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.
This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Pharmaceutical Technology
OCTOBER 12, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on valproate-containing medicines.
Pharmaceutical Technology
FEBRUARY 28, 2023
Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Increasing product yield is the most fundamental way to achieve this.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharmaceutical Technology
NOVEMBER 17, 2022
According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.
Pharmaceutical Technology
SEPTEMBER 8, 2022
A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. We look forward to working jointly with Cellvera to bring this combination drug product forward to improve treatment options for patients worldwide.”. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).
Pharmaceutical Technology
MARCH 22, 2023
Process intensification can loosely be described as making more product with the same or fewer resources. The appeal of process intensification continues to grow in the biopharma industry as a means of not only increasing the productivity, but also improving sustainability. Existing technologies could also be run in a different way.
Bio Pharma Dive
MARCH 20, 2023
Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.
Pharmaceutical Technology
MAY 25, 2023
Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The vaccine contains haemagglutinin from four influenza virus strains, two A and two B.
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 Injectable Emulsion is a terminally sterilized (TS) product. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.
Camargo
MARCH 25, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.
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 Injectable Emulsion, USP is a terminally sterilized (TS) product. deliesschef. Wed, 07/13/2022 - 16:30. NEW YORK, NY., July 13, 2022 Hospira, Inc.,
Camargo
FEBRUARY 16, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.
Medical Xpress
DECEMBER 27, 2024
Food and Drug Administration (FDA) has proposed a new rule to require standardized testing of talc-containing cosmetics for asbestos, a known carcinogen linked to serious illnesses such as lung and ovarian cancers.
Camargo
MAY 19, 2021
The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.
STAT News
FEBRUARY 3, 2023
The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Read the rest…
XTalks
FEBRUARY 21, 2022
BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.
NPR Health - Shots
NOVEMBER 28, 2022
The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. Consumer Product Safety Commission) No injuries have been reported from such incidents. Image credit: U.S.
World of DTC Marketing
OCTOBER 25, 2021
In addition to immediate access to a physician, they offer on-site labs to analyze blood, MRI and CAT scan machines, pharmacies, and a full range of OTC products. The most important touchpoint for pharma continues to be product websites, but there is no indication that pharma understands this. Patients have wanted this for a long time.
World of DTC Marketing
JUNE 6, 2021
Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking. And, like any medication, there is a risk of side effects, some serious. appeared first on World of DTC Marketing.com.
XTalks
SEPTEMBER 19, 2023
The US Food and Drug Administration (FDA) has issued warning letters to eight companies manufacturing or marketing unapproved eye products that violate federal law. The FDA said the warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.
Pharmaceutical Technology
SEPTEMBER 15, 2022
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Containment challenges.
Fierce Pharma
SEPTEMBER 13, 2023
For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter.
Pharmaceutical Technology
SEPTEMBER 14, 2022
As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Improvement to the TIL product itself is an area of intense research. Once infused, TILs are further stimulated by IL-2 treatment. to more than 10%.
Pharmaceutical Technology
DECEMBER 11, 2023
Thousands of over-the-counter (OTC) and prescription healthcare products contain antimicrobial agents. Here’s what you need to know when working with these ingredients.
Pharmaceutical Technology
DECEMBER 12, 2022
An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma.
Pharmaceutical Technology
APRIL 24, 2023
As healthcare confronts challenges such as antimicrobial resistance and the spread of previously geographically constrained diseases as a result of climate change, research into natural products used in traditional medicine, referred to as ‘ethnopharmacology’, could help in finding new, clinically effective drugs.
Pharmaceutical Technology
SEPTEMBER 6, 2022
Hospitals, clinics, pharmacies, wholesalers of medical products and other health centres are catered by pharmaceutical logistics that include handling activities such as procurement, warehousing, and inventory management, as well as transportation, and management of the supply chain for diverse products.
Pharmaceutical Technology
AUGUST 1, 2022
The mRNA-1273.222 vaccine containing the BA.4/5 In June, the company and the European Commission (EC) signed an agreement to amend their previously agreed contractual supply schedules for the former’s Covid-19 vaccine booster product (Spikevax, mRNA-1273) or updated booster vaccine candidate.
Pharmaceutical Technology
MAY 24, 2023
Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients. CGT trials operate with much lower volumes of manufactured final product. The labeling process of the final product is earlier than that for traditional trials.
XTalks
APRIL 10, 2023
As the first OTC naloxone product approved by the FDA, Narcan is expected to be sold directly to consumers without a prescription as an emergency life-saving medication to reverse opioid overdose. Narcan nasal spray contains a single 4 mg dose of naloxone hydrochloride, which is administered intranasally.
Camargo
NOVEMBER 29, 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. Definition of Biologic Products. These products can be derived from humans, animals, or microorganisms with biotechnology.
Pharmaceutical Technology
MARCH 10, 2023
Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. The process eliminates the disadvantages of conventional drying methods or freezing.
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. 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. In October, the U.S.
World of DTC Marketing
OCTOBER 4, 2021
SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Mt recommendation was no and was based on the amount of health misinformation I found on the site.
Pharmaceutical Technology
OCTOBER 6, 2022
According to Adam Bradbury, GlobalData PharmSource analyst “[…] evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow.” The processes and subsequent installation must be adapted to the product,” says Housh.
Pharmaceutical Technology
SEPTEMBER 5, 2022
The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. The document contains detailed information on the suppliers and their product offerings, alongside their contact details to aid your purchasing or hiring decision. Concept evaluation testing.
Pharmaceutical Technology
SEPTEMBER 5, 2022
Pharmaceutical companies hold permission to market their products directly to consumers. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Product claim advertising is allowed with a summary of the product risks included.
STAT News
OCTOBER 7, 2022
The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” They are about selling food products. ” The proposed rules are a lot better than the labeling anarchy that currently exists. Read the rest…
Pharmaceutical Technology
SEPTEMBER 5, 2022
Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.
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.
Pharmaceutical Technology
AUGUST 17, 2022
RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. The Verdict. Northgate Technologies Inc.
Camargo
NOVEMBER 15, 2021
It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.
Drug Patent Watch
MARCH 22, 2022
Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to….
FDA Law Blog
JULY 29, 2024
Newberger — In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. By Jennifer D.
Pharma Mirror
SEPTEMBER 1, 2023
A key option offered with the company’s automated cleaning and disinfecting wash systems, the custom wash rack services were developed to help pharmaceutical and nutritional product manufacturers ensure complete cleaning and disinfection of laboratory glassware, tableting tools, containers, valves, machine parts, and other supplies and equipment (..)
Expert insights. Personalized for you.
We have resent the email to
Are you sure you want to cancel your subscriptions?
Let's personalize your content