Company News

Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) for its Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

On 8th March, 2024, US FDA Inspection at Alembic Pharmaceuticals Limited’s Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

AstraZeneca announced that it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a surplus of available updated vaccines since the pandemic.

The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe.

In Q1 2024, worldwide revenue was USD 8.77 billion, an increase of 26 percent compared with Q1 2023, driven by increases of 16 percent in volume and 10 percent due to higher realized prices. The volume increase was primarily driven by growth from Mounjaro, Zepbound, Verzenio and Jardiance, partially offset by declines in Trulicity.

Novo Nordisk announced the headline results from the kidney outcomes trial FLOW. The announcement follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD).

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

Bristol Myers Squibb announced today that it has successfully completed its acquisition of RayzeBio, Inc. With the completion of the acquisition, RayzeBio shares have ceased trading on the NASDAQ Global Market and RayzeBio is now a wholly owned subsidiary of Bristol Myers Squibb.

US FDA conducted a Pre-Approval Inspection (PAI) inspection of Piramal Pharma Limited's Lexington (USA) facility from 20 th February, 2024 to 23rd February, 2024 for one of the product expected to be manufactured at this facility.

On conclusion of the inspection, a Form-483 was issued with 2 observations. The observations does not pose any risk to site’s compliance standards or its business continuity.

Biogen Inc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.