Less than a week after starting the phase I trial with its lead NLRP3 antagonist, IFM-2427, Boston-based IFM Therapeutics LLC chalked up a contract potentially worth more than $1.5 billion for anti-inflammatory therapies with Novartis AG, which brings aboard the whole portfolio in the class via the buyout of subsidiary IFM Tre. Read More
The FDA ended last week and started this one with drug approvals, clearing Darmstadt, Germany-based Merck KGaA's Mavenclad (cladribine) tablets for relapsing multiple sclerosis (MS) in adults – with a label that includes relapsing-remitting disease as well as active secondary progressive MS (SPMS) – and followed with marketing clearance for Duaklir, a fixed-dose inhaled combination from Circassia Pharmaceuticals Inc., of Oxford, U.K., that pairs long-acting muscarinic antagonist (LAMA) aclidinium bromide with long-acting beta agonist (LABA) formoterol fumarate for chronic obstructive pulmonary disease (COPD) maintenance. Read More
LONDON – Cambridge Innovation Capital has raised £150 million (US$196.6 million) to grow its existing portfolio and invest in new Cambridge University spin-outs and companies in the city. Read More
Springworks Therapeutics Inc. has closed a $125 million series B preferred stock financing, energizing its two late-stage rare disease oncology programs, nirogacestat (PF-03084014), a gamma-secretase inhibitor for treating desmoid tumors, and PD-0325901, an MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas. Read More
ATLANTA – CAR T cells are currently capable of making a giant difference, but only to tiny numbers of patients. But at the annual meeting of the American Association for Cancer Research, both phase I trial and novel preclinical approaches were on view that could bring the approach to more indications with larger numbers of patients. Read More
Puma Biotechnology Inc. shares (NASDAQ:PBYI) fell 8.1 percent to $35.64 on Monday after a European licensing deal for its breast cancer drug, Nerlynx (neratinib), led to what analysts interpreted as disappointment among investors anticipating a sale of the company or asset instead. Licensor Pierre Fabre will pay Puma $60 million up front and up to $345 million in regulatory and commercial milestone payments for rights to develop and commercialize Nerlynx in Europe and parts of Africa. In addition, Puma will receive "significant double-digit royalties," it said. The product's first EU availability is expected in Germany later this year. Read More
HONG KONG – Chinese drugmaker Luye Pharma Group Ltd. said it filed an NDA submission to the U.S. FDA for Rykindo, its novel risperidone extended-release microsphere for injection, to treat schizophrenia and bipolar disorder. It could become the first innovative drug developed by China to get marketing clearance in the U.S. Read More
SHANGHAI – At this year's China Healthcare Investment Conference, the most insistent voices were not Chinese but American. Three speakers – a former U.S. federal judge, a leading biotech entrepreneur and a China pharma executive – each made their case for China's biopharma industry to have more influence, not just in China but globally. Read More
Drug and device companies are all too familiar with the vagaries of how the FDA interprets its own regulations from administration to administration. Last week, the U.S. Supreme Court heard arguments over whether a federal agency's interpretation should hold sway when its ambiguous regulations are challenged in court. Read More
Mustang Bio Inc., of New York, said it entered a $20 million debt financing agreement with Horizon Technology Finance Corp., with $15 million of the loan funded upon closing. Read More
Tyme Technologies Inc., of New York, said a consolidated class action complaint filed in the U.S. District Court for the Southern District of New York was voluntarily dismissed, without prejudice against all the defendants, by the plaintiff and his counsel on March 28. Read More
Fresenius Medical Care AG & Co. KGaA agreed to pay about $231 million to resolve U.S. Department of Justice (DoJ) and SEC investigations into violations of the Foreign Corrupt Practices Act. According to Fresenius' admissions, it paid bribes between 2007 and 2016 to publicly employed health or government officials to obtain or retain business in several countries. Read More
