HYDERABAD, India – To continue expanding their footprint and capabilities beyond simple generics to biosimilars and new chemical entities, Indian pharmaceutical companies will have to improve their quality controls, compliance capabilities and, just as importantly, adopt more effective digital strategies.
With the Simpliciti-T1 phase II trial testing new-mechanism TTP-399 as adjunct therapy in type 1 diabetes (T1D), High Point, N.C.-based Vtv Therapeutics Inc. nailed the HbA1c endpoint with none of the safety concerns foiling developers of type 2 diabetes (T2D) drugs who sought to broaden their labels.
LONDON – Oculis SA reported positive results for its topical nanoparticle formulation of dexamethasone in the treatment of diabetic macular edema (DME), showing the eye drops reduced central macular thickness (CMT) in the phase II proof-of-concept trial.
TORONTO – Calgary, Alberta-based Orpyx Medical Technologies Inc. has launched a sensory insole with remote patient monitoring to prevent potentially fatal diabetic foot ulcers (DFU) and neuropathy-related ulcers. According to Orpyx CEO Breanne Everett, development of the Orpyx SI sensory insole system follows years of study on how DFUs occur and how best to share information with patients and doctors so they can react quickly to first signs of the condition.
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
SANTA CLARA, Calif. – Diabetes seems likely to be the first area to really show concrete products and results for the ambitious Verily Life Sciences, which is the med-tech business of Mountain View, Calif.-based Google parent Alphabet Inc. However, its two major diabetes partners both have been rethinking the relationship.
LONDON – Oviva AG has raised US$21 million in a series B funding to further advance commercialization of its digital diabetes treatment program across Europe.
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. In combination, the devices will operate as a closed loop system to automatically adjust insulin dosage over time in response to blood glucose levels.
SAN FRANCISCO – This was the final presentation for Omar Ishrak at the J.P. Morgan (JPM) Healthcare Conference. He has held the CEO position at Medtronic plc since June 2011. During that period, the Dublin-based company managed to roughly quadruple its valuation to $160 billion from $40 billion – making Ishrak’s tenure clearly a successful one.
SAN FRANCISCO – Dexcom Inc. is working hard to take its business to the next level. Wall Street has been rewarding it heavily, doubling its market cap to about $21 billion since the end of 2018. But investors pulled back a tad on the company’s presentation at the J.P. Morgan (JPM) Healthcare Conference in San Francisco, sending shares down about 4% despite beating analyst expectations.