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Business & Regulation Business Practice



  • In September, Nancy Pelosi and other Democratic members of the House of Representatives unveiled their long awaited plan to reduce the cost of drugs in the US. The US drug market has been crippled by high prices, which have been justified by some as a result of the industry’s desire to pursue innovation. Though the reasoning is contentious, it is undeniable that high prices are forcing patients to make difficult choices about their health. The bill will allow Medicare to negotiate lower prices on as many as 250 drugs and apply discounts to private health plans across the US; focus on the reinvestment of savings from negotiated prices on finding new treatments; and penalize companies that increase prices at a faster rate than inflation. Pelosi’s plan will also establish an international pricing index to help bring the country’s drug pricing in line with what other nations pay.
  • According to a survey by the UK’s National Audit Office, a no-deal Brexit still poses a risk to the country’s supply of medicines. The government watchdog’s report was based on preparations being made by the Department for Health & Social Care, which estimates that of the 12,300 drugs that have market authorization in the UK, around 7000 come from (or through) the EU region. The report also explained that any extra freight capacity offered by the government would only become operational at the end of November, leaving the UK without a robust drug supply for an entire month.


  • In early October, the FDA published draft guidance on patient-focused drug development. The 45-page document – the second in a series of four – aims to help sponsors identify what matters most to patients with respect to their experience with disease burden and treatment. The guidance recommends that sponsors use a combination of qualitative, quantitative and mixed research methods to better understand patient experiences. Further to this, the document includes a section that encourages the inclusion of specific populations and culturally diverse populations, and the use of social media. 
  • The FDA is collaborating with Australia’s Therapeutic Goods Administration (TGA) and Health Canada to accelerate the approval of Eisai’s Lenvima in combination with Merck’s Keytruda. Dubbed “Project Orbis,” the collaboration aims to support patients with advanced endometrial carcinoma that is not “microsatellite instability high” or “mismatch repair deficient.” The three regulatory agencies will work together to review the application, though the labeling used in each country will differ. This is not the first collaboration between TGA and Health Canada – the agencies have previously worked together to approve Eli Lilly’s Verzenio and Janssen’s prostate cancer treatment, apalutamide.


  • GSK is spending $120 million to expand its Pennsylvania-based facility for biopharmaceutical manufacturing. The investment will upgrade the facility’s development of next-generation biologics and put the company’s R&D and manufacturing teams under one roof. 
  • Chinese drugmaker, Zhejiang Jiuzhou is set to purchase a Novartis manufacturing site based in Changshu for 790 million yuan ($111 million). As part of the agreement made with the Chinese drugmaker, Norvartis will continue to have access to the company’s supply of ingredients. The sale should be completed by the end of the year.

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About the Author

Maryam Mahdi

Assistant Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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