Regulatory
Regulatory | 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

Regulatory
Regulatory | 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

Regulatory
Regulatory | 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

Regulatory
Regulatory | 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

Regulatory
Regulatory | 28 September 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan

Regulatory
Regulatory | 28 September 2021

Sun Pharma launches novel cough medicine

Chericof 12, the first prescription cough syrup in India which gives relief for up to 12 hours, is manufactured using Polistirex technology for sustained release of the drug

Regulatory
Regulatory | 27 September 2021

U.S. FDA approves Repatha for paediatric patients aged 10 years and older

The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients

Regulatory
Regulatory | 26 September 2021

AstraZeneca Pharma India receives permission for paediatric drug

It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses

Regulatory
Regulatory | 24 September 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Regulatory
Regulatory | 23 September 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups

Regulatory
Regulatory | 21 September 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States

Regulatory
Regulatory | 21 September 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%

Regulatory
Regulatory | 21 September 2021

Lincoln Pharma plans to launch Cephalosporin product portfolio soon

Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others

Regulatory
Regulatory | 20 September 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting

Regulatory
Regulatory | 18 September 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC

Regulatory
Regulatory | 18 September 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy

Regulatory
Regulatory | 18 September 2021

Zydus Cadila receives final nod for anti-depressant

The medicine helps restore the balance of certain natural substances (serotonin) in the brain

Regulatory
Regulatory | 17 September 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose

Regulatory
Regulatory | 16 September 2021

Lancet study confirms Johnson & Johnson Ebola vaccine safe

Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses

Regulatory
Regulatory | 15 September 2021

Lupin launch a generic version of pain reliever for osteoarthritis in the US

Ibuprofen and Famotidine tablets (Duexise) had estimated annual sales of US $ 765 million in the US as if July 21

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