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The Latest Breaking News from FDA

The Daily Biotech Pulse: Kezar Life Surges On Positive Kidney Disease Trial Data, FDA Rejects Spero Therapeutics' Tebipenem, Graybug Reviews Strategic Alternatives

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

Benzinga

Cybin's Psilocybin Analog CYB003 Gets FDA Clearance For Trial To Potentially Treat Major Depressive Disorder

Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).

Benzinga

New weight-loss treatment is marked by heavy marketing and modest results

First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t enjoy eating.

Tribune News Service

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BCTX: New Sites Expand Bria-IMT Trial

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

Benzinga

ESSA Pharma's EPI-7386 Monotherapy / Combo Therapy Show Early Activity Against Prostate Cancer

ESSA Pharma Inc (NASDAQ:EPIX) presented clinical results from the Phase 1a dose-escalation study of EPI-7386 as a monotherapy for metastatic castration-resistant prostate cancer (mCRPC) resistant to current standard-of-care therapies. The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily…

Benzinga

Gilead Again Seeks HIV Drug Approval From FDA After Addressing Vial Compatibility Issues

Gilead Sciences (NASDAQ: GILD) resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

Benzinga

Spero Therapeutics' Shares Plunge As FDA Issued Refusal Letter For Urinary Tract Infection Candidate

The U.S.

Benzinga

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Abortion rights activists plot next legal steps

Abortion rights advocates are considering a number of options to legally challenge state bans.

Axios

Throw out this Panera corn chowder ASAP

The product in question was only distributed in select supermarkets across 12 different states

Salon

New York Judge Denies Bristol Myers Claim To Dismiss Lawsuit Over Delayed Cancer Drug Approval: Reuters

According to a Reuters report, U.S. District Judge Jesse Furman in Manhattan refused to dismiss a $6.4 billion lawsuit accusing Bristol Myers Squibb Co (NYSE:BMY) of delaying its Breyanzi cancer drug to avoid payments to former Celgene shareholders. The judge rejected Bristol Myers' claim that it was never properly notified about its alleged default…

Benzinga

3 Women's Health Stocks Are Soaring Following Roe v. Wade Ruling

Three days after the U.S. Supreme Court struck down Roe v. Wade in one of the most potentially impactful rulings of the last century, a handful of women's health stocks are on the move on Monday in response to the news.

Benzinga

Medication abortion is common, effective, and under attack by Republicans

Most abortions in the US and overseas involve pills that can be taken at home, but GOP lawmakers have launched a new war on drugs, Alex Woodward reports

The Independent UK

US grapples with whether to modify COVID vaccine for fall

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match the latest changes of the shape-shifting coronavirus

The Independent UK

The Daily Biotech Pulse: CHMP Backs AstraZeneca's Breast Cancer Therapies, Ipsen Buys Epizyme, FDA Holds For Nuvation Bio, Astellas Studies

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

Benzinga

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StockNews.com

Altria is Still a Buy After FDA Orders Pulling JUUL Products Off the Market

Shares of Tobacco giant Altria (MO), a significant stakeholder of Juul Labs, slid last week on the news of the FDA preparing to order removing e-cigarette maker Juul’s products from the U.S. market. However, MO rebounded the following day as investors did not foresee any significant impact of this development…

Benzinga

Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical

Axsome Therapeutics Inc (NASDAQ: AXSM) shares rallied 40% on Monday morning after the company received some positive news from the U.S. Food and Drug Administration regarding its AXS-05 novel treatment for MDD (depression).

Reason

The Next Abortion Battlegrounds

The Supreme Court may have overturned Roe v. Wade, but it has not ended legal battles over abortion.

Tribune News Service

Supreme Court’s Roe ruling tees up fight over abortion pills

The U.S. Supreme Court decision overturning federal abortion rights sets the stage for conservative states to drastically limit access to a pill used to end early pregnancies.

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Benzinga

Astellas's Pompe Disease Gene Therapy Trial Put On FDA Clinical Hold

The FDA has placed a clinical hold on Astellas Pharma Inc's (OTC:ALPMY) FORTIS Phase 1/2 trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. FORTIS trial is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease. The FDA has…

Tribune News Service

Editorial: Smoke and mirrors: On the FDA’s nicotine and vaping rulings

Count us fans of the Food and Drug Administration’s historic push to reduce nicotine levels in cigarettes, which, in concert with a proposed ban on menthol-flavored cancer sticks, promises to liberate millions of Americans from deadly addiction. Cigarette smoking is responsible for nearly a half-million deaths in America per year,…

The Independent UK

Kristi Noem supports banning abortion pills and defends ‘trigger’ ban even in cases of rape or incest

Justice Department warned states against restricting access to FDA-approved drug for medication abortion

The Independent UK

SD gov says women shouldn't be prosecuted for abortion pills

South Dakota’s Republican governor is pledging to bar mail-order abortion pills but says women shouldn't face prosecution for seeking them

The Guardian - US

US bans Juul but young vapers are already switching to newer products

Analysis: Juul is only the fourth most popular e-cigarette with adolescents, who are increasingly opting for disposable alternatives

Tribune News Service

CEO of Davie, Fla.-based company pleads guilty to distributing tainted drugs, conspiring to defraud FDA

FORT LAUDERDALE, Fla. — The former CEO of a Davie-based drug manufacturer accused of selling tainted stool softeners that sickened dozens and killed three infants has pleaded guilty to four felonies after reaching a plea agreement with federal prosecutors.

Reason

Seaweed Is a Promising Food Tangled in Regulations

Regulatory uncertainty is keeping the seaweed market from reaching its full potential.

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