Even as Tesaro Inc. prepares to launch newly approved Zejula (niraparib) late next month in ovarian cancer, the Waltham, Mass.-based company already is setting sights on an expanded clinical development program for the PARP inhibitor, which is not restricted to patients with BRCA mutations. Read More

Arqule Inc., of Burlington, Mass., said partner Kyowa Hakko Kirin Co. Ltd., of Tokyo, reported top-line results for the JET-HCC phase III trial of tivantinib, a small-molecule c-Met receptor tyrosine kinase inhibitor, in Japan, which did not meet its primary endpoint of progression-free survival. Read More

Pfizer Inc., of New York, said the European Commission approved JAK inhibitor Xeljanz tofacitinib citrate) 5 mg twice daily oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Read More

Less than two years after Merrimack Pharmaceuticals Inc. won approval of Onivyde (irinotecan liposome injection) for second-line pancreatic cancer, pundits are weighing Paris-based Erytech Pharma SA's odds with eryaspase (Graspa), which has landed solid phase IIb results in the same indication: a 43 percent reduction in death risk. Read More

Primed with early stage research supporting the bone-building activity of its small-molecule alternative to existing therapies, Los Angeles-based Max Biopharma Inc. is on the hunt for a $12 million series A financing to help it move closer to filing FDA investigational device exemption (IDE) and new drug (IND) applications as it advances localized and systemic bone formation programs. Read More

Positive data from dual phase III studies of oral sarecycline in moderate to severe acne poised originator Paratek Pharmaceuticals Inc. to earn a $5 million milestone payment from partner Allergan plc upon submission of a new drug application, slated to arrive before year-end. Read More

DUBLIN – The lag between the initiation of new research and the approval of targeted or biologic drugs for treating cancer can exceed 40 years, according to a newly published analysis that examines the relationship between the maturation of technologies and their potential to generate successful products. Read More

The U.S. Court of Appeals for the Third Circuit last week reversed a lower court, re-opening multidistrict litigation alleging Merck & Co. Inc., of Kenilworth, N.J., failed to add an adequate warning of the risk of thigh fractures to the labeling for its osteoporosis drug Fosamax (alendronate). Read More

Briacell Therapeutics Corp., of Berkeley, Calif., said it completed its nonbrokered private placement financing of 5.6 million units for aggregate gross proceeds of about C$2.3 million with its president and CEO, William Williams. Read More