The extraordinary demand for COVID-19 testing kits that were seen in 2020 and is yet to subside in 2021 resulted in many of the world's biggest diagnostics companies being thrust into the limelight
Siemens Healthineers- GE Healthcare- Roche- and Abbott are the top players in the race of the global diagnostic companies. The companies are…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012
The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…
The US FDA has approved 7 NDAs and 2 BLA in Dec 2020, leading to treatments for patients and advances in the health care industry.
The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020.
Additionally, last year in 2019, the US FDA has approved…
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
Multiple companies received regulatory bodies EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA's EUA for REGN-COV2 Ab combination while Health Canada accelerated…
The US FDA has approved 5 NDAs and 1 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 96 novel products so far in 2020, including 6 in Nov 2020.…
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B. Apart from…
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed- the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or…
To remain successful in the oncology market- change is now a key to adapt to this altering market dynamics. A recent development in science and technology platforms are likely to grow faster for cancer treatment in comparison to other therapy areas. However- despite robust levels of pipeline activity- oncology remains a challenging area for research…
The US FDA has approved multiple NDAs and BLAs in Aug 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 69 novel products so far in 2020, including 10 in Aug 2020. Additionally,…
In late 2019, a mysterious virus causing infection consisting of dry cough, fever tiredness, and last pneumonia first appeared in Wuhan, China. The world health organization (WHO) named the disease as Coronavirus 2019 (Covid-19). Interestingly, Covid-19 and flu (caused by influenza virus) share the common disease progression asymptomatic (no symptoms), mild symptoms fever or chills,…

