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Novo Nordisk
News

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

      Shots:   The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos.   The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…
October 18, 20240Comments

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Astellas
News

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer 

Shots:   The US FDA has granted approval to Vyloy plus fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+, HER2-ve G/GEJ adenocarcinoma Approval was based on the P-III (SPOTLIGHT & GLOW) studies assessing Vyloy + mFOLFOX6 and Vyloy + CAPOX, respectively, vs PBO as a 1L treatment of…
October 18, 20240Comments

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Know Your Investor- Samsara Biocapital (October’24 Edition)
INSIGHTS+

Know Your Investor: Samsara Biocapital (October’24 Edition)

Shots:  A California-based venture capital fund, Samsara Biocapital partners with medical companies and scientists to infuse cutting-edge innovations in medicines  In 2023, Samsara participated in five funding rounds and invested around $2.3B to add 19 companies to its portfolio  For a curated report on a specific investor or venture capital, reach out to us at connect@pharmashots.com …
October 17, 20240Comments

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Viewpoints_Yelak Biru
VIEWPOINTS

Fund Raising Initiative: Yelak Biru from International Myeloma Foundation in Conversation with PharmaShots

Shots:  As a fund-raising initiative, the International Myeloma Foundation began a 3-day, 2-night cycling expedition from Aug 29thto Sep 3rd The initiative supports patient education, advocacy, and next-gen research to advance a cure for multiple myeloma Today, at PharmaShots we have Yelak Biru, President and CEO of the International Myeloma Foundation, shedding light on this…
October 16, 20240Comments

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Viewpoints_Stella Sarraf
VIEWPOINTS

Enhancing Neurodegenerative Care: Stella Sarraf from Spinogenix in an Enlightening Dialogue Exchange with PharmaShots

Shots: With a broad portfolio of candidates in ALS, Alzheimer’s disease, Schizophrenia, and Fragile X Syndrome, Spinogenix initiated the P-II study evaluating SPG302 for the treatment of patients with Alzheimer’s disease SPG302, a synaptic regenerative therapy, is aimed to provide an effective and patient-friendly solution as a daily pill for ALS and Alzheimer’s disease Today…
October 14, 20240Comments

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Spotlight Interview_Rashmi Gurnani
SPOTLIGHT

CXO Talks: Rashmi Gurnani from AKT Health Analytics in a Riveting Dialogue Exchange with PharmaShots

In the fourth reprise of our recently launched Complimentary Exclusive Video Interview, we have Rashmi Gurnani CEO of AKT Health Analytics. Rashmi sheds light on AKT’s distributor partnership with Certara, known for delivering global drug development solutions to pharmaceutical companies and CROs. While discussing AKT’s role in assisting the US clients with Japan’s PMDA’s approval,…
October 14, 20240Comments

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Pfizer
News

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents 

Shots:   The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe…
October 11, 20240Comments

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News

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots: Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…
October 11, 20240Comments

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Roche
News

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Shots:   The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…
October 11, 20240Comments

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