Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays

The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

PI Industries announces twin acquisitions into Pharma API & CDMO space

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time

Ajinomoto Bio-Pharma receives FDA approval for high potency fill line

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line

NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate

Study efficacy measures will include the expression of dystrophin protein and motor function.

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression

Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData

FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults