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The Latest Breaking News from FDA

The Daily Biotech Pulse: Veru Seeks Emergency Use Nod For COVID-19 Therapy, Vincerx Cuts Workforce, Moderna Starts Dosing In Flu Vaccine Study

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

Benzinga

95 Biggest Movers From Yesterday

Gainers AeroClean Technologies, Inc. (NASDAQ: AERC) shares gained 100.4% to close at $4.75 on Monday after the FDA granted clearance for the company's pūrgo technology, classifying it as a class II medical device.

Benzinga

Novavax's new shot may sway anti-vaxxers

Experts hope the new COVID vaccine, which uses older biotechnology, could help the unvaccinated come around

Salon

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read the most diverse news in one place.

US move affects Africa's vax drive

The US Food and Drug Administration's recent decision to limit the use of the Johnson & Johnson Covid-19 vaccine to adults who cannot or will not get another vaccine will have profound consequences for African countries. The FDA said its move reflected the risk that the vaccine might cause a…

Bangkok Post

Needham Says Merus' ASCO Update On Zeno 'Positive'

Needham writes that Merus NV (NASDAQ: MRUS) has enough data to initiate an FDA marketing application filing in mid-2022 after presenting Zenocutuzumab (Zeno) data in NRG1-fusion (NRG1+) Cancer.

Benzinga

SVB Leerink Sees Over 600% Upside For This Penny Biotech Stock

SVB Leerink initiated Selecta Biosciences Inc (NASDAQ:SELB) coverage with an Outperform rating and a price target of $7. The analysts view ImmTOR's approach to mitigate ADAs as de-risked by early clinical data from SEL-212 and believe that the ability to tame the immune response bodes well for ImmTOR's clinical potential in combination with…

Benzinga

Regulatory Update On Intercept Pharma's Obeticholic Acid For NASH Delayed Again

Intercept Pharmaceuticals Inc's (NASDAQ:ICPT) pre-submission meeting to discuss the marketing application for obeticholic acid (OCA) in NASH has been moved to July (vs. June scheduling). The update follows a recent request from the FDA that topline data from the REGENERATE reanalysis be provided to the agency for review before the meeting. SVB Leerink…

Benzinga

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Do We Really Need the Federal Government To Tell Us What Milk Is?

Everybody knows what almond, oat, and soy milk are. We don’t need the FDA’s intervention, no matter what the dairy lobby claims.

Reason

Stop using these adult bed rails, warns the Consumer Product Safety Commission

Adult bed rails have been linked to hundreds of deaths and injuries over the years. The CPSC is starting work on a federal safety standard, nearly a decade after consumer groups asked for one.

WEKU

Why Are Quoin Pharma Shares Trading Higher Today?

The FDA has accepted Quoin Pharmaceuticals Inc's (NASDAQ:QNRX) Investigational New Drug (IND) application for its licensed formulation, which uses Skinvisible Inc's (OTC:SKVI) Invisicare drug delivery technology. The topical formulation "QRX003" was developed to treat Netherton's Syndrome, a debilitating hereditary disorder that affects the skin, hair, and the immune system. Skinvisible granted Quoin an exclusive, royalty-bearing…

Benzinga

Kids under 5 should soon have access to COVID vaccines, but many parents are likely to say, I don’t feel comfortable'

PHILADELPHIA — Zoli’s parents plan to get their 4-year-old son vaccinated against COVID-19 as soon as shots for young children could finally become available later this month.

The Philadelphia Inquirer

The US is importing baby formula to help end supply shortage – what parents need to know

Industry and federal efforts to alleviate a baby formula shortage in the U.S. are ramping up, with the import of foreign brands supplementing increased domestic production.

The Conversation

Should You Scoop Up Shares of 23andMe?

23andMe (ME) saw its shares slump in price after it reported its fourth-quarter earnings results last month. However, given the company's multiple FDA authorizations for over-the-counter genetic health risk reports, would it be worth scooping up its shares now? Read on, let's find out.

StockNews.com

Proposed menthol ban highlights debate over ‘sin tax’ revenue

WASHINGTON — A proposed federal ban on menthol cigarettes has underscored the tension lawmakers face in using so-called “sin tax” revenue to fund critical social programs at the state and federal levels.

Tribune News Service

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ABC News

US company Abbott Nutrition restarts baby formula plant linked to contamination

The company that runs the largest baby formula factory in the US has reopened its plant, but consumers may be waiting months before supply levels return to normal.

The Guardian - US

Michigan baby formula maker resumes production after safety shutdown

The Abbott facility was closed in February after a recall involving bacterial infections in infants which led to a nationwide shortage

The Independent UK

Abbott restarts baby formula plant linked to contamination

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage

Axios

Some Abbott specialty baby formulas expected in stores later this month

An Abbott plant in Michigan has resumed manufacturing some speciality formulas that are hard to find.

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The Guardian - UK

Dylan and Will McMahon: brothers behind the UK’s only baby milk producer

The brothers helping run Kendal Nutricare on being ‘best mates’, working with their father and tackling a US shortage

Tribune News Service

Faye Flam: People, get your booster shots already

Fewer than half of eligible Americans have received a third COVID vaccine shot despite clear evidence of its benefit. That booster shot improves your odds of avoiding even mild omicron. So why haven’t more people gotten it?

Asharq Al-Awsat

US FDA Concerned over Potential Novavax Myocarditis Risk

The Food and Drug Administration voiced concern Friday about myocarditis being potentially linked to the Novavax Covid-19 vaccine, just as experts are to weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened…

WEKU

The FDA is facing an investigation into its handling of the baby formula shortage

The Department of Health and Human Services wants to know if the FDA followed its rules and procedures in investigating the contamination of baby formula and recalling it.

Benzinga

Kansas Patients Now Have Access To Medicinal Cannabis Without A State Law

On June 2, Governor Laura Kelly (D) signed new legislation that would allow Kansans to obtain prescription drugs derived from cannabis-related products.

Benzinga

Amylyx Pharmaceuticals Shares Shoot Up As FDA Extends Review Of NDA For Neurodegenerative Disease Candidate

The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).

Axios

Novavax COVID shot effective but carries heart risk, FDA says

Novavax evaluation comes days before key FDA meeting

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