Mar 11, 2023

Zachary Brennan Senior Editor The Government Accountability Office on Friday released a report calling on the FDA to better encourage the adoption of advanced drug manufacturing practices, particularly as interviews with 15 stakeholders from industry said delays in adopting advanced tech are related to regulatory uncertainties. In addition to not encouraging more advanced manufacturing practices, like continuous manufacturing, GAO found that the FDA “lacks information on the extent to which its industry engagement and policy and guidance efforts encourage adoption of advanced manufacturing.” What’s more, the FDA has not even defined or documented its goals in this area, GAO found. Read More March 10, 2023 02:14 PM EST Beth Snyder Bulik Senior Editor Amgen wants to open up conversations around relationships and asthma, and is enlisting a well-known therapist and author to help. Lori Gottlieb, a New York Times bestselling author and therapist, is leading the discussion in online videos with people living with asthma, offering advice and guidance directly to them as well as on the campaign website . “The Air Between Us All” campaign was created after a survey Amgen conducted with partner Asthma and Allergy Foundation of America (AAFA) found more than half (56%) of people with asthma don’t share that they have it unless they have to. And while almost half (46%) agreed that asthma can interfere in important moments with significant others, about the same number (47%) felt that family, friends and significant others don’t consider their asthma when planning gatherings. Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,700+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Zachary Brennan Senior Editor Eisai and Biogen’s newly approved Alzheimer’s drug Leqembi (lecanemab) is looking to do what its amyloid-targeted predecessor, Biogen’s Aduhelm (aducanumab), has yet to accomplish — hit blockbuster status. In a press conference yesterday, Eisai execs projected $7 billion (1 trillion yen) in Leqembi worldwide sales by 2030, assuming broader coverage from CMS, which has so far limited the use of any amyloid-targeted Alzheimer’s drugs to clinical trials. The $7 billion estimate is based on the company’s estimate that about 2.5 million people will be eligible for treatment by 2030, with prevalence in Asia/Latin America and China potentially reaching 70% of the global total. Read More March 10, 2023 01:01 PM ESTUpdated 01:24 PM Associate Editor Silicon Valley Bank, the banking arm of SVB Financial Group, has been shut down and taken over by government authorities after days of speculation about its future and a run on deposits. The Federal Deposit Insurance Corporation announced Friday that the bank’s insured assets would be transferred to the newly created Deposit Insurance National Bank of Santa Clara. But the FDIC only insures bank accounts up to $250,000. Customers with accounts over that amount will get “receivership certificate for the remaining amount of their uninsured funds.” Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,700+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Tyler Patchen News Reporter Moderna’s physical presence in the US has mainly been confined to the East Coast. But now it will be planting its flag on the West Coast. The mRNA biotech announced Friday that it will be opening two new offices in South San Francisco and Seattle this year. Moderna chief information officer Brad Miller told Endpoints News the Seattle office is slated to open April 4. The Seattle location will be housing Moderna’s efforts in technology and implementation of AI and cloud tools across its platform. Miller said that Seattle is home to a rich market of tech talent, which makes it an attractive choice for an office. Moderna will look to hire around 100 employees but has room to bring that number up to around 220. Read More March 10, 2023 10:33 AM EST Beth Snyder Bulik Senior Editor Pfizer’s nabbed its first approval out of its Biohaven acquisition with a nod for migraine spray Zavzpret on Friday. The FDA approval also marks a first intranasal delivery method among the newer class of calcitonin gene-related peptide (CGRP) receptor antagonists in migraine treatments. Pfizer picked up zavegepant in its $11.6 billion acquisition of Biohaven, which also included Nurtec ODT and a preclinical portfolio of CGRP assets, finalized in October. Biohaven, or New Biohaven, was spun out as a separate company now developing the remaining non-CGRP assets, keeping the $BHVN ticker and continuing to be led by CEO Vlad Coric. Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,700+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Drew Armstrong Executive Editor Olema Oncology will let go of a quarter of its workforce, as well as two top executives, as the biotech works to keep alive work on an experimental breast cancer drug that has so far been a disappointment. The cuts will affect workers in R&D and corporate functions, the company said in a press release Thursday. Also out are CBO Kinney Horn and Cyrus Harmon, a co-founder of the company and its chief research officer. Harmon will stay as a member of the board. The company had 83 full-time employees as of Jan. 31, according to a financial filing . Read More Tyler Patchen News Reporter With the public health emergency and the national emergency declaration expected to expire on May 11, the FDA will be letting some guidance documents expire along with it. In a document published Friday in the Federal Register, the FDA said that of the 72 Covid-19 guidances that are still active, 22 will no longer be in effect when the declarations expire. Those guidance docs that are being cut, and which typically offered some leniency from the FDA due to the constraints of the pandemic, include ones related to manufacturing considerations for cell and gene therapies, nonhuman primate supply constraints, statistical considerations for clinical trials and more. Read More