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The Latest Breaking News from FDA

Lilly shares slip as FDA seeks more Alzheimer's drug data

Eli Lilly shares slipped Friday morning after regulators said they need to see more data on the company’s application for a quick approval of its potential Alzheimer’s disease treatment

The Independent UK

Fifth Circuit Grants En Banc Rehearing to Challenge to FDA Rejection of Vaping Products

Another potential legal setback for the FDA's attempt to regulate electronic cigarettes as tobacco products.

Reason

Is it time for a reality check on rapid COVID tests?

At-home rapid tests have become a staple of COVID-19 precautions, but some experts worry that people are relying too much on these tests and that's creating a false sense of security.

WEKU

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UV nail lamps can damage DNA and cause mutations, new study finds

Researchers claim frequent exposure to the devices causes cell mutations similar to those observed in skin cancer patients

Evening Standard

Abortion pill sites give Google data

Law enforcement can potentially use this data to prosecute people who end their pregnancies with medication

Salon

FDA suit accuses Florida company of making and selling ‘adulterated’ drugs

The Food and Drug Administration has filed a lawsuit accusing a Boca Raton pharmaceutical manufacturer of selling “adulterated” drugs and failure to correct violations cited by the FDA in 2018.

Tribune News Service

Will your smartphone be the next doctor’s office?

The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient’s health. A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep…

Tribune News Service

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Freshwater fish more contaminated with ‘forever chemicals’ than in oceans

Study also says eating one serving of fish with PFAS could be equivalent to drinking contaminated water every day for a month

The Guardian - US

Your phone is the next doctor’s office

Phones are being commercialized for quick access to information needed for monitoring a patient’s health

Salon

With telehealth abortion, doctors have to learn to trust and empower patients

Getting abortion medication online is easier than ever thanks to regulatory changes. The practice is pushing the boundaries of the traditional doctor-patient relationship.

WEKU

Jameela Jamil says she’s ‘deeply concerned’ about rise in popularity of Ozempic: ‘I fear for everyone’

‘I’m deeply concerned but I can’t change any of your minds because fatphobia has our generation in a chokehold,’ actress says

The Independent UK

Stanford geneticist pays $29m for duping VC friend into investing in bogus cure for Huntington's

The first geneticist to transplant genes from one living organism to another claimed his Huntington’s Disease cure was FDA-approved to grab cash from a friend. Really, there is no cure for HD.

Fortune

FDA decision could increase access to abortion pills across Alaska

A new federal rule change could make it easier for Alaskans to access medical abortions, especially in rural communities.

Tribune News Service

Obesity treatments catch drugmakers’ eyes as sales seen soaring

Three years ago, drugmakers and laboratories around the world responded to the pandemic with Covid-19 vaccines. Now that the urgency has faded, they’re collectively turning attention to an older pandemic: obesity.

Tribune News Service

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The Independent UK

Jeremy Clarkson sparks debate after revealing he is taking ‘wonder drug’ Ozempic

British presenter revealed he has apologised to Duke and Duchess of Sussex over widely criticised column

Irish Mirror

CDC investigating possible link between updated Pfizer Covid vaccine and increased stroke risk among over-65s

"We believe it is important to share this information with the public"

Axios

The symbolic end of Operation Warp Speed

A key member of Biden's COVID team is retiring, and there's no new federal funding.

Wales Online

CDC to investigate possible link between updated Pfizer Covid vaccine and increased stroke risk among over-65s

'It is very unlikely that the signal would represent a true clinical risk, we believe it is important to share this information with the public'

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Tribune News Service

Biden COVID-19 adviser Kessler to depart as pandemic wanes

WASHINGTON — David Kessler, a former FDA commissioner who helped steer President Joe Biden’s COVID-19 policy, will leave the administration — as the government’s response continues to gear down amid a waning pandemic and a funding crunch.

Reason

Great Moments in Unintended Consequences (Vol. 10)

Good intentions, bad results

The Conversation

What the FDA's accelerated approval of a new Alzheimer's drug could mean for those with the disease – 5 questions answered about lecanemab

The U.S. Food and Drug Administration approved the medication lecanemab, sold under the brand name Leqembi, on Jan. 6, 2023, through an “accelerated approval pathway” that fast-tracks promising clinical treatments for diseases in which there are no other currently effective options.

Tribune News Service

Lisa Jarvis: Obesity drugs for kids? Why new guidelines make sense

A leading organization of pediatricians is recommending that teens with obesity be offered weight-loss medication as part of a comprehensive treatment plan. But unless barriers to access fall, it won’t move the needle on the U.S. childhood obesity epidemic — something that affects more than 1 in 5 kids in…

WEKU

The FDA no longer requires all drugs to be tested on animals before human trials

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

The Independent UK

Alabama attorney general could prosecute women who take abortion drugs. Opponents say it’s ‘plainly unlawful’

Steve Marshall says abortion patients could be prosecuted under a ‘chemical endangerment’ law, marking the first time the state’s top law enforcement official has targeted pregnant people in anti-abortion campaign

The Conversation

What the FDA's rule changes allowing the abortion pill mifepristone to be dispensed by pharmacies mean in practice – 5 questions answered

In early January 2023, the U.S. Food and Drug Administration modified its rules for mifepristone, a drug used for medication abortion, allowing it to be offered with a prescription by certified pharmacies. Before this rule change, mifepristone could be dispensed only in person by providers at hospitals, clinics and medical…

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