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The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023
In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease
PharmaShots has…
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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…
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The EMA approved 8 New Chemical Entity (NCE) and 3 Biologic Drugs in April 2023, leading to treatments for patients and advances in the healthcare industry
In April 2023, the major highlights drugs were Rinvoq’s Approval for active Crohn's Disease, Opzelura for non-segmental vitiligo with facial involvement in adults and adolescents
PharmaShots has compiled…
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…
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With the indispensable transformations carried out over the years, the biopharma industry witnessed miraculous changes in operations, technology, and innovation. Such as inclination towards the Pharma 4.0 model, adoption of a multimodal building approach, and dependence on contract manufacturing
While major companies like Johnson & Johnson, Roche, and Pfizer dominated the biopharma industry with…
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Biopharma companies have kept themselves afloat in the ocean of uncertainties by overcoming the hurdles of unmet demands, procurement, and maintaining a constant supply chain. However, the previous year was difficult for biopharma companies as the segment saw multiple insolvencies.
Amidst all kinds of obstacles, many companies have sustained themselves to meet the market…
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Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions
Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Some companies accept the offered period and open doors to biological drugs or biosimilars. In…
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The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry
In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome
PharmaShots has compiled…
Shots:
Post M&A deals, companies often cannot sail through a few key aspects of the partnership, such as limited ownership, exorbitant recovery costs, and poor integration process, leading to deal terminations. The improperly executed expansion program also contributes significantly to the failed partnership
To tackle such scenarios, companies are cautious enough to make backup plans beforehand…
Active Ingredient: Ibrutinib
Dosage Forms & Strengths:
Capsules: 70 mg and 140 mg
Tablets: 140 mg, 280 mg, 420 mg, and 560 mg
Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi)
First Approval: US (13 Nov 2013), EU (Oct 2014)
Revenue Analysis
Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…

