BioSpace News Archive

TLC announced the successful completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on receiving guidance, and discussing the clinical and regulatory pathway for a potential U.S. approval of TLC599, a BioSeizer® liposomal formulation of dexamethasone sodium phosphate for the treatment of knee osteoarthritis.

There is a tendency to look at biotech as being all about developing drugs. And, of course, that is the primary focus of BioSpace. However, from time to time it’s a good idea to remind ourselves that biotech can and does have broader applications besides medicines, and can, in fact, impact our daily lives on a regular basis.

Somerset, NJ-based CRO Catalent announced it is acquiring Baltimore-based Paragon BioServices for $1.2 billion.

Janssen’s Invokana could become the first diabetes medication to demonstrate reduction in progression to end-stage renal failure in Type 2 diabetes patients with chronic kidney disease.

The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.

Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that its ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).

Stephen Quake, a Stanford University bioengineer and inventor, recently shared several years’ worth of email communications between himself and He with The New York Times.

Although 2018 marked a record year for biopharma initial public offerings (IPO), 2019 has had a number of IPOs so far as well. Here’s a look at four recent IPO filings—and $86 million appears to be the magic number.

Major framework agreement signed with Life Healthcare Distribution (“LHC”) for the exclusive distribution of HEMOBLAST Bellows in the sizeable and growing Australian market

Auris Medical Holding Ltd. announced that the Nasdaq Hearings Panel has granted the Company’s request for the continued listing of the Company’s securities on The Nasdaq Capital Market.