Humans depends on livestock for survival and Animal Health has always been an issue to look for since it directly reflects the betterment of human lifeFor a country’s economy and balanced human life, proper care and disease-free health of animals play a key role. Since rapid environmental change has targeted animal health, it becomes…
Innovative horizons are broadening continuously in the field of medicines. Health is not only limited to physical well-being, it also reflects the mental statusPharmaceutical medicines are advancing rapidly in every area of requirement such as immunology, nephrology, oncology, neurology, and Medicines that focuses on treating disease and improving healthWe have compiled a list of global…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012The 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…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency.Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference…
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…
Lockdown' declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.1. Bayer…
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.…
In a recent interview with PharmaShots, Peony Yu, Chief Medical Officer of FibroGen shared her insights and highlights on data of RoxadustatShots:FibroGen presented new efficacy and safety analyses from the roxadustat global P-III program at ASN Kidney Week 2020 Reimagined. FibroGen and its partners, AstraZeneca and Astellas, presented 42 abstracts, including 2 late-breaker poster presentations,…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyMylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar,…

