Just four months after Blue Water Acquisition Corp. raised $50 million in an IPO, it set out on April 27 to merge with Clarus Therapeutics Inc., the developer of testosterone replacement therapy Jatenzo, valuing the Northbrook, Ill.-based firm at $379 million. Earlier in April, BCTG Acquisition Corp. announced plans to buy Cambridge, Mass.-based targeted precision cancer company Tango Therapeutics Inc. for $353 million, about seven months after completing its $167 million IPO. Both Clarus and Tango are seeking the public markets by merging with a special purpose acquisition company, or SPAC, a method that is becoming increasingly popular and an alternative to the traditional IPO.
As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.
The FDA lost another hearing in the lawsuit filed against the agency by Genus Medical Technologies LLC in a case that yet again resurrects the product classification question. Both courts that heard the lawsuit asserted that the FDA does not enjoy unfettered discretion to classify a device as a drug merely as part of its authority under the Administrative Procedures Act (APA).
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.
HONG KONG – Beijing Stonewise Technology Co. Ltd., a med-tech firm that uses artificial intelligence (AI) to aid in the discovery of small molecule drugs, closed series B and B+ financing rounds that added $100 million to its pocket. The company intends to use the proceeds to upgrade its AI-enabled drug discovery platform.
PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities.
The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense (DoD). Beyond that, there is a clear indication that the CDC would see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory.
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”