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Henkel Recalls Hair Mousse Over ‘Risk Of Explosion’; Beauty Regulatory Roundup
Henkel initiates voluntary product recall in the US over packaging; US FDA renews Inter-Center Agreement between the Center for Drug Evaluation and Research and the Office of the Chief Scientist; Beauty Reg Roundup
HBW Insight - August 20, 2026
Lilly Goes Deeper Into Infectious Disease With Amplitude
Deal Snapshot: The big pharma continues its investment in infectious disease through a collaboration with Lilly Gateway Labs participant Amplitude, which is working on trans-amplifying RNA vaccines.
Scrip - August 20, 2026
Finance Watch: Venture Capital Investors Meet Biotechs In The Middle
Private Company Edition: Kynexis raised a €40m ($46.7m) series A extension, bringing the round’s total to €97m ($110m), an example of venture capital investors participating in mid-sized rounds, a segment of the capital markets that has been especially difficult.
Scrip - August 20, 2026
Agentic AI Lowers Trial Costs By Automating Clinical Research Tasks
A study by Tufts CSDD of Medable’s AI clinical monitoring agents quantifies how much drugmakers can save on clinical trial costs when they adopt agentic artificial intelligence to augment the activities of clinical research associate (CRA) staff.
Scrip - August 20, 2026
Number Of Vapers Globally Has Nearly Doubled Since 2020
Adult vaping worldwide has nearly doubled since 2020 to around 129m, according to the latest GSTHR situation report, as governments step up action through bans, flavor restrictions and taxes.
HBW Insight - August 20, 2026
Gubra AI Discovery Engine Uncovers Another Promising Obesity Therapy
The Danish firm has initiated a Phase I/IIa trial on a long-acting corticotropin-releasing hormone receptor 2 agonist which shows pipeline-in-a-product potential.
Scrip - August 20, 2026
Execs On The Move: August 10–14, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - August 20, 2026
Ivermectin Among 10 Rx-to-OTC Switches Approved In Argentina
Argentina's ANMAT has switched 10 APIs from Rx to OTC, including ivermectin and trimebutine maleate, the latter drawing pushback from pharmacists who dispute the regulator's cited international precedents.
HBW Insight - August 20, 2026
Ultragenyx Lands Genglycos Approval And Sets Its Sights On A PRV Double
Ultragenyx has gained US FDA approval for its first gene therapy, Genglycos, and the regulator is set to decide on another therapy from the firm by mid-September.
Scrip - August 20, 2026
After 10-Year Dispute, US FDA Grants Hearing On Lannett Generic Concerta Withdrawal
The central factual issue for the hearing, possibly one of the first of its kind, on CDER’s proposal to withdraw Lannett’s methylphenidate ANDA is whether the generic has been shown to be bioequivalent to Janssen Pharmaceuticals’ Concerta.
Generics Bulletin - August 20, 2026
EU To Procure €2.5m Of Ebola Tests As Medtech Response Builds Momentum
Ten tests emerge as frontrunners in global outbreak response, but rapid tests specifically for the Bundibugyo virus remain elusive.
Medtech Insight - August 20, 2026
Biosimilars Are Powering Henlius’ Global Biopharma Push
Chinese biologics specialist Shanghai Henlius Biotech tells Generics Bulletin how its biosimilars business is funding innovation, supporting global expansion and providing the platform for increasingly complex development programs and partnerships.
Generics Bulletin - August 20, 2026
Outlook Bids On Lytenava’s Differentiated Position As It Readies To Enter The US
Outlook Therapeutics is positioning Lytenava as the only FDA-approved ophthalmic bevacizumab, occupying a distinct space from biosimilars used off-label in the US retina market.
Generics Bulletin - August 20, 2026
Ustekinumab Setback Tests Richter’s Expanding Biosimilar Business
Richter’s Usymro (ustekinumab) biosimilar launch has been put on hold over manufacturing compliance issues, complicating an otherwise improving Biotechnology story as new launches drive growth and breakeven moves closer.
Generics Bulletin - August 20, 2026
FDA Proposes To Reclassify Blue-Light Cystoscopy Systems, Opens Karl Storz–Photocure Bladder Cancer
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
After Two Decades Under PMA, Oncology ISH Companion Tests Get A Lighter Regulatory Path
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026
Estée Lauder Restructuring Hits Mark; Innovation Drives Next Phase
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026

Lilly Goes Deeper Into Infectious Disease With Amplitude
Deal Snapshot: The big pharma continues its investment in infectious disease through a collaboration with Lilly Gateway Labs participant Amplitude, which is working on trans-amplifying RNA vaccines.
Scrip - August 20, 2026
Finance Watch: Venture Capital Investors Meet Biotechs In The Middle
Private Company Edition: Kynexis raised a €40m ($46.7m) series A extension, bringing the round’s total to €97m ($110m), an example of venture capital investors participating in mid-sized rounds, a segment of the capital markets that has been especially difficult.
Scrip - August 20, 2026
Agentic AI Lowers Trial Costs By Automating Clinical Research Tasks
A study by Tufts CSDD of Medable’s AI clinical monitoring agents quantifies how much drugmakers can save on clinical trial costs when they adopt agentic artificial intelligence to augment the activities of clinical research associate (CRA) staff.
Scrip - August 20, 2026
Gubra AI Discovery Engine Uncovers Another Promising Obesity Therapy
The Danish firm has initiated a Phase I/IIa trial on a long-acting corticotropin-releasing hormone receptor 2 agonist which shows pipeline-in-a-product potential.
Scrip - August 20, 2026
Ultragenyx Lands Genglycos Approval And Sets Its Sights On A PRV Double
Ultragenyx has gained US FDA approval for its first gene therapy, Genglycos, and the regulator is set to decide on another therapy from the firm by mid-September.
Scrip - August 20, 2026

Execs On The Move: August 10–14, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - August 20, 2026
EU To Procure €2.5m Of Ebola Tests As Medtech Response Builds Momentum
Ten tests emerge as frontrunners in global outbreak response, but rapid tests specifically for the Bundibugyo virus remain elusive.
Medtech Insight - August 20, 2026
FDA Proposes To Reclassify Blue-Light Cystoscopy Systems, Opens Karl Storz–Photocure Bladder Cancer
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
After Two Decades Under PMA, Oncology ISH Companion Tests Get A Lighter Regulatory Path
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026

Henkel Recalls Hair Mousse Over ‘Risk Of Explosion’; Beauty Regulatory Roundup
Henkel initiates voluntary product recall in the US over packaging; US FDA renews Inter-Center Agreement between the Center for Drug Evaluation and Research and the Office of the Chief Scientist; Beauty Reg Roundup
HBW Insight - August 20, 2026
Number Of Vapers Globally Has Nearly Doubled Since 2020
Adult vaping worldwide has nearly doubled since 2020 to around 129m, according to the latest GSTHR situation report, as governments step up action through bans, flavor restrictions and taxes.
HBW Insight - August 20, 2026
Ivermectin Among 10 Rx-to-OTC Switches Approved In Argentina
Argentina's ANMAT has switched 10 APIs from Rx to OTC, including ivermectin and trimebutine maleate, the latter drawing pushback from pharmacists who dispute the regulator's cited international precedents.
HBW Insight - August 20, 2026
Estée Lauder Restructuring Hits Mark; Innovation Drives Next Phase
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026

After 10-Year Dispute, US FDA Grants Hearing On Lannett Generic Concerta Withdrawal
The central factual issue for the hearing, possibly one of the first of its kind, on CDER’s proposal to withdraw Lannett’s methylphenidate ANDA is whether the generic has been shown to be bioequivalent to Janssen Pharmaceuticals’ Concerta.
Generics Bulletin - August 20, 2026
Biosimilars Are Powering Henlius’ Global Biopharma Push
Chinese biologics specialist Shanghai Henlius Biotech tells Generics Bulletin how its biosimilars business is funding innovation, supporting global expansion and providing the platform for increasingly complex development programs and partnerships.
Generics Bulletin - August 20, 2026
Outlook Bids On Lytenava’s Differentiated Position As It Readies To Enter The US
Outlook Therapeutics is positioning Lytenava as the only FDA-approved ophthalmic bevacizumab, occupying a distinct space from biosimilars used off-label in the US retina market.
Generics Bulletin - August 20, 2026
Ustekinumab Setback Tests Richter’s Expanding Biosimilar Business
Richter’s Usymro (ustekinumab) biosimilar launch has been put on hold over manufacturing compliance issues, complicating an otherwise improving Biotechnology story as new launches drive growth and breakeven moves closer.
Generics Bulletin - August 20, 2026

Regeneron’s Lowy Bets Combinations Will Carry Its Oncology Business Past PD-1
Regeneron built a PD-1 franchise approaching $2bn in annual sales, then bet on antibody combinations, bispecifics and radiopharma. The biology is sound but execution, toxicity and trial design remain challenges.
In Vivo - August 19, 2026
The $2.2tn Efficiency Gap: Who Got Their Money’s Worth?
The top 15 drugmakers spent $2.2tn over a decade. Only BMS and Takeda destroyed value; Lilly, Novo Nordisk and AstraZeneca converted spending into outsized value.
In Vivo - August 19, 2026