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Biotech

FDA Committee Backs Pfizer, Moderna COVID-19 Vaccines For Toddlers, Youngest Children

FDA Committee Backs Pfizer, Moderna COVID-19 Vaccines For Toddlers, Youngest Children

EU, Bavarian Nordic Ink Supply Pact For 110,000 Monkeypox Vaccines

EU, Bavarian Nordic Ink Supply Pact For 110,000 Monkeypox Vaccines

Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids

Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids

EU, Bavarian Nordic Ink Supply Pact For 110,000 Monkeypox Vaccines

EU, Bavarian Nordic Ink Supply Pact For 110,000 Monkeypox Vaccines

Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids

Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids

AstraZeneca-Daiichi Breast Cancer Drug Cuts Disease Progression Or Death Risk By Almost 50%

AstraZeneca-Daiichi Breast Cancer Drug Cuts Disease Progression Or Death Risk By Almost 50%

GSK Confirms Consumer Healthcare Unit Spin-off: What Investors Should Know

GSK Confirms Consumer Healthcare Unit Spin-off: What Investors Should Know

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

Murder For Hire? What You Need To Know About Enochian Biosciences Co-Founder's Arrest

Murder For Hire? What You Need To Know About Enochian Biosciences Co-Founder's Arrest

Biotech Recent News

Filsuvez's European Approval Adds Growth Driver For Amryt Pharma

Filsuvez's European Approval Adds Growth Driver For Amryt Pharma

Jun 24, 2022, 12:54 PM

Intellia's Gene-Editing Candidate Shows Durability In ATTR Amyloidosis

Intellia's Gene-Editing Candidate Shows Durability In ATTR Amyloidosis

Jun 24, 2022, 12:50 PM

U.S. FDA Accepts Emergent's Anthrax Vaccine Candidate Filing For Review

U.S. FDA Accepts Emergent's Anthrax Vaccine Candidate Filing For Review

The U.S. Food and Drug Administration (FDA) has accepted to review Emergent BioSolutions’ (NYSE: EBS) Biologics License Application (BLA) for its new anthrax vaccine candidate AV7909. The regulatory agency sets the Prescription Drug User Fee Act (PDUFA) goal date for a decision in month of April 2023.

Jun 24, 2022, 11:34 AM

Adverum Biotech Receives EMA's Priority Medicines Status For Chronic Eye Disorder Candidate

Adverum Biotech Receives EMA's Priority Medicines Status For Chronic Eye Disorder Candidate

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Adverum Biotechnologies’ (NASDAQ: ADVM) lead drug ADVM-022 for the treatment of wet age-related macular degeneration (wet AMD).

Jun 24, 2022, 11:09 AM

Eton Pharma Shares Tick Higher After Offloading Hospital Products

Eton Pharma Shares Tick Higher After Offloading Hospital Products

Jun 24, 2022, 9:45 AM

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

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:

Jun 24, 2022, 9:08 AM

SciSparc Receives Ethics Committee Approval To Conduct Clinical Trial In ASD With Proprietary SCI-210 Treatment

SciSparc Receives Ethics Committee Approval To Conduct Clinical Trial In ASD With Proprietary SCI-210 Treatment

ASCO Annual Meeting 2022: An Innovation Showcase In Cancer Treatment

ASCO Annual Meeting 2022: An Innovation Showcase In Cancer Treatment

Earlier this month, the American Society of Clinical Oncology (ASCO) hosted its annual meeting, drawing over 40,000 attendees from around the globe. The conference is one of the major events in the healthcare industry and showcases the newest clinical readouts from top biotechnology and pharmaceutical companies.

Moderna Has Multi-Billion-Dollar Opportunity Outside Of COVID-19 Vaccines, Analyst Says

Moderna Has Multi-Billion-Dollar Opportunity Outside Of COVID-19 Vaccines, Analyst Says

Moderna, Inc. (NASDAQ: MRNA) rose to prominence with its messenger RNA-based COVID-19 vaccine.

Jun 24, 2022, 7:43 AM

Merck/Seagen Potential Deal Talks Pick Up Speed: WSJ

Merck/Seagen Potential Deal Talks Pick Up Speed: WSJ

Jun 24, 2022, 7:38 AM

Sanofi-GSK's Beta-Containing COVID-19 Vaccine Shows Efficacy Against Omicron

Sanofi-GSK's Beta-Containing COVID-19 Vaccine Shows Efficacy Against Omicron

Jun 24, 2022, 7:29 AM

Calithera Commences Mid-Stage Study Of DLBCL Candidate

Calithera Commences Mid-Stage Study Of DLBCL Candidate

Calithera Biosciences, Inc. (NASDAQ: CALA) initiates dosing first patient in the phase 2 clinical trial evaluating its spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

Jun 23, 2022, 5:35 PM

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

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.

Jun 23, 2022, 4:44 PM

Why Did HC Wainwright Downgrade Addex Therapeutics

Why Did HC Wainwright Downgrade Addex Therapeutics

Jun 23, 2022, 3:03 PM

Novartis Announces $250M In R&D Funding For Neglected Tropical Diseases, Malaria

Novartis Announces $250M In R&D Funding For Neglected Tropical Diseases, Malaria

Jun 23, 2022, 3:02 PM

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

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

Jun 23, 2022, 2:59 PM

BioNTech Gets EMA's Priority Medicines Status For Testicular Cancer Drug

BioNTech Gets EMA's Priority Medicines Status For Testicular Cancer Drug

BioNTech (NASDAQ: BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.

Jun 23, 2022, 2:42 PM

UniQure Shares Are Up After Low-Dose Cohort Data From Huntington's Gene Therapy Trial

UniQure Shares Are Up After Low-Dose Cohort Data From Huntington's Gene Therapy Trial

Jun 23, 2022, 2:05 PM

RedHill Biopharma Shares Trading Higher On Improved Q1 Profitability

RedHill Biopharma Shares Trading Higher On Improved Q1 Profitability

Jun 23, 2022, 1:01 PM

AstraZeneca's ALXN1840 Shows Promising Action Against Copper Metabolism Disorder

AstraZeneca's ALXN1840 Shows Promising Action Against Copper Metabolism Disorder

Jun 23, 2022, 12:13 PM

Evaxion Biotech To Test EVX-03 DNA Vaccine For Non-Small Cell Lung Cancer

Evaxion Biotech To Test EVX-03 DNA Vaccine For Non-Small Cell Lung Cancer

Jun 23, 2022, 12:10 PM

Bone Health Focused Radius Health Goes Private In $890M Deal

Bone Health Focused Radius Health Goes Private In $890M Deal

Jun 23, 2022, 12:08 PM

SciSparc Announces Ethics Committee Approval To Conduct Its Clinical Trial In Autism Spectrum Disorder

SciSparc Announces Ethics Committee Approval To Conduct Its Clinical Trial In Autism Spectrum Disorder

The Soroka University Ethics Committee Approval Received to Conduct a Clinical trial with SciSparc’s Proprietary SCI-210 Treatment

SIGA Technologies Announces $13M Worth Order For Its Monkeypox Treatment

SIGA Technologies Announces $13M Worth Order For Its Monkeypox Treatment

Jun 23, 2022, 11:28 AM

The Daily Biotech Pulse: F-Star Therapeutics Buyout, Orphan Drug Tag For VBI's Brain Cancer Vaccine, Xenon's Epilepsy Candidate Shows Promise

The Daily Biotech Pulse: F-Star Therapeutics Buyout, Orphan Drug Tag For VBI's Brain Cancer Vaccine, Xenon's Epilepsy Candidate Shows Promise

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

Jun 23, 2022, 10:31 AM

Cognition Therapeutics Begins Mid-Stage Study Of Neurological Disorder Candidate

Cognition Therapeutics Begins Mid-Stage Study Of Neurological Disorder Candidate

Cognition Therapeutics (NASDAQ: CGTX) dosed first patient in the SHIMMER study of lead drug CT1812, an experimental, orally delivered small molecule therapeutic intended to address the underlying biology of dementia with Lewy bodies (DLB).

Jun 23, 2022, 9:24 AM

F-star Therapeutics Shares Are Rallying Today - Read Why

F-star Therapeutics Shares Are Rallying Today - Read Why

Jun 23, 2022, 9:16 AM

How Babylon, One Of The Fastest-Growing Digital Healthcare Companies In The World, Is Looking To Make Healthcare More Accessible And Affordable For Everyone

How Babylon, One Of The Fastest-Growing Digital Healthcare Companies In The World, Is Looking To Make Healthcare More Accessible And Affordable For Everyone

Ali Parsa, CEO of Babylon Holdings Ltd. (NYSE: BBLN), was a guest speaker at Benzinga’s All Access on June 17th, 2022. Babylon delivers a digital healthcare platform and supporting clinical services that offer top-quality healthcare with comparatively lower costs.

Jun 23, 2022, 9:13 AM

BioStem Technologies' Local MicroEnvironment Activation Possible Key To Reversing And Repairing Diseases-Caused Tissue Damage

BioStem Technologies' Local MicroEnvironment Activation Possible Key To Reversing And Repairing Diseases-Caused Tissue Damage

Jason Matuszewski, CEO of BioStem Technologies Inc. (OTCMKTS: BSEM), was a guest speaker at Benzinga’s All Access on June 17th, 2022.

Jun 23, 2022, 9:07 AM

InMed Pharmaceuticals: The Clinical-Stage Company Setting Sites On Dominating Rare Cannabinoid Production And Commercialization Across Global Markets

InMed Pharmaceuticals: The Clinical-Stage Company Setting Sites On Dominating Rare Cannabinoid Production And Commercialization Across Global Markets

Shane Johnson, SVP and General Manager of Baymedica of InMed Pharmaceuticals (NASDAQ: INM), was a guest speaker at Benzinga’s All Access on June 17th, 2022.

Jun 23, 2022, 9:03 AM