BioSpace News Archive

Amgen Submits Supplemental NDA for Mild-to-Moderate Psoriasis Drug Otezla

Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.

February 22, 2021

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2 min read

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Brandon May

Drug Development

Otonomy Shifts Focus to Hearing Loss and Tinnitus After Meniere’s Phase III Failure

Otonomy shares plunged 50.1% at news that its drug to treat Meniere’s disease failed to hit the primary endpoint in its Phase III trial.

February 22, 2021

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3 min read

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Mark Terry

Drug Development

Tweaked COVID-19 Vaccine Starts Phase II for GSK, Sanofi

The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.

February 22, 2021

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2 min read

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Mark Zipkin

Genetown

Israel Real-World Study: Pfizer-BioNTech COVID-19 Vaccine Prevents 98.9% of Deaths

Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths.

February 22, 2021

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3 min read

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Mark Terry

Drug Development

BrainStorm Receives Feedback on Potential BLA Submission for ALS Therapy

The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.

February 22, 2021

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3 min read

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Brandon May

Pictured: AstraZeneca sign on building/Courtesy of

Policy

AstraZeneca Withdraws U.S. Use of Imfinzi as Advanced Bladder Cancer Treatment

AstraZeneca will voluntarily withdraw the use of its checkpoint inhibitor Imfinzi (durvalumab) as a treatment for bladder cancer in the United States following a failure to meet endpoints in a post-approval clinical study.

February 22, 2021

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2 min read

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Alex Keown

Business

NovellusDx Rebrands as Fore Biotherapeutics to Tackle Unaddressed Tumor Mutations

The launch of Fore Biotherapeutics in the U.S. reflects an evolved biotech business model focused on matching patients with unaddressed tumor mutations with the right oncology medicines in the clinic, the company said.

February 22, 2021

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2 min read

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Alex Keown

Policy

LightDeck Diagnostics Gets $5.65 Million for Rapid, Portable SARS-CoV-2 Antigen Test

The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.

February 22, 2021

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4 min read

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Gail Dutton

Drug Development

Ipsen Announces New Data from the Phase II CLARINET FORTE Study Which Demonstrated Preservation of Quality of Life When Increasing Dose Frequencies of Somatuline® Autogel® (lanreotide)

A total of 9 abstracts presented at the 18th Annual European Neuroendocrine Tumor Society (ENETS) Conference showcasing new data across the patient pathway in neuroendocrine tumors

February 22, 2021

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15 min read

Pharm Country

Dr. Reddy’s Laboratories Announces the Launch of Lansoprazole DR Orally Disintegrating Tablets in the U.S. Market

Dr. Reddy’s Laboratories Ltd. announced the launch of Lansoprazole DR Orally Disintegrating Tablets, a therapeutic equivalent generic version of Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg, approved by the U.S. Food and Drug Administration.

February 22, 2021

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3 min read