BioSpace News Archive

FDA

Neurocrine Biosciences Receives FDA Approval for Ongentys, Opts to Delay Launch

Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.

April 28, 2020
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3 min read
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Krystle Vermes
Drug Development

First Patient Dosed in Avdoralimab Phase II Clinical Trial in COVID-19 Patients With Severe PneumoniaInitial translational analysis, EXPLORE, showed overexpression of C5a/C5aR pathway in patients with severe COVID-19

Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia.

April 28, 2020
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6 min read
BioForest

Cromos Pharma Supports R-Pharm in Initiation of a Global Program to Test Two of its Leading Candidates in Patients with Severe COVID-19 Infection. First Patients Have Been Recruited

R-Pharm JSC and Cromos Pharma announced that it has randomized the first patients into a clinical trial evaluating Olokizumab and RPH-104 in patients with severe COVID-19 infection.

April 28, 2020
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4 min read
Pharm Country

Confirmatory Part 2 of FIREFISH Demonstrates Survival and Motor Milestones Not Seen in Natural History in Infants with Type 1 Spinal Muscular Atrophy

Part 2 of pivotal study met its primary endpoint by demonstrating unsupported sitting in infants aged 1-7 months with type 1 SMA after 12 months of treatment

April 28, 2020
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10 min read
Biotech Bay

Genentech’s Risdiplam Shows Significant Improvement in Survival and Motor Milestones in Infants With Type 1 Spinal Muscular Atrophy (SMA)

FIREFISH Part 2 study met its primary endpoint by demonstrating a significant increase in motor milestones in infants aged 1-7 months after 12 months of treatment

April 28, 2020
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7 min read
Biotech Bay

New 6-year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis

Post-hoc analysis from 6 years of Phase III open-label extension studies showed Ocrevus treatment reduced the risk of needing a walking aid (EDSS≥6) by 49% in relapsing multiple sclerosis (RMS) patients compared with patients who switched from interferon beta-1a two years later

April 28, 2020
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11 min read
Business

Prokarium Signs an Exclusive Option Agreement with the Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois - CHUV) for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC)

Prokarium is pleased to announce it has signed an exclusive, worldwide Option Agreement with the Lausanne University Hospital - CHUV, a Switzerland-based research hospital, to acquire a license to cover the treatment of Non-Muscle Invasive Bladder Cancer patients with intravesical instillations of Salmonella.

April 28, 2020
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3 min read
Deals

BioInvent Interim Report January 1 - March 31, 2020

Promising progress reported for BI-1206 in combination with rituximab

April 28, 2020
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6 min read
Deals

Hansa Biopharma Interim Report Jan-Mar 2020. EMA Process on Track; an Opinion From the CHMP is Expected in the Second Quarter 2020

A formal adoption of outstanding questions, incl. definition of patients and design of the post approval study, expected at the CHMP April session

April 28, 2020
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4 min read
Biotech Bay

QBiotics commercialises first tigilanol tiglate pharmaceutical product with launch of STELFONTA®

Australian life sciences company, QBiotics Group Limited has commercialised the first product for its lead compound, tigilanol tiglate, with the launch of STELFONTA® in the European markets at the Virbac Oncology Summit Webinar Event.

April 28, 2020
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3 min read