| |AUGUST 20269PLAQUE PSORIASIS GETS A NEW TREATMENT OPTION IN INDIAFDA NOD BOOSTS LUPIN'S PUSH INTO SLEEP DISORDER DRUGSWHY TELANGANA IS PUTTING FOOD AND DRUG SAFETY UNDER ONE ROOFGLP-1 BOOM SPARKS A NEW RACE ACROSS CONSUMER INDUSTRIESASTRAZENECA PULLS PLUG ON VOLRUSTOMIG LUNG CANCER TRIALPlaque psoriasis patients in India may soon have a new treatment option. Optimus Pharma has received approval from the Drug Controller General of India (DCGI). The approval covers Tapinarof Cream 1% w/w for adult patients with plaque psoriasis. The approval allows Optimus Pharma to manufacture and market the topical medicine in India. The company is among the first Indian firms to receive regulatory approval for this product. Tapinarof is a non-steroidal topical treatment used for plaque psoriasis. It belongs to a newer class of topical medicines called aryl hydrocarbon receptor agonists. The cream is designed for application directly to affected areas of the skin. Its non-steroidal profile may offer another choice for adults managing plaque psoriasis.Lupin has received a key FDA approval that strengthens its position in sleep disorder drugs. The approval covers its generic Pitolisant Tablets for the US market. The Food and drug safety in Telangana has entered a new regulatory phase. The state has brought its Food Safety Department and Drugs Control Administration under one administrative structure called the Telangana Standards Authority for Food and Essential Drugs.The government brought the authority into force on August 15, following an order issued on August 4. The move aims to improve coordination, enforcement, intelligence gathering and testing. However, the two departments will retain their separate statutory functions. TG SAFE will operate through six wings covering administration, enforcement, legal support and laboratories.The GLP-1 boom is pushing companies across consumer industries to rethink what people eat, drink, and buy. Weight-loss drugs are creating new demand beyond the pharmaceutical sector. Companies now see opportunities in nutrition, food, beverages, restaurants, and other consumer markets.Nestlé is among the companies moving into this space. The company is developing new products for people using GLP-1 weight-loss drugs. It is also using AI to study research and consumer needs. The goal is to help users manage nutritional needs during weight loss.Lung Cancer trial development at AstraZeneca has hit a setback. The company discontinued its Phase III eVOLVE-Lung02 study of volrustomig with chemotherapy in metastatic non-small cell lung cancer (NSCLC). An independent data monitoring committee found that the combination was unlikely to meet its primary endpoints.These included progression-free survival and overall survival in patients whose tumors lacked PD-L1. However, AstraZeneca reported positive results from two other late-stage studies involving Tagrisso with Orpathys and Enhertu. The company will also continue testing volrustomig in other cancers.latest regulatory clearance allows Lupin to market Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. The product is bioequivalent to Wakix, the reference listed drug. The development gives Lupin another opportunity to expand its presence in the US pharmaceutical market. It also adds a specialized product to the company's portfolio. The US Food and Drug Administration has approved Lupin's Abbreviated New Drug Application for Pitolisant Tablets. The tablets are available in 4.45 mg and 17.8 mg strengths. Pitolisant is used for conditions linked to narcolepsy and excessive daytime sleepiness.
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