Sarepta Therapeutics Inc. has received a complete response letter (CRL) from the FDA as the agency declined to issue a sought-after accelerated approval for the company's Duchenne muscular dystrophy (DMD) follow-on therapy, Vyondys 53 (golodirsen). Read More
Astrazeneca plc's Farxiga (dapagliflozin), already the company's fifth best-selling product, now has a heart-failure component. The SGLT2 inhibitor met its phase III study's primary composite endpoint in reducing cardiovascular death or the worsening of heart failure compared to placebo in patients with reduced ejection fraction on standard-of-care treatment, including those with and without type 2 diabetes. Read More
IGM Biosciences Inc., a Mountain View, Calif.-based biotech developing engineered immunoglobulin M antibodies for the treatment of cancer, has filed to raise up to $100 million in a Nasdaq IPO little more than a month after closing a $102 million series C financing. The company's lead candidate, IGM-2323, is expected to enter phase I testing for the potential treatment of relapsed/refractory (r/r) B-cell non-Hodgkin lymphoma (NHL) this year. Read More
The latest push to amend the U.S. statute to clear up some issues with patent eligibility is gaining momentum on Capitol Hill, but patent attorney Michael Borella said during an Aug. 20 webinar that the current legislation fails to adequately define the term "useful." The legislation defines "useful" as anything that provides "specific and practical utility," but Borella said that, assuming this definition holds, "I think we're going to end up with a diet version of the Alice test," a reference to a Supreme Court ruling that has invalidated a large number of patents. Read More
HONG KONG – Following a regulatory committee's ruling that three of four deaths previously reported during a phase II trial were unrelated to the study drug, South Korea's Ministry of Food and Drug Safety (MFDS) cleared Yuhan Corp. to continue testing lazertinib (YH-25448) in the non-small-cell lung cancer (NSCLC) study. Read More
Hedgepath Pharmaceuticals Inc., of Tampa, said its corporate name was changed to Inhibitor Therapeutics Inc. and the ticker symbol for its common and preferred stock on the Over-the-Counter Markets was changed to INTI from HPPI, both effective when trading opened on Aug. 20. Read More
Araris Biotech AG, of Zurich, Switzerland, said it closed an oversubscribed seed financing round of CHF2.5 million (US$2.55 million) with participation by Swiss investors Redalpine, Schroder Adveq and VI Partners. The proceeds will be used to develop a pipeline of antibody-drug conjugates. Read More
Endo International plc, of Dublin, said Tuesday that its subsidiaries will pay $10 million to resolve an opioid-related lawsuit filed by two Ohio counties. While the drug company is admitting no wrongdoing in the settlement, it also agreed to provide $1 million worth of its Vasostrict (vasopressin) and Adrenalin (epinephrine) products free of charge to be allocated by the two counties. Read More
The costs associated with navigating a new therapeutic through the regulatory process to final approval and subsequent marketing continue to rise despite industry's collective efforts to speed up the process of drug discovery and development in order to rein in those burgeoning expenses. Read More
