Due to website maintenance this weekend, there could be periodic outages starting Friday evening through Sunday. We apologize for any inconvenience. Read More
Crown Biosciences Inc., of San Diego, published preclinical data in the Journal of the National Cancer Institute in conjunction with Carsgen Therapeutics Ltd., of Shanghai, and the Shanghai Cancer Institute showing CLDN18.2 targeting CAR T cells can eliminate gastric tumors in a PDX mouse model. Read More
Galapagos NV, of Mechelen, Belgium, said it priced its U.S. public offering totaling $300 million gross proceeds from the sale of 2.575 million new ordinary shares in the form of American depositary shares (ADSs) at $116.50 each. In addition, the company has granted the underwriters an option to purchase up to an additional 386,266 ADSs. Read More
The FDA released a batch of 54 draft product-specific guidances Thursday to help sponsors identify appropriate science-based methodologies and evidence for developing generic drugs. Read More
PERTH, Australia – Cellmid Ltd.'s lead anti-midkine antibody, CAB-102, reduced kidney injury and preserved renal function in a preclinical model of focal segmental glomerulosclerosis (FSGS), according to studies performed at the Westmead Institute in New South Wales. Read More
Members of the U.S. Senate and House of Representatives met Thursday to hash out a budget bill for a number of agencies, including the NIH, but an amendment dealing with drug prices in direct-to-consumer (DTC) ads failed to draw enough support to be reinserted into the appropriations bill. The matter is ended for now, but the concept enjoys bipartisan support on Capitol Hill and the support of the Trump administration, which has opened a docket number for drug price transparency. Read More
"We've finally pushed open a door to an entirely new pathway of potential approaches to treat cancer," Walter Klemp, chair and CEO of Moleculin Biotech Inc., said about the initiation of an investigator-led phase I study of STAT3 inhibitor WP-1066 in glioblastoma at MD Anderson Cancer Center. "People have been pounding on this door for a long time, and it was painful getting here, but now it's opened." Read More
Vowing it's only the first step in tackling skyrocketing drug prices in the U.S., the House Energy and Commerce Committee unanimously voted Thursday to favorably report to the House floor a bill banning gag clauses that prevent pharmacists from discussing cheaper payment options with insured customers. Read More
A positive phase II readout for Bristol-Myers Squibb Co.'s lead oral tyrosine kinase 2 (Tyk2) inhibitor in plaque psoriasis has shone a new light on signaling pathways explored by few drugmakers to date. Despite the pathway's implication in multiple immune-mediated diseases, the phase III program BMS is actively enrolling for patients with moderate to severe plaque psoriasis puts it at the head of a cohort that includes just two other clinical-stage drugs of the class – both Pfizer Inc.'s – and only four discovery-stage assets, according to Cortellis. Read More
Cambridge, U.K.-based Astrazeneca plc and its Medimmune unit will introduce the first new drug for hairy cell leukemia (HCL) in more than two decades, with the FDA's approval Thursday for Lumoxiti (moxetumomab pasudotox-tdfk). The CD22-targeted cytotoxin is indicated for adults with relapsed or refractory disease who have received at least two prior systemic therapies, including a purine nucleoside analogue. Read More
Days after a court decision torpedoed four patents protecting Acorda Therapeutics Inc.'s Ampyra (dalfampridine) – clearing the way for generic versions of the only drug approved in the U.S. for improving walking in people with multiple sclerosis – the company learned that the FDA has extended the PDUFA date for its NDA related to Inbrija (levodopa inhalation powder) to treat off-period symptoms in people with Parkinson's disease (PD) on a carbidopa/levodopa regimen. Read More
DUBLIN – Another big gun has entered the oncolytic virus fray. Prompted by positive progress in its collaboration with Viratherapeutics GmbH, Boehringer Ingelheim GmbH has exercised an option to buy the company outright in a deal worth €210 million (US$245 million) in total. Read More
