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The Latest Breaking News from FDA

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

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

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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

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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

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.

WEKU

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.

inkl Originals

How to access abortion post-Roe

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

Salon

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

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

The Independent UK

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.

Roll Call

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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...

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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:

Axios

Juul decision triggers broader tobacco fight

FDA's Juul ban could trigger grinding fight over smoking rules

Los Angeles Times

These machines to help people breathe were recalled a year ago. Many still use them

In Rochester, New York, Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.

Benzinga

Sarepta Therapeutics' Shares Plummet Following FDA's Clinical Hold On MOMENTUM Study

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on SRP-5051 (vesleteplirsen), Sarepta Therapeutics' (NASDAQ: SRPT) lead candidate to treat patients with Duchenne muscular dystrophy.

Benzinga

FDA Gives Approval For Novartis' Tafinlar + Mekinist Broadens BRAF/MEK Cancer Combo Use

The FDA granted accelerated approval to Novartis AG's (NYSE:NVS) pairing of Tafinlar and Mekinist for any advanced solid tumors with the BRAF V600E mutation. The patient must have progressed following prior therapy and have no alternative treatment options. The combo is already approved for BRAF mutated non-small cell lung cancer, melanoma, and thyroid cancer.…

The Independent UK

Sean Hannity challenges FDA to ‘arrest’ him in tantrum over Juul vape bans

Mr Hannity said he would vape live on air if the FDA banned the products

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