The right hand not knowing what the left hand’s doing. Robbing Peter to pay Paul. Talking out of both sides of the mouth. . . . They’re all clichés that aptly describe how the U.S. Congress too often works. Especially when Congress insists on knee-jerk reactions to plaster complex problems with superficial solutions instead of conducting thorough investigations into the root of a problem, followed by a well-reasoned corrective and preventive action plan (CAPA). If Congress were a biopharma company, the FDA would have hit it repeatedly with warning letters for its inadequate responses, lack of CAPAs, failure to build...
Perhaps borrowing from the playbook that Biogen Inc. used to beget the hemophilia and rare blood disease spin-off Bioverativ Inc., Shire plc alerted investors during its second-quarter earnings review that it's considering the same strategy, but in reverse. The Dublin-based company said a formal evaluation of strategic options for its neuroscience franchise is underway – a process Flemming Ornskov, the company's CEO, called "a natural evolution of our strategy post the Baxalta integration."
Spark Therapeutics Inc., of Philadelphia, launched a public offering to raise $300 million. The firm intends to grant underwriters the option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering.
The U.S. Patient-Centered Outcomes Research Institute reported this week that it has awarded more than $3 million for 83 new projects through its Pipeline to Proposal Awards program.
An Australian study reported in the Aug. 2, 2017, edition of Science Translational Medicine has identified a promising new potential target in preclinical models of triple-negative breast cancer (TNBC) and human epidermal growth factor receptor 2 (HER2)-amplified breast cancer (BC).
The FDA Reauthorization Act (FDARA) of 2017 sailed through a final Senate vote of 94-1 despite a drawn-out cloture vote, but several amendments were added to H.R. 2430 by unanimous consent, including a right-to-try bill and a bill that would require the Department of Health and Human Services to develop a standard for "prominently displaying" information related to a patient's opioid addiction history in electronic health records.
Pacira Pharmaceuticals Inc. CEO David Stack said he didn't see "anything that causes us any great concern" in terms of a competitor for Exparel, the liposomal bupivacaine that sold $70 million in the second quarter, although not all analysts agree.
Jazz Pharmaceuticals plc is seeing the first concrete dividend of its $1.5 billion buyout of Celator Pharmaceuticals Inc. with FDA approval for Vyxeos (daunorubicin and cytarabine) for the treatment of adults with two types of high-risk acute myeloid leukemia (AML). It's the second new AML therapy approved this week, following Tuesday's approval of Idhifa (enasidenib) for certain adults with relapsed or refractory AML.
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