Officials from Strongbridge Biopharma plc plan to make their case to the FDA about the potential for an accelerated approval pathway for Recorlev (levoketoconazole) to treat endogenous Cushing's syndrome after the open-label, single-arm SONICS study achieved statistical significance on the pre-specified primary endpoint. Read More
Weighing a mortality imbalance in one clinical trial with the need for new antibacterials amid growing drug resistance, the FDA's Antimicrobial Drugs Advisory Committee gave its support Wednesday for the approval of Paratek Pharmaceuticals Inc.'s omadacycline, the first of a new generation of tetracycline drugs known as aminomethylcyclines. Read More
Ambys Medicines Inc. interim CEO Jeff Tong said the firm's unusual combination of the $60 million series A financing with a deal enlisting Takeda Pharmaceutical Co. Ltd. to the tune of $80 million up front came about because venture backer Third Rock, where Tong is a partner, "wanted to make sure that by doing the deal we weren't going to hamper the growth of the company." Read More
HONG KONG – China's I-Mab Biopharma Co. Ltd. entered a strategic partnering agreement with ABL Bio Inc., of South Korea. I-Mab will out-license its bispecific antibody (BsAb) for an undisclosed target to ABL Bio for about $100 million. Read More
LONDON – Scientists at the Oregon Health and Science University (OHSU) have produced new evidence that gene editing human embryos activates an inherent DNA repair mechanism, leading a mutant paternal gene to be replaced with a newly minted maternal copy. Read More
Kyowa Hakko Kirin Co. Ltd. is expected to begin commercializing its CCR4-targeting monoclonal antibody in the U.S. in the fourth quarter, after winning the FDA's nod Wednesday for use in two types of non-Hodgkin's lymphoma, including Sezary syndrome (SS), for which it becomes the first approved therapy. Read More
HONG KONG – Singaporean biotech startup Dotbio Pte. Ltd. launched this week with seed capital of $2.3 million. The new player on the biotech scene is focused on the development of immuno-oncology drugs based on humanized domain antibodies. Read More
Collplant Holdings Ltd., of Ness Ziona, Israel, a regenerative medicine company using plant-based recombinant human collagen technology for tissue repair products, is voluntarily delisting its ordinary shares and series I warrants and series K warrants from trading on the Tel Aviv Stock Exchange. Read More
Horizon Pharma plc, of Dublin, reported second-quarter net sales of $302.8 million, up 5 percent from its second-quarter 2017 sales of $289.5 million, driven by continued growth of the company's orphan and rheumatology medicines, it said. Read More
The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) said CMS will begin providing Medicare Advantage plans as part of the Trump administration's Patients First blueprint, allowing for the use of tools employed by private sector insurers to negotiate lower prescription drug prices for patients. Read More
Tot Biopharm Co. Ltd., of Suzhou, China, said it completed a series B financing round, raising $102 million. The company focuses on the R&D, manufacturing and marketing of antitumor drugs and has more than 10 drugs at the research stage, including three biologics and three small molecules, which have received IND approvals, as well as one antibody-drug conjugate, which is expected to receive approval in the near future. Read More
