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.
Astrazeneca plc’s buyout of Amplimmune Inc. for $225 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.
In a wagon-circling move typical after Phase III setbacks such as befell Vical Inc.'s compound for metastatic melanoma earlier this month, the company said it will cut its work force by about 39 percent, or 47 employees, leaving 74 still aboard, as the Allovectin project is abandoned and efforts turn to infectious-disease vaccine programs.
Regado Biosciences Inc.'s initial public offering (IPO) may not have made quite the splash that others have made in recent months, but the sale of about 10.7 million shares at $4 each provided $43 million that will help the firm's REG1, on the runway for Phase III trials, move ahead in percutaneous coronary intervention for acute coronary syndrome.
Biomarin Pharmaceutical Inc. has made clearer its Phase III plans for the Pompe disease drug candidate BMN-701, a fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (GAA), but the study has not yet begun to enroll patients and talks are still under way about an endpoint that could help better distinguish the compound from Sanofi SA's competitor Lumizyme.