Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation.
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo.
A new U.K. trial evaluating drugs for hospitalized patients in the early stages of COVID-19 has elected to test Evelo Biosciences Inc.'s anti-inflammatory monoclonal microbial, EDP-1815, after an earlier trial found it led to favorable anti-inflammatory activity in psoriasis patients.
