19th March 2022 | Pharma Updates

PharmaState Updates – Latest Pharma Happenings

GSK gets CDSCO panel approval to conduct trial on antineoplastic medication

GSK has received approval from CDSCO’s Subject Expert Committee to market Mepolizumab injection solution for two rare diseases.

India's first mRNA COVID vaccine's phase 2,3 study has been submitted to the DCGI

Pune-based Gennova Biopharmaceuticals filed data from the phase-II and phase-III trials of India’s first mRNA Covid vaccine to the regulator DCGI.

Sanofi and Seagen partnered for multiple novel antibody-drug conjugates

Sanofi and Seagen announced an exclusive partnership to design, develop, and commercialise antibody-drug conjugates (ADCs) targeting up to three cancer targets.

Amidst Covid outbreak, Center asked states to monitor ILI and SARI cases

Centre has advised nations to resume monitoring influenza-like sickness and severe acute respiratory infections, citing a rise of coronavirus outbreaks in Southeast Asia and parts of Europe.

After two doses of COVAXIN, using COVISHIELD as a booster raises antibodies by six times

According to early findings, giving COVISHIELD as a preventive dosage to people who have already received two doses of COVAXIN would result in a sixfold increase in antibody levels.

ZTALMY® (ganaxolone) has been approved by the FDA for CDKL5 Deficiency Disorder

FDA has approved ZTALMY oral suspension for the treatment of seizures associated with cyclin-dependent kinase like 5 deficiency disorder, a rare form of hereditary epilepsy, in children two years of age and older.

FoundationOne CDx has been approved by the FDA

FoundationOne CDx has been approved by the FDA as a companion diagnostic for patients with NSCLC who have EGFR exon 19 deletions or exon 21 changes and are candidates for EGFR tyrosine kinase inhibitors.

Akston Biosciences and Biolexis have teamed up for 2nd generation COVID-19 vaccine

Akston Biosciences Corporation and Biolexis have announced that they have reached an agreement for Akston’s AKS452, a protein subunit COVID-19 vaccine, to be licenced, manufactured, and commercialised.

Moderna seeks FDA approval for the fourth dosage of the COVID-19 vaccine

Moderna, a pharmaceutical company, petitioned the FDA on Thursday to approve a fourth dose of its COVID-19 vaccination as a booster dose for all adults.

Nivolumab/Relatlimab Combo Approved by FDA for Unresectable or Metastatic Melanoma

For patients with unresectable or metastatic melanoma, the FDA has approved a combination of nivolumab and relatlimab-rmbw. The phase 2/3 RELATIVITY-047 trial compared the combination to single-agent nivolumab.