Latest Pharma Insights
OTC Switch Application Studies Should Be ‘Generalizable To Entire Consumer Audience’
FDA ONPD chief notes literacy levels are low across US population as switch consultant and former FDA application analyst says ONDP has received switch applications based on studies with “almost no limited literacy individuals.”
HBW Insight - May 5, 2026
FDA ONPD chief notes literacy levels are low across US population as switch consultant and former FDA application analyst says ONDP has received switch applications based on studies with “almost no limited literacy individuals.”
HBW Insight - May 5, 2026
US FDA Urged To Modernize Evidence Standards For Rx-To-OTC Switches
OTC stakeholders are urging the FDA’s drug center to update evidence standards for Rx-to-OTC switches, arguing that traditional consumer behavior testing no longer reflects advances in digital tools and real-world data.
HBW Insight - May 5, 2026
OTC stakeholders are urging the FDA’s drug center to update evidence standards for Rx-to-OTC switches, arguing that traditional consumer behavior testing no longer reflects advances in digital tools and real-world data.
HBW Insight - May 5, 2026
Arvinas/Pfizer To Announce Veppanu Commercialization Partner In Weeks
The US FDA approved the drug for ESR1-mutant advanced or metastatic breast cancer as the first PROTAC drug to reach the market.
Scrip - May 4, 2026
The US FDA approved the drug for ESR1-mutant advanced or metastatic breast cancer as the first PROTAC drug to reach the market.
Scrip - May 4, 2026
Sec. 301 Investigation Opens Two-Year Window For Global Drug Pricing Reform, Soriot Says
Section 301 unfair trading practice discussions are expected to expand over the next two years, creating a window to push global drug pricing reforms.
Scrip - May 4, 2026
Section 301 unfair trading practice discussions are expected to expand over the next two years, creating a window to push global drug pricing reforms.
Scrip - May 4, 2026
Celcuity Gedatolisib PIK3CA Mutant Data Preview Pumps Up Investors
The company is already preparing for the launch of gedatolisib later this year, which could now be positioned for a broad approval in second-line HR+/HER2- breast cancer.
Scrip - May 4, 2026
The company is already preparing for the launch of gedatolisib later this year, which could now be positioned for a broad approval in second-line HR+/HER2- breast cancer.
Scrip - May 4, 2026
Pipeline Watch: Seven Approvals And Four Phase III Readouts
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - May 4, 2026
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - May 4, 2026
UCB Bets On T-Cell Engagers With $2.2bn Candid Acquisition
UCB’s proposed acquisition of Candid Therapeutics further signals an expansion of its immunology pipeline into T-cell engager-based approaches.
Scrip - May 4, 2026
UCB’s proposed acquisition of Candid Therapeutics further signals an expansion of its immunology pipeline into T-cell engager-based approaches.
Scrip - May 4, 2026
China Puts Its Stamp On A Record-Breaking Year For Novel Drug Launches
The highest ever number of new active substance launches in 2025 came after China outstripped the US as the market with the most drug debuts.
Scrip - May 4, 2026
The highest ever number of new active substance launches in 2025 came after China outstripped the US as the market with the most drug debuts.
Scrip - May 4, 2026
Paul Stoffels’s Playbook For Impactful Innovation, How India Can Step Up
Industry doyen and J&J research veteran Paul Stoffels talks about the core principles behind getting innovation right and developing the best science with highest impact on disease, sharing experiences from his storied career along the way.
Scrip - May 4, 2026
Industry doyen and J&J research veteran Paul Stoffels talks about the core principles behind getting innovation right and developing the best science with highest impact on disease, sharing experiences from his storied career along the way.
Scrip - May 4, 2026
Mind Over Legs: Two-Way Brain Interface Lets Patient Control Robotic Walking With Thoughts
USC-led researchers tested a bidirectional brain-computer interface (BCI) letting an epilepsy patient control a robotic exoskeleton while feeling each step. Now that the device has been FDA-cleared for clinical trials, the team is seeking funding to advance human studies.
Medtech Insight - May 4, 2026
USC-led researchers tested a bidirectional brain-computer interface (BCI) letting an epilepsy patient control a robotic exoskeleton while feeling each step. Now that the device has been FDA-cleared for clinical trials, the team is seeking funding to advance human studies.
Medtech Insight - May 4, 2026
Stryker Bets On IVL With AVS Acquisition As CEO Eyes Cardiology Platform Play
Stryker is not building a peripheral vascular business. It is buying one, deal by deal. The April 13 agreement to acquire Amplitude Vascular Systems is its second move in the space after Inari – and CEO Kevin Lobo made clear on the Q1 call that it will not be the last.
Medtech Insight - May 4, 2026
Stryker is not building a peripheral vascular business. It is buying one, deal by deal. The April 13 agreement to acquire Amplitude Vascular Systems is its second move in the space after Inari – and CEO Kevin Lobo made clear on the Q1 call that it will not be the last.
Medtech Insight - May 4, 2026
How Stryker’s Cyberattack Hit Ortho And MedSurg Differently – And Recovery Timelines For Each
Forty thousand laptops wiped. Manufacturing shut down. EPS down 8.5%. Yet Stryker walked out of its Q1 earnings call with full-year guidance intact, no identifiable customer losses and a CEO who said the company's brand emerged from the crisis stronger than it went in.
Medtech Insight - May 4, 2026
Forty thousand laptops wiped. Manufacturing shut down. EPS down 8.5%. Yet Stryker walked out of its Q1 earnings call with full-year guidance intact, no identifiable customer losses and a CEO who said the company's brand emerged from the crisis stronger than it went in.
Medtech Insight - May 4, 2026
OTC Switch Application Studies Should Be ‘Generalizable To Entire Consumer Audience’
FDA ONPD chief notes literacy levels are low across US population as switch consultant and former FDA application analyst says ONDP has received switch applications based on studies with “almost no limited literacy individuals.”
HBW Insight - May 5, 2026
FDA ONPD chief notes literacy levels are low across US population as switch consultant and former FDA application analyst says ONDP has received switch applications based on studies with “almost no limited literacy individuals.”
HBW Insight - May 5, 2026
US FDA Urged To Modernize Evidence Standards For Rx-To-OTC Switches
OTC stakeholders are urging the FDA’s drug center to update evidence standards for Rx-to-OTC switches, arguing that traditional consumer behavior testing no longer reflects advances in digital tools and real-world data.
HBW Insight - May 5, 2026
OTC stakeholders are urging the FDA’s drug center to update evidence standards for Rx-to-OTC switches, arguing that traditional consumer behavior testing no longer reflects advances in digital tools and real-world data.
HBW Insight - May 5, 2026
From Trials To Takeovers: How Global Streamlining Unleashed Billions Of Dollars In Biosimilar M&A
In the wake of two major deals aimed at staking out territory in the biosimilars market, Generics Bulletin speaks to industry leaders about how the changing regulatory environment has given investors confidence to place big-money bets on biosimilars.
Generics Bulletin - May 4, 2026
In the wake of two major deals aimed at staking out territory in the biosimilars market, Generics Bulletin speaks to industry leaders about how the changing regulatory environment has given investors confidence to place big-money bets on biosimilars.
Generics Bulletin - May 4, 2026
Stada And Adalvo Debut Ivermectin Cream In Europe
Stada and Adalvo have claimed the first European generic rival to Soolantra, delivering on a day-one launch ambition. Meanwhile, Adalvo has also struck a dermatology deal with Hangzhou SoliPharma for an undisclosed complex product.
Generics Bulletin - May 4, 2026
Stada and Adalvo have claimed the first European generic rival to Soolantra, delivering on a day-one launch ambition. Meanwhile, Adalvo has also struck a dermatology deal with Hangzhou SoliPharma for an undisclosed complex product.
Generics Bulletin - May 4, 2026
Astellas Settles Another Mirabegron Lawsuit, With MSN Pharma
The agreement follows a series of earlier legal settlements over generic versions of overactive bladder drug Myrbetriq in the US market.
Generics Bulletin - May 4, 2026
The agreement follows a series of earlier legal settlements over generic versions of overactive bladder drug Myrbetriq in the US market.
Generics Bulletin - May 4, 2026
Decoding The Regulatory Genome To Target Increased Clinical Success
Early into her role as CSO of Nucleome, a company peeling back the regulatory genome in search of new drug targets, Rising Leader Michelle Morrow took a breather to talk to In Vivo about the journey so far, and to come.
In Vivo - May 4, 2026
Early into her role as CSO of Nucleome, a company peeling back the regulatory genome in search of new drug targets, Rising Leader Michelle Morrow took a breather to talk to In Vivo about the journey so far, and to come.
In Vivo - May 4, 2026