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CXO TALKS

CXO Talks: Vikas Sharma Reveals QurAlis’ Bold Vision for the Future of Neuroscience 

In this episode of CXO Talks, PharmaShots speaks with Vikas Sharma, Chief Business Officer at QurAlis, a biotech company leading the development of precision medicines for neurodegenerative diseases  Vikas discusses the company’s FlexASO platform, a next-generation RNA-targeting technology that tackles the root causes of neurological diseases  Vikas also highlights QurAlis’ lead candidates, QRL-201 and QRL-101,…
November 10, 2025

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NEWS

The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome 

Shots:  The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs)   Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength  Forzinity is a mitochondrial cardiolipin binder. It…
September 19, 2025

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NEWS

Eli Lilly to Acquire Verve Therapeutics for ~$1.3B

Shots: Eli Lilly has entered into a definitive agreement to acquire Verve Therapeutics to advance cardiovascular therapies As per the deal, Lilly will acquire Verve for $10.50/share in an all-cash transaction totaling ~$1B, along with one non-tradeable CVR of $3/share tied to first pts dosing with VERVE-102 for ASCVD in P-III trial by year 10 post-closing;…
June 17, 2025

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NEWS

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots: The US FDA has granted FTD to ADI-001 for treating  adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…
February 6, 2025

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NEWS

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Shots: The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib.  In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…
January 14, 2025

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New Drug Designations - August 2024
INSIGHTS+

New Drug Designations – August 2024 

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices   In August 2024, Invenra’s INV724 received the…
September 25, 2024

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New Drug Designations - May 2024
INSIGHTS+

New Drug Designations – May 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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New Drug Designations - April 2024
INSIGHTS+

New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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New Drug Designations - March 2024
INSIGHTS+

New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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