Puma Biotechnology Inc., of Los Angeles, reported interim results from the phase II CONTROL trial testing the effects of adding budesonide or colestipol to loperamide prophylaxis to control diarrhea caused by Nerlynx (neratinib) in patients with HER2-positive early stage breast cancer who had completed trastuzumab-based adjuvant therapy. Read More

Xoma Corp., of Emeryville, Calif., said it licensed the global development and commercialization rights for XOMA-358, a fully human antibody that inhibits the effects of elevated insulin (hyperinsulinemia) via allosteric modulation of the insulin receptor, to Rezolute Inc. (formerly Antriabio Inc.), of Louisville, Colo., and in return Xoma will be entitled to receive up to approximately $240 million. Read More

Metacrine Inc., of San Diego, said it closed a $22 million series B financing led by new investor New Enterprise Associates (NEA), along with participation from existing investors Arch, Polaris, Venbio and Alexandria Venture Investments. Proceeds will be used to advance MET-409, an oral nonbile acid FXR agonist, into late-stage IND-enabling studies, with first-in-human studies planned to start in the first half of 2018. Read More

The FDA moved its digital health efforts along via the release of one final and two draft guidances, including a final guidance for software as a medical device, but one longtime observer of the digital health scene characterized the draft guidance for clinical decision support systems as "extremely troublesome." Read More

Vedanta Biosciences Inc. has begun a phase Ia/Ib trial of VE-303, its oral immune-modulating bacterial consortia therapy. Study of the medicine, derived from the human microbiome, is expected to finish up in the first half of 2018. If all goes well, the company plans to initiate a phase II trial in 2018 for the treatment of recurrent Clostridium difficile infection (rCDI). Read More

Chemotherapeutic developer Odonate Therapeutics Inc. extended the 2017 biopharma IPO window, offering 6.25 million common shares at $24 apiece to raise $150 million. Although shares priced at the low end of the company's proposed range, Odonate bumped up the size of the offering, originally set at 5.88 million shares. Trading as ODT on Nasdaq, shares of the San Diego-based company closed Thursday at $23. Read More

DUBLIN – Allergy specialist Alk-Abelló A/S grossed DKK698.9 million (US$111 million) in an accelerated bookbuilding process to fund its new strategy. The Hørsholm, Denmark-based firm priced the discounted offering of 92,076 AA shares and 920,760 B shares at DKK690 per share on Thursday. The new shares, which represent just over 9 percent of its post-money share capital, will be admitted for listing on Nasdaq Copenhagen next Wednesday. Read More

SAN ANTONIO – Since overexpression of the HER2/Erbb2 receptor was first described as a feature of some breast cancer in 1987, the overexpression has been turned from a negative to a positive predictive factor by the efforts of first academic researchers and then the biopharmaceutical industry. Read More

"There was always a question of whether or not there was something special about brexanolone," Sage Therapeutics Inc.'s chief medical officer (CMO), Steve Kanes, told BioWorld, referring to the phase III win in post-partum depression (PPD) last month. "It doesn't seem to be the case." Read More

Dicerna Pharmaceuticals Inc., of Cambridge, Mass., announced the dosing of the first subject in DCR-PHXC-101, a phase I trial of DCR-PHXC, the company's most advanced GalXC product candidate. Read More