World of DTC Marketing

JANUARY 10, 2022

This study included 63 of 355 new therapeutic drugs and biologic agents approved by the US Food and Drug Administration between 2009 and 2018. According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period.

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Food and Drug Administration Pharma Marketing Food 213

Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Physicians 52

pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

FDA 52

FDA Food and Drug Administration Medical Patients 52

Legacy MEDSearch

DECEMBER 16, 2022

In comparing the overall accuracy of the ring’s data with data from the study’s reference devices, Movano Health’s ring resulted in an approximate 2% margin of error, well below the FDA consensus standard of 4% for SpO 2. Given these positive results, Movano Health expects to file for FDA clearance of these metrics in 2023.

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FDA Recruitment Medical Healthcare 98

pharmaphorum

NOVEMBER 9, 2022

AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.

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FDA Patients Marketing Sales 57

World of DTC Marketing

JANUARY 4, 2022

billion in 2018. The FDA says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. The real question is how much is three of four months of life worth, and will insurers and the FDA say the drugs that only provide mild efficacy are not worth the money?

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Insurance Transportation Medical Medicine 273

Pharmacy Times

MAY 16, 2023

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

FDA 49

FDA Management 49

World of DTC Marketing

FEBRUARY 1, 2022

The last time the SPDR ETF suffered a drop of 15% or more was in 2018, and the fund followed it up with a 33% increase in 2019. 1ne: More scrutinization by the FDA on new drug applications. The days of approving almost all cancer drugs, for example, maybe over as the FDA takes a closer look at data. 2wo: Crowded markets.

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Food and Drug Administration FDA Pharmaceutical Food 234

Legacy MEDSearch

SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

Medical 52

Medical FDA Recruitment Specialization 52

World of DTC Marketing

JULY 9, 2021

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet” So who to believe?

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Pharma FDA Leads Competition 292

World of DTC Marketing

SEPTEMBER 17, 2020

Not only has the FDA become a political pawn but almost half the population is now obese. The adult obesity rate passed 40 percent nationally for the first time according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES), a 26 percent jump from 2007–2008. IN SUMMARY: American healthcare is failing.

Healthcare 242

Healthcare Healthcare Insurance Healthcare Provider 242

World of DTC Marketing

MARCH 10, 2022

The increase followed total Humira price hikes of 19 percent during 2017 and 2018. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment.

Prescription 205

Prescription Pharmaceutical products Pharmaceutical Marketing 205

World of DTC Marketing

NOVEMBER 24, 2021

From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. The FDA on Tues­day ap­proved Aa­di Bio­science’s first drug and the first treat­ment ap­proved specif­i­cal­ly for pa­tients with an ul­tra-rare and ag­gres­sive form of sar­co­ma that oc­curs most­ly in women.

Food and Drug Administration 266

Food and Drug Administration Insurance Prescription FDA 266

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). ” Every 40 seconds, a person in the United States experiences a stroke, according to the Center for Disease Control (CDC), and the total financial impact of stroke in the United States exceeded $56 billion between 2018 and 2019. The burden on patient functioning is also profound.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

FDA 52

FDA Patients Recruitment Side effects 52

Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

pharmaphorum

JANUARY 11, 2023

The partnership will build on Anima’s previous discovery and development collaborations with Eli Lilly in July 2018 and with Takeda in 2021, giving AbbVie exclusive rights to license and further develop and commercialise the programmes. Anima’s wholly owned pipeline programmes, meanwhile, are in fibrosis, oncology, and neuroscience.

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FDA Medicine Patients Leads 104

pharmaphorum

NOVEMBER 20, 2022

The FDA subsequently raised serious concerns about the accuracy of testing that Theranos did conduct with its machines, and the company eventually retracted two years of blood tests before folding in 2018. “She knew that it could not successfully compete with the established conventional machines.”

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FDA Patients Management Marketing 120

European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. Patent litigation for adalimumab resolved in the US … Mylan’s Hulio (adalimumab), launched in Europe in 2018, is currently undergoing interchangeability studies. Worldwide sales for Humira peaked at $21.2

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Marketing Food and Drug Administration Food Medicine 97

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. FDA’s ‘Accelerated Approvals’ Are Critical But Raise Thorny Issues. FDA; 2018 [cited 2023Jan]. billion, and rising. Internet] 2022.

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Food and Drug Administration FDA Safety Food 97

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept. 2018 Jul 5;1:27.

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FDA Patients Electronics Medical 97

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

Competition 59

Competition Marketing FDA Physicians 59

Pharmacy Times

SEPTEMBER 7, 2022

The FDA initially approved baloxavir marboxil in October 2018 for the treatment of acute, uncomplicated influenza.

FDA 26

FDA 26

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

Medical 95

Medical Food and Drug Administration Patients FDA 95

pharmaphorum

NOVEMBER 11, 2022

Dr Stanley Cohen was sued by Alafi Capital and the Christopher Alafi Family Trust – the only investors in Nuredis – in 2018. The lawsuit claimed he misled them whist persuading them to invest $20 million in the biotech, set up to develop a candidate therapy for neurodegenerative disease Huntington’s disease , in return for a 20% stake.

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Leads FDA Marketing 111

World of DTC Marketing

FEBRUARY 22, 2021

billion in 2018, and is expected to grow at a CAGR of 7.20% to reach $86.01 If I was the FDA is would not allow DTC for this product without clinical proof that it’s non-addictive and that it would only go to patients who REALLY need it after trying other things like losing weight. billion by 2026.

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Pharma Doctors Side effects Prescription 181

Pharmaceutical Technology

MARCH 6, 2023

Tuoyi received marketing authorisation in China for six oncology indications, including NPC, in December 2018. Coherus Biosciences subsequently acquired the rights to commercialise Tuoyi in the US and Canada, and a revised biologics license application (BLA) was submitted to the FDA in July 2022 under priority review.

FDA 52

FDA Patients Competition Leads 52

European Pharmaceutical Review

JANUARY 24, 2023

Regulatory applications for fruquintinib Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018. It was launched commercially in China in November 2018 under the brand name ELUNATE ®. This is planned to be completed in the first half of 2023.

Food and Drug Administration 52

Food and Drug Administration Biopharma Medical Sales 52

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? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

NOVEMBER 23, 2022

uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy for adults with the bleeding disorder in the US. We are incredibly proud to announce the FDA approval of the world’s first #genetherapy for #hemophiliaB.

FDA 57

FDA Patients Medicine Pharma 57

European Pharmaceutical Review

SEPTEMBER 7, 2023

The findings published in Nature Medicine described how the US Food and Drug Administration (FDA)-approved tyrosine kinase inhibitor dasatinib was used in combination with quercetin, a plant-derived flavonoid. “In Instead, the current US study pursued cellular senescence as an alternative area of focus.

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Food and Drug Administration Medicine Food FDA 98

pharmaphorum

NOVEMBER 3, 2022

The FDA rejected the drug last year after its expert advisors voted 15 to one against approval, and the EMA followed suit when its human medicines committee said its risks were too great, and there wasn’t enough evidence to show it provided pain relief compared to standard non-steroidal anti-inflammatory drugs (NSAIDs).

Safety 52

Safety Medicine FDA Pharma 52

Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. In 2020, fruquintinib received Fast Track designation from the US Food and Drug Administration (FDA) to treat metastatic CRC patients. It was commercially launched in the country in the same year under ELUNATE brand name.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Sales 52

Clarivate

SEPTEMBER 11, 2024

It has been shown that Aβ deposition can begin more than 20 years before symptom onset (Gordon, 2018), and that accumulation of NFT starts during the preclinical stage (Counts, 2017), when cognitive function appears normal (Anon., FDA cleared the first CSF diagnostic test based on the detection of Aβ40/Aβ42 (U.S. In 2022, the U.S.

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Food and Drug Administration Pharmacology Food FDA 59

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Food and Drug Administration Pharmacology Side effects Physicians 141

European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs.

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Food and Drug Administration Manufacturing Food Medicine 98

Pharmaceutical Technology

JANUARY 18, 2023

In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults. Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezumab after receiving approval in Mainland China.

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Food and Drug Administration Distribution Food Safety 52