8
Apr
2023
Regulatory Affairs Test
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Recently Published Articles
28
Sep
2022
Case Insight – Torrent Pharma to acquire dermatology company Curatio Health Care
Torrent Pharmaceuticals Ltd will acquire dermatology company Curatio Health Care India Pvt Ltd for ₹2,000 crore. The consideration includes ₹115 crore... Read More
11
May
2022
Pfizer to acquire Biohaven Pharma for $11.6 billion
Pfizer entered into a definitive agreement under which Pfizer will acquire Biohaven for 11.6 billion $. Biohen is the maker... Read More
31
Mar
2022
EMA recommendation for 2022-2023 seasonal flu vaccine composition
The European Medicines Agency (EMA) has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in... Read More
31
Mar
2022
Aurobindo Pharma acquires Veritaz Healthcare
Aurobindo Pharma Ltd has announced the acquisition of the domestic formulation business of Veritaz Healthcare for a consideration of Rs.... Read More
31
Mar
2022
Sun Pharma to launch Vortioxetine in India
Sun Pharma has entered into an exclusive patent licensing agreement with H. Lundbeck A/S (“Lundbeck”) to market and distribute its... Read More
25
Mar
2022
what is meaning of clinically significant endpoint?
Clinically Significant Endpoints are defined as the desired result which determine that treatment is worked. In other word, it is... Read More
25
Mar
2022
US FDA grants Breakthrough Therapy Designation for Pfizer’s RSVpreF
Pfizer Inc. announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the... Read More
24
Mar
2022
Is HEOR and Market Access is same?
HEOR and market access are the two separate domain or functional area within pharmaceutical organization. But they work for the... Read More
23
Mar
2022
Symbicort 1st generic Approval by USFDA
15th of March, 2022, the U.S. Food and Drug Administration approved the first generic of Symbicort, by Mylan Pharmaceuticals. Symbicort... Read More
22
Mar
2022
Case Study : Vimpat patent expired on 17th of March, 2022 and generic entry
It’s all happening now. Finally Vimpat (Lancosamide) patent is expired on 17th of March. And dozens of generics approved on... Read More
22
Mar
2022
Case Study : US FDA approval of Marinus Pharma’s Ztalmy
Marinus Pharmaceuticals, Inc., a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that the... Read More
21
Mar
2022
Lynk Pharma, Simcere licensing deal for development of novel JAK1 inhibitor LNK01001 in China
Lynk Pharmaceuticals Co., Ltd. and Simcere announced a strategic partnership to develop and commercialize a highly selective JAK1 inhibitor LNK01001... Read More
21
Mar
2022
What if Design of experiments (DoE) approach?
Design of experiments (DoE) is a systematic approach aiming to maximize information content from an experimental study, while keeping the... Read More
20
Mar
2022
What are the application of IVIVC?
In vitro-in vivo correlation (IVIVC) models are having various applications. We are hereby listed IVIVC applications: Product development of new... Read More
20
Mar
2022
What is the meaning of IVIVC?
An in-vitro in-vivo correlation is abbreviated as IVIVC. An in-vitro in-vivo correlation has been defined as “a predictive mathematical model... Read More
19
Mar
2022
Insight on AstraZeneca’s global R&D Postdoctoral Challenge initiative
AstraZeneca launched a global R&D Postdoctoral Challenge to help accelerate ideas to transform the treatment of some of the world’s... Read More
8
Mar
2022
Medtronic launched MiniMed 780G system to manage type 1 diabetes
India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc — a global leader in healthcare technology, announced the... Read More
20
Dec
2021
Case Study: Pfizer’s Arena acquisition – A $6.7B deal
Pfizer will acquire Arena Pharmaceuticals for $6.7 billion to expand its pipeline of immuno-inflammatory disease drugs in development. Why Pfizer... Read More