BioPharma Global

09/08/2022

PRESS RELEASE: Pace® Life Sciences acquired BioPharma Global!

Read more about this exciting news here:
https://www.pacelabs.com/company/news-and-insights/life-sciences/pace-life-sciences-acquires-biopharma-global-expanding-fda-regulatory-affairs-strategy-and-consulting-capabilities-to-the-biotechnology-and-pharmaceutical-markets/

08/29/2022

BridgeBio bounces back? Phase 2 readout provides hope for approval of drug to rebalance calcium levels

Read more: https://www.biopharmaglobal.com/2022/08/29/bridgebio-bounces-back-phase-2-readout-provides-hope-for-approval-of-drug-to-rebalance-calcium-levels/

After a series of unfortunate events for BridgeBio Pharma, the biotech may be on a new upward trajectory as it unveiled positive data from 13 patients taking a drug to treat low calcium levels.

08/26/2022

Bluebird Bio gene therapy wins first FDA approval for rare blood disorder

Read more: https://www.biopharmaglobal.com/2022/08/26/bluebird-bio-gene-therapy-wins-first-fda-approval-for-rare-blood-disorder/

SAN FRANCISCO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designa...

08/25/2022

This Week's Rare Disease Highlight is Stargardt Disease

Read more: https://www.biopharmaglobal.com/2022/08/25/rare-disease-highlight-stargardt-disease/

Stargardt Disease, also known as juvenile macular degeneration, is a rare disease of the eyes in which part of the eye called the retina does not function correctly. This is the most common form of inherited macular degeneration, affecting about 30,000 people in the United States2. Stargardt’s is ...

08/24/2022

Attralus Receives U.S. FDA Orphan Drug Designation for AT-01 (Iodine (I-124) Evuzamitide), an Investigational Diagnostic for the Management of Transthyretin Amyloidosis

Read more: https://www.biopharmaglobal.com/2022/08/24/attralus-receives-u-s-fda-orphan-drug-designation-for-at-01-iodine-i-124-evuzamitide-an-investigational-diagnostic-for-the-management-of-transthyretin-amyloidosis/

SAN FRANCISCO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designa...

08/23/2022

Interested about learning the FDA Breakthrough Therapy Designation process?
Learn the requirements, benefits, and more on our services page: https://lnkd.in/egDjZUVu

08/22/2022

ALX Oncology’s Evorpacept Receives Fast Track Designation from FDA as First-Line Treatment for Head and Neck Squamous Cell Carcinoma

Read more: https://www.biopharmaglobal.com/2022/08/22/alx-oncologys-evorpacept-receives-fast-track-designation-from-fda-as-first-line-treatment-for-head-and-neck-squamous-cell-carcinoma/

SOUTH SAN FRANCISCO, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that the U.S. Food and Drug Administration (“FDA”) ...

08/19/2022

FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS

Read more: https://www.biopharmaglobal.com/2022/08/19/fda-accepts-biogens-new-drug-application-and-grants-priority-review-of-tofersen-for-a-rare-genetic-form-of-als/

CAMBRIDGE, Mass., July 26, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The a...

08/18/2022

This Week's Rare Disease Highlight is Netherton Syndrome

Read more: https://www.biopharmaglobal.com/2022/08/18/rare-disease-highlight-netherton-syndrome/

Netherton syndrome (NS), also referred to as bamboo hair syndrome, is a rare and severe genetic skin disorder [1-3]. The disease is characterized by chronic ichthyosiform erythroderma (a condition of fine white and red scales across the entire body), atopy (a genetic tendency to develop allergic dis...

08/17/2022

FDA, in another test of its flexibility, agrees to review Biogen’s closely watched ALS drug

Read more: https://www.biopharmaglobal.com/2022/08/17/fda-in-another-test-of-its-flexibility-agrees-to-review-biogens-closely-watched-als-drug/

Late last year, Biogen disclosed results from a closely watched study evaluating an experimental drug for Lou Gehrig’s disease, also known as ALS or amyotrophic lateral sclerosis. They showed the drug, called tofersen, wasn’t better than a placebo at slowing progression of the fatal nerve disord...

08/16/2022

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