Shots:
The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease
PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s…
Shots:
PharmaShots has compiled a list of US FDA-approved drugs in the month of January 2025
The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry
The major highlighted drug was Daiichi Sankyo &…
Shots:
In 2024, around 50 new drugs were approved by the US FDA across several indications
PharmaShots, in an enlightening report, brings a summarized analysis of the approved drugs. The most explored section remains Oncology, Hematology, Dermatology, and Cardiology
For the complete report with analysis, reach out to us at connect@pharmashots.com
While you embraced the new…
Shots:
Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis
As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…
Shots:
The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…
Shots:
The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT
Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…
Shots:
The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway
Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day…
Shots:
Jupiter has partnered with Zina to support its P-IIa trial of Jotrol for assessing its safety & tolerability (1EP), and PK/PD (2EP) in Parkinson’s pts
As per the agreement, Zina will provide services for P-IIa trial such as protocol design assistance (PK, biomarkers), regulatory strategy, & trial site selection
Jotrol (micellar formulation)…
Shots:
The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD
Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533)
Study met its 1EP of 24% relative…

