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The Latest Breaking News from FDA

Revive Therapeutics Moves On Step Closer In COVID Trial By Submitting Data Access Plan To The FDA

It was an expected step, but a notable one nonetheless. Revive Therapeutics Ltd.(OTC: RVVTF) revealed they have submitted their Data Access Plan to the U.S. Food & Drug Administration (FDA).

Benzinga

FDA Sounds Positive On Bluebird's One Gene Therapy But Doubts Another

The FDA signaled in briefing documents released that it may approve Bluebird bio Inc's (NASDAQ:BLUE) beti-cel gene therapy to treat β-thalassemia for those who require regular blood transfusions. The Prescription Drug User Fee Act (PDUFA) goal dates for beti-cel and eli-cel are August 19 and September 16. Bluebird bio's blood disorder treatment demonstrates "clinically meaningful"…

Benzinga

38 Stocks Moving In Tuesday's Mid-Day Session

Gainers Kiromic BioPharma, Inc. (NASDAQ: KRBP) gained 70% to $0.4900 after the company entered a sponsored research agreement under which in vivo preclinical data will be generated from Kiromic's Gamma Delta T cell allogeneic therapies.

Benzinga

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

In Eli Lilly's Lebrikizumab Atopic Dermatitis Study, Majority Of Patients Maintained Skin Clearance At One Year

Eli Lilly And Co (NYSE:LLY) announced topline results from one-year analyses of the efficacy and safety of lebrikizumab for moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 trials (ADvocate 1 and 2) showed that 8/10 of patients who achieved clinical response with lebrikizumab monotherapy at 16 weeks maintained skin clearance…

Benzinga

Merck, Ridgeback Announce New Molnupiravir Data From Late-Stage COVID-19 Study

Merck & Co Inc (NYSE:MRK) and Ridgeback Biotherapeutics announced that the Annals of Internal Medicine had published additional data from the Phase 3 MOVe-OUT trial of Lagevrio (molnupiravir) in non-hospitalized COVID-19 patients at high risk for progressing to severe disease. A lower proportion of molnupiravir-treated participants in the modified intent-to-treat population had an acute care…

Benzinga

Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment

Veru Inc (NASDAQ:VERU) has submitted an emergency use authorization (EUA) for sabizabulin application to FDA for COVID-19 treatment. The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS). The EUA submission is based on the positive results from the Phase 3 COVID-19 clinical trial…

Benzinga

Drag Shows for Children Under Fire in Texas

Plus: Proud Boys indicted for seditious conspiracy, the FDA prepares to crack down on almond milk, and more...

Reason

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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

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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Reason

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.

WEKU

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.

Benzinga

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…

The Philadelphia Inquirer

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.

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The Conversation

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.

StockNews.com

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.

Tribune News Service

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.

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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