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The Latest Breaking News from FDA

Parents hunting for baby formula as shortage spans US

Parents across the U.S. are scrambling to find baby formula because of supply disruptions and a massive safety recall by manufacturer Abbott

The Independent UK

Robust Uptake Of Antipsychotic Drug Boosts Intra-Cellular's Q1 Earnings

Intra-Cellular Therapies Inc's (NASDAQ:ITCI) Q1 revenues reached $35.0 million, compared to $15.9 million a year ago, beating the consensus of $33.65 million. Net product revenues of Caplyta were $34.8 million, compared to $15.6 million in Q1 FY21. The company reported an EPS loss of $(0.78), beating the consensus of $(0.92) and higher…

Benzinga

Why This Analyst Has 'Little Conviction' On CRISPR's Upcoming Trial Data

RBC Capital Markets says it remains on the sidelines given commercial uptake for CRISPR Therapeutics' (NASDAQ: CRSP) sickle cell disease (SCD)/beta-thalassemia (BT) capped by preconditioning and has little conviction in BCMA/CD70 data within weeks. The analysts lowered its price target to $85 from $95 to reflect higher Opex, with a Sector Perform rating. As recently…

Benzinga

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Parents struggle with baby formula shortage. ‘It’s kind of scary’

For the first months of her life, Ashley Strom’s daughter seemed uncomfortable much of the time — vomiting frequently, squirming with acid reflux and sleeping poorly.

Chicago Tribune

Amid Baby Formula Shortage, Retailers Put Cap On Purchases: Report

The U.S. faced a nationwide shortage of the most popular baby formula brands in the week starting April 24, according to the latest figures from Datasembly, which tracks out-of-stock messages on retailers' websites and apps. An average rate is less than 10%. Reasons For The Shortage: Supply chain issues caused by the COVID-19…

Benzinga

Ecstasy Research Trial Completes Enrollment, Moves Closer To Approval To Treat PTSD

The non-profit Multidisciplinary Association for Psychedelics Studies (MAPS) and its subsidiary MAPS Public Benefit Corporation finished the enrollment stage for the second Phase 3 clinical trial on MDMA (MAPP2).

Benzinga

400 million COVID-19 vaccine doses dumped by Baltimore plant, congressional report finds

BALTIMORE — The Maryland-based vaccine maker Emergent BioSolutions was forced to destroy nearly 400 million doses of COVID-19 vaccine because of potential contamination at its East Baltimore plant, far more than previously known.

Tribune News Service

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The U.S. Baby Formula Shortage Is the FDA's Fault

Plus: Trusting the science is now an explicitly partisan issue, stocks are still plummeting, and more...

Reason

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

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

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WEKU

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.

The Guardian - US

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

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

Tribune News Service

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.

Benzinga

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

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Inverse

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.

Benzinga

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.

Tribune News Service

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?

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.

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