Only days after the first gene therapy finally cleared regulatory hurdles in Europe, Cambridge, Mass.-based gene therapy firm bluebird bio closed a $60 million Series D financing round.
Shares of Onyx Pharmaceuticals Inc. jumped 11.7 percent Friday after its multiple myeloma drug Kyprolis (carfilzomib) won accelerated approval as a third-line treatment.
Nearly two years after a complete response letter (CRL) delayed Lux Biosciences Inc.'s plans for oral voclosporin in noninfectious uveitis, the Jersey City, N.J.-based biotech completed patient enrollment in a new Phase III study aimed at addressing the FDA's request for additional clinical data.
Six months after signing an option agreement on a Phase I-stage antisense program in spinal muscular atrophy (SMA), Isis Pharmaceuticals Inc. and Biogen Idec Inc. agreed to a similarly structured deal for an earlier-stage rare disease program targeting myotonic dystrophy Type I (DM1), a muscular wasting disease also known as Steinert disease.
With a district court judge ruling in favor of Teva Pharmaceutical Industries Ltd.'s patent infringement lawsuit, the Jerusalem-based big pharma should be able to prevent generic competition to its multiple sclerosis (MS) drug Copaxone (glatiramer acetate) from hitting the market until at least Sept. 1, 2015.
BOSTON – Lawmakers reached agreement late Monday on PDUFA V. The House is expected to pass the legislation, S. 3187, Wednesday, followed by the Senate late this week or early next week, coming in well ahead of their self-imposed July 4 goal.
BOSTON – Ambrx Inc. helped kick off the BIO International Convention Monday by disclosing a potential $303 million collaboration with Merck & Co. Inc. using its EuCODE platform to develop antibody-drug conjugates (ADCs) against oncology and other indications.
BOSTON – When the Biotechnology Industry Organization's (BIO) annual international convention opened in Boston five years ago, the industry was basking in all its pre-recession glory, with plenty of money flowing into both new and existing ventures – some said too much – and one of the biggest concerns heading into the BIO meeting was whether lawmakers would quit locking horns and finally pass PDUFA IV.
Heading to Boston next week for the 2012 Biotechnology Industry Organization International convention? So are we. In fact, BioWorld has attended and exhibited at the annual BIO meeting for 18 years, so we know a thing or two about navigating this mega gathering. Check out these tips ‑ gathered by the entire BioWorld staff ‑ on what to bring, how to cope, what to say and how you can enjoy biotech’s annual lollapalooza: Wear comfortable shoes. Leave the fancy Italian loafers and stilettos at home. You’re going to be doing A LOT of walking. Trust us on this. To avoid...
Genentech Inc. said it will be able to meet demand for newly approved Perjeta (pertuzumab), which it plans to roll out within the next two weeks, though the San Francisco-based biotech acknowledged it will have to resolve a manufacturing issue that could affect future supplies of the HER2-positive breast cancer drug.
