Achillion Pharmaceuticals Inc.'s chief commercial officer, Joseph Truitt, said the firm "will certainly assess all the options for the hepatitis C virus [HCV] portfolio" after the ending of the deal by Johnson & Johnson (J&J) unit Janssen Pharmaceuticals Inc., but had no further guidance. Read More
Eli Lilly and Co., of Indianapolis, reported results from the phase III SPARTAN study at the Congress of the International Headache Society in Vancouver, British Columbia, showing that lasmiditan, an oral molecule for the acute treatment of migraine, demonstrated statistically significant improvements vs. placebo. Read More
Amgen Inc., of Thousand Oaks, Calif., and Dublin-based Allergan plc, reported data from a phase III trial testing ABP-980, a Herceptin (trastuzumab, Roche Holding AG) biosimilar compared to the originator product in patients with human epidermal growth factor receptor 2-positive early breast cancer. Read More
Innovation Pharmaceuticals Inc., of Beverly, Mass., said it entered a new $30 million common stock purchase agreement with Aspire Capital Fund LLC, under which Aspire has committed to purchase over the next three years up to an additional $30 million of the company's common stock based on the prevailing market prices at the time of each sale. Read More
Shire plc reported that SHP-616, a ready-to-use subcutaneous formulation of its C1 esterase inhibitor, Cinryze, significantly reduced hereditary angioedema (HAE) attacks vs. placebo in a phase III study that laid the groundwork for the company to seek regulatory approvals of the candidate. Read More
DUBLIN – Advicenne SA plans to seek European approval in the second half of next year for ADV-7103 for treating distal renal tubular acidosis on the back of data from an open-label phase III trial, in which the drug attained its primary endpoint, demonstrating its noninferiority vs. the standard of care. Read More
MADRID, Spain – Enthusiasm among oncologists Monday following positive results from two phase III late-stage melanoma trials – one for an immunotherapy, the other for a combination targeted therapy – suggested Opdivo (nivolumab) and Tafinlar (dabrafenib) may soon replace interferon in Europe and Yervoy (ipilimumab) in the U.S. at the adjuvant setting. Read More
MADRID, Spain – An 11-month progression-free survival (PFS) benefit seen in the PACIFIC trial with Astrazeneca plc's PD-L1 inhibitor, Imfinzi (durvalumab), offers a new potential option for late-stage non-small-cell lung cancer (NSCLC) patients. Read More
MADRID, Spain – Two phase III trials accepted as late-breaking abstracts for the European Society for Medical Oncology (ESMO) 2017 Congress showed abemaciclib reduced the risk of disease progression by 46 percent in advanced breast cancer and Cyramza (ramucirumab) improved progression-free survival (PFS) when added to docetaxel in advanced or metastatic urothelial cancer. Read More
PERTH, Australia – The process to get innovative new drugs listed on Australia's Pharmaceutical Benefits Scheme (PBS) can be a long and arduous process, and pharma companies waiting to get innovative drugs listed will continue to face mounting pressure and lengthy price negotiations. Read More
To protect its patents on dry-eye drug Restasis (cyclosporine), Dublin-based Allergan plc transferred six Restasis patents to the Saint Regis Mohawk Tribe and then exclusively licensed them from the tribe. Read More
Xoma Corp., of Berkeley, Calif. earned a $3 million milestone payment related to the clinical advancement of an anti-botulism product candidate the company licensed to Nanotherapeutics Inc., of Alachua, Fla., in 2015. Read More
