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. For more information on Huma’s regulated platform download the paper below. [1]

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Medicine Doctors Doctor Regulation 130

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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Manufacturing Containment Regulation Medicine 122

Advarra

JULY 26, 2022

with 37 states approving medicinal use and 18 approving recreationally. Cannabis plants and derivatives containing no more than 0.3% Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements.

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Regulation Research Production Cosmetics 97

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.

Genomics 119

Genomics Genome Medicine Gene 119

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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Containment Hormones Regulation Medicine 50

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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Regulation Medicine Containment Life Science 52

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.

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Regulation Compliance Medicine Manufacturing 52

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.

Allergies 86

Allergies Containment Regulation Medicine 86

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. … The European Medicines Agency has not identified any safety signals in the region related to the updated Covid-19 booster shot from Pfizer and BioNTech , Reuters notes. Our choice today is a Mardi Gras blend. And how is your morning going?

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Clinical Trials Clinical Trials Regulation Drugs 97

Pharmaceutical Technology

JUNE 24, 2022

The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 5, there may be enough overlap for the bivalent vaccine to offer protection against all the subvariants, says Dr Prathit Kulkarni, assistant professor of medicine in infectious diseases at Baylor College of Medicine.

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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. Finding the best commercial packaging suppliers in contract marketing.

Packaging 100

Packaging Packaging Marketing Containment 100

Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

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Clinical Trials Clinical Trials Medicine Production 144

pharmaphorum

SEPTEMBER 2, 2020

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. In July, Gilead’s Veklury (remdesivir) became the first drug cleared by EU regulators to treat symptoms in patients hospitalised with COVID-19.

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Regulation Medicine Containment Drugs 59

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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Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Development Bioequivalency Generic Drugs Production 242

Drug Patent Watch

JANUARY 14, 2025

”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. It’s being used extensively to reduce development costs and accelerate access to medicines[3]. Q: What role does real-world evidence play in generic drug development?

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Generic Drugs Development Drugs Manufacturing 87

Pharma in Brief

AUGUST 5, 2020

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. GENVOYA is a designated “innovative drug” in respect to TAF pursuant to the data protection provisions of the Food and Drug Regulations , CRC, c 870 ( Data Protection Regulations ). Background. Minister of Health’s Decision.

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Containment Drugs Regulation Medicine 52

XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

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Regulation Genetics Scientist RNA 52

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 126

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Pfizer completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent Covid-19 vaccine candidate, based on the BA.1 1 sub-lineage on 19 July.

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Manufacturing Vaccine Vaccination Packaging 130

Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

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Regulation Containment Marketing Medicine 52

pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. The Medicinal Products Annex. Unfortunately, this is thin gruel.

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Pharmaceutical Technology

MAY 24, 2023

The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine. This is a primary factor for the staggeringly high unit cost of CGT. plan a, plan b, … charter flight standby option).

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccine Vaccination Trials Protein 104

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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XTalks

AUGUST 16, 2022

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. The primary series of Moderna’s COVID vaccine remains at two doses. 1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.

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Vaccine Vaccination Antibody Regulation 98

Pharmaceutical Technology

FEBRUARY 8, 2023

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. Furthermore, due to smaller patient populations, rare disease trials are often smaller in size than other disease trials.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

pharmaphorum

NOVEMBER 13, 2020

Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports , the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either.

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pharmaphorum

JUNE 9, 2022

The new vaccine contains mRNA coding for the spike protein of both the original wild-type SARS-CoV-2 virus and the Omicron variant, and is being positioned as a second booster shot that could be used in forthcoming immunisation campaigns. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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Vaccine Vaccination Containment Clinical Trials 105

Pharmaceutical Technology

MAY 24, 2023

The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial. Notably, PKD has an estimated prevalence of up to 8,000 patients in the US and Europe and represents one of the most significant patient opportunities in our LV haematology portfolio.”

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Gene Therapy Gene Licensing Licensing 130

pharmaphorum

NOVEMBER 30, 2020

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine.

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Vaccine Vaccination Medicine Production 88

pharmaphorum

JANUARY 30, 2023

Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs. Seeking more detail on how these shortages occur, pharmaphorum reached out to the European Medicines Agency (EMA).

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Medicine Production Manufacturing Regulation 104

Pharma in Brief

JULY 28, 2020

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations ( CSP Regulations ). JULUCA: a new combination of medicinal ingredients. The 282 Patent contains claims directed to dolutegravir, one of the medicinal ingredients in JULUCA.

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Production Containment Drugs Regulation 52

Rethinking Clinical Trials

SEPTEMBER 13, 2023

Patients were randomized 1:1 in blocks of variable size, stratified by trial site with allocation concealed until randomization using opaque envelopes containing trial group assignment. Learn more Read more in the New England Journal of Medicine. For the RSI trial the FDA regulations had not been updated yet.

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Trials Clinical Trials Clinical Trials Medicine 111

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). the PMS Product ). In that case, Manson J. Knowledge of influence.

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Regulation Trials Production Compliance 52

XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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Vaccine Vaccination Production Manufacturing 105