"We're running as fast as we can to look at other populations," said Cara Therapeutics Inc. CEO Derek Chalmers after the company disclosed positive top-line data from the pivotal phase III trial called Kalm-1 with Korsuva (CR-845/difelikefalin) for injection in hemodialysis (HD) patients with moderate to severe chronic kidney disease (CKD)-associated pruritus (CKD-aP). Read More
DUBLIN – The EMA's Committee for Human Medicinal Products (CHMP) diverged from the FDA in its response to an application from the European arm of Emmaus Medical Inc., for approval of Xyndari, an oral formulation of the amino acid glutamine, for treating sickle cell disease. Read More
Amicus Therapeutics Inc. has upped the ante on its seven-month old collaboration with the University of Pennsylvania to research and develop gene therapies for lysosomal disorders and 12 additional rare diseases, many of them affecting extremely young children. Read More
HONG KONG – Invossa-K, a first-in-class cell and gene therapy that made headlines in 2017 when South Korean regulators cleared its use to treat osteoarthritis of the knee, is now on the verge of being phased out of the domestic market at least for one year and possibly for good, after being hit by a scandal involving its component ingredients. Read More
Three new studies conducted as part of the second phase of the Human Microbiome Project (HMP) could lead to improvements in the risk prediction, identification and classification of the conditions they are investigating. Read More
HONG KONG – China's biotechnology industry and ecosystem is growing and approaching a critical mass in terms of innovation, financing and talent. That was the message Wednesday during the second biotech summit held by the Hong Kong Stock Exchange (HKEX). Read More
Ayala Pharmaceuticals Inc., a company developing small-molecule therapies for genetically defined cancers, has completed a $30 million series B financing. The Rehovot, Israel-based startup said the funds will fuel plans to advance its lead candidate, a Notch inhibitor called AL-101, through a phase II study in adenoid cystic carcinoma (ACC) and into a second midstage study in triple-negative breast cancer (TNBC). Novartis AG, Ayala's partner on a second candidate for the potential treatment of multiple myeloma, AL-102, led the financing with a $10 million equity investment. Other participants included SBI JI Innovation Fund, a partnership between the Japanese-based financial services group SBI Holdings and Vertex Venture Capital, and all Ayala's previous investors. Read More
Lifesprout Inc., of Baltimore, an aesthetics and regenerative medicine company founded out of Johns Hopkins University, said it closed a $6.5 million seed-stage financing to support clinical development and scale-up of the first products from its Regenerative Matrix technology platform. Read More
Redhill Biopharma Ltd., of Tel-Aviv, appointed June S. Almenoff chief scientific officer, Rob Jackson vice president of marketing, Robert J. Gilkin Jr. vice president of market access and Steven Thomasian vice president of supply chain. Read More
Anji Pharmaceuticals Inc., of Cambridge, Mass., said it acquired global development rights for a delayed-release formulation of metformin originally developed by Elcelyx Therapeutics Inc., of San Diego, designed to target delivery to the lower small intestine. Terms of the deal were not disclosed. Anji plans to start a pivotal phase III study in chronic kidney disease later this year. Read More
The World Health Organization released a draft resolution Tuesday calling on member states to improve their transparency of prices for drugs, vaccines, diagnostics, medical devices, and cell- and gene-based therapies. Read More
