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But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market. A key regulatory committee sided against the drug this summer.
In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes.
Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.
Artificial intelligence (AI) is no longer a futuristic concept in healthcareits here, embedded in nearly every touchpoint of modern pharma marketing. But as pharma marketers race to adopt these tools, a central question looms: Is AI fueling smarter engagement, or setting the stage for a compliance disaster?
At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.
According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.
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.
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]
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. Advantages of joining PIC/S include the adoption of codes that should reduce the number of audits required for some products, accelerating their time to market.
The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.
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].
These measures are specifically tailored to ensure regulatory compliance, particularly for exports destined for the EU market, thereby bolstering the reputation of Indian […]
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.
In today’s competitive healthcare landscape, PPC campaigns (Pay-Per-Click advertising) have emerged as a critical lever for pharma marketers aiming to deliver timely, targeted, and measurable impact. In a heavily regulated industry like pharmaceuticals, PPC also offers better control than other channels.
In a highly regulated industry like pharmaceuticals, standing out online can feel like navigating a maze. This is where SEO marketing strategies become essentialallowing brands to boost visibility, earn trust, and support both HCP and patient journeys without violating regulatory guidelines.
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.
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. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.
The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).
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.
Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.
On Tuesday, regulators updated the public on their yearslong probe of PBM's business practices. The report faults PBMs for profiting at the expense of patients and independent pharmacists.
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.
by Nataliya Andreychuk, Co-founder and CEO of Viseven Many pharma brands still shy away from marketing directly to patients, depending on conversion through healthcare providers (HCPs). And it is not hard to see why.
With increasing competition and stricter compliance regulations, pharma marketing teams must adopt data-driven and personalized marketing strategies to capture the attention of HCPs. But how can pharma brands stand out in a crowded market? For expert guidance on pharma marketing trends, visit Pharma Marketing Network.
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.
Sionna Therapeutics recently secured an initial public offering (IPO) of $191m on the Nasdaq stock exchange, signalling strong investor confidence in its cystic fibrosis (CF) pipeline, particularly its lead candidates, SION-719 and SION-451, which work by stabilising the nucleotidebinding domain 1 domain of the CF transmembrane conductance regulator (..)
Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). A key natural regulator, NRF2 controls antioxidant genes’ expression.
Apellis Pharmaceuticals has received validation of its four marketing applications for intravitreal pegcetacoplan by regulatory authorities in Switzerland, the UK, Canada and Australia. The marketing applications are based on the data obtained from the Phase III OAKS and DERBY trials at 24 months.
regulators, an expert panel only supported its use in patients on dialysis, limiting its potential market. Though the anemia pill could become the first drug of its kind to avoid a rejection from U.S.
According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial approval of Aduhelm for Alzheimer’s. Finally, they need to withdraw Aduhelm from the market.
The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)
The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.
The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The Committee recommended grant of permission to import and market the drug without these stages of studies.
In the US, the world’s largest pharmaceutical market, most states have legalized cannabinoids for medical use. China and Japan have some of the world’s strictest regulations on cannabinoids, including bans on cannabis for medical use and scientific research, as the drug is classified as a dangerous narcotic.
The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)
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).
Idorsia has received marketing authorisation from Health Canada for Quviviq (daridorexant) to manage insomnia in adult patients. The regulator recommended one Quviviq 50mg oral tablet each night, taken 30 minutes before going to bed with a minimum of seven hours remaining before planned awakening.
The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP).
Earlier this year, I was asked by a client to write a position paper on using Facebook for the DTC marketing of an oncology product. From my estimates, most of it failed because pharma companies are afraid of misinformation concerning regulations around DTC marketing.
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