Calling for an end to the "mindless austerity of sequestration," the White House submitted a nearly $4 trillion budget to Congress Monday, exceeding the spending caps mandated by the 2011 Budget Control Act by 7 percent. Among the spending increases are several health-related initiatives, a 9 percent increase in FDA funding and a 3 percent bump for the National Institutes of Health (NIH). Read More
A pair of papers in the February 2015 issue of Health Affairs shone a harsh spotlight on seemingly disparate, but ultimately related topics: falling revenues from approved drugs and the challenges facing uptake of biosimilars. Read More
Chimerix Inc.'s decision Friday to cancel trials of its antiviral brincidofovir to protect against Ebola in the face of declining numbers of new infections, and thus dwindling numbers of test subjects, brought into sharp relief the hard choices small companies need to make when choosing to develop experimental treatments for neglected tropical diseases. Read More
For treating alcohol dependence and its consequences, an ounce of prevention and a pound of cure might be achieved by targeting the same protein: regulator of G protein 6 (RGS6). Read More
Wave Life Sciences, which began operations in 2013 following the combination of two small biotechs – one in Boston, one in Okinawa, Japan – emerged from stealth this week with an $18 million series A round and plans to lead "a revolution" in the field of nucleic acid therapeutics. Read More
Oxford, UK-based Summit Corp. plc has filed an F-1 with the SEC, seeking to raise $40 million in an initial public offering (IPO). The company said it plans to use the capital raised to help drive its clinical programs focused on Duchenne muscular dystrophy (DMD) and Clostridium difficile infection (CDI). Read More
LONDON – A report from the UK's leading medical ethics body recommends the introduction of criminal penalties, including imprisonment, for the misuse of health data and said those who collect data should have a duty to track how it is used and tell data subjects of any breaches of security. Read More
Tenapanor, the NHE3 sodium transporter inhibitor that yielded positive phase IIb data last fall in constipation-predominant irritable bowel syndrome (IBS-C) for Ardelyx Inc. and partner Astrazeneca plc, hit its efficacy endpoint in a second indication, but disappointed investors with "distinctly" higher-than-expected instances of diarrhea. Read More
Instead of waiting for large drugmakers and other U.S.-based multinationals to bring their foreign profits home, the White House wants to tax those profits now – to help fund transportation projects. Read More
Orbimed, of New York, said it has closed its second health care royalty and credit opportunities fund, Orbimed Royalty Opportunities II LP, with $924 million in commitments, including $24 million from the general partner. Read More
Biospecifics Technologies Corp., of Lynbrook, N.Y., said Swedish Orphan Biovitrum AB (Sobi), of Stockholm, received approval from the EC to market Xiapex (collagenase clostridium histolyticum or CCH) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Read More
Merck KGaA, of Darmstadt, Germany, reported the repatriation of all responsibility for its diabetes and thyroid brands in Russia back to the company. Read More
Kamada Ltd., of Ness Ziona, Israel, reported additional data from its ongoing extension study of the open-label phase I/II trial with its intravenous alpha1-proteinase inhibitor–human in children recently diagnosed with type 1 diabetes (T1D). Read More
Fennec Pharmaceuticals Inc., of Research Triangle Park, N.C., said the independent data monitoring committee (IDMC) overseeing the SIOPEL 6 phase III trial recommended that the study be continued as planned. Read More
