BioSpace News Archive

Pharm Country

Hyperfine’s Portable MRI System Demonstrates High Accuracy for Detection of Brain Hemorrhage in Study Published in Nature Communications

Hyperfine’s Portable MRI System Demonstrates High Accuracy for Detection of Brain Hemorrhage in Study Published in Nature Communications

August 25, 2021
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15 min read
Pharm Country

Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.

August 25, 2021
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17 min read
BioMidwest

Study finds patients with breast cancer benefit from an innovative 4R care plan with detailed list of care and visual timeline

The Innovative 4R Oncology® Model provides patients with a one-page care sequence plan of specific care events and timeframe for the next few weeks and a summary of future care.

August 25, 2021
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2 min read
Drug Development

Turn Therapeutics Announces Human Trial Data for COVID-19 Early Intervention Candidate

Turn Therapeutics, a biotechnology company specializing in advanced wound care and infection control, today announced the results of its Phase 2B, placebo controlled trial of Hexagen Antimicrobial Ointment in treating mild to moderate infected COVID-19 patients.

August 25, 2021
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3 min read
Health Canada Grants Marketing Authorization for KALYDECO(ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age

Vertex Pharmaceuticals Incorporated (Canada) (Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for PrKALYDECO®

August 25, 2021
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4 min read
BioMidwest

College of Medicine University of Central Florida Research Wounds Heal Faster with New Treatment: Military Medicine Discovery

Researchers at the University of Central Florida College of Medicine in Orlando, Florida, have discovered a new technology to accelerate wound-healing using specially designed ceramics wrapped in a rubber blanket fabricated for them by Gladiator Therapeutics.

August 25, 2021
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3 min read
FDA

FDA Approves NGS-Based Companion Diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma

The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for Servier Pharmaceuticals’ TIBSOVO® (ivosidenib tablets).

August 25, 2021
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4 min read
Drug Development

Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations.

August 25, 2021
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12 min read
Business

Personalis Announces Corporate Headquarters Expansion to Accelerate Growth in Laboratory Operations and Research & Development

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced that the company will relocate both its corporate headquarters and the Personalis Clinical Laboratory from Menlo Park to 6600 Dumbarton Circle in Fremont.

August 25, 2021
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3 min read
FDA

FDA Label Updates Reflect Bayer’s Commitment to Women’s Healthcare

Bayer, a leader in women’s healthcare, today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) that extends the duration of use for its market leading1 intrauterine device (IUD) Mirena®.

August 25, 2021
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4 min read