Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 50
Drug Approval
Drug Approval | 29 March 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults

Drug Approval
Drug Approval | 29 March 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients

Drug Approval
Drug Approval | 28 March 2022

Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP

Drug Approval
Drug Approval | 28 March 2022

EU approves Evusheld to prevent Covid-19

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months

Drug Approval
Drug Approval | 27 March 2022

NMPA approves Hansizhuang, its first monoclonal antibody

It also empowers domestic precision immunotherapy for tumours and promotes the high-quality development of China's biopharmaceutical industry

Drug Approval
Drug Approval | 25 March 2022

Aquavit Files IND with USFDA for DTX-021, a new botulinum toxin

Aquavit will officially unveil the Dermatox and Microtox programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA

Drug Approval
Drug Approval | 25 March 2022

USFDA approves Janssen’s injectable regimen for HIV

Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV

Drug Approval
Drug Approval | 25 March 2022

Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma

This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan

Drug Approval
Drug Approval | 24 March 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

The product will be manufactured at Lupin’s facility in Goa, India

Drug Approval
Drug Approval | 24 March 2022

USFDA approves Novartis Pluvicto to treat prostrate cancer

USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions

Drug Approval
Drug Approval | 24 March 2022

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age

Drug Approval
Drug Approval | 23 March 2022

Covovax for teens get DCGI nod

It is the fourth vaccine to get the nod for 12 years and older after Biological E’s Corbevax, Bharat Biotech’s Covaxin and Zydus Lifesciences Zy-CoV-D

Drug Approval
Drug Approval | 22 March 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial

Drug Approval
Drug Approval | 22 March 2022

Indoco Remedies receives USFDA approval for Lacosamide tablets

According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion

Drug Approval
Drug Approval | 21 March 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately

Drug Approval
Drug Approval | 21 March 2022

USFDA approves Perrigo’s Nasonex

Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license

Drug Approval
Drug Approval | 21 March 2022

Zydus receives PAS approval for Mycophenolate Mofetil

The drug is indicated for use in combination with other drugs

Drug Approval
Drug Approval | 21 March 2022

Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older

Drug Approval
Drug Approval | 19 March 2022

Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug

The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis

Drug Approval
Drug Approval | 19 March 2022

USFDA approves Opdualag to treat metastatic melanoma

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab

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