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The Latest Breaking News from FDA

Celcuity Plans To Start Pivotal Gedatolisib Trial In Breast Cancer In 1H 2022

Celcuity Inc (NASDAQ:CELC) concluded two formal meetings with the FDA to obtain their feedback on the gedatolisib Phase 3 trial in the breast cancer setting. The study dubbed VIKTORIA-1 will evaluate gedatolisib combined with fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer. The trial will include adult patients whose disease has…

Benzinga

The Daily Biotech Pulse: Novartis Prostate Cancer Drug Lands FDA Approval, Ligand Announces SPAC Deal To Spin Off Antibody Business, Lilly's Lung Cancer Therapy Hit With CRL

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

Benzinga

Moderna Says Infant Covid Vaccine Succeeded in Trial

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response. Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated…

Asharq Al-Awsat

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Biden Administration Contemplating Second COVID-19 Booster Shot Recommendation Within Weeks: Politico

The Biden administration could authorize a fourth dose or second COVID-19 booster shot for people aged 65 years and above within weeks, amid rising concern over a potential resurgence of cases,

Benzinga

DFFN: Additional Tissue Oxygenation Trial Results Expected Mid-2022…

By David Bautz, PhD NASDAQ:DFFN READ THE FULL DFFN RESEARCH REPORT

Benzinga

EXPLAINER: What to know about COVID vaccines for little kids

Moderna says it will ask regulators to authorize its COVID-19 vaccine for children under 6 but several hurdles need to be cleared before the shots could become available

The Independent UK

LifeMine Therapeutics, GSK Ink $70M Drug Discovery, Development Pact

LifeMine Therapeutics Inc, a drug discovery startup that uses genetically-encoded small molecules, has partnered with GlaxoSmithKline plc (NYSE:GSK) to discover and develop drugs from fungal genomes. GSK will bring three targets for LifeMine to run through its proprietary drug discovery platform, which scans for fungi that could be a match to create a…

Benzinga

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Moderna's COVID-19 Vaccine Shows Neutralizing Antibody Response In Kids Under 6

Moderna Inc (NASDAQ:MRNA) has announced interim data from the Phase 2/3 KidCOVE study of its COVID-19 vaccine (mRNA-1273) in children six months to under six years. The interim analysis showed that two 25 μg doses of mRNA-1273 in participants 6 months to under six years met the primary endpoint with robust neutralizing antibody…

Benzinga

Moderna to seek emergency authorization for COVID-19 vaccine use for kids under 6

Kids, prep those arms.

Tribune News Service

Novavax's COVID-19 Vaccine Scores Green Light In India with First Approval For Adolescents

Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine has got emergency-use authorization from the Drugs Controller General of India for children aged 12 to 17 years. The authorization is a global first approval in adolescents for the vaccine manufactured and marketed in India by the Serum Institute of India under the brand name Covovax. Novavax said…

Benzinga

Pfizer CEO pushes yearly Covid shots

Assertions by pharmaceutical company executives have created pressure for scientists and politicians to take action

Salon

Moderna says its low-dose COVID shots work for kids under 6

Moderna says its COVID-19 vaccine works in babies, toddlers and preschoolers

The Independent UK

FDA Inspection Flags Quality Control Issues At Abbott's Michigan Facility

An inspection at the Abbott Laboratories (NYSE: ABT) facility in Sturgis, Michigan,

Benzinga

FDA details problems at plant behind recalled baby formula

Federal safety inspectors say baby formula maker Abbott failed to maintain sanitary conditions at the Michigan manufacturing plant recently linked to a cluster of infant illnesses

The Independent UK

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The Independent UK

FDA advisory panel to discuss additional Covid-19 boosters: What we know so far

Pfizer and Moderna seek approval for second ‘booster’ doses as White House warns US has exhausted funding to buy more shots

Benzinga

Philips' Ventilator Woes Continue With Another FDA Class I Recall

Koninklijke Philips NV's (NYSE: PHG) Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts put together using an expired adhesive.

Benzinga

Moderna Bolsters Its Pipeline With Two New mRNA-Based Vaccine Programs

Moderna Inc (NASDAQ:MRNA) expands its mRNA pipeline with two new development programs ahead of Annual Vaccines Day, building on Moderna's experience with Spikevax, its COVID-19 vaccine. The development programs include a combination respiratory vaccine candidate and a new program against all four endemic human coronaviruses (HCoV). First, Moderna is launching a respiratory combination…

Benzinga

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

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Benzinga

FDA Gives Green Signal For Palisade Bio's LB1148 Phase 3 Study

Palisade Bio Inc (NASDAQ: PALI) has

Reason

Time for an Operation Warp Speed to Develop Pan-Coronavirus Vaccines

Meanwhile the FDA dawdles over second boosters as new COVID-19 wave approaches

Tribune News Service

Pfizer CEO pushes yearly shots for COVID. Not so fast, experts say

When Pfizer CEO Albert Bourla said March 13 that all Americans would need a second booster shot, it struck many COVID-19 experts as a self-serving remark without scientific merit. It also set off spasms of doubt over the country’s objectives in its fight against the coronavirus.

Benzinga

FDA Approves Second Indication For Merck's Keytruda In Endometrial Cancer

The

Benzinga

The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, Pfizer Strikes COVID-19 Pill Supply Deal, Argenx Reports Positive Late-Stage Readout

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

Benzinga

75 Biggest Movers From Yesterday

Gainers NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) shares jumped 299.4% to close at $6.23 on Monday as the company received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects.

Benzinga

FDA To Hold Advisory Committee Meeting To Discuss COVID-19 Vaccine Future Boosters

The FDA that a panel of independent advisers will meet on April 6 to discuss considerations for using COVID-19 vaccine booster doses.

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