Skip to content Skip to footer
Insights+ Key Biosimilars Events of September 2022

Insights+ Key Biosimilars Events of September 2022

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 During the month of September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…

Read more

Viewpoints_Erika Ross

Erika Ross, Director of Clinical & Applied Research at Abbott Shares Insights on FDA Breakthrough Device Designation to Explore its DBS System to Treat Treatment-Resistant Depression

Shots:  Erika spoke about the FDA Breakthrough Device Designation received by Abbott to investigate its deep brain stimulation (DBS) system to treat treatment-resistant depression (TRD) Erika also talked about how NeuroSphere Virtual Clinic is compatible with the  deep brain stimulation (DBS) system  The interview gives an understanding of Abbott’s vision to bring life-changing technologies in…

Read more

Viewpoints_Yoshio Okubo

Yoshio Okubo, Senior Director, Head of Pandemic Global Product Team for Takeda Shares Insights on the Approval of its Covid-19 Vaccine

Shots: Yoshio spoke about the approval of the Nuvaxovid COVID-19 Vaccine for Primary and Booster Immunization in Japan. Nuvaxovid Intramuscular Injection is the first recombinant protein-based COVID-19 vaccine approved for use in Japan Yoshio also talked about Takeda’s collaboration with Novavax for the development, manufacturing, and commercialization of Nuvaxovid in Japan Further, the interview highlighted…

Read more

Exclusive_Nagesh Mahanthappa_2022

Nagesh Mahanthappa, Interim CEO of Scholar Rock Shares Insights on Treatment Options for Spinal Muscular Atrophy

Shots: Nagesh talked about how Spinal Muscular Atrophy (SMA) is affecting people all over the world and how Scholar Rock’s treatment options are improving the lives of those living with this disease Nagesh also spoke about Scholar Rock’s lead product in SMA, apitegromab, highlighting its trial designs (TOPAZ & SAPPHIRE trials), outcomes, and real-world data…

Read more

Disease of the Month: Duchenne Muscular Dystrophy (DMD)

Disease of the Month: Duchenne Muscular Dystrophy (DMD)

INTRODUCTION Duchenne Muscular Dystrophy (DMD) is a rare and the most frequent genetic neuromuscular disorder affecting all races and ethnicities (affecting approximately 1 in 3,500 population). It is characterized by progressive muscle weakness and some specific abnormalities like changes in muscle fiber size, scar tissue formation, muscle fiber necrosis, and inflammation evidenced from muscle biopsy…

Read more

Insights+ EMA Marketing Authorization of New Drugs in August 2022

Insights+: EMA Marketing Authorization of New Drugs in August 2022

The EMA approved 5 New Chemical Entity (NCE) and 4 Biologic Drugs in August 2022, leading to treatments for patients and advances in the healthcare industry In August 2022, the major highlights drugs were Lynparza’s approval for breast cancer, Imbruvica (ibrutinib) for chronic lymphocytic leukaemia, Sunlenca (lenacapavir) for HIV Infection PharmaShots has compiled a list…

Read more

Viewpoints_Jay Pathmanathan

Jay Pathmanathan, Medical Director at Beacon Biosignals Shares Insights on EEG Neurobiomarkers for the Development of Precision Medicines in Neurology

Shots: Jay spoke about the role of AI-based EEG neurobiomarkers in the development of therapies to treat neurologic diseases Jay also talked about the use of the EEG analytics platform for dose determination clinical research The interview gives an understanding of Beacon Biosignals' vision to accelerate new treatment options for neurological and psychiatric diseases Smriti: Throw…

Read more

Viewpoints_Kindra Whitlatch

Kindra Whitlatch, Product Applications Manager at ThermoFisher Scientific, Shares Insights on Drug Stability Testing

Shots: Kindra talked about the stability testing process and its applications in the pharmaceutical industry She also spoke about the different important parameters for stability testing and the challenges faced during this process The interview gives a deep understanding of ThermoFisher is supporting pharmaceutical and biopharmaceutical manufacturers in the drug stability testing process Smriti: Please discuss…

Read more