European Pharmaceutical Review

FEBRUARY 5, 2024

Incentivising small molecule drug innovation According to the Biotechnology Innovation Organization (BIO), the bipartisan Ensuring Pathways to Innovative Cures ( EPIC Act ) passed last week in the US, is a “critical” step for incentivising small molecule drug innovation.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology.

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European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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European Pharmaceutical Review

NOVEMBER 16, 2022

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. Other drugs in Opiant’s development pipeline include OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO).

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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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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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Legacy MEDSearch

DECEMBER 7, 2022

The company hit an important milestone in March 2022 when it received U.S. Food and Drug Administration market clearance for the ArthroFree System. This was followed in September 2022 by another important step as the first surgery using the system was performed by orthopedic surgeon Laith M. Are you hiring?

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European Pharmaceutical Review

DECEMBER 5, 2022

MOMENTUM was a randomised, double-blind Phase III clinical trial of momelotinib versus danazol in symptomatic and anaemic myelofibrosis patients treated with a US Food and Drug Administration (FDA)-approved JAK inhibitor.

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Pharmaceutical Technology

MAY 25, 2023

18/072,154, filed on 30 November 2022. The tablet form of metronidazole has been the only approved oral form of the drug available on the US market. The US Food and Drug Administration has set 23 September 2023 as the prescription drug user fee action date for ATI-1501.

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European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth.

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European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. In December 2022, results from that trial (NCT03897881) were shown to improve recurrence-free survival (RFS) in melanoma patients. Moderna, Inc.

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European Pharmaceutical Review

DECEMBER 1, 2023

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease.

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European Pharmaceutical Review

JANUARY 11, 2023

The submission comes just after lecanemab’s recent accelerated approval by the US Food and Drug Administration (FDA). The Phase III study findings suggested that the drug could slow progression of the disease by 2.5-3.1 This application was submitted to the European Medicines Agency (EMA).

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European Pharmaceutical Review

JANUARY 3, 2023

Talquetamab is an investigational, off-the-shelf treatment targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 on t-cells. The first Phase II results from the study were presented at the 2022 American Society of Hematology (ASH) Annual Meeting.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 trillion in Q2 2022 to $3.14 trillion in Q3 2022. percent from $3.45 percent and 24.2

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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years? National Cancer Institute.

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European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. 05 October 2022. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. 400(10361); 2022; 1395.

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Tribeca Knowledge

NOVEMBER 28, 2023

T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.

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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology.

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European Pharmaceutical Review

MAY 12, 2023

Approved by the US Food and Drug Administration (FDA) in February 2022, the oral treatment was authorised for adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.

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pharmaphorum

NOVEMBER 2, 2022

The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. The problem is that opioids do not work in the long-term, and this has led to a search for alternatives. The potential for a digital solution.

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Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). It targets Covid-19 patients who were asymptomatic or only had mild symptoms.

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European Pharmaceutical Review

SEPTEMBER 8, 2023

The US Food and Drug Administration (FDA) first approved tirzepatide for type 2 diabetes in May 2022. The European Commission approved the injectable treatment in September 2022. Upon publication, tirzepatide will be made available in the NHS within 90 days, although this is dependent on manufacturing supply.

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European Pharmaceutical Review

JANUARY 26, 2023

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The draft ICH M10 guideline was published for comments in 2019.

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Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. months , compared to 15.1

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European Pharmaceutical Review

AUGUST 30, 2022

The report, Clinical Trials – The Importance of Diversity in Clinical Trials , examined data from clinical trials initiated between 1 January 2013 and 16 June 2022. Earlier this year the US Food and Drug Administration (FDA) published draft guidance to support companies in enrolling more ethnically diverse trial populations.

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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

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. This signifies the growth potential of marketed drugs in established marketplaces and the complexity of oncology treatment paradigms.

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MedCity News

JUNE 16, 2023

The consensus is 2022 was a challenging year for digital health companies. billion in 2022 — down 56% from $40.2 billion in 2022 — down 56% from $40.2 Rather, 2022 represents an overdue correction in the midst of global economic uncertainty after a period of overexuberance and lofty expectations in digital health.

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European Pharmaceutical Review

MARCH 31, 2023

Only seven months after the first regulatory approval of cabotegravir LA for PrEP by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a voluntary licence agreement in July 2022.

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pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. appeared first on.

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