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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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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Pharmaceutical Technology

APRIL 12, 2023

In 2021, they accounted for 0.2% 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. Already, [non-animal models] are assisting greatly in the repurposing of existing drugs,” he says. “We

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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

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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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 FDA approved Vyvgart for the treatment of myasthenia gravis in December 2021.

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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 25, 2023

In October 2021, the World Health Organization recommended the use of GSK’s recombinant protein-based vaccine Mosquirix (RTS,S/AS01) for children at risk of contracting the infectious disease. From 2020 to 2021, cases of malaria increased from 245 million to 247 million in 84 malaria-endemic countries.

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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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Additional studies are still needed to quantify the impact of reducing E.Coli infections in high-risk cancer patients.

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Pharmaceutical Technology

APRIL 21, 2023

Whilst Emergent has broken through to produce a drug that reduces opioid mortality rates , experts say the company’s pricing strategy might put it out of reach for those who need it most. On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription.

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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

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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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. Promising results were observed, with outcomes of 19.0%

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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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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

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

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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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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). Free Report How is the Biopharmaceutical industry evolving?

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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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Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

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