Pharma in Brief

AUGUST 5, 2020

The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA. Background. Minister of Health’s Decision.

Containment 52

Containment Drugs Regulation Medicine 52

Drug Discovery World

AUGUST 4, 2022

Life sciences property provider Bruntwood SciTech has invested £20 million into redeveloped laboratories at the UK’s North West research campus, Alderley Park. . Alderley Park is already a world-leading campus for science and technology and a key location for the North’s thriving life sciences sector.

Life Science 52

Life Science Containment Development Medicine 52

The Pharma Data

NOVEMBER 10, 2020

Crohn’s Disease Therapeutics Market Size $4.7 Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. The CD therapeutic market size will be worth $4.7

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

DECEMBER 13, 2022

This week saw two major life sciences investments in London, as GSK unveiled plans to move its headquarters to a central location in the city, while an ambitious plan to develop a new biosciences hub in Canary Wharf moved to the next stage. Earnshaw building. The building will be a “vertical campus” with 823,000 sq.

Life Science 59

Life Science Sales Development Containment 59

Pharma in Brief

SEPTEMBER 8, 2022

collectively, AbbVie ) product, HUMIRA (adalimumab), sought to be marketed by JAMP Pharma Corporation ( JAMP ). JAMP took the view that it was not required to address any of the patents listed on the Patent Register for HUMIRA because its presentations corresponded to non-marketed presentations of HUMIRA. Background.

Marketing 52

Marketing Drugs Regulation Compliance 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

JULY 14, 2021

In this episode, Ayesha talks about Nestlé’s marketing of Seres Therapeutics’ oral microbiome drug for recurrent C. Seres’ microbiome drug SER-109 aims to restore the healthy bacteria via an oral capsule that contains a protective species of gut bacteria. Nestlé to Market Seres’ Oral Microbiome Drug for C.

Bacteria 52

Bacteria Marketing Drugs Containment 52

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

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Smoking Cessation: What are the drugs available in the market? Some of these approved products contain nicotine as an active ingredient, while others do not. Generics in the Market.

Marketing 52

Marketing FDA Approval Branding Production 52

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. Some of the products contain silver, which may appear on labels as silver sulfate, silver sulphate or agentum. The FDA routinely looks out for illicit drugs on the market.

Production 105

Production Pharmacy Sales Drugs 105

Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan.

Development 52

Development Drugs Life Science Marketing 52

Drug Discovery World

AUGUST 9, 2022

Provider to the life sciences industry BioIVT has acquired enzymes manufacturer Cypex in a bid to enhance its product portfolio. . Cypex’s product portfolio contains more than 115 recombinant enzymes, including CYPs, UGTs, CES, and AOX, and companion chemicals and media. Richard Haigh.

In-Vitro 52

In-Vitro Protein Production Bacteria 52

Drug Discovery World

APRIL 11, 2024

It’s initiatives like these which are vital to helping early-stage companies get access to much-needed funding, but also to enable them to meet the right people who can help them bring their ideas to market. The UK’s national action plan for AMR aims to see the problem effectively contained and controlled by 2040.

Bacteria 52

Bacteria Life Science Development Containment 52

XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

Containment 98

Containment Production Contamination Marketing 98

Pharma in Brief

JANUARY 15, 2024

Galderma ), markets two adapalene products in Canada: Differin ® , which contains 0.1% Differin XP TM , which contains a higher concentration of adapalene: 0.3% ( DIFFERIN XP ). There is no need for Board Staff to demonstrate actual market distortion, and no opportunity for a patentee to prove the contrary.

Dermatology 52

Dermatology Medicine Containment Production 52

XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Present and Future Prospects for the Imaging Agents Market In 2021, the market value of imaging agents was reported to be over $9.2 How Does Posluma Work?

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Marketing 96

pharmaphorum

MAY 26, 2021

Paula Parfitt discusses the importance of workplace diversity and how life science companies can build a thriving, diverse workforce. The life sciences sector is an industry built on collaborative creativity and innovation, providing life saving solutions to some of modern science’s most important problems.

Life Science 98

Life Science Research Containment Marketing 98

XTalks

FEBRUARY 27, 2023

A lack of this enzyme results in a toxic build-up of mannose-containing sugars in the cells of the body, including the central nervous system (CNS). In doing so, the enzyme can degrade the mannose-containing oligosaccharides and prevent their accumulation throughout the body.

FDA Approval 52

FDA Approval Life Science Containment Genetics 52

XTalks

MARCH 6, 2023

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. The US has always been an important market for us,” said Chief Executive Officer of Dr. Reddy’s, Erez Israeli, in a statement.

Production 98

Production Branding Dermatology Hormones 98

Drug Discovery World

AUGUST 9, 2023

The life sciences sector has seen significant M&A activity over the last few weeks. DDW’s Diana Spencer provides an overview. We are thrilled to announce BioIVT’s acquisition of PrecisionMed.

Drugs 52

Drugs Drug Delivery Systems Drug Delivery Life Science 52

Pharma in Brief

OCTOBER 20, 2021

In the context of addressing Health Canada’s requirements for approvability, the submission was withdrawn, refiled and a market authorization was issued. Merck’s application for judicial review was granted, the Minister’s decision was set aside and the application remitted to the Minister for redetermination.

Production 98

Production Clinical Trials Clinical Trials 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

JANUARY 17, 2023

Airsupra is a pressurized fixed-dose combination rescue medication inhaler containing a beta-2 adrenergic agonist (albuterol) and a corticosteroid (budesonide). It’s the first medication that contains an anti-inflammatory inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the US.

FDA Approval 97

FDA Approval Containment Allergies Drugs 97

pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . This large number of e-cigarette users creates a significant market need for vaping cessation therapy. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

Life Science 111

Life Science FDA Approval Trials Development 111

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Lastly, we look to our life science partners themselves, who have undoubtedly spearheaded ECAs for their own pipelines. It is true that RWD contains more potential bias as a result.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

Drug Discovery World

JANUARY 9, 2024

Thirteen new-to-market therapeutics and drugs poised to launch in 2024 will achieve ‘blockbuster’ status by 2029 or deliver game-changing benefits to patients. The therapy has shown positive results in Phase III trials in both breast and lung cancer.

Drugs 67

Drugs Antibody Gene Editing Medicine 67

pharmaphorum

JANUARY 27, 2021

At the time, Johnson said the agreement was “a significant milestone for the British life science industry and will help produce the vaccines this country needs.”. The contract covers production of 100 million doses of the AZ vaccine. He then returned them to the freezer, and 57 patients were subsequently given the shots.

Vaccination 98

Vaccination Vaccine Packaging Packaging 98

The Pharma Data

OCTOBER 26, 2020

Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries. This press release contains certain forward-looking statements concerning Sensorion and its business. The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

pharmaphorum

MARCH 26, 2021

This rule applies across all sectors and enshrines the fundamental principle allowing goods that originate in one market to be exported to the other without tax, duty or quota. The IP chapter of the TCA has specific provisions on SPCs and data/market exclusivity. Medical devices do not feature at all. The Medicinal Products Annex.

Production 119

Production Medicine Marketing Regulation 119

Drug Discovery World

OCTOBER 19, 2022

Ashley Rein , Global Market Manager for Topical Drug Delivery at Lubrizol Life Science Health (LLS Health), explains how by using mucoadhesive drug delivery, developers can bring novel drugs to market and maximise the efficacy of pre-existing APIs. . Consider drug delivery systems early on . Conclusion .

Drug Delivery 52

Drug Delivery Drugs Drug Delivery Systems Development 52

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

Pharma in Brief

JANUARY 7, 2024

Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). According to the Export Guide, the regulations pertain to drugs intended for the Canadian market, namely, those having a drug identification number and a Canadian label.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

Pharma in Brief

DECEMBER 17, 2023

However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not in the public interest to force patients to switch to another biosimilar product. Background In January 2022, JAMP Pharma Corporation ( JAMP ) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab).

Antibody 52

Antibody Production Regulation Marketing 52

Pharma in Brief

JANUARY 24, 2021

The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. Despite the COVID-19 pandemic, 2020 still managed to be a big year for litigation in the pharma and life sciences sector. Introduction. 2020 in the Courts. b) Judicial Review Decisions.

Life Science 52

Life Science Regulation Medicine Drugs 52

XTalks

AUGUST 28, 2020

To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. So while the Blanc 1.0

Containment 111

Containment Bacteria Marketing Production 111

pharmaphorum

FEBRUARY 11, 2022

Sun says Komodo’s Healthcare Map has been built over the last seven and a half years and contains so much information that can help identify and treat patients with rare diseases. He oversees operations, including business development, sales and marketing, and people. About the author.

Life Science 105

Life Science Engineer Development Big Data 105

The Pharma Data

DECEMBER 17, 2020

Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced that it has signed up the first collaborator in its recently announced Early Access Program for its prototype whole transcriptome panel. TUCSON, Ariz., 18, 2020 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics , Inc.

Containment 52

Containment Production Medicine Life Science 52