LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: […]Read More
Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed or new to antiretroviral therapy The results showed that Biktarvy low-dose tablets were found to be effective & well-tolerated @24wks. After switching to Biktarvy, 91% […]Read More
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]Read More
Shots: The P-III trial evaluates the efficacy & safety of a 3-day course of Veklury (IV) vs PBO in a ratio (1:1) in 562 non-hospitalized patients ≥aged 12yrs. with COVID-19 who are at high risk for disease progression. The results will be presented at IDWeek 2021 The results showed an 87% & 81% reduction in […]Read More
Oncology is a rapidly evolving therapy area and all of the top Biopharma players are investing in the research and development of cancer therapies. In 2020, the world witnessed a major acquisition of Immunomedic by Gilead of $21B for Trodelvy Our team at PharmaShots has compiled a list of top 20 oncology companies based on […]Read More
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 […]Read More
Shots: The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO, SC, every 6mos.) in combination with other antiretroviral agents vs PBO in a ratio (2:1) in 36 patients with multi-drug resistant HIV-1 infection Results: viral load reduction from baseline of at least 0.5 log10 copies/mL for 14-day […]Read More
The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA […]Read More
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]Read More
Shots: The submission is based on P-II/III CAPELLA trial evaluating the safety & efficacy of lenacapavir (SC, every 6mos.) in combination with other antiretroviral agents vs PBO in 36 THE patients with multi-drug resistant HIV-1 infection The study demonstrated viral load reduction of ≥ 0.5 log10 copies/mL from baseline for 14days functional monothx. period (88% […]Read More
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