XTalks

OCTOBER 24, 2024

Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA). Nutrient-rich foods containing omega-3 fatty acids, prebiotics and curcumin could also help improve immune function and alleviate symptoms.

Research 105

Research Dermatology Clinical Trials Clinical Trials 105

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

Packaging 98

Packaging Packaging Containment Production 98

XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Sagent Pharmaceuticals Inc.

Drugs 105

Drugs Packaging Packaging Containment 105

Pharma in Brief

AUGUST 5, 2020

The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s s ( Gilead ) product DESCOVY as the Canadian Reference Product. DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. GENVOYA contains a combination of four medicinal ingredients including TAF.

Containment 52

Containment Drugs Regulation Medicine 52

pharmaphorum

SEPTEMBER 22, 2020

Life sciences commercial organizations can now forecast sales, predict churn, analyze brand propensity and launch new products with BirdzAI . P360 , a leading developer of technology for life sciences companies, today announced major updates to its sales enablement platform BirdzAI. About P360.

Sales 71

Sales Life Science Branding Production 71

XTalks

JULY 26, 2024

The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.

Drug Delivery Systems 97

Drug Delivery Systems FDA Approval Drug Delivery Containment 97

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. mg and 2.4 mg doses of Wegovy.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

pharmaphorum

JANUARY 27, 2021

The plant was visited by Prime Minister Boris Johnson last month along with Wrexham’s conservative MP Sarah Atherton, shortly after the UK government reserved one fill and finish production line at the unit for its exclusive use for 18 months. The contract covers production of 100 million doses of the AZ vaccine.

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Vaccine Vaccination Packaging Packaging 98

Pharma in Brief

JULY 28, 2020

JULUCA ® is a fixed-dose combination ( FDC ) drug product containing the medicinal ingredients dolutegravir and rilpivirine ( JULUCA ). The 282 Patent contains claims directed to dolutegravir, one of the medicinal ingredients in JULUCA. It is used for the treatment of HIV in adults who are virologically stable and suppressed.

Production 52

Production Containment Drugs Regulation 52

pharmaphorum

OCTOBER 31, 2022

The Galien Foundation, which acknowledges “extraordinary scientific innovations that improve the human condition”, has awarded its Best Biotechnology Product 2022 accolade to Regeneron Pharmaceuticals, Inc.’s The Prix Galien is regarded as the equivalent of the Nobel Prize for the life science industry. Amgen, Inc.

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Production FDA Approval Antibody Gene 52

pharmaphorum

DECEMBER 7, 2021

Since the onset of the Covid-19 pandemic, life science companies have acted quickly to address the evolving digital needs of healthcare professionals, with mixed success (see graph 1). For the most part, life science companies have a relatively good knowledge of what their audiences want and need from them.

Life Science 105

Life Science Pharma Companies Branding Marketing 105

XTalks

MARCH 6, 2023

to acquire Mayne Pharma’s US generic prescription products portfolio. The portfolio contains approximately forty-five commercial products, four products in the pipeline, and forty approved non-marketed products, many of which are generics focused on women’s health. Dr. Reddy’s Laboratories Ltd.

Production 98

Production Branding Dermatology Hormones 98

pharmaphorum

MARCH 26, 2021

Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. Even where products do originate in the UK or EU, thus qualifying for tax and duty-free status, this does not mean they can cross the border without friction.

Production 119

Production Medicine Marketing Regulation 119

XTalks

JULY 16, 2021

The company said that while benzene is not an ingredient in any of its sunscreen products, it was detected during routine internal testing in some samples of its aerosol sunscreen finished products. Therefore, levels should be monitored at different stages of production to avoid harmful benzene contamination.

Contamination 105

Contamination Production Drugs Branding 105

Pharma in Brief

APRIL 25, 2021

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., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”).

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Regulation Medicine Generic Drugs Containment 98

pharmaphorum

FEBRUARY 4, 2021

That’s why CIOs and CTOs working within the life sciences industry need to include Salesforce org management as a key component of their standard operating procedures. As such, many in the life sciences industry view Salesforce as more than just a CRM, and are running the entire enterprise with it.

Compliance 105

Compliance Life Science HR Development 105

pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine. New partnership tests low-dose psilocybin.

Medicine 122

Medicine Life Science FDA Approval Development 122

pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences. Whether present in electronic or combustible cigarettes, nicotine is a highly addictive substance.

Life Science 111

Life Science FDA Approval Trials Development 111

Pharma in Brief

OCTOBER 20, 2021

A CSP provides patent-like rights and is intended to compensate patentees for a period of patent term lost while innovative pharmaceutical products undergo research and regulatory approval. [1]. The Regulatory Impact Analysis Statement ( RIAS ) calls this the “Timely Submission Requirement”. [2].

Production 98

Production Clinical Trials Clinical Trials Containment 98

XTalks

SEPTEMBER 6, 2022

Konvomep is contraindicated in patients with known hypersensitivity to any components of the formulation and in patients receiving rilpivirine-containing products. Konvomep comes as a kit of two bottles, where one bottle contains omeprazole powder, and the other bottle is diluent that contains sodium bicarbonate.

FDA Approval 98

FDA Approval Containment Pharmacy Medicine 98

XTalks

JANUARY 24, 2022

While some of the bottles contained authentic mediation, others had over-the-counter painkillers or an antipsychotic drug instead of the antivirals. The safety of individuals taking Gilead medication is always our first priority,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in the press release. “We

Drugs 98

Drugs Pharmacy Production Containment 98

XTalks

NOVEMBER 28, 2023

Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.

FDA Approval 103

FDA Approval Bacteria DNA Drugs 103

XTalks

JUNE 14, 2023

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. As a water-free product, it does not have an associated pH value or osmolarity.

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

XTalks

JULY 18, 2023

Johnson & Johnson is turning the tables and launching its own lawsuits against several doctors who conducted studies on the company’s talc-based products. Johnson & Johnson has been accused of knowing about, and covering up, the higher-than-acceptable amounts of asbestos in some of its final talc products since the 1970s.

Research 95

Research Contamination Doctor Doctors 95

XTalks

APRIL 25, 2023

For the past 20 years at Xtalks , marketers from the life sciences, medical device and food industries have truly embraced our webinars as a tool of choice. Generating less waste: Tradeshows typically generate considerable waste in the form of printed materials, promotional items, food and beverage containers and booth setups.

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Production Marketing Life Science Containment 97

XTalks

AUGUST 28, 2020

And to ensure that the user is breathing clean, filtered air, the mask contains FDA-approved HEPA filters that provide up to 99 percent protection against particles including dust, aerosols and droplets. The parts contain magnets that allow for optimal adjustment of the mask to the user’s face. The mask also comes in different colors.

Containment 111

Containment Bacteria Marketing Production 111

pharmaphorum

JANUARY 27, 2023

Through the integration of precision technologies, healthcare providers can reduce excessive workloads, increase productivity, and ultimately help eliminate the burnout many professionals are currently experiencing. Doing so will result in increased trial productivity, accuracy, and efficiency. About the author Marie E.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Clinical Research 111

XTalks

JUNE 1, 2022

Xtalks learned more about BONESUPPORT and its first FDA-approved drug-device combination product Cerament G through an email interview with BONESUPPORT’s CEO Emil Billbäck. In May this year, BONESUPPORT received market authorization in the US for its drug-device combination product Cerament G. Read on to learn more!

Filler 98

Filler FDA Approval Production Marketing 98

The Pharma Data

MAY 17, 2021

About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

Life Science 52

Life Science Containment Branding Sales 52

XTalks

MARCH 10, 2022

In another study, Kligman and his colleagues investigated whether the type of containers that the baby powder was stored could have an effect on the skin. After administration of talc from different containers and covered with dressings, Kligman reported that “neither sample from the different containers caused a reaction.”

Containment 98

Containment Dermatology Contamination Sales 98

The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

XTalks

SEPTEMBER 10, 2020

At the same time, the FDA also issued warning letters to companies who sell or distribute unauthorized e-cigarettes or other electronic nicotine delivery systems (ENDS) products to remove them from the market. The incorporation of appealing flavors and product innovations are some of the factors that have contributed to this increase.

Production 69

Production Marketing Containment Manufacturing 69

XTalks

SEPTEMBER 15, 2020

In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.

Vaccine 103

Vaccine Vaccination Insulin Trials 103

Pharma in Brief

JUNE 9, 2021

The Federal Court has quashed a notice of compliance ( NOC ) issued to Médunik Canada ( Médunik ) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. Catalyst ) filed an NDS for FIRDAPSE, which contains amifampridine.

Containment 52

Containment Production Compliance Drugs 52

XTalks

AUGUST 7, 2023

He also thanked the 500 patients, caregivers, investigators and healthcare professionals involved in the Phase III trials and stated that Verrica’s commercial team is actively preparing for the product’s commercial launch in September 2023. ’s berdazimer gel, containing 10.3 What is Molluscum Contagiosum?

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

DECEMBER 5, 2022

Epidiolex contains sesame seed oil, restricting its use for some individuals. Big pharma continues to eye the medicinal CBD market as it’s currently wide open with high anticipation of growth with new products. Meanwhile, net product sales of Epidiolex grew by 22 percent to $196.2 billion deal in 2021.

Bioavailability 97

Bioavailability FDA Approval Trials Drugs 97

XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. These resulting transcripts facilitate the production and secretion of mature COL7, forming elongated and slender structures known as anchoring fibrils.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111