Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Shots: US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds Based on durability…

ByDipanshu DixitApril 26, 2024

NEWS

Bausch + Lomb’s Lumify Receives the US FDA’s Approval to Treat Ocular Redness

Shots: Bausch + Lomb has received the US FDA’s approval for Lumify Preservative Free eye drops to treat ocular redness due to minor eye irritations The studies demonstrated low incidence of side effects such as rebound redness and loss of efficacy over time with Lumify Preservative Free eye drops. The company plans its availability in…

ByDipanshu DixitApril 26, 2024

NEWS

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

Shots: The US FDA has granted accelerated approval to Ojemda for treating r/r pLGG patients (≥6mos.) with BRAF fusion/rearrangement or BRAF V600 mutation. It further obtained FDA’s rare pediatric disease priority review voucher The approval was based on the P-II (FIREFLY-1) study assessing the efficacy (arm 1, n=77) & safety (arm 2, n=60) of Ojemda.…

ByDipanshu DixitApril 23, 2024

NEWS

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024 The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…

ByDipanshu DixitApril 22, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in March 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2024 The US FDA approved a total of 14 drugs including 12 new molecular entities and 2 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was BeiGene’s Tevimbra for treating Advanced…

ByDipanshu DixitApril 15, 2024

VIEWPOINTS

Fund Secured: MediWounds’ CEO Ofer Gonen in Conversation with PharmaShots

Shots: Ofer Gonen, CEO at MediWound, in conversation with PharmaShots, sheds light on recent funding from the US Department of Defence to further develop NexoBrid for the US Army NexoBrid an FDA-approved enzymatic therapy to treat severe burns is jointly developed by Vericel and received US FDA approval in Dec’22 MediWound secured an additional $6.7M…

BySaurabh ChaubeyApril 4, 2024

NEWS

Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections

Shots: The US FDA has approved Zevtera to treat adult patients with SAB infections such as right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) as well as community-acquired bacterial pneumonia (CABP) in adult & pediatric patients (3mos. to <18yrs.) The NDA was based on efficacy & safety results from P-III trials incl.…

ByDipanshu DixitApril 3, 2024

INSIGHTS+

New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…

BySenior EditorMarch 28, 2024

NEWS

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Shots: The US FDA has approved the company’s Vafseo (vadadustat) tablets as a treatment of anemia associated with chronic kidney disease (CKD) in adults on dialysis for at least 3mos. The company, in collaboration with CSL Vifor, will commercialize Vafseo across the US The approval was based on the safety and efficacy results from INNO2VATE…

ByDipanshu DixitMarch 27, 2024

NEWS

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Shots: The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along…

ByDipanshu DixitMarch 26, 2024

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Bausch + Lomb’s Lumify Receives the US FDA’s Approval to Treat Ocular Redness

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Insights+: The US FDA New Drug Approvals in March 2024

Fund Secured: MediWounds’ CEO Ofer Gonen in Conversation with PharmaShots

Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections

New Drug Designations – February 2024

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

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