Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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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. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Pfizer Drug Safety.

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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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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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Regulation Medicine Generic Drugs Containment 98

pharmaphorum

JANUARY 20, 2022

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

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Drugs Medicine Containment Branding 111

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. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Pfizer Drug Safety.

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Pharmaceutical Technology

DECEMBER 27, 2022

Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor.

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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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pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. The limits of animal models in drug discovery are well known. Organ-on-a-chip.

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Drugs Licensing Licensing Pharma Companies 143

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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STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

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Druggist

MARCH 23, 2021

Ibuprofen is one of the most common drugs purchased over the counter in the UK. Ibuprofen prescribing decreased significantly in recent years due to the NHS strategy to minimise issuing of medicines that are available over the counter. Today I will review ibuprofen alternative drugs. Other alternative drugs to ibuprofen.

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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. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. GDP and GMP advisory.

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Packaging Packaging Compliance Manufacturing 130

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. 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

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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Regulation Medicine Containment Drugs 72

pharmaphorum

MAY 11, 2021

Flagship Pioneering, the VC fund run by Moderna’s co-founder Noubar Afeyan has launched a new biotech Laronde , with an ambitious plan to create a new class of drugs based on Endless RNA. Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body.

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RNA Drugs Protein Immune Response 98

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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XTalks

JANUARY 24, 2022

Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. While Biktarvy brought in $7.3

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

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Pharmaceutical Technology

JUNE 8, 2023

Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication. Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant.

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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. CGT drugs fall into two major categories: autologous and allogeneic. What are the general differences in the supply chain of CGT vs. traditional clinical trials?

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Most codeine products are combination products of codeine and another drug. Restrictions on the supply of codeine-containing products. Each 5ml of codeine linctus contains 15mg of codeine phosphate.

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Production Containment Pharmacy Licensing 98

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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Camargo

SEPTEMBER 14, 2021

The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics. INDs must contain full study reports of nonclinical and clinical (if available) studies. In this section, we will focus on Breakthrough Therapy designation in the US and priority medicines (PRIME) in the EU.

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Clinical Trials Clinical Trials Medicine Production 144

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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Allergies Containment Regulation Medicine 86

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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Vaccine Vaccination Antibody Medicine 264

Pharmaceutical Technology

MARCH 10, 2023

In Lebanon, the battle for access to medicines rages on and is further heightened by dramatic decreases to the healthcare budget last year. Consequentially, the five-year average price trend in Lebanon for all medicines has increased to 1,123%. Additionally, Lebanon relies on foreign currency for 80% of drugs.

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STAT News

SEPTEMBER 29, 2022

The Food and Drug Administration wants to update its rules for which foods can be branded “healthy.” ” The proposed label rule aims, in part, to address a question as old as medicine: What does it mean for a food to be healthy? Read the rest…

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pharmaphorum

OCTOBER 31, 2021

Pilocarpine is already used to reduce pressure inside the eye in ophthalmic diseases like glaucoma, so ophthalmologists are already familiar with the drug, and that could assist take-up of Vuity. The drug is in two phase 3 trials – NEAR-1 and NEAR-2 – that got underway a year ago. Brimochol is in phase 2 testing.

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Drugs FDA Approval Trials Development 105

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. Food and Drug Administration and the U.S. Our choice today is a Mardi Gras blend. And how is your morning going? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Last Friday, the U.S.

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Clinical Trials Clinical Trials Regulation Drugs 97

XTalks

JUNE 16, 2023

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

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Druggist

JANUARY 9, 2021

Where possible, I will review the evidence to answer what the best over the counter migraine medicine is. Over the counter codeine-based medicines. Migraine management with drugs in broadly divided into prophylactic treatment (to prevent migraines) and acute treatment for managing migraine-associated headaches and nausea.

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Containment Pharmacy Drugs Production 98

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Gene Therapy Gene Protein Sales 246

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies. Pharmaceutical compounding may fulfil the specific requirements of patients, unlike mass-produced medicines. Test method development.

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Marketing Pharmacy Containment Sales 100

Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.

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