BioSpace News Archive

Policy

FDA Blocks Alnylam’s Bid to Expand Onpattro Label

Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.

October 9, 2023
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2 min read
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Tristan Manalac
Deals

BMS Buys Mirati for $4.8B to Boost Cancer Business

Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio.

October 9, 2023
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2 min read
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Tristan Manalac
FDA

Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

The Swiss pharma continues its winning streak with the FDA’s approval of the intravenous formulation of Cosentyx for ankylosing spondylitis, axial spondyloarthritis and psoriatic arthritis.

October 9, 2023
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2 min read
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Tristan Manalac
Sigrid Therapeutics Announces First Patient Treated with SiPore21® Medical Device for Sustained Diabetes and Obesity Control

Sigrid Therapeutics announces the commencement of the SHINE clinical trial for SiPore21® – an innovative medical device designed for sustained diabetes and weight control.

October 9, 2023
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2 min read
Masimo Receives EU MDR CE Mark for LiDCO® Module for Hemodynamic Monitoring

Masimo announced the CE mark, under the European Union Medical Device Regulation, for the LiDCO® board-in-cable module.

October 9, 2023
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11 min read
LimmaTech Biologics Raises $37 Million Series A to Advance Its Pipeline of Vaccines Against Multidrug-Resistant Bacterial Infections

LimmaTech Biologics AG announced the closing of a USD 37 million Series A financing round co-led by Adjuvant Capital, AXA IM Alts, and the Novo Holdings REPAIR Impact Fund.

October 9, 2023
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9 min read
BioMidwest

Exact Sciences to Present Late-Breaking Data from Pivotal BLUE-C Study on Next-Generation Cologuard at ACG 2023

Exact Sciences Corp. announced the company will present late-breaking data on next-generation Cologuard® from the BLUE-C pivotal trial during the American College of Gastroenterology Annual Meeting, taking place October 20-25, 2023, in Vancouver, Canada.

October 9, 2023
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6 min read
PolyPid Announces Presentation at the American College of Surgeons Clinical Congress 2023

PolyPid Ltd., a late-stage biopharma company aiming to improve surgical outcomes, announced that SHIELD I Phase 3 clinical data for D-PLEX100 will be highlighted in a presentation at the American College of Surgeons Clinical Congress 2023, to be held on October 22-25, 2023, in Boston, MA.

October 9, 2023
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1 min read
Pharm Country

Eyenovia to Present Data on Preservative-Free Microbial Integrity of the Optejet®

Eyenovia, Inc. announced that it will deliver a presentation on the microbial integrity of its Optejet dispensing device at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting, which is being held October 11-14, 2023.

October 9, 2023
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5 min read
Pharm Country

OKYO Pharma Announces Filing of an Investigational New Drug (IND) Application for OK-101 to Treat Neuropathic Corneal Pain (“NCP”)

OKYO Pharma Limited (NASDAQ: OKYO) today announced that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP).

October 9, 2023
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6 min read