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The Latest Breaking News from FDA

Why Molecular Partners Shares Are Getting Hammered

Molecular Partners AG (NASDAQ: MOLN) shares are trading lower by 36.52% at $8.38 after the company and its partner Novartis expects the FDA may require additional clinical data for the Emergency Use Application for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.

Benzinga

Novartis - BeiGene's Tislelizumab Aces Late-Stage Esophageal Cancer Trial

Novartis AG (NYSE:NVS) has announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC). Data showed that tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic…

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo (OTC:DSKYF) and AstraZeneca Plc's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months…

Benzinga

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U.S. FDA Grants Orphan-Drug Designation for Allogene's ALLO-605 for multiple myeloma

Allogene Therapeutics, Inc. (Nasdaq: ALLO) received Orphan-drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its drug candidate ALLO-605 for the treatment of patients with multiple myeloma.

Benzinga

The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

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

Benzinga

U.S. FDA accepts Fennec Pharma's New Drug Application (NDA) Resubmission for PEDMARK

Fennec Pharmaceuticals Inc. (NASDAQ: FENC) announced that the U.S.

Benzinga

Edwards Lifesciences Clocks 10% Top-Line Growth In Q1; Forecasts Lower Than Expected Q2 Sales

Edwards Lifesciences Corp (NYSE:EW) posted a Q1 adjusted EPS of $0.60, compared to $0.54 posted a year ago and beating the consensus of $0.57. Sales increased 10% to $1.34 billion (underlying 13%), beating the consensus of $1.31 billion. Transcatheter aortic valve replacement sales grew to $881 million, up 11%. Globally, the company's…

Benzinga

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Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

Benzinga

Molecular Partners, Novartis Note EUA For COVID-19 Therapy May Need Additional Data

Molecular Partners AG (NASDAQ:MOLN) has provided an update regarding the Emergency Use Application (EUA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19. The Company says that EUA, in review with the FDA, may require additional clinical data to be authorized. Vas Narasimhan also noted that the current omicron wave of SARS-Cov-2,…

Benzinga

HIV PrEP is supposed to be covered, but often isn't

HIV prevention still comes with unexpected costs

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71 Biggest Movers From Yesterday

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Benzinga

MMJ BioPharma Cultivation To Produce Quality Cannabis, Meeting DEA's Definition Of Chemical Reproducibility

MMJ BioPharma Cultivation, a cannabis company, received its DEA schedule 1 Analytical Lab Registration, which allows for the international importation of cannabis for research and development.

Benzinga

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

Salon

What's the difference between CBD & THC?

For starters, which one gets you high?

Salon

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Benzinga

Pro-Patient Psychedelic Treatments Are Finally Moving Forward In A 'New Paradigm Shift'

Last week, Benzinga’s Psychedelics Capital Conference brought a premier gathering of the biggest publicly traded psychedelics companies in North America with forward-thinking investors to Miami, where the hottest topic seemed to revolve around LSD and derivative molecules.

Benzinga

Editas Medicine's EDIT-301 receives FDA Rare Pediatric Disease designation for Beta Thalassemia

The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia from leading genome editing company, Editas Medicine, Inc. (NASDAQ: EDIT).

Benzinga

Prothena Receives FDA Fast Track Designation for PRX012 for the Treatment of Alzheimer's Disease

Prothena Corporation plc (NASDAQ: PRTA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the anti-amyloid beta (Aβ) antibody therapy drug candidate PRX012 for the treatment of Alzheimer's disease.

Benzinga

Gamida Cell Shares Jump On FDA Nod To Cell Therapy Trial In Blood Cancer Settings

The FDA has signed off and removed the clinical hold for a cryopreserved formulation of Gamida Cell Ltd's (NASDAQ:GMDA) GDA-201, an off-the-shelf cell therapy candidate for follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.…

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Benzinga

U.S. FDA Grants Fast Track designation To Ofra-Vec (VB-111) For Platinum-Resistant Ovarian Cancer

VBL Therapeutics (NASDAQ: VBLT) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Ofra-Vec (VB-111) in combination with Paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.

Benzinga

The Daily Biotech Pulse: Protagonist's Ulcerative Colitis Study Disappoints, Gilead's Remdesivir Approved For Pediatric COVID-19 Patients, FDA Gives Nod To Gamida's Cell Therapy Trial, Fast Track Tag For Vascular Biogenics Ovarian Cancer Gene Therapy

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

Benzinga

Evoke Shares Skyrocket On New FDA Market Exclusivity For Gimoti Nasal Spray

The FDA has granted new drug product exclusivity to Evoke Pharma Inc's (NASDAQ:EVOK) Gimoti (metoclopramide) nasal spray to relieve symptoms associated with acute and recurrent diabetic gastroparesis in adults. Evoke now has exclusive marketing rights over three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from…

The Conversation

The dietary supplement you're taking could be tainted with prescription medications and dangerous hidden ingredients, according to a new study

The Research Brief is a short take about interesting academic work.

Bangkok Post

Rush for weed licences ahead of narcotic delisting in June

Thailand’s Food and Drug Administration (FDA) has received some 4,700 applications for licences from people and organisations to import, possess, grow and produce cannabis and hemp.

Benzinga

Gilead's Remdesivir Becomes First Approved Treatment For Pediatric COVID-19 Patients

The FDA has approved Gilead Sciences Inc's (NASDAQ:GILD) supplemental marketing application for Veklury (remdesivir) for pediatric COVID-19 patients older than 28 days. The approval covers patients weighing at least 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe infection. This approval…

Benzinga

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