Shots:ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024
MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…
Shots:The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industryIn July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancerPharmaShots has compiled a list…
Shots:Dr. Harmony gave the details about the positive 12-month findings from the P-IIIb SOLAR trial of the first and only complete long-acting injectable regimen Cabenuva vs. BiktarvyShe also talked about the comparison of the Cabenuva regimen with the other existing & developing products for HIV including the Biktarvy regimenThe interview gives an…
Shots:The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industryIn February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndromePharmaShots has compiled…
“Putting Ourselves to the Test: Achieving Equity to End HIV” -Theme of the year 2022 Introduction:HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system.HIV, a type of retrovirus that isn't…
Shots:Kimberly talked about the approval for label update of ViiV’s lead candidate in HIV, and how an optional oral lead-in will be efficient for people receiving itKimberly also spoke about ViiV’s collaboration with Janssen for the commercialization of the product The interview gives an understanding of the different treatment options for HIV and…
In an interview with PharmaShots, Kimberly Smith, Senior Vice President, Head of Research & Development at ViiV Healthcare shared her views on the US FDA’s approval of the first long-acting injectable option of Apretude for the prevention of HIVThe approval is based on the P-IIb/III (HPTN 083/084) trial to evaluate cabotegravir (q8w) vs FTC/TDF (200/300 mg) in 7,700+ patients who…
The US FDA has approved 9 NDAs and 1 BLAs in Mar 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 20 novel products in 2022In Mar 2022, the major highlights drugs were Adlarity for Alzheimer's Disease, Rinvoq for Ulcerative Colitis, Ztalmy for CDKL5 Deficiency Disorder…
The first quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Stryker signed a definitive agreement to acquire Vocera Communications for ~$3.09B, Biohaven acquire Channel Biosciences for ~$3BThe first quarter of the year also showcases regulatory events…
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229MThe key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…
