Update

A series of cardiometabolic-related news items have been observed from Provention Bio, Lifescan, Diamyd, Dario, Nemaura, and Adocia. Below, FENIX provides highlights and insights for the respective new items.

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