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. Thus, the biosimilar presented a similar efficacy to the reference product.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Nixon Gwilt Law

SEPTEMBER 7, 2023

Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. Beyond approval, be prepared for a higher bar in terms of safety data, clinical endpoints accepted, trial size and duration, and supplemental post-market surveillance requirements.

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LEVO Health

OCTOBER 26, 2022

You need a marketing strategy that sets your medical device apart from the competition. Food & Drug Administration (FDA) classifies medical devices. Food & Drug Administration (FDA) classifies medical devices. You need to be more than a medical device company.

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European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

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Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

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Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

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Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration approved Boehringer Ingelheim and Eli Lilly’s oral medicines Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to manage blood sugar in children with type 2 diabetes (T2D) aged ten years or older. in the placebo group.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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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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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

Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy. 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.

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Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

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