US Drug Approvals

Drug major Cipla Ltd on Thursday said its wholly owned subsidiary, Invagen Pharmaceuticals Inc, has entered into a strategic partnership with Qilu Pharmaceutical for the licensing and supply of a biosimilar to the cancer drug Keytruda in the United States. The product, QL2107, is a biosimilar to pembrolizumab (Keytruda) and aims to improve access to advanced therapies for cancer patients while lowering treatment costs, Cipla said in a regulatory filing. Under the agreement, Qilu will be responsible for the development, regulatory registration, and supply of the product, while Cipla will leverage its commercial presence to market the asset in the US. "This partnership reflects Cipla's confidence in the long-term potential of biosimilars and supports our strategy to build a strong oncology-focused portfolio," said Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla. Hanchang Zhang, General Manager of Qilu Pharmaceutical, said, "We are pleased to establish this ..

Company's Lacosamide Injection, available in single-dose vials, is a generic version of UCB's Vimpat; reference drug recorded annual sales of $15.2 million

The DEA said it is working closely with Indian law enforcement agencies to identify and dismantle such criminal networks at their source

Unlike most developed nations, the United States lacks a centralised price control system. Instead, prices are set by pharmaceutical firms and negotiated by insurers

It reported total revenue of $13.70 billion for the first quarter, compared with analysts' expectations of $13.91 billion, according to LSEG data

The first source said he had been told directly by government health officials that they were exploring such a policy, which he described as a mid-level priority for the Trump administration

Agreement enables company to make 'strategic entry' in ophthalmology sector in the US, it says

Biocon Biologics on Tuesday said it has inked a settlement and licensing pact with Regeneron, paving the way to commercialise its biosimilar product Yesafili in the US. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept). Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division, Biocon Biologics said in a statement. The agreement enables the company, a unit of Biocon Ltd, to launch its product in the US in the second half of 2026 or earlier in certain circumstances, it added. The terms of the settlement are confidential, it stated. "This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality ..

The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world, The Associated Press has found. An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic. The firms that are overdue for safety and quality inspections represent about 42 per cent of the 4,700 plants that are currently registered to produce drugs for the US and previously underwent FDA review before May 2019, the AP found. Most of the overdue plants are in the US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions. Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality, sa

Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1,313.05 per share on the BSE in Friday's intraday deals

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade

Endometrial cancer ranks as the fourth most prevalent cancer among women in the US. In 2022, it affected more than 66,000 patients

Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US

When you buy eyedrops at a US store, you might assume you're getting a product made in a clean, well-maintained factory that's passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little US officials know about the conditions at some manufacturing plants on the other side of the world and the limited tools they have to intervene when there's a problem. The Food and Drug Administration is asking Congress for new powers, including the ability to mandate drug recalls and require eyedrop makers to undergo inspections before shipping products to the US. But experts say those capabilities will do little without more staff and resources for foreign inspections, which were a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits. The FDA is not getting its job done in terms of drug quality assurance inspections abroad, said David Ridley of Duke University and co-author of a recen

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic pantoprazole sodium delayed-release tablets used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC, it added. Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) -- a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus. The medicine is also used for the maintenance ..

CSL Behring's Hemgenix, administered just once, cut the number of bleeding events expected over the course of a year by 54%, a key study of the therapy found