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The Latest Breaking News from FDA

The Daily Biotech Pulse: Pfizer Acquires Migraine Drugmaker For $11B, Biogen Files For Second Alzheimer's Drug Approval, Longeveron CEO Leaves

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Turning Point Therapeutics Gets FDA Breakthrough Therapy designation For Repotrectinib

Turning Point Therapeutics, Inc. (NASDAQ: TPTX) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate Repotrectinib in Patients With One Prior ROS1 Tyrosine Kinase Inhibitor and no Prior Chemotherapy.

Benzinga

Eisai - Biogen Seek Accelerated Approval For Their Second Alzheimer's Drug

Eisai Co Ltd (OTC:ESALY) has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD. Eisai is collaborating with Biogen Inc (NASDAQ:BIIB) for drug development. Eisai has requested a Priority Review, while the lecanemab Phase 3…

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

America's Trade and Regulatory Policies Have Contributed to the Baby Formula Shortage

Why do we have tariffs on imported formula in the middle of a shortage?

Reason

Analysts Expect Clarity Imminent On Intercept's NASH Story

RBC Capital Markets writes that following the Advanz deal, Intercept Pharmaceuticals Inc (NASDAQ:ICPT) should be well-capitalized into make-or-break upcoming readouts for obeticholic acid (OCA) in NASH, with REGENERATE re-analyses on deck, REVERSE reading in the next quarter. The analysts say it remains challenging to get visibility on how the efficacy/safety analyses will look,…

Benzinga

Rare cases of COVID returning pose questions for Pfizer pill

A small number of COVID-19 patients are relapsing after taking Pfizer's antiviral pill, raising questions about the drug at the center of the U.S. response effort

The Independent UK

Mexican border town sees an increase in sales of abortion drugs to women from the US

US customers started deluging Mexican border pharmacies after Texas passed an anti-abortion law last fall. A two-pill combination costs about $400 and does not require a doctor's prescription.

WEKU

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‘It’s a nightmare’: baby formula shortage leaves US parents desperate

Strained supplies are further exacerbated after a recall by manufacturer Abbott, experts say

The Guardian - US

Flavored vapes, menthol cigarettes could soon be banned in Colorado

DENVER — The nicotine landscape in Colorado is likely to change in the near future, but how much depends on what lawmakers do in the final days of this year’s legislative session.

Tribune News Service

Why LogicBio Therapeutics Shares Are Popping Off Today

LogicBio Therapeutics Inc (NASDAQ: LOGC) shares are trading higher by 63.48% at $0.81 after the company announced the FDA lifted the clinical hold on its LB-001 Investigational New Drug Application, allowing patient enrollment to resume in the Phase 1/2 SUNRISE trial for pediatric patients with methylmaloni

Benzinga

NASA’s plan to put humans back on the Moon hits yet another snag

In today's Inverse Daily, read science stories on NASA’s Moon woes, hidden delights under the Antarctica ice sheet, and female reproductive healthcare.

Inverse

LogicBio Therapeutics Shares Skyrocket As FDA Lifts Clinical Hold On Its Pediatric Trial

The FDA has lifted the clinical hold on LogicBio Therapeutics Inc's (NASDAQ:LOGC) LB-001 Investigational New Drug Application (IND) to resume patient enrollment in Phase 1/2 SUNRISE trial in pediatric methylmalonic acidemia patients. Methylmalonic acidemia is an inherited disorder in which the body cannot process certain proteins and fats (lipids) properly. The FDA acknowledged that…

Benzinga

FDA Lifts Clinical Hold on LogicBio Therapeutics' IND for LB-001 in pediatric patients with Methylmalonic Acidemia

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on LogicBio Therapeutics’ (NASDAQ: LOGC) Investigational New Drug Application (IND) of its drug candidate LB-001 for pediatric patients with methylmalonic acidemia.

Benzinga

Ask the Pediatrician: What can parents do about baby formula shortage?

Q: There’s been a shortage of baby formula at the grocery stores and I’m starting to worry about running out. What can I do?

Tribune News Service

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The Conversation

The US FDA has moved to ban menthol cigarettes. Australia should do that and more

Menthol is the minty cigarette ingredient that conjures up images of beaches, snow-covered ski slopes and glamorous yacht parties, all crisp white and fresh green. Menthol as a deadly additive is under threat at last.

Inverse

What’s in your dietary supplements could be secretly hurting you

What are these hidden substances, and why do they matter? Supplements for weigh loss and erectile dysfunction harbored dangerous and even banned drugs.

Tribune News Service

‘Please pay attention’: Scientist flagged heart-pill toxins early on

A scientist at a China-based company that makes crucial ingredients for generic drugs warned a year before the start of a global recall that some blood-pressure pills could become tainted with potentially cancer-causing chemicals, according to court documents.

Salon

11 of Kellogg's strangest inventions

Many of the health guru's inventions would fail to find FDA approval today, but a few were ahead of their time

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Bangkok Post

Thailand's first lot of local Covid vaccine produced

The first batch of ChulaCov19, the first messenger-RNA vaccine developed in Thailand, has been produced and is awaiting Food and Drug Administration (FDA) approval for the first two phases of human trials, a government spokesperson said on Saturday.

WEKU

Texas' abortion law led some to get abortion pills in Mexico, with grim consequences

Since Texas passed its anti-abortion law, more and more women have been getting abortion pills at unregulated pharmacies in Mexican border towns — where they are freely sold without a prescription.

Inverse

What overturning Roe means for medication abortion

The fact that there's an FDA-approved drug for use up to 10 weeks and states are saying ‘no, you can only use it for six,’ makes no sense.”

Benzinga

ECOR: First Quarter 2022 Financial and Operational Results

By John Vandermosten, CFA NASDAQ:ECOR READ THE FULL ECOR RESEARCH REPORT

StockNews.com

Worried About a Market Meltdown? Then Buy These 5 Stocks Now

The market’s near-term outlook remains uncertain on concerns over the persistent macroeconomic and geopolitical issues. But we think investors worried about a market meltdown can look to add quality stocks Coca-Cola FEMSA (KOF), CGI (GIB), Novartis (NVS), PLDT (PHI), and Fresenius Medical Care (FMS) to their portfolios because these names…

Benzinga

U.S. FDA extends review of Pfizer and Myovant Sciences supplemental New Drug Application (sNDA) For MYFEMBREE by three months

The U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) from Pfizer Inc.

Benzinga

The Daily Biotech Pulse: Limited Use Of JNJ's COVID-19 Shot, Myovant-Pfizer's Relugolix Application Delayed, Gain Therapeutics' Parkinson's Data

Here's a roundup of top developments in the biotech space over the last 24 hours.

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