FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. Section 1006 refers to the “Practice of Medicine” provision of the FDC Act (21 U.S.C. §

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Regulation Medicine Doctors Doctor 114

Pharmaceutical Technology

FEBRUARY 3, 2023

The field of genomic medicine has reached a true turning point. In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1] CEVEC became part of Cytiva in October 2022.

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Genomics Genome Medicine Gene Therapy 244

Pharmaceutical Technology

FEBRUARY 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Me rck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir). Merck and Ridgeback intend to appeal the decision and request a re-examination of the regulator’s opinion.

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Medicine Regulation Trials Production 162

Pharma Marketing Network

NOVEMBER 23, 2024

Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience.

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Marketing Research Big Data Medicine 52

Bio Pharma Dive

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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Marketing Regulation Medicine Drugs 164

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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Marketing Sales Manufacturing Drugs 173

BioPharma Reporter

NOVEMBER 18, 2021

Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.

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Regulation Medicine Marketing 141

STAT News

NOVEMBER 15, 2022

Antitrust regulators in Spain have fined a drugmaker $10.6 million for years of “excessive” price hikes on a rare disease medicine, the latest instance in which European authorities have cracked down on the pharmaceutical industry for harming consumers and taxpayers. There was a low-cost version available for decades.

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Regulation Drugs Genetics Medicine 98

Pharmaceutical Technology

JULY 28, 2022

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU).

Medicine 262

Medicine Regulation Trials Marketing 262

Pharma Marketing Network

DECEMBER 31, 2024

Table of Contents Sr# Headings 1 Introduction: The Pharma Marketing Challenge 2 Building a Winning Pharma Marketing Strategy 3 The Role of Branded Drug Campaigns 4 Innovating for Future Success Introduction: The Pharma Marketing Challenge Marketing pharmaceuticals is no small feat.

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Marketing Branding Compliance Drugs 52

Pharmaceutical Technology

DECEMBER 20, 2022

The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well. Rather than regulatory bodies alone setting standards for approval, industry can provide real-world data and evidence to help optimize processes and shape regulations. Moving forward.

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Regulation Contamination Manufacturing Production 130

Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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Regulation Clinical Trials Clinical Trials Medicine 162

pharmaphorum

JANUARY 13, 2022

In 2020, over half of total spending on brand medicines went to the supply chain, middlemen and other stakeholders, overtaking the amount going to drug manufacturers for the first time, according to a new study. ” The post Supply chain middlemen ‘pocket half of US branded medicine spending’ appeared first on. .

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Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction.

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Medicine Production Generic Drugs Regulation 290

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

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Marketing Antibody Licensing Licensing 130

Pharmaceutical Technology

JUNE 21, 2023

It can be used as a monotherapy or along with cholesterol-lowering medicines. It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. It has been designed to target residual inflammation as an underlying cause of ASCVD.

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman.

Drugs 298

Drugs Manufacturing Production Marketing 298

pharmaphorum

JANUARY 27, 2023

So, here are three “best guesses” for what 2023 will hold for the off-patent medicines segment — which accounts for roughly 70% of medicines prescribed worldwide (including the vast majority of system-critical antibiotics and ICU therapies), but only about 20% of the total cost.

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Medicine Production Marketing Packaging 105

Advarra

JULY 26, 2022

with 37 states approving medicinal use and 18 approving recreationally. Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Currently, cannabis use is legal across many states in the U.S.,

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Regulation Research Production Cosmetics 97

Pharmaceutical Technology

MARCH 2, 2023

The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. We are grateful to Friedreich’s ataxia patients, investigators, US regulators, and our scientists and employees who made this approval possible. “As

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FDA Approval Trials Genetics Drugs 264

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Finding the best commercial packaging suppliers in contract marketing.

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Packaging Packaging Marketing Containment 100

BioPharma Reporter

FEBRUARY 20, 2023

In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.

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Medicine Marketing Production Regulation 90

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA).

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Marketing Research Trials Clinical Trials 97

Pharma Mirror

NOVEMBER 7, 2023

The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products. In the United States, for example, the Food and Drug Administration (FDA) plays a central role, while the European Medicines Agency (EMA) oversees regulations in the European Union.

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Compliance Regulation Manufacturing Production 130

pharmaphorum

APRIL 11, 2022

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines. Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world.

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Medicine Clinical Trials Clinical Trials Development 115

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

Marketing 130

Marketing Sales Manufacturing Drugs 130

Fierce Pharma

JANUARY 26, 2024

Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will (..)

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Regulation Drugs Medicine Production 84

Outsourcing Pharma

MAY 29, 2024

UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.

Medicine 105

Medicine Sales Production Development 105

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Compliance standards in medicines are evolving rapidly. References: Ellis, J. 2023, November 17). link] Societal CDMO. 2023, October 12).

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Compliance Manufacturing Production Regulation 98

Pharmaceutical Technology

JULY 18, 2022

There are currently no approved therapies for the treatment of bronchiectasis; although some off-label medicines do exist, they only alleviate symptoms and manage frequent infections. Novartis is developing icenticaftor (QBW251), a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator.

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Marketing Trials Development Protein 147

Drug Patent Watch

DECEMBER 10, 2024

The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48 Accelerated Time to Market : By leveraging a connected network of internal experts, integrated CDMOs can help eliminate downtime, optimize processes, and minimize errors, ultimately accelerating time to market.

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Manufacturing Development Drugs Compliance 96

pharmaphorum

FEBRUARY 23, 2022

Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars.

Marketing 98

Marketing Production Development Medicine 98

pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. This is reinforced by web-focused marketing strategies that give them a highly-targeted approach when it comes to marketing execution.”. Be more agile .

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Branding Marketing Pharma Companies Life Science 130

pharmaphorum

JANUARY 7, 2021

There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation. In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion.

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Vaccination Vaccine Regulation Medicine 141

STAT News

JANUARY 23, 2023

In an unexpected move, the Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.

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Drugs Medicine Regulation Marketing 111