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Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. . ALISO VIEJO, Calif. ,

FDA Approval

FDA Approval Treatment FDA Therapies

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

AUGUST 12, 2024

For animal drugs approved under FDC Act § 512, the “testing phase” begins on the earlier of the effective date of an Investigation New Animal Drug (“INAD”) exemption or the date a major health or environmental effects test on the drug was initiated and ends on the date a NADA is “initially submitted” to FDA under FDC Act § 512(b).

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Otsuka beats back Novartis opposition with $15M purchase of smart pill developer Proteus

The Pharma Data

AUGUST 20, 2020

Otsuka wasn’t Proteus’ only pharma investor, though; Novartis threw in $24 million back in 2010. Now that Otsuka is approved to fold in Proteus, the world will officially say goodbye to the “smart pill” unicorn, once valued at $1.5 One potential reason for the struggle?

FDA Approval

FDA Approval FDA Production Marketing

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § To that end, 35 U.S.C. § 156(c)(4)

FDA Approval

FDA Approval FDA Production Therapies

Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

The Pharma Data

NOVEMBER 10, 2020

FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (“PMX”). PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. ” About Spectral and Dialco. Spectral is a Phase III company seeking U.S.

Therapies

Therapies FDA Nurses FDA Approval

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. But despite a recent attempt by the FDA to wrangle the industry into some degree of control, the agency has not followed through on a threat to go after companies that failed to go through a required premarket review process.

FDA

FDA Science Production FDA Approval

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC | APR 24, 2024 10:56 PM CDT Biosimilars and interchangeable products The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act. Yes, the guidance confirms.

Biosimilars

Biosimilars Science FDA Licensing

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval

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FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

OCTOBER 14, 2020

agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate. 2010 Jul;59(7):1131-5. Epub 2010 Apr 2. and its affiliate NantKwest, Inc. The Oncol, 25: 479-e899. doi: 10.1634/theoncologist.2019-0608.

Vaccine

Vaccine Trials FDA Clinical Trials

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. LUMAKRAS received accelerated approval based on overall response rate and duration of response. In May, the U.S.

Biosimilars

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014. Curiously, there is no direction for the patient to seek out the full FDA-approved labeling.

FDA

FDA FDA Approval Production Regulations

Beyond Steel Tanks

Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

Engineering

Engineering Vaccine Production RNA

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Countries supported by PEPFAR saw HIV cases drop by 52 percent in 2023 compared to 2010, outpacing the 39 percent global decline. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. In Peru, that number is 6,300.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 21, 2023

23, 2010) ( here ), can supersede our list, so far they’ve been thankfully uncommon. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale. Novartis , 407 P.3d

FDA Approval

FDA Approval FDA Drugs Production

Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. The class period is between 1999 and 2010. at *3 (footnote omitted).

Testimonials

Testimonials Pharmacy FDA Doctors

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

Drug & Device Law

MARCH 16, 2023

2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Indeed, she claimed FDA told the defendant to remove the drug from the market because of those risks in 2005, the year she was first prescribed it. The short version is that the Sixth Circuit in Wimbush v. Wyeth , 619 F.3d 3d 632 (6th Cir. Wyeth , 85 A.3d

FDA Approval

FDA Approval FDA Testimonials Production

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA

FDA FDA Approval Testimonials Vaccine

Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

Webinars

Trending Sources

Otsuka beats back Novartis opposition with $15M purchase of smart pill developer Proteus

Webinars

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

Amgen Reports Second Quarter 2021 Financial Results

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Beyond Steel Tanks

Making a “Miracle” HIV Medicine

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Another RICOdiculous Decision

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

The FDA and Feasible Alternative Designs

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