Featured Story | By Nick Paul Taylor The FDA has granted a priority review to asthma drug candidate tezepelumab, teeing Amgen and AstraZeneca up to win approval for the thymic stromal lymphopoietin inhibitor in the first quarter of 2022. read more |
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Top Stories By Amirah Al Idrus After leading oncology teams at GlaxoSmithKline and Bristol Myers Squibb, Axel Hoos, M.D., Ph.D., is heading back to biotech. Next month, he’ll take the helm at Scorpion Therapeutics, a biotech working on “precision medicine 2.0,” where he hopes to “fill some of the white spaces” left in cancer care. read more By Kyle LaHucik AstraZeneca is the latest Big Pharma to link arms with clinical-stage cancer biopharma F-star Therapeutics in a deal worth $12 million upfront. The U.K. Big Pharma snagged the global rights to research, develop and bring to market stimulator of interferon genes (STING) inhibitor compounds. This includes exclusive access to F-star's novel preclinical STING inhibitors. read more By Annalee Armstrong Cel-Sci CEO Geert Kersten begged investors in 2018 to hold on until phase 3 data could prove the struggling biotech’s cancer drug worked. Fast forward to 2021: The results are in, and they are unlikely to inspire the rally needed to save the company. Kersten has turned to his keyboard once again in an effort to spin the results for Multikine into a win. read more By Ben Adams As the U.K. looks to boost the economy after a major COVID hit—and the looming spotlight of Brexit—the government is creating a new £1 billion public-private partnership in life sciences. British Patient Capital, the commercial arm of the U.K. government’s British Business Bank, is kickstarting the program, funneling £200 million to “specialist funds” designed to “unlock the potential of innovative U.K. life sciences companies so that they can grow their operations and create high-skilled jobs in the U.K.,” according to the government. read more By Kyle LaHucik As pharmaceutical manufacturing grows increasingly complex, Merck KGaA wants to ramp up its development capabilities for clinical trial compounds. The German life sciences company got one step closer this week with the topping out of its new Biotech Development Center in Corsier-sur-Vevey, Switzerland. The €250 million ($296 million) undertaking is slated to be fully operational in 2023. read more By Nick Paul Taylor The FDA has put all studies of Oncopeptides’ melflufen on partial hold after a blinded reassessment of phase 3 data found large differences in overall survival in pre-specified subgroups. read more By Amirah Al Idrus As Verge Genomics plugs away at its amyotrophic lateral sclerosis program, it is teaming up with Eli Lilly to pursue even more targets for new treatments against the devastating disease. The drug discoverer will pick up $25 million in an upfront fee, equity and near-term payments, but stands to collect up to $694 million down the line. read more By Kyle LaHucik Nuvalent has brought in $185 million through two funding rounds since launching in January, but the precision cancer biotech wants more: an IPO. Cambridge, Massachusetts-based Nuvalent filed Wednesday for a $100 million IPO, but that customary initial sticker price is likely short of what will actually be raised when the biotech lists on the Nasdaq under the symbol "NUVL." read more By Angus Liu China’s drug regulators released a draft guideline for conducting oncology drug trials, raising concerns of tightened regulation. But, as two industry experts view it, the guideline's call for a patient-oriented approach for cancer drug R&D and its proposed requirement for incorporating standards of care into clinical trials are all but formalizing existing practice. read more By Angus Liu Scientists from Karolinska Institutet in Sweden and U.S. biotech Aileron Therapeutics showed that reactivating the “guardian of the genome,” p53, with an MDM2 inhibitor developed by the company could boost an immune response against tumors. The team recorded positive results from combining the drug with a PD-1 inhibitor in mouse models. read more By Andrea Park So far, only two complaints pertaining to the guidewire have been filed with the agency, with no reports of related injuries or deaths. However, the FDA noted some serious adverse events caused by the guidewires may have gone unreported since physicians didn’t know the devices had not been sterilized. read more By Noah Higgins-Dunn After facing intense pushback, Biogen on Thursday said the FDA approved an updated label for its Alzheimer's drug Aduhelm that recommends the amyloid-beta targeting antibody for patients with mild cognitive impairment or mild dementia. read more By Robert King New polling aims to pressure House Democrats who may be reluctant to support legislation to give Medicare the power to negotiate lower drug prices. read more Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. 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