Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices
Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
Shots:
The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industry
In October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…
Shots:
Prescription drugs have an instrumental role in effectively controlling chronic diseases like heart-related conditions, diabetes, arthritis, hypertension, and cancer, among others. Unlike over-the-counter drugs, prescription drugs are advised not to be taken without the authorization of a doctor
In 2022, the global market size of prescription drugs was worth $1035.5B and is envisioned to…
Shots:
The EMA approved 11 New Chemical Entity (NCE) and 8 Biologic Drugs in September 2023, leading to treatments for patients and advances in the healthcare industry
In September 2023, the major highlight drugs were Litfulo (ritlecitinib) for adolescents and adults with s9ere alopecia areata & Orserdu (elacestrant) for ER+, HER2- locally advanced or metastatic…
Shots:
Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT
He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…
Shots:
The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023
In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…
“Get Informed, Get Screened, Get Vaccinated” – WHO
Introduction:
Cervical cancer is the 4th most common cancer among women and 7th most commonly occurring cancer overall. When a malignant growth or tumor occurs in the cells lining the walls of the cervix, it is called cervical cancer. The cervix is the narrow, lower part of the uterus…
Shots:
The pharmaceutical companies have shown continual efforts towards developing enhanced and innovative treatment options to address the unmet needs of patients with disease eradication being the goal of developing these treatments
Advancements in cellular and molecular biology have increased the possibilities for generating new pharmaceutical products imposing major impacts on the prevention, diagnosis, and…
Active Ingredients: Pembrolizumab
Strength: 100 mg/4 mL (25 mg/mL)
Dosage Form: Syringe, Vial
Mechanism of Action: PD-1 ligands antagonists
First Approval: US (Sep 4, 2014), EU (Jul 17, 2015)
Revenue
Keytruda (pembrolizumab) has been a key player in Merck & Co. immuno-oncology drugs for the past years – reaching nearly $17B in annual sales in 2021. Despite the dampening impact…
Active Ingredients: Adalimumab
Strength: 40 mg/0.8 ml
Dosage Form: Syringe, Vial
Mechanism of Action: TNF-alpha inhibitors
First Approval: US (Dec 31, 2002), EU (Aug 09, 2003)
Revenue
Humira (adalimumab) has been the top-selling biologic drug product for the last few years – reaching nearly $21B in annual sales in 2021. Humira is one of the main drivers of AbbVie’s immunology…

