European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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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

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. In 2019, Synlogic and Ginkgo Bioworks entered a platform collaboration to support a synthetic bionic medicines pipeline.

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European Pharmaceutical Review

JULY 3, 2023

Positively, regarding the drug’s development , Mayer added that Ipsen plans “to move forward with regulatory submissions to the US Food and Drug Administration and the European Medicines Agency [EMA].” The post Could small molecule medicine treat rare liver disease?

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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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European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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European Pharmaceutical Review

AUGUST 7, 2023

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. The post First oral medicine for postpartum depression approved appeared first on European Pharmaceutical Review.

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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

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

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European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Pharmaceutical Technology

MAY 12, 2023

The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. The division of infectious diseases at Weill Cornell Medicine carried out the work in collaboration with JAFRAL and JMI Laboratories.

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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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European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. How can AI and ML support development and regulation of medicines?

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European Pharmaceutical Review

MARCH 1, 2024

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries.

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European Pharmaceutical Review

MARCH 27, 2024

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

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European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings.

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European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Some, 250,000 child deaths per year can be attributed to counterfeit malaria and pneumonia medicines.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

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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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European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). The latest designation comes after the European committee for orphan medicinal products provided a positive opinion on the company’s application for the therapy.

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Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

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World of DTC Marketing

FEBRUARY 1, 2022

Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications. The days of approving almost all cancer drugs, for example, maybe over as the FDA takes a closer look at data.

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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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World of DTC Marketing

OCTOBER 6, 2021

to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London. government $712 for the same amount of medicine or 40 times the price. Remdesivir was the first drug approved by the Food and Drug Administration to treat COVID-19.

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European Pharmaceutical Review

FEBRUARY 9, 2023

Oral difelikefalin could potentially relieve the moderate-to-severe itching associated with notalgia paresthetica, according to a study published in the New England Journal of Medicine. To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder.

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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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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

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

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European Pharmaceutical Review

FEBRUARY 27, 2024

The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. It is the company ’s most advanced manufacturing facility to date.

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European Pharmaceutical Review

MARCH 27, 2024

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

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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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Pharmaceutical Technology

APRIL 3, 2023

BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe.

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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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