Latest Pharma Insights
Supplement Registration And Pre-DSHEA Lists: Key Missing Tools Limiting US Pre-Market Review
FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.
HBW Insight - December 11, 2025
FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.
HBW Insight - December 11, 2025
Aerogen’s Vibrating Nebulizer Could Be Breakthrough For Premature Infants
Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes
Medtech Insight - December 11, 2025
Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes
Medtech Insight - December 11, 2025
Finance Watch: Biopharma Firms Price $3.2bn In Follow-On Offerings In One Night
FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.
Scrip - December 10, 2025
FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.
Scrip - December 10, 2025
Pfizer Could Claim Tukysa First-Line HER2+ Metastatic Breast Cancer Indication
Pfizer’s Phase III data show an 8.6-month increase in progression-free survival for Tukysa as first-line maintenance treatment of HER2+ breast cancer, a setting where the standard of care hasn’t changed since 2012.
Scrip - December 10, 2025
Pfizer’s Phase III data show an 8.6-month increase in progression-free survival for Tukysa as first-line maintenance treatment of HER2+ breast cancer, a setting where the standard of care hasn’t changed since 2012.
Scrip - December 10, 2025
Roche’s Giredestrant Data Could Set The Stage For A New Standard Of Care
The selective estrogen receptor degrader reduced the risk of invasive disease recurrence or death by 30% in ER-positive early stage breast cancer.
Scrip - December 10, 2025
The selective estrogen receptor degrader reduced the risk of invasive disease recurrence or death by 30% in ER-positive early stage breast cancer.
Scrip - December 10, 2025
Autolous Looks To Expand Its CAR-T Into Crowded Lupus Field
After a solid but modest launch in acute lymphoblastic leukemia, Autolus sees an opportunity for its CAR-T in autoimmune disease, starting with lupus nephritis.
Scrip - December 10, 2025
After a solid but modest launch in acute lymphoblastic leukemia, Autolus sees an opportunity for its CAR-T in autoimmune disease, starting with lupus nephritis.
Scrip - December 10, 2025
GSK Boosts ADC Heft Through Pact With Oxford BioTherapeutics
GSK builds up its arsenal of antibody-drug conjugates, while Oxford BioTherapeutics adds another pharma heavyweight to its expansive roster of partners.
Scrip - December 10, 2025
GSK builds up its arsenal of antibody-drug conjugates, while Oxford BioTherapeutics adds another pharma heavyweight to its expansive roster of partners.
Scrip - December 10, 2025
Gamida Cell Goes From Strength To Strength With Another US FDA Nod
The company, which was on the verge of bankruptcy last year, has secured an expanded approval for Omisirge for severe aplastic anemia.
Scrip - December 10, 2025
The company, which was on the verge of bankruptcy last year, has secured an expanded approval for Omisirge for severe aplastic anemia.
Scrip - December 10, 2025
Phrontline’s Two-Pronged Shot At Bispecific, Dual-Payload ADCs
To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.
Scrip - December 10, 2025
To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.
Scrip - December 10, 2025
Aerogen’s Vibrating Nebulizer Could Be Breakthrough For Premature Infants
Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes
Medtech Insight - December 11, 2025
Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes
Medtech Insight - December 11, 2025
Supplement Registration And Pre-DSHEA Lists: Key Missing Tools Limiting US Pre-Market Review
FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.
HBW Insight - December 11, 2025
FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.
HBW Insight - December 11, 2025
Formycon Partners With Zydus To Capture US-Canada Keytruda Biosimilar Market
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
Generics Bulletin - December 10, 2025
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
Generics Bulletin - December 10, 2025
FDA Publishes PSGs For GLP-1 Giants Mounjaro, Wegovy, Victoza/Saxenda
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Generics Bulletin - December 10, 2025
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Generics Bulletin - December 10, 2025
Teva Files LAI Olanzapine With FDA, Paving Way for $2bn Schizophrenia Franchise
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
Generics Bulletin - December 10, 2025
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
Generics Bulletin - December 10, 2025
German Giants Rise Up The Ranks In Generics Bulletin’s Top 50
Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.
In Vivo - December 10, 2025
Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.
In Vivo - December 10, 2025
Europe Leads Charge As Private Equity Roars Back Into Off-Patent Pharma
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
In Vivo - December 10, 2025
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
In Vivo - December 10, 2025
Execs On The Move: November 2025
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - December 10, 2025
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - December 10, 2025
Indegene Exec On R&D Operations In The Age Of GenAI, One Click Submissions
Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.
In Vivo - December 10, 2025
Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.
In Vivo - December 10, 2025
Podcast: Kairos Pharma’s Approach To Resensitizing Tumors
In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.
In Vivo - December 10, 2025
In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.
In Vivo - December 10, 2025