Alexion Pharmaceuticals Inc. plucked another rare disease pearl with a deal to acquire Syntimmune Inc. and its humanized monoclonal antibody, SYNT-001, which is in phase I/II studies in the skin diseases pemphigus vulgaris (PV) and pemphigus foliaceus and the hematology indication warm autoimmune hemolytic anemia (WAIHA). SYNT-001, which inhibits interaction of the neonatal Fc receptor (FcRn) with immunoglobulin G (IgG) and IgG immune complexes, offers Boston-based Alexion development prospects in other rare IgG-mediated diseases, including neurology indications, with proof of mechanism showing rapid IgG reduction. Read More
With generic competition poised to cut deep into revenue from its top product, the preterm birth drug Makena (hydroxyprogesterone caproate), Amag Pharmaceuticals Inc. has moved to acquire a midstage preeclampsia drug from Velo Bio LLC. If successful, it could transform the old digoxin poisoning treatment into an essential maternal care product for an indication with no FDA-approved therapy, a scenario that CEO Bill Heiden called "a potential $1 billion project opportunity." Read More
With its reactive aldehyde species (RASP) inhibitor reproxalap a winner in phase IIb results against dry eye disease (DED) and already undergoing study at the phase III stage in allergic conjunctivitis (AC), Aldeyra Therapeutics Inc. might be able to pull off a dual NDA submission. Read More
DUBLIN – Minoryx Therapeutics SL raised €21.3 million (US$25 million) in a series B round to move its lead drug candidate, MIN-102, into at least two additional indications, on top of its lead indication adrenomyeloneuropathy (AMN), in which it is currently undergoing a phase II/III trial. Read More
For the first time in 22 years, the NIH, and most of the other Health and Human Services (HHS) agencies, will head into fiscal 2019 fully funded – that is if President Donald Trump signs off on the $855.1 billion bill the House passed Wednesday to fund the departments of Defense, Labor, HHS and Education. Read More
TAIPEI, Taiwan – Astrazeneca plc said this week it would make a TWD1 billion (US$32.5 million) R&D investment in Taiwan over the coming three years, nearly tripling its clinical R&D spending. The company said that investment will drive the roll-out of 10 new medicines by 2021, which will target ovarian cancer, lung cancer, severe asthma and diabetes. Read More
Bluewillow Biologics Inc., of Ann Arbor, Mich., formerly Nanobio Corp., said it received an NIH Small Business Innovation Research grant to develop an intranasal Nanovax vaccine for the prevention of chlamydia. The one-year award will fund in vivo studies combining the firm's Nanovax technology with a proven chlamydia antigen. Read More
Eton Pharmaceuticals Inc., of Deer Park, Ill., plans to sell 3 million shares at $6 per share in an IPO, netting the company $15.5 million, or approximately $17.9 million if the underwriters exercise their option to purchase an additional 450,000 shares in full. The company plans to list on Nasdaq under the symbol ETON. National Securities is the sole bookrunner on the deal. Read More
In conjunction with the UN General Assembly's high-level meeting on ending tuberculosis (TB) Wednesday, the NIH unveiled its strategic plan for TB research. The plan prioritizes the use of modern tools, such as imaging and systems biology methods, to better understand how TB infection remains latent in some individuals and then progresses to active disease. Read More
