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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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 maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products. Overall, 2022 phenylephrine retail sales reached $1.8

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Drug Target Review

JULY 5, 2023

The first critical decision is whether to access one of the commercially available host cell line, vector and CLD platforms on the market, or to develop a novel, proprietary system in house. 2007), 103(7): 40–47. Host cell line, vector and cell line development process – to outsource or not? References: Jayapal KP, Wlaschin KF, et al.

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The Pharma Data

JUNE 25, 2021

Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD.

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The Pharma Data

JULY 29, 2021

Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

f) clarify that a marketing application “is initially submitted on the date it contains sufficient information to allow FDA to commence review of the application.” FDA also consistently interpreted it that way between 1990 and 2007. The “review phase” is the period between the initial submission and approval of the NADA.

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Conversations in Drug Development Trends

MAY 23, 2024

Navigating Advanced Therapy Medicinal Products (ATMPs) in the EU: Regulatory Challenges : The EU has an overall regulatory framework for ATMPs , Regulation (EC) No 1394/2007. However, they also bring unique regulatory challenges.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions. 112-144 (2012).

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The Pharma Data

JUNE 1, 2022

Dr. Anderson joined Pfizer via Wyeth in 2007. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. “I want to thank Kathrin for her tremendous contribution to our scientific community and the world at large.

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Conversations in Drug Development Trends

FEBRUARY 28, 2023

Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. We are joining these researchers and patient communities on a decades-long journey to get a drug to market. But what was truly remarkable?

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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 Approved indications include CE MRI of the CNS, CE-MRA (2003), CE MRI of the liver and kidneys (2007), and CE MRI of all body regions (whole body, 2012) within the EU and other countries. mmol/kg weight. “At

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Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Under DSHEA, manufacturers are responsible for ensuring their products are safe prior to release to the market. An NDI is defined as a dietary ingredient not marketed before October 15, 1994.

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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

DECEMBER 28, 2020

Arch Gen Psychiatry , 2007 May; 64(5): 543-552. [link] . 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Accessed on Dec. 28, 2020 from [link]. 3 Merikangas et al. +1 781 609 6377.

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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

months (Vermorken et al, JCO 2007). The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6% overall response rate, a median time to progression of 2.3 months and a median overall survival of 5.8 About Innate Pharma: Innate Pharma S.A.

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Agency IQ

NOVEMBER 27, 2023

The requirement related to the presentation of side effects and contraindications was amended in 2007, with the passage of the Food and Drug Administration Amendments Act (FDAAA). In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations.

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The Pharma Data

DECEMBER 1, 2020

2007) Am J. . National Institute of Mental Health. Major Depression. Retrieved from [link]. World Health Organization. Fact Sheets: Depression, accessed November 23, 2020, [link]. Rush AJ, et al. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study). Forward Looking Statements.

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Agency IQ

NOVEMBER 10, 2023

Services incurring fees include marketing authorization applications, variations, scientific advice, and inspections. The 1995 regulation on fees recognizes 23 different basic procedural fees, according to a European Commission working document assembled as part of an evaluation of EMA’s fee system.

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New Drug Approvals

JANUARY 13, 2023

Higuchi S, Ohtsu H, Suzuki H, Shirai H, Frank GD, Eguchi S (April 2007). . “Angiotensin receptor blockers: current status and future prospects” The American Journal of Medicine. 121 (8): 656–63. doi : 10.1016/j.amjmed.2008.02.038. 2008.02.038. PMID 18691475. 112 (8): 417–28. doi : 10.1042/cs20060342. Click here to purchase.

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Agency IQ

JULY 22, 2024

EPA’s regulatory agenda for Spring 2024 Agenda Stage of Rulemaking Title Estimated Publication Former Estimated Date First on Agenda Proposed Rule Stage Removal of Affirmative Defense Provisions from Specified CAA Section 111 and 112 Regulations July 2024 Spring 2024 Final Rule Stage Standards of Performance for New, Reconstructed, and Modified Sources (..)

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LifeSciVC

NOVEMBER 30, 2023

Several years into the post-bubble bear market, the public biotech sector has only contracted by 4.5% Here are the data from BMO Capital Markets, looking at the changes to the overall public market company counts: Shutdowns were only 2% of the sector: declaring failure and closing up shop just hasn’t happened often.

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Perficient: Drug Development

AUGUST 29, 2023

Market Overall, the automotive industry is up 13%. Further, there are fresh signs of labor market strength that reinforce a picture of an economy with broad momentum despite high interest rates. Tighter than expected labor market. An Overview of the U.S. On the retail side, it is up 9% while the fleet side is up 35%.

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FDA Law Blog: Biosimilars

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect.

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The Pharma Data

MARCH 17, 2021

This approval allows marketing of KEYTRUDA monotherapy in all 27 EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland. “We are driven to advance therapies to help improve outcomes for patients with blood cancers, including those with relapsed or refractory classical Hodgkin lymphoma, through our broad clinical program.”.

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PLOS: DNA Science

SEPTEMBER 21, 2023

The October 2007 general meeting featured a panel of physicians and genetic counselors representing a trio of companies announcing plans to market direct-to-consumer (DTC) genetic tests in the coming year, deCODE Genetics and 23andMe among them.

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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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FDA Law Blog: Biosimilars

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

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Agency IQ

JUNE 2, 2023

In 2007, the FDA held a public workshop to hear from the public about the Medication Guides system; per the agency , “the public testified that the Medication Guides distribution processes needed improvement” and that it should be “shorter and easier to read.”

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The Pharma Data

APRIL 25, 2021

Estimating the burden of respiratory syncytial virus (RSV) on respiratory hospital admissions in children less than five years of age in England, 2007-2012. Infect Disord Drug Targets. 2012;12(2):92-97 5. Reeves RM et al. Influenza Other Respir Viruses. 2017;11(2):122-129 6. Sanofi Pasteur. Data on file. Rose E B et al.

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Agency IQ

MARCH 7, 2024

This follows a contentious April 2023 meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, at which the committee members raised serious concerns about the methodology of such a study and did not support its utility for a post-marketing requirement (PMR). The Tropical Disease Priority Review Voucher (PRV) program.

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Adulteration of MDMA in the Unregulated Market "Most of the concern with MDMA adulteration focuses on the plethora of other substances that have been detected in the MDMA supply. Piperazines first appeared in 2000 but saturated the market from 2008–2013, when these compounds were detected in about one-quarter (24 %) of drug items.

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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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Perficient: Drug Development

JANUARY 16, 2024

Gallup’s data shows that Americans’ trust in the healthcare system is only three points above its all-time low in 2007. With that in mind, it’s a good idea to start beefing up your team’s efforts at physician-to-physician marketing and outreach. Today’s consumers are looking at everything with a critical eye.

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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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The Pharma Data

MAY 7, 2021

It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”. . More than a third of clinical trial results never make it to the website, according to a 2020 study published in The Lancet. .

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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.

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