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

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

TOP 20

Top 20 Biopharma Deal Terminations of 2023 Based on Total Deal Value

Shots: Sticking to M&A and licensing agreements can be really challenging, especially when dealing with stringent antitrust laws and evolving regulatory challenges. In such adverse scenarios, the rational and right step seems to be nullifying the existing deals. In 2023, the termination of the deal between Janssen and Arrowhead remained the talk of the town…

ByPrince GiriApril 18, 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

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

NEWS

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Shots: The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks. The study depicted a greater reduction…

ByDipanshu DixitMarch 22, 2024

NEWS

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Shots: The US FDA has granted approval to Italfarmaco’s Duvyzat (givinostat), histone deacetylase (HDAC) inhibitor, to treat Duchenne muscular dystrophy (DMD) patients (6yrs. or above) The approval was supported by the P-III (EPIDYS) study assessing the safety & efficacy of Duvyzat (BID) vs PBO in DMD ambulant male patients (n=179, 6yrs. or above) The trial…

ByDipanshu DixitMarch 22, 2024

NEWS

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Shots: The US FDA has approved Tryvio (12.5mg, oral, QD, with/without food) in addition with antihypertensive drugs to treat hypertensive adults not controlled on other drugs The P-III (PRECISION) trial assessed the efficacy of Tryvio for hypertensive adults with SBP ≥140 mmHg receiving at least 3 antihypertensive therapies with the 1EP as change in SiSBP…

ByDipanshu DixitMarch 20, 2024

INSIGHTS+

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

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of February 2024 The US FDA approved a total of 7 drugs including 6 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Takeda’s Eohilia (budesonide oral suspension) for treating eosinophilic…

BySenior EditorMarch 13, 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

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

Top 20 Biopharma Deal Terminations of 2023 Based on Total Deal Value

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

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

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

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

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