Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The post FDA adcomm votes down Cytokinetics heart failure drug appeared first on. There was also no impact on quality-of-life measures.

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Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. with placebo.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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PM360

OCTOBER 24, 2022

In December 2020, a startup out of southern California, Urovant Sciences, Inc., received FDA approval for once-daily GEMTESA—the first new oral OAB medication approved by the FDA since 2012. With all of this, GEMTESA was shown to be safe and tolerable—with only 2% of study participants discontinuing GEMTESA due to side effects.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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pharmaphorum

OCTOBER 1, 2022

That same study was deemed inadequate to support approval of OCA at Intercept’s first attempt in 2020, resulting in a complete response letter from the FDA, causing the company to pull its marketing application for the drug in Europe shortly afterwards. In REVERSE, 11.1%

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Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

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pharmaphorum

JULY 19, 2022

China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy, partnered with US biotech G1 Therapeutics. The Chinese company secured rights to Cosela in Greater China for $170 million in 2020.

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European Pharmaceutical Review

NOVEMBER 4, 2022

based treatment concomitant with reductions in traditionally unavoidable and problematic side effects. In 2020, Athenex completed a Phase III trial in metastatic breast cancer comparing Oraxol to three-weekly (q3w) IV paclitaxel. FDA Feedback Leads to Discontinuation of Tesetaxel Development in Solid Tumors [Internet].

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PM360

AUGUST 9, 2022

According to an August 2021 report from the Business Research Company , after experiencing a decline in 2020 due to pandemic, the medication adherence market is expected to recover and grow at a compound annual growth rate (CAGR) of 11.4% KEEP was named in the top 100 best inventions list in TIME magazine following its launch in 2020.

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

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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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Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Communication Skills: Effective communication is essential when interacting with HCPs in order to build relationships in sales.

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European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

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Contrarian Sales Techniques

FEBRUARY 10, 2023

They are designed to be safe and comfortable for patients, and typically have minimal side effects. According to various market research reports, the global non-invasive medical devices market was valued at approximately USD 45 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of over 6% from 2021 to 2028.

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PM360

AUGUST 26, 2024

During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. That’s how money is saved and quality of life (QOL) is improved.

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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

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects.

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World of DTC Marketing

NOVEMBER 16, 2020

The announcement of the effectiveness is one thing, but approval is another. Assuming both Moderna & Pfizer vaccines are granted FDA Emergency Use Approval status, what’s going to happen when the media picks up on stories of severe side effects from those who receive the vaccine.

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