Incyte Corp.'s decision to buy into the costly phase III development of baricitinib in rheumatoid arthritis (RA) looked even smarter Wednesday, upon release of top-line data showing the oral JAK1/2 inhibitor superior to top-selling drug Humira (adalimumab), potentially positioning it for a larger share of the crowded RA market than previously predicted.
It's a busy time to be a bioethicist, thanks to the passage of right-to-try bills in several states, the introduction of federal right-to-try legislation and the onslaught of social media campaigns seeking patient access to experimental drugs.
Since the middle of 2014, Insys Therapeutics Inc.'s pharmaceutical cannabidiol (CBD), a synthetic version of the plant-derived cannabinoid, has been awarded FDA orphan status in a total of six indications – most recently for infantile spasms – and the company looks to accelerate its research. But there's a hitch: The schedule I designation of synthetic CBD by the Drug Enforcement Agency (DEA) continues to drag the drug development process.
With multiple midstage trials ongoing of apatorsen in several cancer types, Oncogenex Pharmaceuticals Inc. is unlikely to spend too much time ruminating on the failure of the phase II Ranier trial testing the drug, formerly known as OGX-427, in pancreatic cancer, an arguably long-shot indication from the start.
After making the jump from drug discovery to drug development and quietly ramping up a clinical-stage oncology pipeline, Deciphera Pharmaceuticals LLC found a new backer in New Leaf Venture Partners, which led a $75 million series B round aimed at getting its lead switch control kinase inhibitor candidates through proof of concept and moving others into human testing.
The potential of an oral therapy that could treat autoimmune disease by preventing the activation of T cells against self antigens while preserving the immune system's activity against external pathogens proved promising enough for small 2013 start-up Artax Biopharma Inc. to attract one of biotech's biggest names.
Aerie Pharmaceuticals Inc. – as well as its share price – returned to its previous heights following positive results from the second phase III trial of its triple-action eye drop Rhopressa, which hit its endpoints in lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Shares of Intra-Cellular Therapies Inc. (NASDAQ:ITCI) hit a 52-week high after unveiling top-line data from the first phase III study of ITI-007, showing the drug met the primary endpoint of antipsychotic efficacy in acutely exacerbated schizophrenia, without demonstrating the side effects that usually lead to patients discontinuing treatment.
Data from the much-anticipated SUMMIT study failed to show that Relvar/Breo Ellipta (fluticasone furoate/vilanterol) statistically significantly extended the lives of chronic obstructive pulmonary disease (COPD) patients, indicating to investors that the product, dubbed the "son of Advair" likely won't be restoring Glaxosmithkline plc's respiratory disease franchise to its once-great heights.
Sucampo Pharmaceuticals Inc. is buying Japanese firm R-Tech Ueno Ltd. through an all-cash tender offer valued at ¥33 billion (US$278 million), a deal CEO Peter Greenleaf said marks both the culmination of the company’s transformation over the past year and the trajectory of its future growth via business development efforts.
