Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Commissioner Admonishes Health Care Stakeholders To Know Agency Better, Help More ( MedtechInsight ) Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months ( WSJ ) FDA Panel Recommends Pfizer and Moderna Vaccines for Youngest Children ( NYTimes ) ( STAT ) Abbott Baby Formula Plant Again Stops Production, This Time Because of Flooding ( NYT...

The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.   On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages...

The U.S. Food and Drug Administration (FDA) on Monday announced the approval of Biogen’s human monoclonal antibody Aduhelm (aducanumab) for use in patients with Alzheimer’s disease under the agency’s accelerated approval pathway.   FDA’s approval of aducanumab is based on results from two Phase 3 clinical trials of patients with early Alzheimer’s disease (AD), EMERGE and ENGAGE . Both trials were stopped in March 2019 due to apparent futility by a data safety monito...

The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...

The US Food and Drug Administration (FDA) on Friday finalized its guidance for sponsors looking to submit an investigational device exemption (IDE) to conduct clinical trials for neurological devices targeting disease progression in diseases such as Alzheimer's and Parkinson's. "FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients," FDA w...

Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research. According to Alteri, doing so could help the scientific community not only learn from past failures in Alzheimer's research, but enable the development and validation of new targets. Scientific Gaps "There are gaps...

The US Food and Drug Administration (FDA) on Friday released draft guidance to assist sponsors who intend to submit an investigational device exemption (IDE) to conduct clinical trials on medical devices targeting neurological disease progression, including for Alzheimer’s disease, Parkinson’s disease or primary dystonia. “Medical devices intended to slow, stop, or reverse the effects of neurological disease face challenges with regard to collecting safety and efficacy d...

The European Medicines Agency (EMA) on Monday released new draft guidance on the development of Alzheimer’s disease treatments that would allow treatments to be evaluated in earlier disease stages before dementia sets in. The new guidance comes as EMA recognizes that the field of Alzheimer’s disease (AD) research and development “witnessed a recent paradigm shift in the diagnostic framework of AD which is now considered a continuum with a long-lasting presymptomatic phas...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swedish Regulators Limit Availability of Paracetamol Sweden has prohibited the sale of paracetamol tablets outside of pharmacies. The action follows a decision by the Swedish Medical Products Agency (MPA), which ruled in April to limit where the drug is sold in an attempt to curb the rise in paracetamol poisonings.  MPA’s ruling overturned a decision from 2009, at which ...

In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology. Why are There Effective Treatments for Some Diseases and not Others? Califf raises this question, and points to some diseases like HIV/AIDS, where advances in scientific understanding hav...

The European Medicines Agency (EMA) has announced the release of a new concept paper calling for the revision of its guideline on the development of products intended to treat Alzheimer's disease "and other dementias," saying a new approach is needed to accommodate patients who are pre-symptomatic or in the early stages of disease progression. The Need for a Guideline The concept paper is similar to a draft guidance released in February 2013 by the US Food and Drug Ad...

The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments. C-Path, which was founded in 2005 under FDA'...