- Spark Newswire

1 minute read

BioCryst Exhibits Positive Data From Early-Stage Rare Kidney Disease Study

Today, 11:10 AM

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that its lead asset BCX9930 has demonstrated >99 percent suppression of the alternative pathway (AP), and that >98 percent suppression was maintained for 24 hours post-dosing, in patients with C3 glomerulopathy (C3G), a rare renal disease that is characterized by dysregulation of the AP of the complement system.

BCRX

2 minute read

Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:10 AM

Pfizer (NYSE:PFE) announced positive top-line data from the Phase 3 clinical trial RENOIR investigating its bivalent RSV prefusion F…

APTX

1 minute read

FDA Announced Clearance To Century Therapeutics’ Allogeneic Cell Therapy Candidate Study

By Ragothaman Srinivasan

Today, 11:10 AM

Century Therapeutics, Inc. (NASDAQ: IPSC) received ELiPSE-1 clinical study may proceed notification from the U.S. Food and Drug Administration (FDA) to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies.

IPSC

2 minute read

Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:10 AM

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene…

AIMD

2 minute read

BioMarin Receives European Commission’s Conditional Marketing Authorization For Gene Therapy Candidate

By Ragothaman Srinivasan

Today, 11:10 AM

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ: BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A in adult patients.

BMRN

1 minute read

Surgalign Gets FDA 510(k) Clearance For Spinal Fixation System

By Ragothaman Srinivasan

Today, 11:10 AM

Surgalign Holdings (NASDAQ: SRGA) announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Cortera Spinal Fixation System.

SRGA

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Apellis Shares Show Mixed Reaction After Positive 2 Years Data From Late-Stage Retinal Disorder Study

By Ragothaman Srinivasan

Today, 11:10 AM

Apellis Pharmaceuticals (NASDAQ: APLS) revealed top-line data readout at 24 months showing increased effects over time with intravitreal pegcetacoplan in the Phase 3 DERBY and OAKS studies in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

APLS

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Ainos Seeks FDA Nod For Mid-Stage Covid-19 Study

By Ragothaman Srinivasan

Today, 11:10 AM

Ainos, Inc. (NASDAQ: AIMD) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for conducting a Phase 2 trial of its drug candidate VELDONA, for treatment of mild symptoms related to COVID-19.

AIMD

3 minute read

Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:10 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck‘s (NYSE:MRK) lead asset MK-2060…

AMGN

1 minute read

Bristol Myers Squibb Secures Canadian Regulatory Nod For Lung Cancer Candidate In Neoadjuvant Setting

By Ragothaman Srinivasan

Today, 11:10 AM

Health Canada announced approval for Bristol Myers Squibb’s (NASDAQ: BMY) OPDIVO (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles in adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setti

BMY