Lawmakers caught between the threat of rising drug costs and fears that a proposed nationwide Centers for Medicare & Medicaid Services (CMS) Part B drug reimbursement pilot would be bad for patients held to their individual calls for CMS to either scrap or modify the program during a Tuesday hearing of the House Energy and Commerce Health Subcommittee, suggesting little potential for the experiment to find much support there.
Heeding growing interest in the sway of tiny microorganisms over human health, climate change and other critical issues, a new National Microbiome Initiative launched by the White House kicked off Friday with a commitment of $121 million in federal dollars and more than $400 million in financial and in-kind contributions from private stakeholders to support interdisciplinary research, platform technology development and new applications in the young field.
Prima Biomed Ltd.'s quest to divest its one-time lead program, Cvac, has ended with the cell therapy's adoption by biotech entrepreneur Joseph Hernandez, who will carry it ahead under the banner of Sydys Corp., a repurposed public company that will seek to fund new trials to build on earlier data in ovarian cancer. The deal includes more than A$400 million (US$293 million) in potential development, regulatory and commercial milestone payments, but no up-front cash.
A day after settling with two of seven drugmakers seeking to advance generic challenges to its top-selling product, Xyrem, Jazz Pharmaceuticals plc moved to acquire Alizé Pharma II, the developer of a pegylated recombinant L-asparaginase program that could bolster Jazz's second largest commercial program, Erwinaze.
In a coup for Chemocentryx Inc., Switzerland's Vifor Pharma Ltd. has agreed to pay $85 million in cash and equity to license commercial rights to CCX168, the company's complement 5a receptor inhibitor for orphan and rare renal diseases. The deal, which covers multiple ex-U.S. markets, is part of a transformational year, Chemocentryx CEO and President Tom Schall told BioWorld Today.
Aptinyx Inc., an Evanston, Ill.-based spinout of Allergan plc-acquired Naurex Inc., has completed a $65 million series A financing that will carry the company's lead candidate through initial clinical proof of concept in a yet-to-be chosen CNS indication, while also funding discovery in its specialty, small-molecule modulators of the N-methyl-D-aspartate (NMDA) receptor.
Anticipating an FDA complete response letter (CRL) for rociletinib, Clovis Oncology Inc. quit enrolling ongoing studies of the drug, withdrew its European marketing authorization application (MAA) filing and expects to trim its headcount by 35 percent from its 2015 level by year-end. In wake of the reckoning, Clovis is turning its full attention to potential approval and commercialization of its PARP 1-3 inhibitor, rucaparib.
Wave Life Sciences Ltd. has landed a $40 million up-front payment from Pfizer Inc. in a collaborative deal to develop genetically targeted therapies for metabolic diseases.
Just a few years after the 1996 approval of the first treatment for pulmonary hypertension, Glaxosmithkline plc's epoprostenol, a two-line advertisement in The Chronicle of Philanthropy drew nonprofit consultant Rino Aldrighetti's attention: "Small rare disease association looking for part-time executive director."
Briefing documents prepared for FDA advisors considering potential approval of Kempharm Inc.'s abuse-deterrent prodrug of hydrocodone, Apadaz (KP-201/acetaminophen), on Thursday appeared supportive of the 505(b)(2) filing, while simultaneously acknowledging the complexity of making recommendations on the drug's label in light of the critical public health issues on the road to safer opioid analgesics.
