Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 59
Drug Approval
Drug Approval | 31 January 2022

USFDA approves Genentech’s Vabysmo to treat causes of vision loss

Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need

Drug Approval
Drug Approval | 28 January 2022

European Commission approves Merck’s KEYTRUDA as adjuvant therapy for RCC

KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)

Drug Approval
Drug Approval | 28 January 2022

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq

Potassium chloride is used to prevent or to treat low blood levels of potassium

Drug Approval
Drug Approval | 28 January 2022

Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%

Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA

Drug Approval
Drug Approval | 27 January 2022

Sun Pharma launches ophthalmic solution in Canada

CEQUA’s nanomicellar (NCELL) technology improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration

Drug Approval
Drug Approval | 27 January 2022

Glenmark receives ANDA approval for hydrochlorothiazide tablets

According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million

Drug Approval
Drug Approval | 26 January 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date

Drug Approval
Drug Approval | 21 January 2022

Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir

The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list

Drug Approval
Drug Approval | 21 January 2022

Bristol Myers Squibb receives approval for Abecma in Japan

It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan

Drug Approval
Drug Approval | 21 January 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain

Drug Approval
Drug Approval | 20 January 2022

Australia grants provisional registration for Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine to receive approval for provisional registration in Australia

Drug Approval
Drug Approval | 20 January 2022

Zydus receives final approval from USFDA for Vigabatrin tablets

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain

Drug Approval
Drug Approval | 20 January 2022

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

First launches expected in H1 2022

Drug Approval
Drug Approval | 20 January 2022

Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide

Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach

Drug Approval
Drug Approval | 17 January 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA

Drug Approval
Drug Approval | 17 January 2022

Strides receives USFDA approval for influenza medicine

The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval

Drug Approval
Drug Approval | 14 January 2022

WHO recommends two new drugs for COVID-19

Their strong recommendation is based on moderate certainty evidence that it improves survival and reduces the need for ventilation

Drug Approval
Drug Approval | 14 January 2022

U.S. FDA approves treatment to control pain in cats with osteoarthritis

It is the first monoclonal antibody drug for use in any animal species

Drug Approval
Drug Approval | 14 January 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily

Drug Approval
Drug Approval | 13 January 2022

South Korea approves Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine granted approval in South Korea

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