BioSpace News Archive

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  FDA

  CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End

  The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.

  April 21, 2023

   · 

  7 min read

   · 

  Ana Mulero
• 

  FDA

  FDA Action Alert: Biogen/Ionis, Seres, Otsuka/Lundbeck and More

  This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.

  April 21, 2023

   · 

  5 min read

   · 

  Tristan Manalac
• 

  AACR Highlights the Potential of Cancer Vaccines

  Cancer vaccines enjoyed a moment in the spotlight this week as Moderna, Merck, Nykode Therapeutics and Transgene shared promising updates at AACR and beyond.

  April 21, 2023

   · 

  5 min read

   · 

  Kate Goodwin
• 

  Drug Development

  AbbVie’s Migraine Drug Scores Another Phase III Win

  AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.

  April 21, 2023

   · 

  2 min read

   · 

  Kate Goodwin
• Drug Development

  AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting

  AbbVie announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications.

  April 21, 2023

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  9 min read
• Innate Pharma to Participate in Upcoming April 2023 Investor Conference

  Innate Pharma SA announced that members of its senior management team are scheduled to participate in the following upcoming investor conference.

  April 21, 2023

   · 

  3 min read
• Business

  Vitrolife AB: Interim report Q1, 2023: Good start to the year

  In local currencies Consumables sales increased by 12%, Technologies 7% and Genetic Services excluding discontinued business by 7%.

  April 21, 2023

   · 

  1 min read
• Drug Development

  Oblato Announces the First Enrollment in a Phase 1 Clinical Trial for an Oral Formulation of OKN-007 in Recurrent High-Grade Glioma Patients in the USA

  Oblato, Inc., a subsidiary company of HLB Therapeutics in Korea, has announced the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007.

  April 21, 2023

   · 

  3 min read
• Business

  Angle PLC Announces Results for the Year Ended 31 December 2022

  ANGLE plc, a world-leading liquid biopsy company, announces audited preliminary results for the year ended 31 December 2022.

  April 21, 2023

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  34 min read
• Freeline Announces Proposed ADS Ratio Change

  Freeline Therapeutics Holdings plc announced that it plans to change the ratio of its American Depositary Shares to its ordinary shares, nominal value £0.00001 per share, from the current ADS Ratio of one ADS to one ordinary share to a new ADS Ratio of one ADS to fifteen ordinary shares.

  April 21, 2023

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  5 min read