Citeline Podcasts

In this episode, HBW Insight talks to Mihai Inceu about the challenges of innovating in Europe’s thriving food supplements market. Senior Regulatory Affairs Officer at Jenson R+, Inceu highlights some of the issue companies face in putting new wellness products onto the European market, particularly if they want to make health claims for herbal ingredients, also known as botanicals. As well as giving good advice about how to avoid getting into trouble with regulators, Inceu also points to some of the latest trends in this dynamic consumer healthcare space.

Medtech Monthly, Ep. 2: Where Does Diabetes Tech Stand? by Citeline

: 世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。

A Japanese-language summary of selected content from Scrip and Pink Sheet, one story at a time.

今回取り上げた記事はこちら

The article for this episode is: MSD’s Asia Pacific Chief On Lagevrio’s Gains In Clinical Utility Amid Paxlovid Luster

（邦題意訳「アジアの医療現場で躍進　コロナ治療薬ラゲブリオの強みと戦略は」）

https://scrip.pharmaintelligence.informa.com/SC146732/MSDs-Asia-Pacific-Chief-On-Lagevrios-Gains-In-Clinical-Utility-Amid-Paxlovid-Luster

【コンサルティングサービスのご紹介】

ファーマインテリジェンスのコンサルティングチームは、製薬やバイオ技術、医療機器といった分野で活躍する企業のお客様と緊密に連携し、個別の課題をピンポイントで解決します。開発途中の薬剤に関するビジネス機会評価や売上予測、価格予測をはじめ、医療経済評価モデルや臨床試験計画、ベンチマークの策定、協業戦略の策定やポートフォリオの優先順位評価など、幅広いニーズに応え、エビデンスに基づいた意思決定を支援します。今解決したい課題をお持ちの方、ぜひご相談ください。

担当者：今堀 逸太郎（[email protected]）

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC146801/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.

Gennova Biopharma’s founder CEO Sanjay Singh talks to Scrip on developing the first Indian and the world’s third mRNA vaccine against COVID-19, following Moderna and Pfizer. After a couple of years in the US at The National Institutes of Health, he returned to set up the company, which is looking at using the technology against cancer and infectious diseases like dengue and is now being sought by funds/companies for an equity stake

https://scrip.pharmaintelligence.informa.com/SC146770/CEO-Of-Indias-mRNA-Pioneer-Gennova-On-Cancer-Vaccines-VC-Interest

In this episode, I speak to Adam Ricciardone, global head of self-care research and development at Johnson & Johnson Consumer Health. Adam identifies four macro trends the company is observing worldwide: total wellness, sustainability, a focus demographic shifts and the “techceleration” of self-care. International Self Care Day was last weekend on July 24, so Adam walks us through some of J&J’s new self-care technology and explains the importance of R&D in the self-care industry. Finally, while self-care trends are similar around the globe, Adam explains why non-western countries, particularly Asian countries, are quicker to adopt some than western countries are.

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC146762/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

DCTs: Exploring The Innovative Technologies, Push For Diversity, Cybersecurity, And the Future Of Remote Trials

While diversity is largely recommended by regulators today, it is quickly becoming apparent diversity is vital for successful clinical trials in the future.

For sponsors to fulfil the requirements, continual exploration and use of decentralized trials (DCTs) are the obvious solutions.

For more information, listen to the podcast with experts from our partner at Clario.