FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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The Pharma Data

JULY 3, 2025

Comprehensive Report Reveals Key Trends in Gynecology Collaboration and Licensing Deals from 2016 to 2025 Gynecology Collaboration and Licensing Deals report offers a deep dive into the evolving landscape of partnerships in women’s health, providing unparalleled insights into over 150 strategic deals executed globally between 2016 and 2025.

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Perficient: Drug Development

APRIL 2, 2025

Data plays a crucial role in Xerox’s digital transformation strategy and highlights the importance of integrating data from various sources to create a unified view that enables better decision-making and more effective marketing. Listen to the podcast to hear more about internal disruption and digital innovation!

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SCIENMAG: Medicine & Health

JUNE 8, 2023

Chilean policies aimed at reining in unhealthy food marketing are succeeding in protecting children from the onslaught of television advertisements (TV ads) for these products, according to new research.

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Drug Channels

AUGUST 17, 2021

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. That’s about six times its 2016 figure. That’s about six times its 2016 figure. Instead, consider how GoodRx is affecting patients, payers, and PBMs. We estimate that the company accounted for $4.1 billion in U.S.

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Drug Channels

DECEMBER 13, 2021

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. That’s about six times its 2016 figure. Consequently, discount cards could become the force that upends PBMs’ pharmacy benefit economics, plan sponsors’ decisions, and the entire generic market. billion in U.S.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). Fincoeur et al.

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LifeSciVC

APRIL 26, 2024

Fundamentally, even during tighter markets like today, great talent is always a very constrained resource, and spreading it too thinly across too many companies isn’t good for the ecosystem. Overall, this contraction is a strong positive sign of healthy discipline, and should be good for the sector’s mid- and long-term prospects.

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 The oncology market for antibody–drug conjugates.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

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Common Sense for Drug Policy Blog

JUNE 17, 2024

Growth in New/Novel Psychoactive Substances "The most recent data shows that drug producers continue to create new substances to avoid legal controls, although the rate at which new psychoactive substances are now entering the market appears to be slowing.

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Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. Select the right partner with experience meeting regulatory standards for all target markets.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. At the time, in 2016, the Gree Companies’ settlement for $15.45 It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co. and Gree USA Inc.

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Conversations in Drug Development Trends

AUGUST 5, 2024

Role at Worldwide: Associate Director of Project Management/Global Project Lead Joined Worldwide: September 2016 LinkedIn: Margo A Smith Get to Know Margo through this Q&A What attracted you to Worldwide and what keeps you here? I started Worldwide as a clinical trial manager back in 2016. Describe the culture at Worldwide.

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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. 2016 Sep 1;81:15–20. 2016 Jan 15;96:253–73. J Pharmacol Toxicol Methods. Toxicol In Vitro.

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New Drug Approvals

OCTOBER 12, 2024

After tramiprosate failed in Phase 3, its maker, NeuroChem, marketed it as a nutritional supplement. 2016 ; Abushakra et al., A more recent study found that homotaurine activates GABA receptors, and suggests an alternative mechanism of action for ALZ-801 ( Meera et al.,

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FDA Law Blog: Biosimilars

JUNE 29, 2025

In 2016, we said that “OCP has earned a reputation for designating products as drugs rather than devices.” A sponsor may submit an RFD, not to exceed 15 pages, to the Office of Combination Products (OCP) to obtain the product classification (i.e., drug, device, biologic, or combination product) and/or review/lead Center (i.e., 21 CFR 3.7 (c)(2)(iv),

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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. since 2016. Li and Weisser are intended to succeed Johanna W.

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Advarra

OCTOBER 15, 2024

The guidelines also facilitated international harmonization of clinical research making it easier to conduct multi-national trials and bring new therapies to market more efficiently. The Council was first formed in 1990 with the goal of harmonizing regulatory requirements across Europe, Japan, and the United States.

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The Pharma Data

MARCH 20, 2021

According to the Demand Generation Benchmark Report, 2016, 47% of buyers viewed 3-5 pieces of content before engaging with a sales rep. In today’s Information Age, content marketing gets three times more leads than paid search advertising (Content Marketing Institute, 2017). Choosing the Medium. Producing the Content .

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New Drug Approvals

AUGUST 21, 2023

9] [10] A 2016 study demonstrated that palovarotene also inhibited spontaneous heterotopic ossification, maintained limb mobility and functioning, and restored skeletal growth in fibrodysplasia ossificans progressiva mouse models. [11] September 2016). Archived (PDF) from the original on 22 April 2016. 23] SYN Desjardins, C.,

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Eye on FDA

OCTOBER 19, 2022

Tik Tok was first released in 2016. Communicators and marketers would love black and white answers about concrete platforms. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. But OPDP speaks not in black and white, but gray.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Taiho’s counsel quickly followed up with a letter to FDA and a supplemental submission to the PTO in February 2024 arguing otherwise: “[P]ermission for commercial marketing” was not effective under the September 30, 2022 FDA letter because the product would have been misbranded if marketed thereunder. sections 331(a) and 352.(a)(l),

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Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures. Reference 1 Bazan H A, et al.

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The Pharma Data

NOVEMBER 15, 2020

Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. SHANGHAI , Nov.

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Vial

MAY 13, 2024

only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 Length and Cost of Clinical Trials McKinsey’s analysis compared the average length of Phase II clinical trials between 2011 – 2015, when it was 41 months, and 2016 – 2021, when it lengthened to 44 months. A 2016 study by Sertkaya et al.

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DrugBaron

JANUARY 8, 2021

Sarepta is no stranger to controversy, following the decision of the US regulator to approve the company’s earlier product, eteplirsen, which induces exon-skipping to improve expression of dystrophin protein in individuals who carry the mutant gene, as Exondys 51 back in 2016.

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Drug Target Review

SEPTEMBER 20, 2023

He then joined the pharmaceutical industry as a senior scientist at Evotec in 2016, working to develop drug candidates for a wide variety of internal and external clients. He believes drug discovery and design can be streamlined and improved through the use of computational methods, resulting in better drugs being brought to market sooner.

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The Pharma Data

MARCH 17, 2021

As of 2016, more than half of the CF population are 18 years or older. It is not necessary for scholarship applicants to have taken, currently take, or intend to take in the future, any medicine or product marketed by AbbVie, and this is not a consideration in the selection criteria.

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The Pharma Data

JUNE 11, 2023

In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease 1-10. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health.

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Advarra

AUGUST 16, 2022

In 2016, the FDA granted 333 (57%) of the 582 orphan drug designation requests it received – nearly 10 times the number of designations the agency awarded in 1986. The impact was clear: Between 1983 and 2020, FDA approved 599 orphan drugs. Since 1983, the FDA has continued to expand its attention to rare diseases and the drugs treating them.

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The Pharma Data

AUGUST 19, 2021

As of 2016, more than half of the CF population are 18 years or older. It is not necessary for scholarship applicants to have taken, currently take, or intend to take in the future, any medicine or product marketed by AbbVie, and this is not a consideration in the selection criteria.

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The Pharma Data

NOVEMBER 11, 2020

For this study, Vu and her team looked at more than 1,400 people who vaped in 2016. “There should be much closer regulation of what type of devices are allowed to be on the market,” said Bhatnagar, who wasn’t part of the study. It named the problem after increasing numbers of vapers fell ill with severe lung illness.

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Agency IQ

MAY 26, 2023

EPA proposes amendments to TSCA new chemicals and to remove exemptions for PFAS and PBTs EPA has proposed long-awaited amendments to the Toxic Substances Control Act (TSCA) review of new chemicals to codify practices in keeping with the 2016 TSCA amendments. MAY 21, 2023 1:17 PM CDT Regulatory background On June 22, 2016, the “Frank R.

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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. 2016), 32: 1301-1307 Matasci M, Baldo L, et al. Host cell line, vector and cell line development process – to outsource or not?

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The Pharma Data

OCTOBER 26, 2020

With this new joint venture, to be known as Arizona Diagnostic Radiology Group, RadNet has established an operating platform in the Phoenix metropolitan area, a rapidly growing market and home to almost five million people. In 2016, we began our partnership with Dignity Health, which we have expanded and grown in California.

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