India

Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.

Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.

To tackle the increase in demand for remdesivir in India amidst the second wave of COVID-19, Gilead Sciences is helping local licensees to scale up production of the product, including by providing API supplies. The company is also donating at least 450,000 vials of the Veklury brand “to help address the immediate needs of Indian patients.”

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

Indegene’s CTO talks to Scrip about the state of GenAI implementations in pharma amid hype and limited clarity on ROI, the need to address foundational issues early on, promising pilots, the firm’s alliance with Microsoft and Google’s generalist LLM for therapeutics.

Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.

A round-up of the latest global health and wellness moves: Nestlé and Dr Reddy's name JV head; Be-sup hires comms and regulatory director; Ascendis Health appoints interim CFO.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

Zydus has begun Phase I trials for an anti-properdin drug in India while its sitagliptin franchise in US, distinct from Merck’s Januvia and Janumet, looks promising. Meanwhile MD Sharvil Patel says a biosimilars entry in developed markets is possible if certain conditions are met.

Biocon maintains it doesn’t expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years.

Zydus has begun Phase I trials for an anti-properdin drug in India while its sitagliptin franchise in US, distinct from Merck’s Januvia and Janumet, looks promising. Meanwhile MD Sharvil Patel says a biosimilars entry in developed markets is possible if certain conditions are met.

Biocon maintains it doesn’t expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years.

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

With a clear focus on complex products, Lupin sets out its launch plans for the year ahead, while battling ongoing litigation over some of its generics.

Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.