Less than three years after inking a potential $500 million cell therapy partnership with SQZ Biotechnologies Co., Roche Holding Co. is going back for seconds in an expanded deal that could more than triple the economics. SQZ is set to receive $125 million in up-front and near-term milestones and could earn up to $250 million in clinical, regulatory and sales milestones for each product that emerges from the expanded collaboration. In addition, the Watertown, Mass.-based company may receive development milestone payments exceeding $1 billion. Moreover, the five-year-old biotech could share commercial rights with Roche, of Basel, Switzerland, for certain approved products. Read More
A preemptive strike by the Pharmaceutical Research and Manufacturers of America (PhRMA) didn't come soon enough to forestall a proposed rule requiring drug companies to include list prices in their direct-to-consumer (DTC) TV ads. Read More
Krystal Biotech Inc. is moving ahead with plans to start a pivotal phase III test of its off-the-shelf topical gene therapy for dystrophic epidermolysis bullosa (DEB) in the second half of 2019 after interim data from two patients in its ongoing phase I/II test met all primary efficacy endpoints. Pivotal testing of the candidate, KB-103, is expected to last about six months, with a potential six-month FDA review to follow. Company shares (NASDAQ:KRYS) climbed 27.6 percent on the news to close at $20. Read More
Matinas Biopharma Holdings Inc. CEO Jerome Jabbour told BioWorld that, with the company's omega-3 fatty acid-based MAT-9001 for high triglycerides, "we've come full circle," thanks to cardiovascular (CV) outcomes data disclosed last month by Amarin Corp. plc with omega-3 drug Vascepa (icosapent ethyl). "Now we find ourselves sitting on a potential best-in-class asset," which beat Dublin-based Amarin's compound in a head-to-head trial several years ago. Read More
Sarepta Therapeutics Inc.'s potential licensing deal with Paris-based Lysogene SA drew more attention to the already hot space of gene therapy for lysosomal storage disorders (LSDs), the news coming just a week after Amicus Therapeutics Inc. – eager to guard its franchises in Pompe and Fabry disease – signed a pact with Perelman School of Medicine at the University of Pennsylvania (Penn) to pursue gene therapy treatments for those two conditions as well as CDKL5 deficiency and an additional rare metabolic disorder that was not disclosed. Read More
SHANGHAI – Alphamab Oncology Co. Ltd., of Suzhou, China, has kicked off a phase I study in Australia for KN-046, a PD-L1/CTLA-4, a potentially first-in-class bispecific that combines two domain antibodies fused with IgG Fc. Read More
First, it was valsartan from Zhejiang Huahai Pharmaceuticals Co., of Linhai, China. Then it was losartan made by Hetero Labs Ltd., of Hyderabad, India. And now, low levels of N-nitrosodiethylamine (NDEA), a potential carcinogen, have been found in a third sartan, irbesartan, made by Aurobindo Pharma Ltd., also of Hyderabad. As a result, the European Directorate for the Quality of Medicines & Healthcare has suspended the use of Aurobindo's irbesartan API in EU drugs, and national authorities in the EU are considering whether to recall medicines containing the API that are already on the market. Read More
Hifibio Therapeutics Inc., of Cambridge, Mass., acquired H-Immune Therapeutics SAS, of Paris, France, gaining access to H-Immune's in vitro immunization-based fully human antibody generation platform. Terms of the deal weren't disclosed. Read More
Synthetic Biologics Inc., of Rockville, Md., said it closed its public offering for gross proceeds of about $18.6 million. Funds will be used for preclinical and clinical programs and for working capital and general corporate purposes, including to acquire, license or invest in complementary businesses, technologies, product candidates or other intellectual property. Read More
