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Home » Newsletters » BioWorld

BioWorld

Nov. 9, 2016

View Archived Issues

Acadia impresses with script, revenue numbers for PDP drug Nuplazid

The dollars were small but the trend was mighty. Such was the consensus of analysts on the first full quarter results for Acadia Pharmaceuticals Inc. following the launch of Nuplazid (pimavanserin) on May 31 to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Read More

Curevac tops up with $29.5M financing as prostate cancer trial readout nears

Messenger RNA (mRNA) drug developer Curevac AG added $29.5 million in new funds to its coffers from German investors looking to support the Tübingen-based home team in a hot field defined by sizable early investments. Read More

Building great biopharma partnerships from A to D

COLOGNE, Germany – Alignment and differentiation emerged as the two key requirements for successful partnerships during a panel discussion on the transformational deals that shaped the biopharma industry during 2016, here at BIO-Europe on Tuesday. Read More

Bacterial metabolite shows activity in breast cancer

HONG KONG – The bacterial metabolite prodigiosin and its analogue, obatoclax, have been shown to have therapeutic activity in advanced breast cancer, providing the rationale for clinical trials, Chinese researchers reported in the Oct. 31, 2016, online edition of Proceedings of the National Academy of Sciences. Read More

Regulatory front

The FDA finalized a 2010 guidance on using noninferiority trials to establish the effectiveness of new drugs and biologics. Published in Tuesday's Federal Register, the guidance advises on when noninferiority studies can provide interpretable results, how to choose the noninferiority margin and how to test the hypothesis. Read More

Appointments and advancements

Ardelyx Inc., of Fremont, Calif., appointed Reginald Seeto chief operating officer. Read More

Other news to note

Santhera Pharmaceuticals AG, of Liestal, Switzerland, said the Swiss Agency for Therapeutic Products accepted for review the firm's marketing authorization application for Raxone (idebenone) for the treatment of Duchenne muscular dystrophy in patients with respiratory function decline not taking concomitant glucocorticoids. Read More

In the clinic

Imago Biosciences Inc., of San Carlos, Calif., said the first patients were dosed in a phase I/II trial of IMG-7289 for the treatment of high-risk acute myeloid leukemia and high-risk myelodysplastic syndrome. Read More

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