World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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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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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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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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European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 billion in Q3 from its eye disease drug Eylea. percent from $3.45 trillion in Q3 2022.

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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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Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designations for Eagle Pharmaceuticals’ CAL02. Eagle expects to obtain eight to ten years of regulatory exclusivity for the therapy with QIDP, upon receipt of its new drug application approval.

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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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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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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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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

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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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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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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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MedCity News

JUNE 16, 2023

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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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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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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European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.

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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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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?

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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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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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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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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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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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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

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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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

Nixon Gwilt Law

DECEMBER 16, 2021

So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., Katherine also warns, “with the high volume of competitors in the space, competition for the best money will come down to details, including healthcare compliance in the corporate space.

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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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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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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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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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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World of DTC Marketing

JULY 12, 2022

Patients on Medicare who don’t qualify for low-income subsidies could see out-of-pocket costs for the drug of over $12,000. A bill to lower drug prices via negotiations with Medicare is finally moving forward, but PhRMA has bought some politicians. Innovation and Competition Act. Administration on Aging.

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Cadensee

JULY 20, 2021

It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? Do you listen to them to improve your marketing and the way they should take the drug or the drug should be administered and so on so forth?

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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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