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

MAY 29, 2024

As such, the FDA stated that the monoclonal antibody Bkemv has approval for use in the following conditions: Paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis Atypical haemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

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Pharmaceutical Technology

MARCH 4, 2025

Genentechs label expansion for TNKase consolidates its market position for pharmacological stroke treatments.

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PharmExec

SEPTEMBER 28, 2023

Eye drop treatment indicated for pharmacologically induced mydriasis.

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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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Pharma Leaders

APRIL 17, 2023

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva.

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Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

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PharmaTech

FEBRUARY 1, 2024

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

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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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PharmExec

JULY 2, 2024

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

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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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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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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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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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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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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?

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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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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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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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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

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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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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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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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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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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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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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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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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Infuse Medical

DECEMBER 17, 2024

Whether you are marketing a new medical product or creating animations for instructional reasons, you must satisfy regulatory criteria established by the FDA, EMA, or another health authority. Regulatory compliance is obviously very important, hence every animation we create satisfies industry standards including FDA and EMA criteria.

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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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Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported.

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European Pharmaceutical Review

JULY 18, 2024

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. She also heads three of Ipsen’s specialised functions that support the entire pipeline from discovery through to lifecycle management.

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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

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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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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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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