Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. 2007 Jul;7(4):348–54. Brain Behav Evol. 2000 Jun;55(6):287–99. Scharfman HE. The Neurobiology of Epilepsy.

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The Pharma Data

JUNE 1, 2022

Anderson has led the team of infectious disease biologists that validated and delivered to an emergency use authorization PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), Pfizer’s novel COVID-19 oral treatment. Dr. Anderson joined Pfizer via Wyeth in 2007.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA will follow these procedures for both agency-initiated operations (e.g., developing or amending a monograph) or sponsor-initiated operations (e.g.,

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The Pharma Data

OCTOBER 1, 2021

Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 Safety was evaluated by analyzing the frequency of treatment-emergent adverse events (TEAE). The administration of GBCAs during MRI helps physicians answer critical medical questions within the diagnosis and monitoring of disease.

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The Pharma Data

DECEMBER 28, 2020

About ALKS 3831 (olanzapine/samidorphan) ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. Arch Gen Psychiatry , 2007 May; 64(5): 543-552. [link] .

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Agency IQ

APRIL 12, 2024

For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need. The proposed compromise tried to find a middle ground on the two outstanding issues: regulatory data protection and market exclusivity. years in the compromise text.

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The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She has been a member of the board of directors and a member of the executive committee of the New York Biotechnology Association since 2007. She earned a BA from Durham University, U.K.,

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The Pharma Data

OCTOBER 22, 2020

The steady and rapid progress of this program is a testament to our strong collaboration with AstraZeneca, and we are hopeful that together we will bring a novel treatment option to this patient population with high unmet medical need.”. months (Vermorken et al, JCO 2007). overall response rate, a median time to progression of 2.3

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New Drug Approvals

JANUARY 13, 2023

Indications Forasartan is indicated for the treatment of hypertension [6] and, similar to other ARBs, it protects the kidneys from kidney blood vessel damage caused by increased kidney blood pressure by blocking renin–angiotensin system activation. [7] Higuchi S, Ohtsu H, Suzuki H, Shirai H, Frank GD, Eguchi S (April 2007).

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The Pharma Data

MARCH 17, 2021

This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88];

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The Pharma Data

JUNE 18, 2021

On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. Bacterial Meningitis in the United States, 1998–2007.

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The Pharma Data

APRIL 25, 2021

We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. Estimating the burden of respiratory syncytial virus (RSV) on respiratory hospital admissions in children less than five years of age in England, 2007-2012. Sanofi is dedicated to supporting people through their health challenges.

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Agency IQ

MARCH 7, 2024

In particular, legislators cite “a voluntary pilot program intended to evaluate the risks when targeted cancer treatments are approved without a companion diagnostic” – referring to the pilot program established by the Oncology Center of Excellence (OCE) last year. The Tropical Disease Priority Review Voucher (PRV) program.

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Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. The Primary Copper Smelting area source NESHAP, subpart EEEEEE, was promulgated pursuant to section 112(d) of the CAA on January 23, 2007. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

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Drug Patent Watch

JANUARY 26, 2025

The Battle for Sleep: A Patent Dispute that Could Shake the CNS Market As we navigate the complexities of the pharmaceutical industry, it's not uncommon to come across disputes over patents and intellectual property. This case has significant implications for the CNS market, where sleep disorders are a growing concern.

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Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. The EPA received a petition for reconsideration of the 2006 rulemaking and, in 2007, EPA announced its reconsideration of several aspects of the rule.

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Perficient: Drug Development

DECEMBER 19, 2024

Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Pumps & Pipes: A Convergence of Expertise Founded in 2007, Pumps & Pipes exemplifies Houstons unique position as a global hub for medicine, energy, and aerospace. Anderson Foundation.

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Agency IQ

MARCH 29, 2024

These subparts were originally promulgated pursuant to section 111(b) of the CAA on June 29,1990 (subparts III and NNN), August 31, 1993 (subpart RRR), and November 16, 2007 (subpart VVa). Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal.

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. Healthy patients who would otherwise not need treatment cannot seek extended coverage. The investigational agent is considered IND exempt per the following criteria : The drug is lawfully marketed in the United States. Limitations.

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Codon

FEBRUARY 2, 2025

Although this had less to do with advanced microbial understanding, and more to do with observation and folk wisdom, some of the elements of these treatments did indeed help — especially those relating to the curative nature of good air quality. A sanatorium for tuberculosis patients in St. Blasien, Germany (1911).

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Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. Researcher Jerome Horwitz at the Michigan Cancer Foundation developed it as a potential cancer treatment by chemically-modifying thymine, a DNA building block. By February, the U.S. In Peru, that number is 6,300.

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. While we know that a late-breaking holiday horror, such as T.H. Goodbye to all that in CPAP.

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Drug & Device Law

DECEMBER 11, 2023

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. Implantable Defibrillators Products Liability Litigation , 2007 WL 2572048, at *2 (D. 30, 2007) (“joinder of the malpractice claim. . . Zimmer, Inc. 2009 WL 1809990 (S.D.

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Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. remain on the market and have been determined not to contain any nitrosamine impurities. Valsartan , 2023 WL 1818922, at *24.

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Drug & Device Law

AUGUST 24, 2023

Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention , a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams. at *8-10. at *14 (citation omitted).

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Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). Leading Market Technologies, Inc. , 2016) (applying Georgia law), held that digital marketing software was “a service and not a product.” Paragon 28, Inc.

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Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. Financial harm,” such as loss of a potential market “is a classic and paradigmatic form of injury in fact.” Sorsaia , 2023 WL 3211847, at *4.

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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.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v.

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Drug & Device Law

OCTOBER 3, 2022

The most blatant problem with Nicholson has to do with the treatment of certain data from the FDA’s medical device adverse reporting system (called “MAUDE”). It was apparently uncontradicted that “on the week of [the] surgery in 2007, the MAUDE database. . . Still, Nicholson was pretty darn depressing. was simply a non sequitur.

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. 2d 880, 892 (D.

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Drug & Device Law

MAY 30, 2022

That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. at *3 (emphasis original). Hoffman-LaRoche, Inc. , 2d 806, 817 (5th Cir. 1992) (applying Mississippi law). 692, 694 (5th Cir. Another recent decision is Hubbard v.

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