Biodel Inc. officials, during a conference call with investors, sounded rightly happy about the top-line Phase II win with BIOD-123, an ultra-rapid-acting mealtime insulin for Type I diabetes, which proved non-inferior to Eli Lilly and Co.’s Humalog – but injection-site pain data between the two compound failed to match, and Wall Street moved the shares’ needle down instead of up.
Paxvax Inc.’s just-begun Phase III effort with PXVX0200 could lead to the first cholera vaccine approved for marketing in the U.S., and the company could become the first to gauge the resale value of the FDA’s priority review voucher (PRV), an incentive put in place six years ago to boost work against neglected tropical diseases.
Not surprisingly, Rigel Pharmaceuticals Inc. has decided not to pursue the oral spleen tyrosine kinase (Syk) inhibitor fostamatinib in rheumatoid arthritis (RA) after Astrazeneca plc, unhappy with trial data, returned the rights to the compound last month.
Otonomy Inc.’s $45.9 million Series C round should last the firm into the second half of 2014, when one of its ear disease drugs is expected to be ready for a new drug application filing, another will have finished the first of a pair of pivotal trials and a third will be eligible for an investigational new drug application.
Cytokinetics Inc. and licensor Amgen Inc. will wait until a Phase II study in chronic heart failure with orally given omecamtiv mecarbil generates data to decide the fate of the compound, which fizzled in a Phase II trial testing the intravenous (I.V.) form of the cardiac myosin activator against acute heart failure (AHF).
Start-up Epirus Biopharmaceuticals Inc.’s in-market, for-market approach to making and selling biosimilars in emerging territories could be just the “David” ticket to beat pharma Goliaths that dominate the realm, said Amit Munshi, president and CEO of the Boston-based firm.
Pharmacyclics Inc. gained a $75 million milestone payment from Johnson & Johnson (J&J) unit Janssen Biotech Inc. for progress with the oral Bruton’s tyrosine kinase inhibitor ibrutinib, and the future looks even brighter for the compound, if the FDA grants approval.
Rexahn Pharmaceuticals Inc. is going ahead with development of RX-3117 after Teva Pharmaceutical Industries Ltd. declined its option to continue with the cancer therapy, which proved orally bioavailable with no adverse events in a small, European Phase I trial.
Astrazeneca plc’s buyout of Amplimmune Inc. for $225 million up front could put the pipeline-strapped pharma giant high on the short list of leaders in combination immunotherapy, if the latter’s early stage candidates pan out, and the deal carries another $275 million in potential milestone payments.
Argos Therapeutics Inc.’s Series E financing – which has raised $42.5 million so far, including $30 million from the venture arm of a Russian pharma firm – is staying open and could turn into enough for the company to finish its pivotal Phase III trial with AGS-003, a personalized immunotherapy for metastatic kidney cancer.
