Citeline Podcasts

Scrip’s Five Must-Know Things – 30 May 2022 by Citeline

Reporters and editors from the Pink Sheet and sister publications covering the medical device and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.

Japanese-language summary insights from Scrip and Pink Sheet, a selected story at a time.

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。

The article for this episode is:

今回取り上げた記事はこちら

Is It Tougher To Conduct Decentralized Trials In The EU? ‘Don’t Fall Prey To Negative Narrative’

邦題意訳「EU圏ではDCTがやりにくい？　ネガティブな思い込みの盲点」

https://pink.pharmaintelligence.informa.com/PS146158/Is-It-Tougher-To-Conduct-Decentralized-Trials-In-The-EU-Dont-Fall-Prey-To-Negative-Narrative

世界の薬事規制ニュースPink Sheet（ピンクシート）とは？

https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet

In this episode, HBW speaks to Barbara Kochanowski and David Spangler from the Consumer Healthcare Products Association about OTC monograph reform. The old OTC monograph system was reimagined as a part of the 2020 CARES act passed in the early stages of the pandemic. Designed to streamline and modernize the OTC monograph system, the results have been slow as the FDA has had most of its attention on the pandemic. However, as the agency hires more staff, Spangler says that we should expect to see a ‘faster moving FDA’ in the next three years. Spangler and Kochanowski also talk about the efficacy of the reforms and how they have helped educate their members about the changes.

Scrip’s Five Must-Know Things – 23 May 2022 by Citeline

EU MedTech Forum 2022: Regulatory Predictability Impacts Renewed Calls For Devices Agency by Citeline

Ausbiotech’s CEO and the Senior Trade and Investment Commissioner at the Australian Embassy in South Korea talk to Scrip’s Jung Won Shin on the sidelines of Bio Korea 2022 about what makes Australia an attractive clinical trial destination for Korean and other foreign firms, as well as collaborations and other opportunities between the two countries.

Cybin CEO: Big Pharma Can No Longer Sit On The Sidelines In Psychedelics by Citeline

In this month’s podcast, Medtech Insight's Reed Miller discusses iRhythm’s CEO Quentin Blackford’s vision for the company as it plans for expanding its remote cardiac monitoring and arrythmia diagnostics market. Marion Webb highlights conversations with ORCHA’s clinical lead Fatima Ahmed on the shortfall of trustworthy femtech apps and with medical robotic authority Moshe Shoham on the future of robotics. Barnaby Pickering introduces SpectralMD’s developed AI-augmented imaging system and NHS’ recently published readout of the OCTAPUS AI study.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Don’t Trust That (Femtech) App – Most Health Apps Don’t Meet ORCHA’s Data Privacy, Assurance Standards

SpectralMD Has Developed A Breakthrough Tool For Wound Healing

Minute Insight: NHS Employs OCTAPUS AI To Predict Lung Cancer Recurrence

Exec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Future

Exec Chat: Israel’s Authority On Medical Robotics Lifts Curtain Behind Technion’s Success Stories

Scrip’s Five Must-Know Things – 16 May 2022 by Citeline