Less than two weeks after disclosing an upbeat but not very specific press release about phase III bioequivalence results comparing its version of albumin-bound paclitaxel, Cynviloq, to Celgene Corp.'s marketed blockbuster Abraxane, Sorrento Therapeutics Inc.'s potential $1.3 billion-plus deal with Nantworks Inc. gained what one analyst called a "huge validation" of the candidate's potential.
To develop safer combination therapies is still critical, and "we think that's particularly true in breast cancer," Oncothyreon Inc. CEO Robert Kirkman told BioWorld Today, even though Thursday's overwhelming torrent of abstracts seem to suggest that immunity-based approaches will steal the show again at the American Society of Clinical Oncology (ASCO) meeting later this month.
Despite headwinds, Vertex Pharmaceuticals Inc.'s Orkambi won favor from members of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC), who voted 12-1 to recommend approval despite plenty of questions about the prospective new therapy that combines the firm's already approved Kalydeco (ivacaftor) and lumacaftor for homozygous F508del cystic fibrosis (CF) patients.
CEO Maurits Geerlings told BioWorld Today that Formula Pharmaceuticals Inc. may have found a way around the drawbacks of chimeric antigen receptor (CAR) methods that deploy autologous T cells, thanks to the worldwide exclusive license the firm has gained to an allogeneic, nonviral CAR platform that leverages instead cytokine-induced killer (CIK) cells as immune effectors.
Briefing documents for Tuesday's meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) showed reviewers are unconvinced about Vertex Pharmaceuticals Inc.'s Orkambi, which consists of the firm's already approved Kalydeco (ivacaftor) and lumacaftor combined for homozygous F508del cystic fibrosis (CF) patients.
Spyryx Biosciences Inc. is "quickly going from virtual to nonvirtual" with $18 million of series A money in hand, CEO John Taylor told BioWorld Today, and aims to move a therapeutic respiratory compound into the clinic as soon as possible.
In rare conditions, "it's very difficult to see an opportunity when there's such a lack of awareness for the disease," CEO David Hallal said, but Alexion Pharmaceutical Inc.'s established expertise lets the firm "evaluate all the medical literature and connect the dots" in order to find a market worth growing.
The Medicines Co. may have prospectively eased the pain of generic competition that looms for flagship product Angiomax (bivalirudin) – and may have helped stanch the money hemorrhage that would result – by winning FDA approval of two drug-device combo therapies: one for patients who need opioid analgesia in the hospital and another to control bleeding.