The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached Step 4 of the ICH process, meaning it’s ready for regulators to adopt in their jurisdictions.   The guideline provides considerations for the design, timing and conduct of preclinical BD studies, and offers various recommendations for sponsors on the animal species or model to be used, the ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US California Picks Generic Drug Company Civica to Produce Low-Cost Insulin ( KHN ) ‘A safe place to fail’: ARPA-H chief on building a culture of risk-taking in science ( STAT ) Moderna CEO made $398 million in 2022, but still pledges to give most to charity ( STAT ) FDA staff says safety issues with Biogen's ALS drug to not prevent approval ( Reuters ) Wyoming govern...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA released more details on its FY2024 budget request, Pfizer announced it is recalling millions of packages of a migraine drug over concerns about its packaging and FDA advisors back the approval of Pfizer’s COVID-19 drug Paxlovid.   FDA’s nearly 300-page FY 2024 budget ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Novo Nordisk to slash US insulin prices, following move by Eli Lilly ( Reuters ) ( STAT ) ( NYTimes ) Amgen is sued for concealing $10.7 billion tax bill from investors ( Reuters ) ( Bloomberg ) Pfizer's COVID drug data supports use in high-risk patients - FDA staff ( Reuters ) With positive combo meningococcal vaccine data, GSK eyes US approval ( Reuters ) US sues...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This was a big news week for FDA watchers – we saw the release of the Biden administration’s FY 2024 budget request and FDA’s roadmap for how it will handle dozens of COVID-19 pandemic era guidances now that the COVID-19 public health emergency (PHE) is winding down.   In a Federal...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. FDA extends review of BioMarin's bleeding disorder therapy ( Reuters ) California to not do business with Walgreens over abortion pills issue, Governor says ( Reuters ) WeightWatchers Moves Into the Ozempic Market With Telehealth Deal ( WSJ ) ( Reuters ) FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless ( C...

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last week sent an untitled letter to Los Angeles-based Thomas Advanced Medical LLC stating that the firm’s stem cell products, which it markets for various diseases including Alzheimer’s disease and COVID-19, require regulatory approval under the agency’s regenerative medicine framework.   The untitled letter is the first sent by CBER’s bioresearch monitoring program (BIMO) ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Merck's drug boosts exercise capacity in pulmonary hypertension patients ( Reuters ) ( STAT ) After its drug was shown to prevent heart attacks, what’s next for Esperion? ( STAT ) ( NYTimes ) Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab ( Reuters ) ( Endpoints ) Aclaris shares tank as skin disorder drug fails mid-stage study ( Reuters ) ...

The US Food and Drug Administration’s (FDA) top neuroscience official, Billy Dunn, who oversaw the controversial approval of Biogen’s Alzheimer’s disease drug Aduhelm (aducanumab-avwa), is leaving the agency after an 18-year tenure.   Dunn’s departure was announced in an internal email from Peter Stein, director of the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER), which said Dunn is retiring from the agency to pursue “other opport...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming patient-focused drug development (PFDD) meeting focused on long COVID. It also announced the authorization of the first at-home test for COVID-19 and influenza.   On Friday...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Bernie Sanders Has a New Role. It Could Be His Final Act in Washington. ( NYTimes ) U.S. government to buy 1.5 mln more Novavax COVID vaccine doses ( Reuters ) Elon Musk’s Neuralink is under investigation for possible unsafe transport of contaminated hardware ( CNBC ) Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight ( Fie...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we watched FDA Commissioner Robert Califf testify before the new Congress for the first time and read about the use of artificial intelligence/machine learning (AI/ML) image analysis tools to characterize biotherapeutics.   On Wednesday, Califf and other top Biden administ...