A divided Congress will mark the next two years of U.S. government, with the Democrats controlling the House of Representatives and the Republicans likely increasing their hold on the Senate. That could portend increased gridlock on major initiatives and the likelihood that Congress won't do much in the way of making new policy. In other words, the status quo will solidify. For many in the biopharma and med-tech sector, that's good news, as it could improve investor sentiment and lessen concerns about congressional pressure on drug pricing. Read More
The midterm elections are over and the 116th Congress will be sworn in to start the new year, but the changing of the guard in the House of Representatives is likely to ramp up the scrutiny on drugmakers, particularly on the question of pricing. In contrast, the impact of the Democratic Party's takeover of the House of Representatives on the regulation of drugs, devices and diagnostics may prove negligible, suggesting that federal government agencies will sustain the associated deregulatory effort that commenced in January 2017. Read More
Mirum Pharmaceuticals Inc., a San Diego-based startup picking up the unfinished work of Shire plc's 2014 buy, Lumena Pharmaceuticals Inc., has landed a $120 million series A led by New Enterprise Associates (NEA) to advance what it sees as a viable and well-validated therapy for a pair of rare liver diseases. Its team plans to advance the candidate, maralixibat, into phase III trials next year, targeting progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS). Read More
COPENHAGEN – Given the central role of Copenhagen in the industrialization of insulin production almost a century ago and given its ongoing strength in diabetes through the presence of global leader Novo Nordisk A/S, it was fitting that the region's next generation of contenders was invited to pitch its wares at a metabolic disease showcase on the final day of BIO-Europe. Read More
On Wednesday, Revive Therapeutics Ltd., a tiny Toronto-based company that trades on the OTCQB as RVVTF, revealed that it secured FDA orphan drug designation for cannabidiol (CBD) to prevent hepatic ischemia and reperfusion injury resulting from solid organ transplantation. Under license from South Carolina Research Foundation, a unit of the University of South Carolina, Revive also is investigating REV-200, described as a cannabinoid CB1/CB2 receptor modulator, for the potential treatment of liver diseases such as autoimmune hepatitis and nonalcoholic steatohepatitis, or NASH. But the company, which markets a hemp-based CBD chewing gum branded Relicann, is primarily looking to partner the asset for development. A coveted FDA regulatory designation helps to set it apart. Read More
Near the start of this year, Mimedx Group Inc. looked poised to stretch up toward a $2 billion valuation. But it has struggled to right itself all year, since in February it became clear that the regenerative and therapeutic biologics maker was subject to a U.S. Department of Justice (DoJ) investigation of its sales and marketing practices, including undisclosed payments to doctors. Read More
Sitryx Therapeutics Ltd., of Oxford, U.K., is collaborating with CRO Sygnature Discovery Ltd., of Nottingham, U.K., to discover multiple therapeutics in the immuno-oncology and immuno-inflammation spaces. Terms of the deal weren't disclosed. (See BioWorld, Oct. 9, 2018.) Read More
Acadia Pharmaceuticals Inc., of San Diego, reported that net third-quarter sales of Nuplazid, (pimavanserin), to treat hallucinations and delusions associated with Parkinson's disease psychosis, were $58.3 million, an increase of 64 percent, as compared to $35.6 million reported for the three months ended Sept. 30, 2017. Read More
Xoma Corp., of Emeryville, Calif., said it plans an offering to raise approximately $20 million through the distribution of subscription rights to holders of its common stock and series X preferred stock, which will entitle the holders to purchase shares at $13 each. Read More
Five Prime Therapeutics Inc., of South San Francisco, appointed David V. Smith executive vice president and chief financial officer, effective Nov. 26. Read More
