Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

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…

BySenior EditorAugust 17, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in June 2023

Shots: The US FDA approved 12 NDAs and 3 BLA in June 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 69 novel products in 2023 In June 2023, the major highlights drugs were Talzenna + Xtandi approval for prostate cancer, Rystiggo for generalized myasthenia gravis PharmaShots…

BySenior EditorJuly 19, 2023

INSIGHTS+

New Drug Designations – June 2023

Shots: PharmaShots' designation report provides a condensed overview of several drugs and their designations by the US FDA, the EU, China, and the UK. This month’s report includes 7 biological drugs, 13 small molecules and 9 cell and gene therapies CellCentric’s Inobrodib, for multiple myeloma and Rocket Pharmaceuticals’ RP-A601, for PKP2-arrhythmogenic cardiomyopathy were the two…

BySenior EditorJuly 17, 2023

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2023

Shots: The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B The second quarter of the year also showcases multiple approvals of the therapies…

BySenior EditorJuly 3, 2023

THOUGHTSPOT

Intelligent Automation in Pharmaceutical Industry (AI & ML)

Shots: Driven by the influx of life-changing innovations and technological advances, the pharmaceutical industry is forging ahead at a momentous pace. With the impelling Pharma 4.0, automation has now been embedded in various aspects of current business practices Delving deeply into the importance of automation, primarily focusing on AI & ML, PharmaShots unveils its eight-step…

BySaurabh ChaubeyJune 6, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2023

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…

BySenior EditorMay 17, 2023

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases…

BySenior EditorApril 3, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in January 2023

Shots: The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 9 novel products in 2023 In January 2023, the major highlights drugs were Rykindo (risperidone) approval for schizophrenia and bipolar 1 disorder, Brenzavvy (bexagliflozin) for type…

BySenior EditorFebruary 15, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2022

Shots: The EMA approved 6 New Chemical Entity (NCE) and 6 Biologic Drugs in December 2022, leading to treatments for patients and advances in the healthcare industry In December 2022, the major highlights drugs were Pluvicto’s approval for progressive PSMA+ metastatic castration resistant prostate cancer, Dupixent for Prurigo Nodularis PharmaShots has compiled a list of…

BySenior EditorJanuary 24, 2023

INSIGHTS+

Disease of the Month: Cervical Cancer

“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…

BySenior EditorJanuary 12, 2023

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Insights+: The US FDA New Drug Approvals in June 2023

New Drug Designations – June 2023

PharmaShots’ Key Highlights of Second Quarter 2023

Intelligent Automation in Pharmaceutical Industry (AI & ML)

Insights+: The US FDA New Drug Approvals in April 2023

PharmaShots’ Key Highlights of First Quarter 2023

Insights+: The US FDA New Drug Approvals in January 2023

Insights+: EMA Marketing Authorization of New Drugs in December 2022

Disease of the Month: Cervical Cancer

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