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Interview with Cody Simmons, CEO of DermaSensor, Maker of Handheld Skin Cancer Evaluation Tool – Xtalks Life Science Podcast Ep. 107

XTalks

Hear more about the innovative technology and application of DermaSensor in this episode. Carli P, Nardini P, Crocetti E, De Giorgi V, Giannotti B. Stanganelli I, Serafini M, Bucch L. Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Melanoma Res 2004;14(5):403-407. Dermatology.

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Fantastic News – EU initiative: Extension of the transition period for medical devices

Pharma Business Blog

The MDR has been applicable since 26 May 2021 3. – This provision extends the validity of certificates issued under Council Directives 90/385/EEC or 93/42/EEC that were valid on the day of the MDR’s date of application (26 May 2021) and which have not been withdrawn by a notified body.

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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace

FDA Law Blog

112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.” Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § Patent Nos.

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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

The Pharma Data

vs 0.25) in ASCLEPIOS I and II, respectively ( P < 001 in both studies) (primary endpoints) 1. Showed a relative risk reduction of 34% ( P =.002) 002) in 3-month confirmed disability worsening (CDW) and 32% ( P =.01) vs 0.22) and 58% (0.10

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Access solutions: the missing link that prevents biopharma innovation from reaching patients

pharmaphorum

We believe that innovation in patient access models is the necessary catalyst to aid patients in starting on and staying on the therapies they need to improve their lives. Why current patient access solutions have come up short. Yet, the healthcare experience is antiquated. On top of that, traditional solutions provide delayed program data.

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Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

The Pharma Data

After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients in the induction-only control group (p<0.001). analysis plan), with 52 percent on risankizumab 360 mg achieving clinical remission versus 41 percent in the induction-only control group (p<0.01).

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Combating antimicrobial resistance with a viable alternative to traditional antibiotics

pharmaphorum

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 million 1 people per year and projected to rise to 10 million people by 2050 2. It occurs when bacterial pathogens adapt over time to develop resistance to traditional antibiotics, resulting in “superbugs” that are near impossible to treat.

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