Biogen Advances Leading Research in Spinal Muscular Atrophy with New Data

 

• Initial findings from the DEVOTE study suggest no new safety concerns and support continued development of a higher dose of SPINRAZA® (nusinersen)

• Additional research reinforces the potential of biomarkers and highlights new digital tools that may help guide future treatment approaches and decisions for people with SMA

Biogen Inc. (Nasdaq: BIIB) today announced new data from the SPINRAZA® (nusinersen) clinical development program aimed at optimizing outcomes for people with spinal muscular atrophy (SMA) and advancing understanding of the disease. These data are being presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, April 17-22.

https://finance.yahoo.com/news/biogen-advances-leading-research-spinal-113000056.html

Abbott Shipping COVID-19 Self Test to Walgreens, CVS

  BinaxNOW is the most studied and widely available rapid antigen test in the U.S. and initially will be available at CVS Pharmacy, Walgreens and Walmart without a prescription

- Abbott to manufacture tens of millions of BinaxNOW Self Tests per month and can scale capacity upward based on demand

- The BinaxNOW Self Test will be sold in 2-count packs for an MSRP of $23.99, making it the most affordable over-the-counter (OTC) COVID-19 rapid test available in the U.S.

https://finance.yahoo.com/news/abbott-begins-shipping-binaxnow-covid-123000979.html

Allogene Gets FDA IND Clearance for Multiple Myeloma Med

 

• TurboCAR Technology Allows a Programmable Cytokine Signaling to Potentially Control T Cell Exhaustion and Improve Function and Potency of AlloCAR T™ Cells

• Phase 1 IGNITE Trial Expected to Begin in Mid-2021

• ALLO-605 is One of Allogene’s Three Strategies to Target BCMA for the Treatment of Patients with Multiple Myeloma

https://finance.yahoo.com/news/allogene-therapeutics-receives-ind-clearance-123000162.html

Anixa: FDA Requests Additional Information on CAR-T Therapy

 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that the U.S. Food and Drug Administration (US FDA) has requested additional information regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (MCC).

The study under the Investigational New Drug (IND) application has been placed on clinical hold pending submission of additional information requested by the FDA. Within the next 30 days, it is expected that the FDA will provide a letter to MCC with detailed and specific information requested. MCC will assemble and submit information addressing the request as soon as possible thereafter. Successive to the submission, the FDA will continue its review of the IND.

https://finance.yahoo.com/news/anixa-biosciences-moffitt-cancer-center-123000480.html

Translate Bio Details Preclinical Results for COVID-19 mRNA Vaccine Candidate

 Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the peer-reviewed publication of preclinical results of its COVID-19 vaccine candidate, MRT5500, in the journal npj Vaccines. Preclinical evaluation of MRT5500 demonstrated a favorable immune response profile against SARS-CoV-2 and conferred protective efficacy against the disease in an infection challenge model. The full journal article is available here. MRT5500 is being developed under a collaboration agreement between Sanofi Pasteur and Translate Bio. The Phase 1/2 clinical trial of MRT5500 began in March 2021 and clinical data is anticipated in the third quarter of this year.

Frank DeRosa, PhD, chief technology officer at Translate Bio and an author of the publication said, “These preclinical results demonstrated the ability of MRT5500 to elicit a robust immune response and protection against COVID-19 in multiple species through a highly rigorous set of studies. This growing body of preclinical data for MRT5500, as well as the new variant mRNA constructs that we are testing, support the potential for our mRNA vaccine candidates to play a role in protecting people against COVID-19. We look forward to seeing the results from the ongoing first-in-human trial.”

https://www.biospace.com/article/releases/translate-bio-announces-publication-of-preclinical-results-of-covid-19-mrna-vaccine-candidate-mrt5500-in-npj-vaccines/

India to fund capacity boost at Serum Institute as vaccines run short

 India is set to accept the Serum Institute of India's (SII) request for a 30 billion rupee ($400 million) grant to boost its capacity to make the AstraZeneca (AZN.L) COVID-19 vaccine, a government source with knowledge of the matter said.

https://www.reuters.com/world/india/india-fund-capacity-boost-serum-institute-vaccines-run-short-source-2021-04-19/

Clot treatment advice key to U.S. resuming J&J COVID vaccines: Doctors

 Resuming the use of Johnson & Johnson's (JNJ.N) COVID-19 vaccine in the United States will require clear guidelines for the medical community on how to best treat patients that develop a rare type of blood clot, as well as alerting vaccine recipients to be aware of the telltale symptoms, according to heart doctors and other medical experts.

https://www.reuters.com/business/healthcare-pharmaceuticals/doctors-say-clot-treatment-advice-key-us-resuming-jj-covid-vaccines-2021-04-19/