BioSpace News Archive

$David Mdzinarishvili\TASS via Getty Images$

Genetown

BioNTech-Pfizer Increase COVID-19 Vaccine Output Target Again

With the ongoing global pandemic, BioNTech and Pfizer announced that they will be boosting their manufacturing capacity of the COVID-19 vaccine to 2.5 billion for 2021.

March 30, 2021
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2 min read
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Kristiane Polido
Drug Development

AbbVie Receives NDA for Atogepant, Aims to Stop Migraines in Their Tracks

AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.

March 30, 2021
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2 min read
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Heather McKenzie
Drug Development

Global Vaccine Passports Edge Closer, Speeding Arrival of the Next “Normal”

Vaccine passports are an interim step that can speed the return of some semblance of normality by allowing the rapidly growing numbers of vaccinated people to travel more easily and to attend typically crowded sporting events, concerts and religious services.

March 30, 2021
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5 min read
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Gail Dutton
Business

After About 50 Years, the mRNA Revolution is Here

Between the Moderna and Pfizer-BioNTech COVID-19 vaccines, there are two mRNA therapeutics on the market … the only two.

March 30, 2021
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4 min read
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Mark Terry
Drug Development

Bionic Sight’s Optogenetic Therapy Yields Bright Results

The first four patients that were administered BS01, Bionic Sight’s investigational gene therapy for advanced retinitis pigmentosa (RP), all reported the ability to detect light and motion. Two of the patients were also able to detect direction.

March 30, 2021
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2 min read
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Kristiane Polido
Policy

PTC Therapeutics Announces the European Approval of Evrysdi™ for the Treatment of Spinal Muscular Atrophy

PTC Therapeutics, Inc. announced that the European Commission has granted marketing authorization to Evrysdi™ for the treatment of spinal muscular atrophy in patients 2 months and older.

March 30, 2021
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9 min read
Deals

Breakthrough year in the development of Selvita - strategic acquisition & strong financial results

In 2020, Selvita recorded EUR 31.8 million in revenues, achieving an increase of 35% on a year on year (y/y) basis. Commercial revenues increased in 2020 to EUR 25.5 million, showing a 39% y/y increase

March 30, 2021
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6 min read
Policy

Health Canada Provides Positive Feedback on Tetra Bio-Pharma’s Application for ARDS-003 to be Studied in COVID-19 Patients at Risk of Developing Acute Respiratory Distress Syndrome

Health Canada acknowledges that the preclinical safety data are robust and sufficient to file a Clinical Trial Application aimed at treating hospitalized COVID-19 patients at risk of developing ARDS

March 30, 2021
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7 min read
Drug Development

InDex Pharmaceuticals enters agreement with Parexel Biotech for phase III clinical study of cobitolimod for ulcerative colitis

InDex Pharmaceuticals Holding AB announced that the company has entered an agreement for services with global clinical research organization Parexel Biotech for the phase III study CONCLUDE.

March 30, 2021
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4 min read
Critical Limb Ischemia Treatment Market: Increase in Preference for Revascularization as Treatment Option to Drive Devices Segment

The global critical limb ischemia treatment market is driven by rise in prevalence of critical limb ischemia. Growth of the market is also attributed to increase in awareness about critical limb ischemia and rich product pipeline.

March 30, 2021
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4 min read