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Home » Newsletters » BioWorld

BioWorld

Aug. 6, 2018

View Archived Issues

Regulatory actions for Aug. 3, 2018

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Clinical data for Aug. 3, 2018

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Earnings

Tesaro Inc., of Waltham, Mass., reported $53.9 million in second-quarter sales of its PARP inhibitor, Zejula (niraparib), and $2.6 million in sales of Varubi/Varuby (rolapitant) for chemotherapy-induced nausea and vomiting. The company reported a net loss of $166.7 million, or $3.04 per share, and ended the quarter with $575.1 million in cash and cash equivalents. Shares of Tesaro (NASDAQ:TSRO) fell $8.31, or 23.6 percent, to close Friday at $26.97. Read More

Financings

Impact Therapeutics Inc., of Nanjing, China, said it completed $30 million in series C financing led by Decheng Capital, with participation from existing investor Lilly Asia Ventures. Read More

Other news to note

PDL Biopharma Inc., of Incline Village, Nev., said it has amended a royalty purchase and sale agreement with Newark, Calif.-based Depomed Inc. As a result, it has acquired all of Depomed's remaining rights to royalties and milestones payable on sales of type 2 diabetes products licensed by the firm for up to $20 million. Read More

Nanomedicine gains traction as therapies begin testing

The high expectations that have been swirling around the nanomedicine field for almost a decade are still yet to be fully realized. However, there are promising signs that significant investments in early stage research over the past few years are starting to reap dividends with new generation therapeutic applications moving into clinical testing. Read More

Medicinal chemistry goes digital, at long last

Medicinal chemistry is lagging behind in the digital world, but now scientists at Glasgow University, U.K., have reported the development of an automatic synthesis robot that can apply machine learning to search for new reactivity in real time. Read More

NTAPs on tap as La Jolla, others hearing from CMS; reimbursement help near

After the Centers for Medicare & Medicaid Services (CMS) brought up reimbursement concerns about Giapreza (angiotensin II), La Jolla Pharmaceutical Co.'s intravenous therapy to increase blood pressure in adults with septic or other distributive shock, investors had cause to worry that the compound wouldn't qualify for a new technology add-on payment (NTAP) under the inpatient prospective payment system (IPPS). Read More

Life sciences companies face uncertainty over new California privacy law

California's new Consumer Privacy Act, the toughest data privacy law in the nation, will impose stringent new requirements on the state's high-profile tech companies in 2020. Its impacts on the life sciences industry, though, remain unclear. Read More

ALIS in Adcomland: FDA review looks balanced, barring sputum culture quibbles

It's been a long trip down the rabbit hole for Insmed Inc. to move ALIS (amikacin liposome inhalation suspension) before an FDA advisory committee. Briefing documents for Tuesday's meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) suggest the drug, formerly known as Arikayce and Arikace, may receive a balanced review for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults as part of a combination antibacterial approach. Read More

Bench Press: BioWorld looks at translational medicine

Stanford University scientists have shown that homeostatic plasticity was disrupted in fragile X syndrome (FXS) through effects on retinoic acid (RA) signaling. The fragile X mental retardation 1 (FMR1) gene that is mutated in FXS codes for an RNA binding protein with multiple interaction partners. Read More

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