pharmaphorum

JANUARY 4, 2024

CVS Health will remove AbbVie’s immunology blockbuster Humira from national lists of reimbursable products, and offer biosimilars of the drug instead

Production 105

Production Drugs 105

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.

Manufacturing 147

Manufacturing Production Containment Antibody 147

FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s.

Generic Drugs 104

Generic Drugs Drugs Production Marketing 104

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical Technology has listed the leading payers in pharma based on its intel, insights, and decades-long experience in the sector. The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. Concept evaluation testing. Pricing research.

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Branding Production Scientist Compliance 147

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.

Manufacturing 152

Manufacturing Production Clinical Trials Clinical Trials 152

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. Pharmaceutical Technology has listed the top direct-to-consumer pharmaceutical marketing companies based on its intel, insights and decades-long experience in the sector. No product is mentioned for help-seeking advertising.

Marketing 130

Marketing Compliance Doctors Doctor 130

Pharma Mirror

MARCH 31, 2022

The leading European pharmaceutical marketplace now hosts more than 85 000 CTD dossiers for finished dosage formulation products. Compared to 19 600 products at the start of 2021, the product offering has increased fourfold over a single year. While quantity is sometimes a quality in itself, our product listings are curated by.

Pharma Production 130

Pharma Production Production Drugs 130

FDA Law Blog

MARCH 26, 2024

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. Last time, back in 2022 , the FTC took on REMS patents, explaining in litigation between Jazz and Avadel that the listing of REMS patents in the Orange Book is anticompetitive; this time, the FTC is going after device patents.

Production 59

Production Drugs Containment Generic Drugs 59

Scienmag

FEBRUARY 7, 2021

Disconnects between the front labels and ingredient lists of packaging containing fruits and vegetables make it more difficult for parents to understand what kind of food they are buying for their children, according to the Journal of Nutrition Education Credit: Journal of Nutrition Education and Behavior Philadelphia, February 8, 2021 – Early (..)

Packaging 76

Packaging Packaging Production Containment 76

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

Vaccination 363

Vaccination Vaccine Protein Clinical Trials 363

Pharmaceutical Technology

JUNE 12, 2023

Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list. It noted that the injection’s latest approval will help reduce the recent supply issues for the product in the country. The sodium acetate injection 2MEQ/mL was also an FDA drug shortage listed product.

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FDA Approval Production Drugs 130

Fierce Pharma

AUGUST 4, 2023

In a bid to thwart shortages of critical hospital drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. | In a bid to thwart shortages of critical drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list.

Production 78

Production Drugs 78

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.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. The one thing I remembered was that “death” was listed in the fair balance. DTC TV ads are meant to do one thing: raise awareness of the product.

Contamination 297

Contamination Production Marketing Drugs 297

Pharmaceutical Technology

SEPTEMBER 20, 2022

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population.

Marketing 130

Marketing Drug Delivery Systems Production Containment 130

Pharmaceutical Technology

JUNE 20, 2023

They are also listed in China on the very narrow strains list permitted for use in infant food. Our product, supported by decades of scientific, marketing and regulatory accomplishments, has achieved the almost impossible nowadays: getting an approval in Brazil! It is the first one this year.

Compliance 130

Compliance Clinical Trials Clinical Trials Production 130

Pharmaceutical Technology

JULY 15, 2022

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution.

Insulin 328

Insulin Manufacturing Contract Manufacturing Production 328

FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. DEA’s notice of updates with the Special Surveillance List is attached here.

Manufacturing 59

Manufacturing Containment Production Regulation 59

STAT News

MARCH 14, 2023

list prices for several insulin products by up to 75%, the latest big drugmaker to take such a step in response to a years-long outcry over the cost of the diabetes treatments. The company plans to cut the list price of its NovoLog insulin by 75%, and the prices for Novolin and Levemir by 65% starting in January 2024.

Insulin 98

Insulin Branding Production Drugs 98

FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

Manufacturing 59

Manufacturing Production Drugs Marketing 59

Medical Xpress

DECEMBER 22, 2022

Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products.

Production 93

Production 93

World of DTC Marketing

MARCH 9, 2021

Email list segmentation and personalization were t he most effective email strategies, and segmented email campaigns show 50% higher CTR than untargeted campaigns. Pharma has an opportunity to engage customers and caregivers via email but they can’t send out product flyers. ” Email automation.

Marketing 289

Marketing Branding Packaging Packaging 289

FDA Law Blog

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. 21 U.S.C. § 21 U.S.C. §§ 802(38), (39)(B). Thus, such persons are subject to identification, recordkeeping, and reporting requirements. See, e.g. , DEA’s Fake Pills Fact Sheet.

Sales 116

Sales Regulation Compliance Production 116

Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. Requirements for obtaining a listing are set out in O.

Drugs 52

Drugs Regulation Production Generic Drugs 52

STAT News

MARCH 14, 2023

Meanwhile, we have assembled the latest list of interesting items for you to peruse. list prices for several insulin products by up to 75%, the latest big drugmaker to take such a step in response to a years-long outcry over the cost of the diabetes treatments , STAT writes.  The Please feel free to join us.

Insulin 98

Insulin Production Branding 98

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.

Containment 147

Containment Pharmacy Life Science Production 147

XTalks

DECEMBER 19, 2023

From the mystery of missing ingredients to the introduction of unconventional products, these top ten food news stories on Xtalks.com showcase the food industry’s resilience, innovation and ever-changing landscape. Our 2022 exploration into the world of quark cheese shed light on this lesser-known dairy product.

Branding 98

Branding Packaging Packaging Production 98

XTalks

JUNE 30, 2023

As consumer tastes and preferences continue to evolve, innovative food companies have risen to the occasion, captivating the market with their exceptional products and compelling narratives. Since Financial Times ’ ranking encompasses a spectrum of industries, we’ll focus solely on the food companies that made the list.

Branding 97

Branding Production Marketing Protein 97

Pharmaceutical Technology

APRIL 20, 2023

While roughly 100 drugs received additional price premiums, the majority of products saw their price reduced as a result of discrepancies between their NHI and market prices. In other words, NHI-listed products with more than a 4.375% rate of price discrepancy would face an off-year price reduction or price increase.

Drugs 130

Drugs Branding Production Manufacturing 130

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

Allergies 98

Allergies Packaging Packaging Containment 98

World of DTC Marketing

AUGUST 4, 2021

Pharma websites are not consdiered a top resource for infromation on new products. TV spots are the number one way people learn about new pharma products. 3hree: Pharma product websites are not listed as a top online health resource even when looking for information on a specific product. WebMD is still number one.

Marketing 279

Marketing Pharma Production Production Drugs 279

FDA Law Blog

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Radiology 119

Radiology Regulation Production Development 119

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical Technology has listed some of the top pharmacies in retail based on its intel, insights, and decades-long experience in the sector. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs. Discover the top retail pharmacies. Speciality care.

Pharmacy 147

Pharmacy Generic Drugs Containment Production 147

BioPharma Reporter

JUNE 28, 2021

Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.

Production 145

Production Development 145

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The company has also submitted applications to the World Health Organisation (WHO) for an emergency use listing and to the European Medicines Agency (EMA) for marketing authorisation.

Vaccination 298

Vaccination Vaccine Protein Medicine 298

Fierce Pharma

AUGUST 28, 2023

Now, Pfizer has clarified the timeline by which it expects manufacturing to resume.

Production 69

Production Medicine Manufacturing 69

FDA Law Blog

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §

Manufacturing 53

Manufacturing Production Containment Drugs 53