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The Latest Breaking News from FDA

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

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…

StockNews.com

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).

Benzinga

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

The Next Abortion Battlegrounds

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

Reason

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.

Tribune News Service

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…

Benzinga

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,…

Tribune News Service

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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 Independent UK

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

The Guardian - US

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.

Tribune News Service

Seaweed Is a Promising Food Tangled in Regulations

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

Reason

America bans the sale of all Juul vaping products amid safety concerns

Retailers and shops face 'enforcement action' if they are found to have any Juul products on sale.

Daily Record

pg working Biden, Democrats lack options to do much on abortion access

WASHINGTON — President Joe Biden and congressional Democrats are under pressure to enact new policies to ensure U.S. women retain access to abortions, but their options are sorely limited and risk generating new court challenges.

Tribune News Service

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WEKU

Juul can keep selling its vaping products in the U.S. — for now

The e-cigarette maker had asked a federal appeals court to pause a ban by the Food and Drug Administration that would have required the company to immediately halt its business.

inkl Originals

The Weekly Wrap for Saturday, 25 June 2022

Afghanistan has suffered its most-deadly earthquake in two decades. The scale of destruction is, in the words of one official, "far beyond imagination". But a fight is brewing over emergency aid and who receives it.

Salon

How to access abortion post-Roe

An individual states' ban cannot prevent you from getting an abortion in other ways and through other states

The Independent UK

US Attorney General says states cannot ban FDA-approved abortion drug

Republican state legislators have introduced dozens of proposals to ban medication abortion

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Roll Call

Advocates mobilize as abortion bans take effect - Roll Call

The impact of the Supreme Court’s decision was immediate: By afternoon, at least eight states had banned abortion with limited exceptions.

Benzinga

Filsuvez's European Approval Adds Growth Driver For Amryt Pharma

Yesterday, Amryt Pharma plc (NASDAQ:AMYT) received European approval for Filsuvez for partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients six months and older. Filsuvez becomes the first approved treatment for EB. HC Wainwright notes that the Medicines and Healthcare products Regulatory Agency in the U.K. is expected to grant authorization…

The Independent UK

Juul seeks to halt FDA order banning e-cigarette sales in US

Juul has asked a federal court to block a government order to stop selling its electronic cigarettes

The Independent UK

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

Reason

The Online Freakout Over Yesterday's Supreme Court Decisions

Plus: Abortion and free speech, Juul fights back, and more...

Benzinga

Eton Pharma Shares Tick Higher After Offloading Hospital Products

Eton Pharmaceuticals Inc (NASDAQ:ETON) has sold its hospital products to Dr. Reddy's Laboratories SA, a subsidiary of Dr. Reddy's Laboratories Ltd (NYSE:RDY), for $50 million. "The sale of our hospital products allows us to focus our resources on our core rare disease business, which is rapidly growing, and also provides an attractive opportunity to monetize…

Benzinga

The Daily Biotech Pulse: European Backing For Novavax's COVID-19 Shot In Adolescents, Sanofi-GSK's Updated Vaccine Effective Against Omicron, FDA's Clinical Hold On Sarepta's Duchenne Trial

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

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