Pharmaceutical Technology

MAY 11, 2023

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients.” The regulator accepted and gr anted priority review for the sNDA in January 2023.

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Pharmaceutical Technology

APRIL 26, 2023

in December 2022, the digital therapy, called CT-132, secured a Breakthrough Device designation from the US Food and Drug Administration (FDA) as an adjunctive preventive treatment for episodic migraine in patients above the age of 18 years. Its use is especially applicable in mental health and neurology.

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Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

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Legacy MEDSearch

DECEMBER 12, 2022

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older. Press Release by: Theranica.

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Legacy MEDSearch

OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. See Full Press Release at the Source: Nevro Announces FDA Approval of HFX iQ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain. Press Release by: Nevro Corp. Are you hiring?

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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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pharmaphorum

OCTOBER 25, 2022

At the time of the Encore Vision takeover, there were pharmacological therapies for presbyopia, but that changed last year when AbbVie secured FDA approval for Vuity , a once-daily eyedrop formulation of pilocarpine, as the first drug for the common eye condition.

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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). Expert Review of Clinical Pharmacology. Plant cannabinoids: a neglected pharmacological treasure trove. British journal of pharmacology. 2023 Mar 4;16(3):257-66. Mechoulam R.

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pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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pharmaphorum

JANUARY 4, 2023

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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Pharmaceutical Technology

AUGUST 16, 2022

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling.

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PM360

NOVEMBER 29, 2022

Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA. A drug label exploration tool was deployed using FDA Drug Labels, EMA Drug Labels, as well as several European local databases.

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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.

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pharmaphorum

JANUARY 12, 2023

The Attorney General of Alabama has threatened to use an obscure law passed in 2006 to prosecute women who terminate a pregnancy using pharmacological means, shortly after the FDA made access to the drugs easier.

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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.”

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European Pharmaceutical Review

AUGUST 23, 2022

“Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

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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. Internet] [link].

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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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pharmaphorum

JANUARY 3, 2023

With the results of the GEMSTONE-304 study, sugemalimab becomes the latest immuno-oncology agent to show improvements in survival outcomes in first-line ESCC, contributing to the transformation in pharmacological treatment for the aggressive cancer. The post CStone gets a win for sugemalimab in oesophageal cancer appeared first on.

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pharmaphorum

DECEMBER 20, 2022

That’s impressive, as it has proved exceedingly difficult for pharmacological therapies to show an impact on fibrosis in prior studies. Similarly, a one-stage or greater improvement in liver fibrosis was seen in 24% and 26% of the resmetirom groups, respectively, versus 14% of patients taking placebo.

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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.

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European Pharmaceutical Review

APRIL 13, 2023

The US Food and Drug Administration (FDA) has decided to fast-track psilocybin for depression, with full support from President Biden’s administration. Pharmacological Reviews. Additionally, several US and Canadian states have legalised or decriminalised magic mushrooms. References Nichols DE. Psychedelics. 2016;68(2):264–355.

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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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European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection. Firstly, the pharmacological response to LBPs does not follow traditional pharmacokinetic principles.

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Pharmaceutical Technology

MAY 16, 2023

Nuvectis Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for NXP900. The approval also includes clearance for a Phase I clinical trial protocol of NXP900. Nuvectis has licensed the exclusive global rights to NXP900 from the University of Edinburgh in Scotland, UK.

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Contrarian Sales Techniques

DECEMBER 5, 2023

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. Moreover, regulatory compliance and adherence to industry standards are not just boxes to tick. Embracing a mindset of lifelong learning keeps you agile and adaptable.

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Pharmaceutical Technology

MARCH 17, 2023

Companies are testing the use of digital platforms along with pharmacological treatments. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging. But creating a combined product is tricky from a regulatory perspective, says Sørensen.

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pharmaphorum

NOVEMBER 22, 2022

Non-pharmacological interventions like CBT are generally recommended as first-line treatment for fibromyalgia, a complex disorder with no known cause, but these are usually delivered by a therapist – often in short supply in health systems around the world. It is due to generate results next year.

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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. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

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Evolve Your Success

OCTOBER 24, 2023

They understand the American and European requirements of the FDA and the EU. I worked at a now-defunct pharmaceutical company in San Diego and did benchtop research in a couple of different pharmacology models for two years. I was using all I knew about biology, physiology, and pharmacology. Let’s switch gears a little bit.

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Pharmaceutical Technology

DECEMBER 16, 2022

This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. The company now expects to complete its submission for a BLA with the FDA by the end of the year.

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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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Medgadget

MAY 2, 2023

While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective. Following the successful FDA clearance of this product, we are further developing the core EFP technology behind Prism for PTSD to address additional mental disorders.

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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.

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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).

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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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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.

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