Pharma News

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.

Roche India and Cipla Limited announced that the first batch of the Antibody Cocktail (Casirivimab and Imdevimab) is now available in India while a second batch will be made available by mid-June. In total they can potentially benefit 200,000 patients as each of the 100,000 packs that will be available in India offers treatment for two patients. Cipla will distribute the product by leveraging its strong distribution strengths across the country. The drug will be available through leading hospitals and COVID treatment centers.

Zydus Cadila, a global innovation driven healthcare company, launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name Ujvira. HER2 positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all Breast Cancers.

Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

Roche announced interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumours express PD-L1≥1%, compared with best supportive care (BSC). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced.

Moderna, Inc a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s mRNA COVID-19 vaccine, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. Distribution by Takeda in Japan will begin immediately.