06.07.2020
The Drug controller of India (DCGI) given the approval for Mylan Remdesivir  Lyophilized use in COVID -19 patients in India

The Drug controller of India (DCGI) given the approval for Mylan Remdesivir  Lyophilized use in COVID -19 patients in India

The Drug controller of India (DCGI) given the approval for Mylan Remdesivir Lyophilized powder for injection under the brand name of DESREM for restricted emergency use in COVID -19 patients in India

04.07.2020
Rukobia Fostemsavir from ViiV Healthcare  gots the USFDA  approval  for HIV in Patients with Limited Treatment Options

Rukobia Fostemsavir from ViiV Healthcare  gots the USFDA  approval  for HIV in Patients with Limited Treatment Options

Rukobia (Fostemsavir) from ViiV Healthcare gots the USFDA approval for HIV in Patients with Limited Treatment Options

Rukobia (Fostemsavir) got the approval based on the  P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort

In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4 + T-cell count @ 96wks., HIV-1 RNA <40 copies / mL @ 24 & 96wks. (53% & 60%); changes in CD4 + cell count (90 & 205 cells / mm3) respectively

In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies / mL @ 24 & 96wks .; HIV-1 RNA <200 copies / mL (42% & 39%); mean changes in CD4 + cell count (41 & 119 cells / mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA's review with additional submissions to regulatory authorities anticipated in 2020 & 2021

 

02.07.2020
Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

  • Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
  • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
  • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production
02.07.2020
Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it.

02.07.2020
Insights+ KOL Articles: Virtual Clinical Trials – Are They the Future of India?

Insights+ KOL Articles: Virtual Clinical Trials – Are They the Future of India?

2020 is a year that nobody ever thought could turn their lives upside down. The beginning of this year witnessed the worldwide onset of Coronavirus disease or COVID-19 that has till now infected millions of people around the globe killing tens of thousands. In March 2020, WHO declared it to be a pandemic.

02.07.2020
Biogen Signs a License Agreement with Massachusetts Eye and Ear to Develop Treatment for Inherited Retinal Disorder

Biogen Signs a License Agreement with Massachusetts Eye and Ear to Develop Treatment for Inherited Retinal Disorder

  • Biogen will receive an exclusive license to develop the product worldwide and will be responsible for all US FDA required IND enabling studies, clinical development, and commercialization
  • The companies collaborated to develop a therapy for IRDs due to mutations in the PRPF31 gene. Research performed at Harvard Ophthalmology demonstrated that AAV-mediated gene augmentation therapy for PRPF31 can restore normal function to mutant RPE cells
  • The agreement emphasizes Biogen’s commitment to the acquisition of Nightstar Therapeutics in 2019 and its active clinical trials targeting different genetic forms of IRD. Biogen will leverage its pre/ clinical experience to PRPF31 program
01.07.2020
G1 Therapeutics and Boehringer Ingelheim Collaborate to Co-Promote Trilaciclib for Small Cell Lung Cancer in the US and Puerto Rico

G1 Therapeutics and Boehringer Ingelheim Collaborate to Co-Promote Trilaciclib for Small Cell Lung Cancer in the US and Puerto Rico

  • Boehringer to receive payments to cover start-up expenses and pre-approval initiatives for a successful commercial launch. Additionally, it receives mid-twenties percentage of net sales in the 1st yr. of commercialization, which decreases to a low double-digit/high single-digit percentage in the 2nd and 3rd year respectively
  • G1 will book revenue in the selective territories and retain global development and commercialization rights to Trilaciclib. In the US and Puerto Rico, G1 will lead marketing, market access, and medical engagement initiatives while Boehringer will control salesforce engagements
  • G1 will not make any payments after the expiration of 3yrs. agreement and does not extend the agreement to additional indications for the therapy. Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with CT and has received the FDA’s BT designation and has submitted NDA for SCLC in Jun’2020