Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 42
Drug Approval
Drug Approval | 18 October 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting

Drug Approval
Drug Approval | 18 October 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm

Drug Approval
Drug Approval | 16 October 2021

Dr Reddy’s Lab launches carmustine in the US market

The BiCNU brand and generic market had U.S. sales of approximately US $ 19.4 million MAT for the most recent twelve months ending in August 2021, according to IQVIA Health

Drug Approval
Drug Approval | 14 October 2021

IOL receives Korean FDA approval

The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead

Drug Approval
Drug Approval | 13 October 2021

Dr Reddy’s launch anti-cancer drug in China

Abiraterone by Dr Reddy's becomes the first anti-cancer drug from India to enter the Chinese market

Drug Approval
Drug Approval | 12 October 2021

Covaxin for kids gets nod, final approval awaited

The two doses of Covaxin are likely to be administered to children with a gap of 28 days

Drug Approval
Drug Approval | 12 October 2021

Intas launches the world's first SB-100mg Itraconazole

Conventional Itraconazole mainstay drug to fight fungal infection has high result variance and low patient compliance because of dosing dependence upon food, acidic beverage and antacid consumption

Drug Approval
Drug Approval | 11 October 2021

Glenmark launches Tavulus for COPD treatment in Spain

It is one of the first companies to launch a bioequivalent version of the dry powder inhaler and it's part of the company’s strategic exclusive in-licensing arrangement to market Tiotropium DPI in Western Europe and the UK

Drug Approval
Drug Approval | 09 October 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery

Drug Approval
Drug Approval | 07 October 2021

WHO gives its go-ahead for first-ever malaria vaccine

It recommends using the vaccine to prevent the spread of the disease

Drug Approval
Drug Approval | 06 October 2021

WHO decision on Covaxin approval next week

Bharat Biotech has been submitting data to the WHO on a rolling basis and submitted additional information at WHO’s request on September 27th 2021

Drug Approval
Drug Approval | 06 October 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India

Drug Approval
Drug Approval | 06 October 2021

EMA authorises booster dose of Moderna’s Spikevax

A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects

Drug Approval
Drug Approval | 04 October 2021

Biocon launches Everolimus tablets in the US

According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021

Drug Approval
Drug Approval | 04 October 2021

Lilly to transfer rights of two diabetes drugs to Cipla in India

Lilly will continue to maintain its existing operating model for the remaining portfolio of products

Drug Approval
Drug Approval | 01 October 2021

Natco announces launch of 10 mg Everolimus in the US

According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021

Drug Approval
Drug Approval | 30 September 2021

Glenmark receives marketing approval for Ryaltris in 13 countries across the EU and UK

Ryaltris is a fixed dose combination nasal spray that combines an antihistamine (Olopatadine) with a steroid (Mometasone Furoate) for treatment of allergic rhinitis

Drug Approval
Drug Approval | 29 September 2021

Lupin launches Droxidopa capsules in the US

Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA

Drug Approval
Drug Approval | 29 September 2021

MSD India launches 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9

India’s first gender-neutral HPV vaccine to help reduce HPV -related disease burden in Indian girls, women and boys

Drug Approval
Drug Approval | 28 September 2021

Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low

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