Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 27
Drug Approval
Drug Approval | 17 August 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations

Drug Approval
Drug Approval | 16 August 2022

Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP

Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.

Drug Approval
Drug Approval | 16 August 2022

Eugia Pharma receives USFDA approval for Vasopressin Injection USP

The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.

Drug Approval
Drug Approval | 16 August 2022

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)

Drug Approval
Drug Approval | 13 August 2022

Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP

The product will be manufactured at Lupin’s facility in Goa, India.

Drug Approval
Drug Approval | 13 August 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age

Drug Approval
Drug Approval | 13 August 2022

Regen BioPharma develops novel dedifferentiation approach for increasing efficacy of CAR-T Cells to treat solid tumors

Company creates Younger T Cells for fighting cancer using its NR2F6 technology

Drug Approval
Drug Approval | 09 August 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy

Drug Approval
Drug Approval | 04 August 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.

Drug Approval
Drug Approval | 04 August 2022

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

Drug Approval
Drug Approval | 03 August 2022

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.

Drug Approval
Drug Approval | 03 August 2022

Strides receives USFDA approval for Cyclosporine Softgel Capsules

Strides is the first Indian company to get approval for the product.

Drug Approval
Drug Approval | 31 July 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.

Drug Approval
Drug Approval | 31 July 2022

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing

Drug Approval
Drug Approval | 28 July 2022

Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market

The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022

Drug Approval
Drug Approval | 26 July 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.

Drug Approval
Drug Approval | 26 July 2022

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.

Drug Approval
Drug Approval | 24 July 2022

SMS Pharmaceuticals receives approval for Ibuprofen by EDQM

With this, the company can start selling Ibuprofen in the European markets.

Drug Approval
Drug Approval | 24 July 2022

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market

Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.

Drug Approval
Drug Approval | 20 July 2022

Brii Bio inks partnership with China Resources Pharmaceutical to advance the commercialization of Long-acting COVID-19 neutralizing antibody therapy

The partnership will accelerate stockpiling, channel distribution and hospital access for the amubarvimab/romlusevimab combination in China

Startup

Digitization