Pharmaceutical Technology

APRIL 21, 2023

Orphan drug development company Orphalan has introduced Cuvrior, a new trientine tetrahydrochloride (TETA-4HCl), for commercial use in the US for Wilson disease. Cuvrior received approval from the US Food and Drug Administration (FDA) and orphan drug exclusivity for this patient group in April 2022.

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Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years.

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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharmaceutical Technology

JULY 1, 2022

The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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European Pharmaceutical Review

OCTOBER 24, 2024

The biologic treatment was granted approval as Kisunla (donanemab-azbt) in the US by the Food and Drug Administration (FDA) in July 2024. However, side effects of these drugs, such as “the development of amyloid-related imaging abnormalities (ARIAs), remains a significant concern”. billion and $2.0

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Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

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Pharmaceutical Technology

JUNE 2, 2023

The Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure announced that Eisai’s Leqembi (lecanemab) will be covered under Medicare Part B, contingent on clinicians’ and hospitals’ participation in a nationwide, CMS-facilitated registry to track outcomes. upon its widespread use.

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Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). Tenaya is also running two supplementary non-interventional studies for the drug.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

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Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). ” The PMA Module III submission provided data from the prospective, multi-center, controlled IDE trial comparing LimiFlex to interbody fusion, considered the standard of care. Empirical Spine, Inc.,

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European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.

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Legacy MEDSearch

APRIL 13, 2023

Food and Drug Administration for an Expanded Access Program following the successful completion of enrollment in ALIVE, a prospective, multi-center, dual-arm pivotal study. BioVentrix recently received approval from the U.S.

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European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.

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Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S.

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Legacy MEDSearch

APRIL 25, 2023

Food and Drug Administration (FDA). “As a clinician, the prospect of accessing a more complete set of data intraoperatively is very exciting.” Proprio , a Seattle-based medical technology company, today announced its surgical navigation platform, Paradigm, has received 510(k) clearance from the U.S.

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Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

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Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. . ” This latest FDA clearance for the EyeArt v2.2.0 sensitivity and 91.1%

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PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. Bright Spots.

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Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

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Pharmaceutical Technology

MAY 30, 2023

In January, the oral SERD Orserdu made waves by becoming the first approved drug to treat patients with estrogen receptor (ER)+, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with ESR1 mutations. months, versus 1.87 months on standard of care (SOC) (HR 0.518; 95% CI: 0.216-1.165).

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Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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Pharmaceutical Technology

APRIL 25, 2023

The Serum Institute of India’s R-21 malaria vaccine may follow the success of GSK’s vaccine, having received its first approval from Ghana’s Food and Drug Administration on April 15. The majority of this rise came from the African region. R-21 contains Matrix-M, a saponin-based adjuvant from Novavax.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. These range from therapies used to treat urinary tract infections to antibiotics for uncomplicated gonorrhoea.

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Pharmaceutical Technology

APRIL 17, 2023

In December 2021, the US Food and Drug Administration (FDA) approved argenx’s Vyvgart for the treatment of myasthenia gravis in December 2021, marking the company’s first approval. The drug works by degrading circulating disease-causing IgG antibodies by binding to FcRN which controls the antibodies’ half-life of IgG.

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Pharmaceutical Technology

MAY 15, 2023

In a closely contested debate, a US Food and Drug Administration Advisory Committee (AdCom) panel voted eight to six in favour of the accelerated approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene transfer therapy delandistrogene moxeparvovec (SRP-9001).

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Pharmaceutical Technology

MAY 31, 2023

Following a rocky and somewhat controversial road to securing a US Food and Drug Administration (FDA) approval, Amylyx’s amyotrophic lateral sclerosis (ALS) drug is likely to hit another regulatory snag in Europe. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry.

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Rep-Lite

SEPTEMBER 21, 2024

For effective prospecting and lead generation in the medical field: Attend industry-specific conferences. Knowing this helps you target the right people, like physicians or administrators. Ensure your plan reflects your company’s vision and objectives. Next, map out the customer journey and define a clear sales process.

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Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

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Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

JUNE 27, 2023

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Conversely, in the US, it has always been clear and regulated as a drug. coli strains in the gut”.

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Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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European Pharmaceutical Review

DECEMBER 16, 2022

The gene therapy was recently approved by the US Food and Drug Administration (FDA). After the initial six-month period, patients received a single intravenous administration of etranacogene dezaparvovec at the 2×10 13 gc/kg dose. HOPE-B trial for etranacogene dezaparvovec.

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Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

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