UK MHRA publishes guidance on medicines containing valproate
Pharmaceutical Technology
OCTOBER 12, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on valproate-containing medicines.
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LACTOSE-Free Medicines: Which Drugs Contain LACTOSE?
Drug Patent Watch
MARCH 7, 2024
LACTOSE-Free Medicines, 2024 is part of DrugPatentWatch’s deep library of business intelligence on biopharmaceutical drugs. Buy Lactose-Free Medicines from Amazon This guide is designed to provide information for healthcare providers to… The post LACTOSE-Free Medicines: Which Drugs Contain LACTOSE?
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GELATIN-Free Medicines: Which Drugs Contain GELATIN?
Drug Patent Watch
MARCH 6, 2024
GELATIN-Free Medicines, 2024 is part of DrugPatentWatch’s deep library of business intelligence on biopharmaceutical drugs. Buy Gelatin-Free Medicines on Amazon This guide is designed to provide information for healthcare providers to… The post GELATIN-Free Medicines: Which Drugs Contain GELATIN?
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EMA recommends suspension of 17-OHPC medicines in EU
Pharmaceutical Technology
MAY 20, 2024
The EMA's PRAC has advised suspension of marketing authorisations for therapeutics containing 17-OHPC in the European Union (EU).
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Ethnopharmacology: traditional medicine and modern drug discovery
Pharmaceutical Technology
APRIL 24, 2023
Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture.
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What’s next for Container Closure Integrity Testing?
Pharmaceutical Technology
NOVEMBER 30, 2022
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The post What’s next for Container Closure Integrity Testing?
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The rising importance of containment in small molecule drug development
Pharmaceutical Technology
DECEMBER 6, 2022
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. On the other hand, the current trend is for fully closed systems that use negative pressure to keep particles contained inside isolators. Prioritising safety in early-stage development.
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Streamlining development with containment in early drug discovery
Drug Discovery World
AUGUST 4, 2022
It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. However, starting early can greatly improve the efficiency and speed of the development process. Testing compatibility.
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The pangenome is making personalised medicine more equitable
Pharmaceutical Technology
JUNE 14, 2023
metres of supercoiled DNA contained within its nucleus. The future of personalised medicine In May 2023, scientists unveiled the pangenome, an update on the human reference genome that includes genetic maps of 47 people from the Americas, Europe, Africa, and Asia. It is these characteristics that make us uniquely human.
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After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs
Fierce Pharma
MAY 17, 2024
last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.
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Medicines adherence: Overcoming pharma’s biggest barrier to treatment success
Pharmaceutical Technology
MAY 25, 2023
Some RPM apps, such as those from Huma, contain specific features that can help both patients and clinicians log and track medications. Other medical apps contain information on drugs and dosages for prescription writing purposes. Companion apps can support clinician-to-patient messaging with reminders and notifications.
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Common medications contain animal byproducts, study finds
Scienmag
MARCH 29, 2021
No FDA regulations in place to alert patients when medication is derived from animals More physicians and pharmacists are advocating for patients to be made aware of animal byproducts contained in common medications, according to new research in the Journal of Osteopathic Medicine.
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Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates
Pfizer
AUGUST 22, 2022
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.
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Six Velocity Principal Investigators Co-Author Article Published in Nature Medicine
Velocity Clinical Research
SEPTEMBER 28, 2023
Six Velocity Principal Investigators coauthored an article recently published in Nature Medicine. 5-containing bivalent mRNA-1273.222 vaccine with the ancestral Wuhan-Hu-1 mRNA-1273 as booster doses. The article covers the results of a Phase 2/3 trial of the Omicron BA.4/BA.5-containing
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Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate.
Pfizer
JULY 13, 2022
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.
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MHRA publishes guidance on medicine regulation after Brexit
pharmaphorum
SEPTEMBER 2, 2020
The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. The concern is that UK patients will face delays to receiving the latest medicines because of the changes to the regulatory system.
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Abacus Medicine Pharma Services and Laboratoires CTRS extend partnership to improve access to Orphacol® in Spain
Pharmaceutical Technology
APRIL 4, 2023
Abacus Medicine Pharma Services (AMPS) and Laboratoires CTRS, marketing authorization holder of Orphacol®, are proud to announce a strategic partnership that ensures continuous stock of Orphacol® in Spain. Orphacol® is a pharmaceutical product containing cholic acid, a substance found in the bile, which is used to digest fats.
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Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? (Carl T. Bergstrom, PhD)
Rethinking Clinical Trials
AUGUST 3, 2023
Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine?
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‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study
The Pharma Data
SEPTEMBER 24, 2020
Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study. The team looked through the National Institute of Health’s Dietary Supplement Label Database and the Natural Medicines Database for products containing unapproved drugs. Conor Kavanagh.
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Where is the promise for plant-based medicines? Part 3
Drug Discovery World
SEPTEMBER 4, 2023
In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. References [link] [link] [link] [link] The post Where is the promise for plant-based medicines?
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What is the best medicine for chesty cough?
Druggist
NOVEMBER 6, 2020
Patients commonly request over the counter medicines for a chesty cough. In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK. The best evidence for or against the effectiveness of medicines comes from well designed clinical trials.
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PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines
Pharma in Brief
DECEMBER 23, 2021
Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. The amendments.
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The Lancet Inf. Dis.: Vaccination alone is unlikely to contain COVID-19 infections in UK
Scienmag
MARCH 18, 2021
Vaccination alone is unlikely to contain COVID-19 infections in the UK but gradual reopening and high vaccine uptake could minimize future waves of infection COVID-19 vaccines being rolled out in the UK are effective in preventing severe disease, but the extent to which they prevent against infection is still unclear.
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Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register
Pharma in Brief
APRIL 25, 2021
These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,
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Unlike a Cluttered Desk, A Cluttered Medicine Cabinet…
FDA Law Blog
OCTOBER 19, 2022
Houck — If, as Albert Einstein supposedly quipped, a cluttered desk is the sign of a cluttered mind, what then does a cluttered medicine cabinet signify? More than a mere sign, a cluttered medicine cabinet can be hazardous if it contains unneeded and expired prescription medication susceptible to theft, misuse and abuse.
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Why have medicines progressed so little in the last decades?
Drug Discovery World
FEBRUARY 12, 2024
Why has there been so little progress in medicine? 7 Human biology-based research At Safer Medicines Trust, we believe that using human biology-based research is the best way to develop safe and effective treatments for patients. Rat Trap: The Capture of Medicine by Animal Research – and How to Break Free. BMJ Open Sci.
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“Off-the-shelf” cellular medicine resubmitted to the FDA
Drug Discovery World
FEBRUARY 6, 2023
It contains new long-term survival data of children enrolled in a Phase III trial showing durability of treatment effect through at least four years. “There is an urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD” said Dr Silviu Itescu, Chief Executive of Mesoblast.
Medicine 52
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Precision medicine study could find new options for rare cancers
Drug Discovery World
NOVEMBER 25, 2022
Cancer Research UK, The University of Manchester and Roche have opened a multi-drug, precision medicine trial for people with rare cancers. . The trial is set up to recruit both paediatric and adult patients with any rare cancer type and is one of very few precision medicine platform trials in the world targeting these populations. .
Medicine 52
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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster
Pharmaceutical Technology
NOVEMBER 9, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Each booster dosage contains 15?g 5 sub-variants.
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PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines
Pharma in Brief
JULY 7, 2021
Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until January 1, 2022. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices.
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Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable
Pharma in Brief
AUGUST 5, 2020
DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA. GENVOYA contains a combination of four medicinal ingredients including TAF. Minister of Health’s Decision.
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Leading commercial packaging companies in contract marketing
Pharmaceutical Technology
SEPTEMBER 15, 2022
The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Pharmaceutical packaging formats and materials. Trends in pharmaceutical contract packaging.
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Where is the promise for plant-based medicines? Part 1: Cannabis
Drug Discovery World
AUGUST 3, 2023
In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.
Medicine 52
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The future of genomic medicine: can it fulfil its promises?
pharmaphorum
SEPTEMBER 14, 2020
Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. At that time, we thought this would be the holy grail for medicine. Now, however, the field is changing with respect to genomic medicine.
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Thirty years of the Patented Medicines (Notice of Compliance) Regulations
Pharma in Brief
DECEMBER 3, 2023
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).
Regulation 52
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Where is the promise for plant-based medicines? Part 2: Psilocybin
Drug Discovery World
AUGUST 24, 2023
In the second part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of psilocybin in drug discovery. As of February 2023, there are no approved therapeutic products containing psilocybin in Canada. The first part explored medical cannabis. What is the regulatory landscape of psilocybin?
Medicine 52
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EU bans cough syrup chemical over severe allergies
Medical Xpress
DECEMBER 2, 2022
Cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic, the European Union's drug regulator said Friday.
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India’s lax oversight of pharmaceutical manufacturing imperils health around the world
STAT News
JANUARY 9, 2023
Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.
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Nationwide study suggests children's mental health during pandemic linked to family financial situation
Medical Xpress
MARCH 13, 2023
Financial disruption as a result of pandemic containment policies in the United States adversely influenced children's mental health, according to a new study co-led by Weill Cornell Medicine and Columbia University investigators.
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Medicinal cannabis: Why more clinical trials and better access is needed
Drug Discovery World
FEBRUARY 1, 2023
Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. The use of medicinal cannabis across much of the world is still in its infancy.
Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin
Roots Analysis
MARCH 8, 2023
It is worth noting that smart labels contain a transponder code which can be read by sophisticated devices, including radio frequency identification device (RFID) tags and near-field communication (NFC) chips. The post Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin appeared first on Blog.
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52 Brain noise contains unique signature of dream sleep
Scienmag
AUGUST 6, 2020
First EEG measure of REM sleep allows scientists to distinguish dreaming from wakefulness When we dream, our brains are filled with noisy electrical activity that looks nearly identical to that of the awake brain.
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White House backtracks on medicine price control plans
pharmaphorum
OCTOBER 29, 2021
President Joe Biden has jettisoned a raft of policy proposals aimed at curbing the price of prescription medicines as part of the US administration’s $1.75 The document released by the Biden administration yesterday contained no mention of price reform. trillion ‘build back better’ framework.
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Leading pharmaceutical wholesalers
Pharmaceutical Technology
SEPTEMBER 5, 2022
Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Worldwide sourcing and drop-ship of orphan medicines, and. GDP and GMP advisory. Temperature control facilities and supply solutions.
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