Australia's Therapeutic Goods Administration (TGA) is proposing to adopt more than 20 EU guidelines related to the development, manufacturing and monitoring of drugs and vaccines. Read More

Incyte Corp., of Wilmington, Del., reported a 38 percent year-on-year growth in product-related revenue, in its 2017 third-quarter financial results. Read More

Kogenix Therapeutics Inc., of Boston, said in a paper published in Nature's Molecular Psychiatry from Universitat Autonoma de Barcelona and the Vall d'Hebron Research Institute, it showed for the first time cognitive improvements in old animals that were treated at younger age with secreted alpha Klotho gene therapy. Read More

Incyte Corp., of Wilmington, Del., expanded its 2014 clinical trial collaboration agreement with Cambridge, U.K.-based Astrazeneca plc's Medimmune unit. Read More

Soligenix Inc., of Princeton, N.J., said it entered definitive agreements with investors for the purchase and sale of 1.57 million shares of common stock at $2 each in a registered direct offering and 982,000 shares of common stock at a purchase price of $2 per share in a concurrent private placement. Read More

DUBLIN – Continuing its strong funding run of late, Europe's biopharmaceutical sector closed out October with another clutch of new share issues, from both listed firms and those aiming to join their ranks. Read More

All therapies targeting CD123 are not created equally, Stemline Therapeutics Inc. CEO Ivan Bergstein told BioWorld after the company reported top-line data confirming that the phase II pivotal trial of SL-401 hit its primary endpoint for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). Although other modalities, from CAR Ts to bispecifics, are directed to the interleukin-3 receptor, "you can't necessarily predict the safety and efficacy of a drug just because it hits the same target as another drug," Bergstein said. Read More

After more than three decades of joint adventure for Japan's Kirin Holdings Co. Ltd. (KHK) and Thousand Oaks, Calif.-based Amgen Inc., the partners are winding down a JV with a $780 million payout to redeem the Asian conglomerate's shares in the business, Kirin-Amgen Inc. The business will now become a wholly owned subsidiary of Amgen. KHK said that it will continue to develop, manufacture and sell pharmaceuticals licensed by Kirin-Amgen. Read More

Voyager Therapeutics Inc. CEO Steven Paul said his firm is "pleased to retain – and gain, if you will – worldwide rights to this [Parkinson's disease (PD)] program" from Sanofi SA. "We believe it's a winner." Read More

LONDON – Biogeneration Ventures announced the final close of its third early stage fund, far exceeding the initial target of €50 million (US$58.2 million) and going past the revised target of €75 million set in June, to raise €82 million. Read More

Months ahead of its priority review PDUFA date, Calquence (acalabrutinib) got the FDA's green light Tuesday as a second-line therapy for adults with mantle cell lymphoma. Read More