Almost five years after the first patient-powered approvals for Clinuvel Pharmaceuticals Ltd.'s Scenesse (afamelanotide) arrived in Europe, the FDA has granted the company U.S. approval to increase pain-free light exposure in adults with a history of skin damage from the rare inherited disorder erythropoietic protoporphyria (EPP). Read More
Unexplained price increases are a recurring theme whenever a congressional committee discusses U.S. prescription drug prices, and both state and federal lawmakers have proposed measures to force drug manufacturers to justify those increases. Read More
Something of a duel may be shaping up between Menlo Park, Calif.-based Adverum Biotechnologies Inc. with ADVM-022, the phase I gene therapy candidate for wet age-related macular degeneration (AMD) and Regenxbio Inc., of Rockville, Md., with a similar candidate. Read More
HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines. Read More
Minoryx Therapeutics SL, of Barcelona, completed recruitment early for its FRAMES phase II trial of MIN-102 (leriglitazone), a peroxisome proliferator-activated receptor gamma agonist, to treat Friedreich's ataxia. Read More
HONG KONG – I-Mab Biopharma (Shanghai) Co. Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for its CD73 antibody, getting the go-ahead for a phase I/II trial of TJD-5 in patients with advanced solid tumors. Read More
Cygnal Therapeutics Inc., of Cambridge, Mass., was unveiled by Flagship Pioneering this week as a startup developing drugs targeting exoneural biology, an understanding of how nerves and neural signaling drive human health and disease. The company, led by CEO Pearl Huang, is focused initially on cancer and inflammatory disease. Read More
Viela Bio Inc., of Gaithersburg, Md., said it closed its IPO of 9.08 million shares, a total that includes 1.18 million shares sold from the exercise in full by the underwriters of their option to purchase additional shares, at $19 each. The gross proceeds were approximately $172.6 million. Read More
Theratechnologies Inc., of Montreal, reported that for the third quarter ended Aug. 31, consolidated revenue for the three- and nine-month periods totaled $16.11 million and $46.8 million, respectively, compared to $13.52 million and $31.23 million, respectively, for the same periods last year, an increase of 19.1% and 49.9%. Read More
The Biotechnology Innovation Organization (BIO) said President and CEO Jim Greenwood intends to step down after the 2020 election and will help transition a new leader. A former congressman from Pennsylvania, Greenwood was appointed head of BIO in 2005, succeeding the organization's founding president, Carl Feldbaum. Read More
DUBLIN – Novartis AG gained FDA approval for its VEGF-A inhibitor Beovu (brolucizumab) in wet age-related macular degeneration (AMD) a week ahead of its presumed PDUFA date. The Basel, Switzerland-based pharma used a priority review voucher to speed up the review process, which kicked off on April 15. The stage is now set for what could be an eye-catching – pun intended – contest between Beovu, a single-chain antibody fragment that binds all VEGF-A isoforms, and Eylea (aflibercept), the VEGF trap that has developed into a multibillion-dollar behemoth straddling several ophthalmic indications since its original approval for treating wet AMD in November 2011. Read More
