Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 9
Drug Approval
Drug Approval | 12 December 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market

Drug Approval
Drug Approval | 09 December 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen

Drug Approval
Drug Approval | 07 December 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients

Drug Approval
Drug Approval | 06 December 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma

Drug Approval
Drug Approval | 05 December 2024

Alembic Pharmaceuticals gets USFDA tentative approval for OTC

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

Drug Approval
Drug Approval | 05 December 2024

Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets

Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Drug Approval
Drug Approval | 04 December 2024

Gland Pharma receives approval for Latanoprost Opthalmic Solution, 0.005%

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan

Drug Approval
Drug Approval | 25 November 2024

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse

Drug Approval
Drug Approval | 21 November 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors

Drug Approval
Drug Approval | 20 November 2024

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US

Drug Approval
Drug Approval | 19 November 2024

Shilpa Pharma Lifesciences received CEP from EDQM for API, Octreotide

Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis

Drug Approval
Drug Approval | 19 November 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years

Drug Approval
Drug Approval | 16 November 2024

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

Drug Approval
Drug Approval | 16 November 2024

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial

Drug Approval
Drug Approval | 13 November 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

Drug Approval
Drug Approval | 11 November 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Drug Approval
Drug Approval | 10 November 2024

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Drug Approval
Drug Approval | 09 November 2024

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Drug Approval
Drug Approval | 02 November 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature

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