XTalks

AUGUST 30, 2022

Due to consistent changes in pharmaceutical regulation, pandemic-related disturbances and the ongoing effects of digitization, visionary leaders could find themselves co-constructing their vision. Although these leadership styles are of very different natures, they also contain some commonalities. Final Thoughts on Leadership Styles.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § FDA regulations, at 21 C.F.R. 355(j)(2)(A)(v). patients in harm’s way.”

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FDA Law Blog

MARCH 26, 2024

Because a “drug product” is defined by regulation as a “Finished dosage form. that contains a drug substance ,” FTC explains that “only those [patents] that claim the finished dosage form containing the drug substance of the relevant NDA” can be listed. Teva’s patents do not meet that criterion.

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The Pharma Data

JANUARY 27, 2021

Since its inception, Vektor has worked for major and emerging drug companies to develop new and generic dosage formulations based on its sublingual and transdermal drug delivery platforms. Further, Vektor is currently engaged in the development of a sublingual drug formulation for a major European generic drug company.

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The Pharma Data

JANUARY 17, 2021

In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), a leader in the development of transdermal and sublingual drug formulations reported significant advancements in four therapeutic development programs. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. Forward looking statements.

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The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Pharmaceutical Technology

OCTOBER 28, 2022

They will need to conduct crossover studies in healthy individuals who will receive the brand name and the generic drug; the plasma concentration-time profile results will then be compared to see if the two are bioequivalent.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. That regulation is pretty clear. Take, for example, a recent instance this blogger faced when submitting generic drug Controlled Correspondence to FDA on behalf of a prospective generic drug applicant.

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Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Generics in the Market. Quitting smoking is an arduous, exhausting process. However, it is possible.

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XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program.

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FDA Law Blog

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. FOIA is a U.S.

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The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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FDA Law Blog

OCTOBER 16, 2024

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months. Drugs and Vaccines. Here in Canada, retail sales dropped by 26.4 The main reason the elastomeric respirators are being so little used?

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