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Economía y empresa

Economía y empresa

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Economía y empresa

Economía y empresa

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Economía y empresa

Economía y empresa

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Economía y empresa

Economía y empresa

Cada semana
Economía y empresa

Economía y empresa

Cada semana
Economía y empresa

Economía y empresa

Cada dos meses
Economía y empresa

Economía y empresa

hace 2 días

11 sep

Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the impact of Michael Davis and Karim Mikhail’s promotions to permanent directors of the US Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, respectively (1:05), as well as the impact a new commissioner could have on the positions (3:20). They also discuss the FDA’s limited advisory committee schedule and the potential reasons recent senior leadership changes have not spurred more meetings (18:22). More On These Topics From The Pink Sheet US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-davis-mikhail-gain-permanent-cder-cber-director-positions-47N2SXKPHRB6BCBFLJGUF3Y2NA/ US FDA Advisory Committee Meetings Remain Rare Despite Leadership Changes: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-meetings-remain-rare-despite-leadership-changes-LD3DFLJYQFDVFCERZXRBVECY3M/
hace 2 días

Digital Health Roundup: Oura Plans IPO, FDA’s Home Health, Digital Tools For Alzheimer’s Detection

In this month: Marion Webb highlights Oura’s IPO, new partnerships, and a class-action lawsuit. George Underwood discusses digital tools for early Alzheimer’s detection and Brian Bossetta FDA’s READI-Home Innovation Challenge. Shubham Singh interviews AI longevity firm BAiO.
hace 4 días

Strategic Intent: Next‑Generation Cancer Vaccines And Nouscom’s Strategy For Interception And Personalization

"Personalized and off‑the‑shelf cancer vaccines are moving from concept to clinic, raising new questions about differentiation, manufacturability, and commercial value. In this episode of Strategic Intent, In Vivo’s David Wild speaks with Marina Udier, CEO of Nouscom, about how the Basel‑based biotech is positioning its viral vector platform in this evolving landscape. They discuss NOUS‑209, an off‑the‑shelf neoantigen vaccine for MSI‑H/dMMR tumors and cancer interception in Lynch syndrome, the company’s personalized program NOUS‑PEV, and what it will take—scientifically, operationally, and commercially—for next‑generation cancer vaccines to succeed."
hace 1 día

Assessing the current dealmaking environment for psychedelic medicine.

Joseph Haas and Emma Wille overview the dealmaking environment for psychedelic medicine given recent developments in the space: Eli Lilly's $2.8 billion acquisition of AtaiBeckley in July, the imminent FDA filing of Compass Pathways' COMP360 for treatment-resistant depression and a more relaxed regulatory environment for psychedelic therapies under the current administration.
11 sep

Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the impact of Michael Davis and Karim Mikhail’s promotions to permanent directors of the US Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, respectively (1:05), as well as the impact a new commissioner could have on the positions (3:20). They also discuss the FDA’s limited advisory committee schedule and the potential reasons recent senior leadership changes have not spurred more meetings (18:22). More On These Topics From The Pink Sheet US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-davis-mikhail-gain-permanent-cder-cber-director-positions-47N2SXKPHRB6BCBFLJGUF3Y2NA/ US FDA Advisory Committee Meetings Remain Rare Despite Leadership Changes: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-meetings-remain-rare-despite-leadership-changes-LD3DFLJYQFDVFCERZXRBVECY3M/
4 sep

Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59). More On These Topics From The Pink Sheet US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/ US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-scraps-program-that-paid-bonuses-for-completing-speedy-drug-reviews-JF5MQA73GJHDZADHXQSTB6JA2A/ US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/
8 sep

Strategic Intent: Evolving Requirements Of Life Sciences Leadership

In this episode of Strategic Intent, Nick Stephens, chairman of the recruitment and executive placement company RSA group, looks at the state of executive leadership across the life sciences and biotech industries, reflecting on inflection points for hiring practices and emerging structural trends.
hace 4 días

Scaling Self-Care In Asia Pacific, With APSMI's Rachmadi Joesoef and Anama O'Reilly

In this episode of Over the Counter, now also in video, HBW Insight talks to Rachmadi Joesoef, APSMI chair and CEO of Indonesian manufacturer PT Konimex, and Anama O'Reilly, who co-leads APSMI's public affairs and communications committee and heads public affairs for the ASEA zone at Opella, ahead of the association's joint congress with Self-CARER and GP Farmasi Indonesia in Bali. We cover why Indonesia is hosting, what Self-CARER has actually delivered on regulatory streamlining and digital health, why e-labelling deserves more attention than it gets, and the 5am fun run closing the summit. The congress runs 29 October to 1 November at the Paradisus by Meliá, Bali. The open conference covers the afternoon of 30 October and all day 31 October. Register at apsmibalimeeting2026.com, with standard pricing until 20 October. The 5K run on 1 November is a separate sign-up at selfcareamrunbali2026.com.
hace 5 días

Scrip's Five Must-Know Things - Sept, 14, 2026

Audio roundup of selected biopharma industry content from Scrip over the business week ended Sept. 11, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time—what’s next in cardiovascular R&D following recent Phase III failures; sequential gains for nine of the world’s 10 best-selling drugs in Q2; AstraZeneca’s first-in-class COPD contender out-performs Dupixent in Phase III trial; Renexxion’s co-founder explains why naronapride can succeed in gastroparesis; and Chinese companies expand global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-G5UM7ATTY5E3DAD6X7NW2OI4EA/ This and all our other podcasts are available on the new Scrip channel on Apple Podcasts, and Spotify Podcasts and on TuneIn. Contact us on podcasts@norstella.com.
4 sep

Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59). More On These Topics From The Pink Sheet US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/ US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-scraps-program-that-paid-bonuses-for-completing-speedy-drug-reviews-JF5MQA73GJHDZADHXQSTB6JA2A/ US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/

A home for specialist reporting, sharp analysis and industry intelligence across the biopharma, regulation, medtech, generics and the consumer health landscape. Norstella brings together the life sciences industry’s most authoritative news and insights brands - Scrip, Pink Sheet, In Vivo, Medtech Insight, HBW Insight and Generics Bulletin.