5 FDA decisions to watch in the fourth quarter
Bio Pharma Dive
OCTOBER 3, 2022
The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.
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FDA approves Novartis’ copycat of blockbuster Biogen drug
Bio Pharma Dive
AUGUST 25, 2023
market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.
FDA Approval 
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Analyzing biosimilar market dynamics in different patient populations
Drug Patent Watch
JANUARY 13, 2025
As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 from 2020 to 2025[1]. .
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FDA suspends US testing of Sarepta Duchenne drug over safety concerns
Bio Pharma Dive
JUNE 23, 2022
The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.
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The Brazilian pharma market: Key information and what may change
Pharmaceutical Technology
DECEMBER 9, 2022
Brazil is the largest country in Latin America, with a population of over 212 million, and consequently has the biggest pharmaceutical market in the region. Brazilian public spending on healthcare, drug pricing reforms and remote medicine. The generics market in Brazil.
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Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine
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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Pharma Research Trends: Leveraging Innovation for Smarter Marketing Strategies
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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Biogen holds onto Tecfidera market in Europe for a little longer
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.
Marketing 164
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Wellcome funds work on regulating digital mental health tools
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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Warnings for Japanese pharmaceutical market may lead to more lenient price controls
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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Latin America: How pharma can navigate a complex market
pharmaphorum
DECEMBER 7, 2020
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.
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Biogen receives ‘negative trend vote’ for aducanumab in the EU
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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STAT+: Spain’s antitrust regulator fines drugmaker for ‘excessive’ pricing of a rare disease drug
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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Mastering Pharmaceutical Marketing: Strategies to Drive Success in the Pharma Industry
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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European regulators begin rolling review of AZ’s COVID-19 vaccine
pharmaphorum
OCTOBER 2, 2020
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.
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How competitors are collaborating to shape biopharma best practices and regulations of the future
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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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict
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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Supply chain middlemen ‘pocket half of US branded medicine spending’
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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Brexit fallout continues with batch testing concerns
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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Biogen and Eisai seek UK’s marketing authorisation for lecanemab
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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GSK hits trouble with Trelegy as EU regulators block asthma indication
pharmaphorum
MARCH 1, 2021
European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. Trelegy Ellipta is already approved in four markets to date including the US and Japan for the treatment of asthma.
Regulation 105
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Valuation of Pharma Companies: 5 Key Considerations
Drug Patent Watch
APRIL 8, 2025
Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Regulatory Environment : Changes in regulatory policies can impact a company's valuation.
Do generics producers have what it takes to tackle complex and specialty drugs?
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.
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CBD Research: A Dive into the Regulations of Cannabis Research
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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Overcoming regulatory issues with investigational medicinal product labelling
Pharmaceutical Technology
JUNE 19, 2023
Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Regulations can be challenging, with ever-changing rules. And accurate labelling and translation are critical for this sector.
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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia
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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Leading commercial packaging companies in contract marketing
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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EMA gave the green light to 89 medicines in 2022; including more ATMPs
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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Post Marketing Research
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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Navigating Regulatory Compliance in the Pharmaceutical Industry
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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Warnings for Japanese pharmaceutical market may lead to more lenient price controls
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
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Bristol Myers wins, Apellis loses in busy week at Europe's drug regulator
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 (..)
Regulation 84
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Teva says medicines access at risk in Northern Ireland
pharmaphorum
NOVEMBER 16, 2022
The North Ireland Protocol has been a source of tension between the UK and EU since it came into force at the start of 2021 – and according to one pharma company the end of the so-called ‘grace period’ could result in major issues with medicines supply. “The warning presented by Teva UK is stark,” according to Cameron.
Medicine 105
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UK-based company selling breakthrough cannabis-based medicines now supplying the US
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
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How CDMOs Can Help with Regulatory Challenges
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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Addressing the treatment gap in the bronchiectasis market
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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The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing
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.
STAT+: Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity
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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Disc maps out US filing for porphyria drug bitopertin
pharmaphorum
NOVEMBER 5, 2024
Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the (..)
Drugs 110
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Teva UK and Closed Loop Medicine announce partnership to advance personalised medicines
Outsourcing Pharma
MARCH 26, 2024
Under the agreement, Closed Loop Medicine â a leading TechBio company â and pharmaceutical company, Teva UK, will investigate opportunities to use Closed Loop Medicineâs proprietary software as a medical device (SaMD) technology platform.
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STAT+: AstraZeneca is fined by South Korea for an anticompetitive deal over a cancer drug
STAT News
OCTOBER 13, 2022
South Korea’s anti-trust regulator has fined AstraZeneca and a local generic drugmaker a total of $1.8 million for striking a deal that thwarted rivals from marketing a cancer treatment, the latest instance in which a global pharmaceutical company has been cited for anticompetitive behavior.
Regulation 128
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India’s ICMR and Ministry of AYUSH to research integrated medicine
Pharmaceutical Technology
MAY 12, 2023
The Indian Council of Medical Research (ICMR) has entered a memorandum of agreement (MoA) with the Ministry of Ayush to carry out research in the field of integrated medicine. The MoA allows scholars, trainees and researchers access to improved instrumentation systems and other infrastructure, in line with current rules and regulations.
Medicine 130
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EU nears decision on Novavax COVID-19 vaccine
BioPharma Reporter
NOVEMBER 18, 2021
The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.
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EU Regulator Pulls Approval for Preterm Labor Drug One Year After FDA
BioSpace
MAY 16, 2024
A European Medicines Agency panel on Friday cited a possible but unconfirmed risk of cancer and recommended that hydroxyprogesterone caproate drugs be suspended from the European Union market.
Regulation 70
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