European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs.

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Food and Drug Administration Pharmaceutical products FDA Pharmacology 73

European Pharmaceutical Review

JULY 13, 2023

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). In the future, by adopting these novel approaches to drug development we may see an increase in the number of medications receiving market authorisation. Expert Review of Clinical Pharmacology.

Medical 83

Medical Food and Drug Administration Pharmacology Medicine 83

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.

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Side effects Medical sales reps Insurance Pharmacology 52

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

Patients 98

Patients Recruitment Pharmacology Side effects 98

pharmaphorum

DECEMBER 22, 2022

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy.”

Pharmacology 52

Pharmacology Safety Patients Marketing 52

pharmaphorum

JANUARY 3, 2023

The result is good news for Pfizer, which has exclusive marketing rights to the drug in mainland China under an agreement signed in 2020. ” CStone said it will file a marketing application based on the new data in the near future. The post CStone gets a win for sugemalimab in oesophageal cancer appeared first on.

Pharmacology 57

Pharmacology Patients Marketing FDA 57

pharmaphorum

DECEMBER 20, 2022

Although, so far efforts to bring a therapy to market have failed. The condition is largely associated with obesity and an unhealthy diet and lifestyle, and is on the rise in industrialised nations, leading to estimates it could present a market opportunity worth tens of billions of dollars worldwide.

Pharmacology 52

Pharmacology Pharma Marketing Biopharma 52

European Pharmaceutical Review

APRIL 13, 2023

Legislative hurdles aside, in the same way as any other pharmaceutical companies, psychedelics companies will need to obtain regulatory approvals in the countries where they will carry out clinical trials or market products. Pharmacological Reviews. References Nichols DE. Psychedelics. 2016;68(2):264–355. How LSD originated.

Medicine 113

Medicine Food and Drug Administration Doctors Government 113

Contrarian Sales Techniques

DECEMBER 5, 2023

Regulation changes, like the introduction of the Prescription Drug Marketing Act in the 1980s, brought about a more structured approach. Keeping abreast of the latest regulations, like FDA approvals and industry guidelines, ensures that you're not just a salesperson, but a trusted advisor to your clients.

Pharmaceutical Sales 52

Pharmaceutical Sales Training Sales Pharmaceutical 52

Pharmaceutical Technology

MAY 15, 2023

Pyridine derivatives contain one nitrogen atom in a six-membered aromatic ring and are the most extensively used heterocycles in the field of drug design, due to their promising effect on pharmacological activity, which has led to the discovery of numerous broad-spectrum therapeutic agents.

Pharmaceutical 52

Pharmaceutical Leads Pharmacology Medicine 52

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Pharmacology Patients Pharmaceutical 105

Evolve Your Success

OCTOBER 24, 2023

Sean breaks down the acronym, demystifying its meaning while sharing his transition from a lab manager to holding the role of Vice President of Global Sales and Marketing. I am working in OEM sales for a healthcare solutions company that provides adjunct devices for medical device products on the market. Y ou are the market leader.

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Sales Medical Manufacturing Medical sales 64

Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. Companies are testing the use of digital platforms along with pharmacological treatments.

Prescription 111

Prescription Pharmacology Pharma Medical 111

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Innovation will power the market. Gene therapies, some of which are already in market, will see a strong uptick in 2023.

FDA 80

FDA Healthcare Healthcare Medicine 80

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

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Food and Drug Administration FDA Medicine Patients 122

Medgadget

MAY 2, 2023

While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective. Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers.

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Side effects Prescription Healthcare Healthcare 87

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 75

Food and Drug Administration Safety Patients Leads 75

Pharmaceutical Technology

OCTOBER 10, 2022

The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds. In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD). A one-size-fits-all approach.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

MARCH 1, 2023

Recently, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Paxlovid, an inhibitor for the first protease of SARS-CoV-2 (Mpro). The licensed technology specifically includes small molecules found to be efficient PLpro inhibitors. Please check your email to download the Whitepaper.

Biopharma 59

Biopharma Food and Drug Administration Pharmacology Food 59

Pharmaceutical Technology

MARCH 16, 2023

For example, Ontario, Canada-based Verity Pharmaceuticals’s Trelstar was FDA approved for palliative treatment of advanced prostate cancer and the other two are indicated for treating central precocious puberty and endometriosis, respectively. Please check your email to download the Report.

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Ethics Prescription Safety Healthcare 144