Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year.

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European Pharmaceutical Review

MARCH 8, 2023

Ekaterina received her medical degree from St Petersburg Medical Academy in St Petersburg, Russia, and then moved to the US where she completed her Internal Medicine residency training. She worked in private practice, academic medicine and public health for more than 15 years in the greater New York area.

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Pharmaceutical Technology

JUNE 6, 2023

Gildeuretinol is the first and only medicine in clinical development to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration.

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European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.

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European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals.

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Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It can be used as a monotherapy or along with cholesterol-lowering medicines. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

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European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. percent through 2027.

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European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

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World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. Generic drugs versus branded is also a considerable expense.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma. The “landmark approval” declared Krish S.

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European Pharmaceutical Review

NOVEMBER 27, 2023

This leads to a lipid build-up in vital organs such as the liver, blood vessels and other tissues, and is usually fatal for these individuals within their first twelve months of life, Alexion reported. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

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Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Nefecon represents the first non-oncology medicine to gain breakthrough therapy designation in China.

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European Pharmaceutical Review

SEPTEMBER 8, 2023

Tirzepatide The novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, is licensed for adults with insufficiently controlled type 2 diabetes when metformin cannot be tolerated, Helen Knight, Director of medicines evaluation at NICE explained.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The Cedars-Sinai Board of Governors Regenerative Medicine Institute and the Smidt Heart Institute will lead the project.

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Pharma Leaders

MARCH 20, 2023

The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS). Earlier, ARO-APOC3 received Orphan Drug designation from the FDA and the European Union.

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

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European Pharmaceutical Review

AUGUST 18, 2023

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). EMA’s CHMP will begin its review of the MAA under the centralised licensing procedure for all 27 member states of the EU.

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Pharmaceutical Technology

JUNE 2, 2023

AB Science has secured a Canadian patent for its lead compound masitinib to treat amyotrophic lateral sclerosis (ALS), a fatal motor neuron disorder. Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS.

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European Pharmaceutical Review

JANUARY 4, 2024

Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). The drug tocilizumab for example, has been used historically to treat CRS from immunotherapies. An overactive immune response [is] the hallmark of CRS,” Landgren added.

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European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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European Pharmaceutical Review

DECEMBER 5, 2023

Currently, imetelstat is being reviewed by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approval in transfusion dependent anaemia in patients with lower risk MDS who have failed to respond or have lost response to or are ineligible for ESAs, according to Geron.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Machine Learning in Medicine. 2023; 44(3):1384-1392. cited 2023Dec]. N Engl J Med.

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European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. In parallel, European Medicines Agency (EMA) has issued an update on its guidance.

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Pharmaceutical Technology

JANUARY 23, 2023

Disc Medicine has entered an exclusive licence agreement with Mabwell Therapeutics for the latter’s new Anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibodies to modulate iron homeostasis. development and commercial milestones. development and commercial milestones.

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Pharmaceutical Technology

MARCH 10, 2023

Sandoz, a division of Novartis , has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.

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Pharmaceutical Technology

MARCH 29, 2023

The partnership pursues an innovative approach to discovering and developing new medicines, using many of the modality-agnostic precision medicine platforms of Evotec. Together with our BMS colleagues, we are confident that we will deliver new medicines that matter to patients with neurodegenerative diseases.”

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Pharmaceutical Technology

APRIL 20, 2023

Abdera Therapeutics president and CEO Lori Lyons-Williams stated: “Radiopharmaceuticals hold the potential to transform the treatment of cancer, but the ability to finely tune radioisotope delivery to the tumour, while sparing healthy tissue, remains a major challenge for this class of drugs.

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Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. It is located on the company’s existing Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade.

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