Common Sense for Drug Policy Blog

SEPTEMBER 8, 2023

3.61), working in the unregulated drug market (AOR: 4.93; 95% CI 2.87–8.49), In 2009–2012, 67.8% Odds of drug seizure were not significantly different between the two time periods (2019–2021 vs. 2009–2012) (AOR: 0.93; 95% CI: 0.64–1.35)." 8.49), and naloxone administration (AOR: 2.15; 95% CI 1.23–3.76).

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The Pharma Data

MARCH 13, 2021

Fei-Fei Li (44), a leading expert in artificial intelligence and Professor in the Computer Science Department at Stanford University in California, and Alberto Weisser (65), a renowned agricultural expert with decades of capital market experience in the United States. Li and Weisser are intended to succeed Johanna W.

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The Pharma Data

DECEMBER 7, 2020

based clinical trials investigating interventions for high blood pressure between 2009-2018, just 52 were exclusively in Black people. While the numbers grew over that decade – from 3.9% (3 of 77 trials) in 2009 to 6.2% (9 of 146) in 2018 – the increase was not enough to be statistically significant.

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Perficient: Drug Development

MARCH 15, 2024

The US is taking some oil off the market by refilling our strategic petroleum reserves. of the market. The EV market and economy have slowed, and there were fewer government incentives. $2.68 Automotive Economic Factors For the U.S. million units. million units. EV’s share of retail sales is 7.4%

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Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Eye on FDA

FEBRUARY 10, 2021

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. It was also noted that the “ Bad Ad ” program turned 10 years old this year.

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LifeSciVC

APRIL 14, 2023

Venture capital funding of private biotech startups is a process: companies are created and then serially financed as they advance their pipelines (Series A, B, C, and beyond), and if they are successful they either get bought or they matriculate into the public equity markets where they continue to access the funds required for R&D.

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The Pharma Data

NOVEMBER 9, 2020

Image: Copyright © 2009-2020 Merck Sharp & Dohme Corp., Merck and Eisai intend to discuss their new data with global regulatory authorities, with the intent to submit marketing authorization applications based on these results. a subsidiary of Merck & Co., Kenilworth, N.J., All rights reserved.

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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. 2009 Sep;14(17–18):876–84. Neurotoxicology. 2010 Aug;31(4):331–50. Drug Discov Today. Toxicol In Vitro.

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Drug Target Review

JUNE 29, 2023

It’s great that we are in clinical trials, and we are helping a certain number of patients, but if you don’t make it to the market and all that involves, then you haven’t really won because you think of all those patients that you’re no longer serving if you don’t get to that end goal.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

3582 —well before the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) established the biosimilar biological product licensure pathway, and years before the U.S. Supreme Court declined to hold, in FTC v. Actavis, Inc. , 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful.

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The Pharma Data

NOVEMBER 10, 2020

In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada.

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The Pharma Data

MAY 27, 2022

ViiV Healthcare has submitted marketing applications in? ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV.

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The Pharma Data

NOVEMBER 11, 2020

In 2009, he established Ironstone Separations Inc., He attributes his success to good fortune and hard work, and hopes to see some of his patented compounds gain approval and reach market readiness in the coming years. McChesney entered the private sector in 1996 as the vice president of development at NaPro BioTherapeutics Inc.,

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The Pharma Data

NOVEMBER 9, 2021

Apost-marketing surveillance study of cases with RA in Japan estimated the safety of OLUMIANT 4-mg and OLUMIANT 2-mg in clinical practice and no new safety signals were linked. Marketing authorization for the treatment of rehabilitated cases with COVID-19 has been granted for OLUMIANT in multiple countries. population.

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The Pharma Data

DECEMBER 20, 2020

Collaboration Strengthens Peijia’s Position for Competing in a Largely Untapped Market and Supports Global Expansion of HighLife’s Technology. Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential.

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Agency IQ

AUGUST 4, 2023

Article 18 of Regulation (EC) No 1223/2009 prohibits the marketing of cosmetic products that involved animal testing to meet the regulation’s requirements. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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LifeSciVC

JUNE 13, 2023

In the end, the government backed all our collective monies using the emergency relief fund that was spawned from the banking crisis of 2008-2009. Many CFOs likely have all this knowledge at their fingertips but for many, like me concepts of sweep accounts and money markets quickly became new jargon we had to learn.

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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.” The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. On August 8, 2024, the Court granted Nissan et al.’s

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Agency IQ

MAY 10, 2024

Ecophyto II+ also incorporated European obligations under Directive (EC) 2009/128 on the sustainable use of pesticides (SUD) to adopt national action plans setting targets for pesticide reduction. Products containing group 1 active substances which are placed on the European market are given a weighting of 1 for the calculation of HRI 1.

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The Pharma Data

OCTOBER 21, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) recently issued a positive opinion recommending marketing authorisation for long-acting cabotegravir and rilpivirine in both injectable and tablet formulations. About ViiV Healthcare.

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Drug Target Review

APRIL 8, 2024

In 2009, he became the Joseph R. Impath, one of the first companies to bring esoteric testing for cancer analysis to the market, was founded in 1988 and underwent an IPO in 1996. Dr Cote later founded Clarient, which brought high tech diagnostic capabilities to practicing pathologists and oncologists and was acquired by GE in 2009.

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Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998).

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LifeSciVC

DECEMBER 13, 2022

During the spring of 2009, when the markets hit bottom, Schrödinger’s Ramy Farid and I co-founded the company, then called Project Troubled Water, and we incubated it in the Atlas offices. Starting with some background, Nimbus isn’t a new startup – in fact, we just celebrated our 13 th anniversary.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. Patent Nos.

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New Drug Approvals

AUGUST 21, 2023

19] In January 2023, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for palovarotene for the treatment of fibrodysplasia ossificans progressiva. [20] 22 October 2009. Hind M, Stinchcombe S (November 2009). 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C., 20 June 2022.

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The Premier Consulting Blog

OCTOBER 21, 2024

However, the challenges surrounding confirmatory trials often revolve around delays and the complexities of conducting them once a drug has already hit the market. This decision, communicated in November 2022, delayed the BLA submission as the confirmatory trial needs to reach full enrollment before submission of the marketing application.

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The Pharma Data

NOVEMBER 25, 2020

The company develops, manufactures and markets pharmaceutical products for precision patient care. 2009 Oct 7; 15(37): 4638-4643. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Qual Life Res. 2000;9:491-497. Fernando B, et al. World J Gastroenterol. Favrat, B.,

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Practical Cheminformatics

APRIL 3, 2023

Marketed Drugs - 1935 marketed drugs taken from the ChEMBL database. An elegant approach to this question is the synthetic accessibility (SA) score published in 2009 by Peter Ertl and Ansgar Schuffenhauer. As usual, the code and data used in this post are available on GitHub.

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Agency IQ

JULY 22, 2024

A total ban on animal testing for cosmetics has been in place in the EU since 2013 under Regulation (EC) No 1223/2009 on cosmetic products (Cosmetics Regulation). The Commission further stated that it would “immediately” begin work on a roadmap to further reduce animal testing and transition to an animal-free regulatory framework.

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Agency IQ

FEBRUARY 15, 2024

Registration at this high level indicates that the substance has a significant presence on the EU market and, given the wide variety of its applications, has a relatively high likelihood of coming into contact with diverse populations, including consumers, and professional and industry workers. eye damage, cat. 1; skin sensitization, cat.

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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 billion and is expected to climb at a compound annual growth rate (CAGR) of 19.44% between 2023 and 2030.

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Agency IQ

MARCH 7, 2024

Influenza strains are named according to the HA and NA subtypes (at least 18 HA and 11 NA subtypes have been identified), as with the H1N1 influenza strain that famously wreaked havoc in 2009. That influenza A virus strain is now termed A(H1N1)pdm09, to signify the pandemic of 2009.

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The Pharma Data

MARCH 27, 2022

Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for OLUMIANT in multiple countries. It is approved in the U.S. To date, more than 343,000 patients have been treated with OLUMIANT worldwide across approved indications. See the full Prescribing Information here.

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Agency IQ

AUGUST 11, 2023

Similar disagreements between member states concerning the true hazard of glyphosate have at times led to a chaotic processing of market authorization in the EU. Votes held in October and November 2022 failed to garner a qualified majority to approve or reject glyphosate’s renewed market authorization.

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The Pharma Data

AUGUST 19, 2021

Under Mr. Gorsky’s leadership, the Company has delivered exceptional financial performance, with its market capitalization growing from nearly $180 billion to more than $470 billion as the share price increased over 170%. “I In 2012, he was appointed CEO and Chairman. Outside Johnson & Johnson, Mr.

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The Pharma Data

FEBRUARY 25, 2021

Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature. Tick-borne encephalitis virus in wild rodents in winter, Finland, 2008-2009. Genome Announc. Tonteri E, et al. Data on file.

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