Pharma News

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.

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.

Pfizer Inc. announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY, the companies COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses.

Takeda Pharmaceutical Company Limited announced updated data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC) who received prior platinum-based chemotherapy. The results showed mobocertinib continued to demonstrate clinically meaningful benefit after over a year of follow up and will be presented at the virtual 57th American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.

Rivaroxaban, in addition to low dose aspirin, significantly reduced the occurrence of total severe events of the heart, limb or brain and issues related to other vascular complications in patients with symptomatic peripheral artery disease who underwent lower extremity revascularization, a procedure to open blocked arteries in the leg.

Patients saw 30 percent reduced risk of adverse events after two years of follow up. Clopidogrel outperformed aspirin in what is believed to be the first and largest randomized trial to compare the effectiveness of the two antiplatelet drugs as long term maintenance therapy for patients who had no adverse events after one year of dual antiplatelet therapy following the insertion of a coronary stent.

Shilpa Biologicals Private Limited, SBPL, has entered into a 3 year DefInitive Agreement with Dr. Reddys Laboratories Limited, DRL, for production supply of the Sputnik V vaccine from its integrated biologics R&D cum manufacturing center at Dharwad, Karnataka.

American India Foundation (AIF), on Thursday confirmed, that in collaboration with Paytm, Indian Biogas Association, Foundation For Innovation & Research In Science & Technology and Acquafront Infrastructure Pvt. Ltd., it is set to roll out Oxygen Plants in 25 of the most virus-ravaged cities in the country.

Dr. Reddys Laboratories Ltd announced that it has entered into a royalty-free, non-exclusive voluntary  licensing agreement with  Eli Lilly and Company for the manufacture and commercialization of the drug, baricitinib,in India.