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

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

NEWS

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Shots: The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759) The results after 52wks. showed improved NASH resolution (incl. a…

ByDipanshu DixitMarch 14, 2024

NEWS

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24 The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs…

ByDipanshu DixitMarch 14, 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)

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

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Contact US

FOLLOW US