Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. You can also subscribe here to receive email notifications when a new issue is available.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

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European Pharmaceutical Review

MAY 7, 2024

A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6 Injectable drugs are adopted widely as treatments for chronic infections such as HIV/AIDS and tuberculosis (TB). This has resulted in more access to injectable drugs. The market is anticipated to value $1139.4

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European Pharmaceutical Review

NOVEMBER 6, 2023

The findings presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, revealed that the treatment continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-month dosing compared to sham treatment over two years in geographic atrophy secondary to age-related macular degeneration (AMD).

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European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.

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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. The drug is not currently approved in any markets globally.

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European Pharmaceutical Review

MARCH 27, 2024

percent from 2023 to 2032, according to the research. For example, in 2023, Lonza Group launched several new solutions for endotoxin and pyrogen testing, the report highlighted. During a market recession, companies put less investment in R&D and consequently, this potentially slows the production of drugs, the authors shared.

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European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. On 2 May 2023, the FDA published draft guidance which included recommendations for delivering decentralised clinical trials.

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European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

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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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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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Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. In fact, the Amputation Reduction and Compassion (ARC) Act, introduced in Congress in June 2023, seeks to reduce the high rates of amputation in the U.S. Cardio Flow, Inc. , Announces U.S.

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European Pharmaceutical Review

MARCH 14, 2023

Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer. billion of revenue in 2023.

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European Pharmaceutical Review

MARCH 2, 2023

This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023. EU Clinical Trial Information System From February 2023 all new clinical trials applications must be submitted via the new portal.

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European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. The biologic is approved for intravenous (IV) and subcutaneous (SC) administration.

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Pharmaceutical Technology

MAY 25, 2023

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

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

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European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. The year 2023 also brought much advancement in the Alzheimer’s space for the pharmaceutical industry. Since then, EPR has covered developments for several of the therapies highlighted in the report.

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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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European Pharmaceutical Review

JULY 21, 2023

The US Food and Drug Administration (FDA) published its discussion paper on AI in drug development in May 2023, and now European regulators following a similar route to help chart a new course for this emerging technology.

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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. These agreements have amassed a total deal value of $21 billion.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

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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

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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Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Press Release by: Inspira Technologies.

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European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously.

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European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs? However, these are still investigational products.

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European Pharmaceutical Review

JULY 31, 2023

This follows the first and only approved treatment for rare neuromuscular disease Friedreich’s ataxia authorised by the US Food and Drug Administration (FDA) in February 2023. This transaction is anticipated to close in the fourth quarter of 2023. What is Friedreich’s ataxia?

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The regulator will announce its decision during the fourth quarter of 2023.

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European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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