Coherus Biosciences Inc.'s CHS-1701 has become the latest biosimilar candidate for Neulasta (pegfilgrastim) to hit a regulatory snag, earning a complete response letter (CRL) that is expected to delay for at least a year approval of its version of Amgen Inc.'s long-acting G-CSF drug.

For those working in the area of cancer today, it’s impossible to attend a meeting or scientific session without hearing about genetically targeted therapies or efforts in the increasingly hot immuno-oncology space. But a small firm out of Boston has a different view when it comes to cancer therapy.

Shares of Inovio Pharmaceuticals Inc. enjoyed a nice boost Wednesday after the Plymouth Meeting, Pa.-based firm reported immune response rates approaching 100 percent in the first clinical study for its Pennvax-GP HIV vaccine. Though early, the data readout "represents to us very clearly" that there is a path forward, said Niranjan Sardesai, chief operating officer.

Roche Holding AG's interleukin-6 antagonist, Actemra (tocilizumab), gained a supplemental approval Monday, becoming the first FDA-approved treatment for giant cell arteritis (GCA), a chronic form of vasculitis for which the only current treatment option involves steroids.

Though the debut of its stock was marred by the U.S. market's overall decline Wednesday, G1 Therapeutics Inc. priced an IPO to raise $105 million to advance lead candidates aimed at inhibiting cyclin-dependent kinases (CDKs).

While last year's positive readout from the first part of Array Biopharma Inc.'s phase III COLUMBUS trial testing binimetinib and encorafenib in BRAF-mutant advanced, unresectable or metastatic melanoma cleared the way for regulatory filings, supplementary results from the study's second part, released late Tuesday, could bolster the combination's prospects for approval and market penetration.

The FDA has joined Japanese and South Korean regulators in approving edaravone, an intravenously administered antioxidant free radical scavenger, for treating amyotrophic lateral sclerosis (ALS), with its late Friday approval coming more than a month ahead of the PDUFA date.

Astrazeneca plc won FDA accelerated approval for durvalumab, its breakthrough-designated PD-L1 inhibitor, for treating locally advanced or metastatic urothelial carcinoma, a market in which it will face Roche Holding AG’s Tecentriq (atezolizumab), approved in May 2016.

Companies ignoring the advice of their independent data monitoring committees (IDMCs) do so at their own peril, but Argos Therapeutics Inc. might have a more compelling case than most for opting to continue the phase III ADAPT study testing rocapuldencel-T in combination with Sutent (sunitinib, Pfizer Inc.) in metastatic renal cell carcinoma (mRCC), despite a disappointing interim analysis in February, in which the IDMC recommended the study be stopped for futility.

Ultragenyx Pharmaceutical Inc. said it believes data from a phase III study testing burosumab (KRN23), a recombinant fully human monoclonal IgG1 antibody, are sufficient to support a BLA filing this year in X-linked hypophosphatemia (XLH), a bone disease characterized by phosphate wasting due to excess activity of FGF23.