Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services
Pharmaceutical Technology
SEPTEMBER 26, 2024
West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.
Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
Fierce Pharma
SEPTEMBER 11, 2024
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva.
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ECNP 2023: new esketamine NS safety data for depression
European Pharmaceutical Review
OCTOBER 10, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD).
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Apellis attempts to clear the air around Syfovre safety as eye drug launch gains steam
Fierce Pharma
JULY 31, 2023
For Apellis Pharmaceuticals, the emergence of rare but serious side effects has cast a pall over the launch of the company’s geographic atrophy med Syfovre. While touting the “strong commercial execution” of Syfovre’s launch, Apellis’ CEO Cedric Francois, M.D.,
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Drug safety driving pyrogen testing market expansion
European Pharmaceutical Review
MARCH 27, 2024
Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.
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Improving packaging integrity of pharmaceutical borosilicate glass vials
European Pharmaceutical Review
OCTOBER 8, 2024
While borosilicate glass is the most common type of pharmaceutical container, it can be prone to certain issues that can endanger the safety and efficacy of the drugs inside the container, according to Abd-Elsatar et al. Overall, Abd-Elsatar et al. This paper is for publication in the journal Open Ceramics.
Considerations for safety data migration methods
European Pharmaceutical Review
SEPTEMBER 26, 2023
Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. In this method, Individual Case Safety Reports (ICSRs) are manually entered into the target database using outputs obtained from the source database.
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Pharmaceutical microbiology: key developments 2022
European Pharmaceutical Review
JANUARY 16, 2023
This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?
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Achieving pharmaceutical drug traceability compliance
European Pharmaceutical Review
SEPTEMBER 25, 2023
The post Achieving pharmaceutical drug traceability compliance appeared first on European Pharmaceutical Review.
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Pharmaceutical industry: 2023 in retrospect
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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Monitoring pharmaceuticals in the environment
European Pharmaceutical Review
APRIL 18, 2024
What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). A well-designed wastewater sampling plan will ensure that representative samples are collected.
Sweden gets new pharmaceutical aseptic filling line
European Pharmaceutical Review
OCTOBER 18, 2023
Features of the new line for syringes include the latest automated systems and quality control measures, ensuring the highest levels of safety, efficiency, and product integrity. The post Sweden gets new pharmaceutical aseptic filling line appeared first on European Pharmaceutical Review.
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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
European Pharmaceutical Review
MARCH 8, 2024
Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Quality by design supports the move towards Pharma 4.0, The paper was published in Drug Discovery Today.
Covid vaccine profits and the strain on supply channels
World of DTC Marketing
JANUARY 8, 2021
At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50 Pharmaceutical companies are in business to make money, and if taxpayers have to pay the bill well, then so be it. So let’s be real.
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Is the pharmaceutical sector realising its potential for sustainable manufacturing?
European Pharmaceutical Review
APRIL 11, 2024
The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. appeared first on European Pharmaceutical Review.
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Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field
MedCity News
JANUARY 2, 2024
Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.
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Key developments in pharmaceutical manufacturing – September 2023
European Pharmaceutical Review
OCTOBER 12, 2023
September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. While the data was based on responses from 292 manufacturers across all sectors, the outcomes are applicable to pharmaceutical manufacturing. Meath opened last month.
Elevating pharmaceutical manufacturing processes with real-time insights
European Pharmaceutical Review
DECEMBER 4, 2023
The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety. principles.
How did pharma develop a vaccine so quickly?
World of DTC Marketing
DECEMBER 29, 2020
A key consideration is funding – public and private cash has been poured into the race for a Covid vaccine, pushing aside the usual financial concerns facing pharmaceutical companies. All vaccines go through clinical trials to test safety and effectiveness.
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WHO grants emergency use listing to SK bioscience’s SKYCovione
Pharmaceutical Technology
JUNE 20, 2023
Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein. The findings also showed that the Covid-19 vaccine had a standard safety and reactogenicity profile.
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Pharma responds to 2024 UK General Election
European Pharmaceutical Review
JULY 5, 2024
Following the Labour Party’s win yesterday in the UK 2024 General Election, industry representatives have voiced their opinions on what this could mean for the future of the pharmaceutical industry under the new government. EU pharmacovigilance is stronger with the UK, and UK research is stronger with the EU.”
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Should we be worried about pharma’s supply chain?
World of DTC Marketing
APRIL 12, 2021
We need a 21st-century approach that puts patient safety first. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety.
In Depth Focus QA/QC Microbiology/RMM 2023
European Pharmaceutical Review
JUNE 30, 2023
A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The post In Depth Focus QA/QC Microbiology/RMM 2023 appeared first on European Pharmaceutical Review.
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Innovative small molecule shows promise in obesity
European Pharmaceutical Review
JUNE 28, 2024
HUADONG MEDICINE, via its subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. According to the trial data, the dose range of 10mg to 600mg for HDM1002 offered good safety and tolerability. Twenty-eight days of continuous dosing within the dose range of 50-400mg revealed that HDM1002 had “good” safety and tolerability.
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AbbVie doesn’t care about employees
World of DTC Marketing
SEPTEMBER 14, 2020
THE BASICS: A “critical part” of pharmaceutical company AbbVie ‘s success is “face-to-face” interaction, CEO Richard Gonzalez explained in an Aug. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S.
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First CRISPR-based gene-editing therapy authorised
European Pharmaceutical Review
NOVEMBER 16, 2023
According to Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is a genetically modified autologous CD34+ cell enriched population containing human hematopoietic stem and progenitor cells edited ex vivo by CRISPR/Cas9 at the erythroid-specific enhancer region of the BCL11A gene.
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European authorities recognised for leading medicine regulatory oversight
European Pharmaceutical Review
MAY 22, 2024
The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.
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Modifier gene therapy – clinical development and manufacturing considerations
European Pharmaceutical Review
JUNE 13, 2024
Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD. The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases.
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MHRA Chief Executive to step down
European Pharmaceutical Review
FEBRUARY 27, 2024
While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.
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Could Eli Lilly deliver first-line atopic dermatitis treatment?
European Pharmaceutical Review
OCTOBER 20, 2023
The safety profile of lebrikizumab in ADjoin was found to be consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis. There were no new safety signals reported up to two years of treatment, stated Eli Lilly. appeared first on European Pharmaceutical Review.
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Switzerland and US sign drug inspection agreement
European Pharmaceutical Review
JANUARY 16, 2023
A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The post Switzerland and US sign drug inspection agreement appeared first on European Pharmaceutical Review.
Investing in the future of pharmaceutical microbiology QC
European Pharmaceutical Review
DECEMBER 5, 2024
Rapid microbiology methods have been gaining more visibility in the pharmaceutical microbiology industry due to the increased demand for faster turnaround times for microbiological results, especially for cell and gene therapy products where the urgency to deliver a safe and quality product to patients is within days.
UK medical cannabis manufacturer granted GMP registration
European Pharmaceutical Review
JANUARY 18, 2023
The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. It has plans to expand to other indications such as autism and multiple sclerosis.
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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment
European Pharmaceutical Review
APRIL 18, 2024
EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in uncomplicated urogenital gonorrhoea. GSK shared that the safety and tolerability profile of gepotidacin in this trial was consistent with data seen in Phase I and II trials.
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Bridging the healthcare digital divide: a gradual approach to adopting ePI
European Pharmaceutical Review
JANUARY 25, 2024
Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).
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MHRA publishes strategy on AI regulation
European Pharmaceutical Review
MAY 2, 2024
As such, the MHRA highlighted that it views the opportunities and risks that AI holds through the lens of being: a regulator of AI products a public service organisation delivering time-critical decisions an organisation making evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties.
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EMA starts review into hair loss drugs about potential link to suicidal thoughts
Pharmaceutical Technology
OCTOBER 7, 2024
The safety review was requested by the French medicines agency, citing new safety reports that alter the risk profile of finasteride.
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Major study on DMT shows promise for depression
European Pharmaceutical Review
JANUARY 25, 2023
The Phase IIa study investigated the efficacy and safety of intravenous DMT, with supportive therapy, in 34 patients with moderate/severe MDD. Safety and tolerability The intravenous dose of DMT for major depressive disorder was well tolerated by all patients receiving an active dose.
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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
European Pharmaceutical Review
FEBRUARY 15, 2024
The investment expands the site to over 30,000ft 2 and includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP product customers who require the highest levels of safety, sterility, and stability.
Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis
European Pharmaceutical Review
MAY 8, 2024
By uniquely targeting the OX40 receptor without depleting T cells and with its long half-life, IMG-007 presents a best-in-class potential to not only minimise safety risks associated with T cell depletion, but also provide patients with a more convenient dosing regimen.” “We
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Could GSK myelofibrosis treatment gain EU-first approval?
European Pharmaceutical Review
NOVEMBER 13, 2023
According to GSK, the positive CHMP opinion is supported by data from the pivotal Phase III MOMENTUM study , which evaluated the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population.
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MHRA approves ‘safer’ medicine alternative for rare disease
European Pharmaceutical Review
JANUARY 15, 2024
“In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth,” Dr Shabir Hasham, Chief Medical Officer of Santhera Pharmaceuticals shared. Initial European launch will be in Germany in Q1,” Dr Hasham confirmed.
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Novel LAI antipsychotic approved in EU
European Pharmaceutical Review
MARCH 29, 2024
Otsuka Pharmaceutical Europe Ltd and H Lundbeck A/S highlighted that the new LAI formulation is provided in a single-chamber prefilled syringe for intramuscular injection, which does not require reconstitution. The post Novel LAI antipsychotic approved in EU appeared first on European Pharmaceutical Review.
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Aseptic packaging market to value $35bn by 2033
European Pharmaceutical Review
SEPTEMBER 22, 2023
Aseptic packaging has vastly improved the stability and safety of medications, as it provides benefits such as drug stability and more efficient distribution methods. Growth of the European aseptic packaging market The pharmaceutical industry in Europe is witnessing growth in the market for aseptic packaging.
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