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The Latest Breaking News from FDA

Why Veru Shares Are Soaring Today Premarket

In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients. The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for…

Benzinga

‘Hurt, angry, anxious, scared’: Converging crises lead to US baby formula shortage

Along with much of the globe, US consumers are reeling from a cost of living and supply-chain crisis. One example is a shortage of baby formula caused by a constellation of factors, from rampant inflation to a massive recall over safety concerns.

France 24

Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19

The FDA approved Eli Lilly And Co's (NYSE:LLY) Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. The FDA first issued an emergency use authorization (EUA) for Olumiant combined with remdesivir to treat…

Benzinga

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Fast-track drug approval process marked for limited changes

Axios

Can a monthly injection be the key to curbing addiction? These experts say yes

OAKLAND, Calif. — Dr. Andrew Herring has a clear goal walking into every appointment with patients seeking medication to treat an opioid use disorder: persuade them to get an injection of extended-release buprenorphine.

Tribune News Service

FDA says it is "doing everything in our power" to improve baby formula supply

The shortage has intensified in recent weeks due to supply chain issues and a devastating recall.

Axios

FDA Extends Review Of Amicus Therapeutics' AT-GAA For The Treatment Of Pompe Disease By Three Months

The U.S.

Benzinga

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LPCN: First Quarter 2022 Financial and Operational Results

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

Benzinga

Fake Cannabis Vapes: How To Tell If Your Weed Vape Cartridge Is Safe Or Counterfeit?

By WeedMaps News' Tyler Koslow, provided exclusively to Benzinga Cannabis.

Benzinga

PreMarket Prep Stock Of The Day: Good News From Aurinia Pharmaceuticals In A Down Week

Rarely mentioned in the recent chaos in the markets is the biotech sector. With a heavy emphasis in 2020 and 2021 on finding cures and treatments for COVID-19, major drug approvals from the FDA have been few and far between this year.

Benzinga

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

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

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Benzinga

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).

Tribune News Service

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.

Reason

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...

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Benzinga

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…

Reason

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?

Benzinga

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,…

The Independent UK

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

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.

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