Latest news and insights on the pharmaceutical industry | Indian Pharma Post
Drug Approval
Drug Approval | 01 July 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S

Drug Approval
Drug Approval | 01 July 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.

Drug Approval
Drug Approval | 30 June 2022

India’s first mRNA vaccine from Gennova gets DCGI approval

It is a two dose vaccine to be administered intramuscularly at 28 days apart

Drug Approval
Drug Approval | 29 June 2022

Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions

Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2

Drug Approval
Drug Approval | 28 June 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients

Drug Approval
Drug Approval | 27 June 2022

Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease

The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects

Drug Approval
Drug Approval | 24 June 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally

Drug Approval
Drug Approval | 24 June 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.

Drug Approval
Drug Approval | 24 June 2022

Rivaroxaban approved in Japan for patients with PAD after revascularisation

It´s the first trial to demonstrate the benefits of dual pathway inhibition

Drug Approval
Drug Approval | 23 June 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients

Drug Approval
Drug Approval | 16 June 2022

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation

Drug Approval
Drug Approval | 15 June 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head

Drug Approval
Drug Approval | 14 June 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial

Drug Approval
Drug Approval | 12 June 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive

Drug Approval
Drug Approval | 12 June 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.

Drug Approval
Drug Approval | 12 June 2022

China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer

Tislelizumab is now approved in nine indications in China

Drug Approval
Drug Approval | 10 June 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood

Drug Approval
Drug Approval | 09 June 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.

Drug Approval
Drug Approval | 08 June 2022

Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection

he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.

Drug Approval
Drug Approval | 08 June 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.

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