European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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European Pharmaceutical Review

MARCH 27, 2025

According to the findings, nearly 90 percent of US biotechs rely on imported components for at least half of their products approved by the US Food and Drug Administration. This makes supply of medicines vulnerable especially to proposed tariffs on the EU, China, and Canada, according to BIO.

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Medicine Food and Drug Administration Manufacturing Food 52

World of DTC Marketing

JUNE 22, 2021

SKIMMERS SUMMARY: There is one and only one social responsibility of business–to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud. billion to $29 billion on the drug in a single year.

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Patients Food and Drug Administration Pharma Government 156

Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. The post ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition appeared first on Pharmaceutical Technology.

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Competition Marketing Food and Drug Administration Physicians 64

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The regulator will announce its decision during the fourth quarter of 2023.

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Food and Drug Administration FDA Food Competition 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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Marketing Food and Drug Administration Medicine Prescription 103

Pharma Marketing Network

MARCH 11, 2025

Strict guidelines from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) require marketers to ensure transparency and accuracy in all communications. Resources like the FDAs OPDP (Office of Prescription Drug Promotion) provide guidance on drug advertising and communication.

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Marketing Pharma Food and Drug Administration Education 52

PM360

OCTOBER 25, 2023

Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. Similarly, major pharmaceutical companies are not likely to up their engagement in cannabis drug development. On August 30, the U.S.

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Food and Drug Administration FDA Medical Insurance 119

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 97

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved?

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Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

AUGUST 25, 2023

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Haruvi added that Tyruko has the potential to extend the reach of natalizumab treatment for these patients and “fuel innovation through competition in the market”.

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Food and Drug Administration FDA Distribution Food 98

Infuse Medical

JANUARY 9, 2020

Medical device products require approval by the Food and Drug Administration (FDA) before they go to market. Know Your Competition. As you gather competitive intelligence, don’t forget to incorporate it into your product launch and use it to your advantage. Plan Ahead Before FDA Approval. Create Powerful Content.

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Training Food and Drug Administration Sales Marketing 130

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Food and Drug Administration Physicians Competition FDA 59

Pharmaceutical Technology

JUNE 2, 2023

This helps to prevent generic competition for eight years after initial approval. Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS. According to AB Science, approximately 3,000 Canadians are now living with ALS.

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Food and Drug Administration Food Competition Medicine 52

Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The company aims to offer the device at a competitive price point, but further pricing details will be shared closer to the product’s release date.

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Food and Drug Administration FDA Food Management 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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Food and Drug Administration FDA Medicine Competition 98

European Pharmaceutical Review

AUGUST 22, 2022

1 This has led to a great deal of pre-competitive data sharing. For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. Available from: [link].

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Food and Drug Administration Prescription Food Medicine 59

Pharmaceutical Technology

JUNE 19, 2023

Coherus BioSciences intends to launch its anti-PD-1 antibody, toripalimab, to treat nasopharyngeal carcinoma, after receiving approval from the US Food and Drug Administration (FDA). The CCR8 antibody SRF114 is currently being evaluated as a monotherapy in a Phase I/II trial in advanced solid tumour patients.

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Food and Drug Administration Food Competition FDA 52

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Food and Drug Administration Pharma Manufacturing Prescription 52

Medico Reach

OCTOBER 17, 2022

Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. The potential increase in industry competition could also spell trouble for some. Development Of Smart Implants And Augmented Reality (AR) In Orthopedic Technology.

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Medical Food and Drug Administration Healthcare Healthcare 98

Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines. The technology identifies.

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Marketing Food and Drug Administration Pharma Doctors 52

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

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Food and Drug Administration FDA Pharmaceutical Prospecting 52

Pharmaceutical Technology

JUNE 2, 2023

The Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure announced that Eisai’s Leqembi (lecanemab) will be covered under Medicare Part B, contingent on clinicians’ and hospitals’ participation in a nationwide, CMS-facilitated registry to track outcomes. upon its widespread use.

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Food and Drug Administration FDA Prospecting Patients 52

PM360

AUGUST 29, 2022

Now, compounded by indications of a national recession and an ever-increasing inflation rate, employers and employees alike have heightened concerns over potentially significant increases in the cost of medical services, pharmaceutical drugs, and medical supplies and devices. Excluding food, energy, and trade, the core PPI was up 6.4%.

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Food and Drug Administration Medical Healthcare Healthcare 98

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

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FDA Patients Food and Drug Administration Prospecting 52

Medico Reach

JULY 3, 2022

Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. Notably, this will help you incorporate competitive intelligence into your product launch. Begin Preparation Before FDA Approval. It is vital to assess the current market before you offer your product.

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Medical Food and Drug Administration Training Marketing 97

Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). Tenaya is also running two supplementary non-interventional studies for the drug.

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Food and Drug Administration FDA Patients Prospecting 97

Pharma Marketing Network

MARCH 25, 2023

Pharmaceutical advertising is a crucial aspect of promoting and marketing drugs to the public. With the increase in competition, it has become essential for pharmaceutical companies to find the most effective methods of advertisement to reach their target audience. “Direct-to-Consumer Advertising of Prescription Drugs.”

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Pharma Food and Drug Administration Pharmaceutical Prescription 52

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.

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Food and Drug Administration FDA Safety Marketing 52

Pharmaceutical Technology

APRIL 24, 2023

While Imbruvica maintained a previously strong position on the market, competition has chipped away at the inhibitor’s market share. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31 billion in the same year.

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Food and Drug Administration Side effects Sales Food 52

Clarivate

SEPTEMBER 26, 2023

In therapeutic areas where there is competition for trial participants (e.g. Food and Drug Administration. In addition to clinical data tied to sites and investigators, RWD allows trial sponsors to know which investigators have experience in conducting a clinical trial in their patient population.

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Food and Drug Administration Patients Electronics Healthcare 59

Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.

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Patients Food and Drug Administration Biopharma FDA 52

Pharma Marketing Network

OCTOBER 3, 2024

In the competitive landscape of the pharmaceutical industry, effective marketing strategies are crucial for brand success. In addition to understanding the broader market dynamics, pharmaceutical marketers must also consider the competitive landscape.

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Marketing Pharmaceutical Healthcare Healthcare 52

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.

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Food and Drug Administration Safety Side effects FDA 98

LEVO Health

OCTOBER 26, 2022

You need a marketing strategy that sets your medical device apart from the competition. Food & Drug Administration (FDA) classifies medical devices. You need to be more than a medical device company. You need to be a trusted partner for both patients and their providers alike. .

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Medical Marketing Patients Food and Drug Administration 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. Proper planning can be a competitive edge for your pediatric digital health organization. Many states also have their own privacy laws that may exceed federal rules. Want to tackle these legal hurdles with confidence?

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Medico Reach

OCTOBER 17, 2022

Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. The potential increase in industry competition could also spell trouble for some. Development Of Smart Implants And Augmented Reality (AR) In Orthopedic Technology.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52