BioSpace News Archive

Policy

Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

Diamyd Medical announced that the U.S. Food and Drug Administration has granted Fast Track designation for Diamyd® that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

February 15, 2024

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4 min read

Biotech Beach

MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza®

MannKind Corporation announced that it has fully enrolled 305 patients living with type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population.

February 15, 2024

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4 min read

Biotech Bay

Freenome Raises $254 Million in New Funding to Accelerate its Platform for Early Cancer Detection

Freenome, a biotechnology company developing blood tests for early cancer detection, announced the addition of $254 million from new and existing investors.

February 15, 2024

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4 min read

Business

Poolbeg Pharma PLC Announces Board Role Change and Launch of EIP

Poolbeg Pharma announces a change of Board role and the Remuneration Committee’s approval of the adoption of an Employee Performance Incentive Plan for a number of the key senior management, to align medium and long term objectives with those of shareholders and to encourage retention.

February 15, 2024

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13 min read

BioMidwest

Mikart, LLC Expands Oral Solid Dose Manufacturing Capabilities

Mikart, LLC announces the addition of cutting-edge, Fette® double-sided tablet presses to bolster its production capacity and meet the product demands of its increasing number of clients.

February 15, 2024

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2 min read

Business

West Announces Fourth-Quarter and Full-Year 2023 Results

West Pharmaceutical Services, Inc. announced its financial results for the fourth-quarter and full-year 2023 and introduced full-year 2024 financial guidance.

February 15, 2024

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18 min read

Drug Development

Osivax Announces Vaccination of First Participant in First-in-Human Trial Evaluating Sarbecovirus Vaccine Candidate OVX033

Osivax announced that the first participant has been vaccinated in its new Phase 1 trial evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate.

February 15, 2024

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4 min read

Pharm Country

Immunic, Inc. to Announce Financial Results for the Year Ended December 31, 2023, and Provide Corporate Update

Immunic, Inc. announced that the company will release its financial results for the fourth quarter and year ended December 31, 2023, including a corporate update, on Thursday, February 22, 2024, before the opening of the U.S. financial markets.

February 15, 2024

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5 min read

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (ustekinumab)

Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area for AVT04, a biosimilar to Stelara®.

February 15, 2024

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8 min read

Genetown

KalVista Pharmaceuticals Announces Pricing of a $160.1 Million Public Offering of Common Stock and Pre-Funded Warrants

KalVista Pharmaceuticals, Inc. announced the pricing of its underwritten public offering of 7,016,312 shares of its common stock at a price to the public of $15.25 per share and pre-funded warrants to purchase 3,483,688 shares of common stock in lieu of KalVista common stock to certain investors.

February 15, 2024

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5 min read