Remove topic market-access
article thumbnail

Dr. Nirmal Kumar, VP-Quality, Alkem Laboratories

Express Pharma

Nirmal Kumar, VP – Quality, Alkem Laboratories Topic: Global market access and evolving regulatory landscapes Key Takeaway: In pharma, gaining market access provides a global dimension to the country’s economy.

52
article thumbnail

FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

FDA Law Blog: Biosimilars

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. However, Table 1 states that if the SIR request is received within 60 days of the FDA “marketing submission letter” FDA would, resources permitting, have the meeting or provide written feedback within 21 days.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Economics of Copay Accumulators, Maximizers, and Alternative Funding Programs (Video)

Drug Channels

In my most recent video webinar , I explored how plans and PBMs are turning to novel—and highly controversial—benefit design tools that access manufacturers’ patient support spending: copay accumulators, maximizers, and alternative funding programs. Click here if you can’t see the video below. d/b/a Drug Channels Institute.

78
article thumbnail

Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Nina is London based.

article thumbnail

Moderna and UK government sign deal to establish mRNA facility

Pharmaceutical Technology

This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper.

Vaccines 140
article thumbnail

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

article thumbnail

Informa Connect’s Trade and Channel Strategies

Drug Channels

A program driven by market dynamics and led by champions of channel strategy, join now to master the complexities of pharmacy and distribution models to accelerate market access –It's all happening December 11-13, 2023. Why should you attend this pivotal event? How is health policy affecting the distribution channel?