Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More

BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3

Shots: Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, […]Read More

Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Shots: Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20 Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung […]Read More

Insights+: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 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 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, […]Read More

Cadila to Launch its Bevaro (bevasizumab, biosimilar) in India

Shots: Cadila plans to launch multiple biosimilars including Bevaro in 2020 which are safe and efficacious compared to conventional treatment medicine has cleared The company has also cleared he USFDA inspection in Feb’20 and holds approved 16 ANDAs and currently filed 30 ANDAs   Bevaro is a mAb will be available in two strengths of […]Read More

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More