Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.

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XTalks

MAY 17, 2024

Given concerns about safety, the company said no unsafe products should be on the market, especially given that neither the FDA nor any global regulatory agency has reviewed the compounded products for safety, quality or efficacy. If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.

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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. The year saw the first trials and decisions in actions under the new Patented Medicines (Notice of Compliance) Regulations ( PM(NOC) Regulations ). Introduction.

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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.

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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? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.

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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.

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Drug Discovery World

SEPTEMBER 28, 2023

In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. For example, BIOHM, Daye, La Biome, Ombre and Thorne already market probiotics for general vaginal health. The influence of these microbiomes extends to children as well.

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. 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. Medical devices do not feature at all.

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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).

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pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. It is true that RWD contains more potential bias as a result.

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Pharma in Brief

MARCH 2, 2021

of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1). the Plaintiffs ) are involved in litigation under the Regulations against Sandoz Canada Inc. of the Regulations.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Pharma in Brief

JUNE 14, 2022

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Janssen ) markets OPSUMIT® in Canada for the treatment of pulmonary arterial hypertension ( PAH ). OPSUMIT® is a tablet containing macitentan.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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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.

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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 communication of this press release in certain countries may constitute a violation of local laws and regulations.

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XTalks

DECEMBER 2, 2022

Related: Nestlé to Market Seres’ Oral Microbiome Drug for C. Additionally, Rebyota could contain food allergens, which poses an unknown risk for food allergen-related adverse reactions. Last year, the company partnered with Nestlé to market the drug once approved. Rebyota is not indicated for the first occurrence of C.

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Pharma in Brief

JULY 18, 2022

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product.

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XTalks

APRIL 24, 2023

This is an increase from the EMA’s approval of two novel ATMPs with orphan designation in 2021 (although the marketing authorization for one of these ATMPs was withdrawn in the European Union in November 2021) and three novel ATMPs with orphan designation in 2020. As a result, there are several EU regulations and directives to follow.

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The Pharma Data

OCTOBER 21, 2020

This Announcement Contains Inside Information for the Purposes of Article 7 of Regulation (EU) No 596/2014. Abcam’s ordinary shares are admitted to trading on the AIM market of the London Stock Exchange under the symbol “ABC.” This press release contains forward-looking statements. LONDON, Oct. Forward Looking Statements.

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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

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Pharma in Brief

MARCH 9, 2022

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). markets ACTONEL DR® in Canada for the treatment of osteoporosis. However, the Court also found that neither direct nor indirect infringement were established.

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Pharma in Brief

APRIL 19, 2022

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). In reaching its decision, the Court provided substantive guidance on hearsay evidence in infringement actions under the Regulations.

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XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. These include: Desiccated thyroid extract (DTE) : DTE is a natural form of thyroid hormone that contains both T4 and T3 (triiodothyronine). The thyroid disease market is huge, and lucrative.

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The Pharma Data

MAY 15, 2023

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022. Gallen (HSG), Switzerland.

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The Pharma Data

JANUARY 19, 2021

Over the course of her career, she has held a variety of roles in public affairs, corporate, science and product communications, patient advocacy and marketing at AbbVie, GSK and Schering Plough. The Group must face or might face competition from generic products that might translate into a loss of market share.

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The Pharma Data

JANUARY 7, 2021

Dr. Anne Prener has more than 25 years of leadership experience within life sciences companies, and currently serves as Chief Executive Officer of Imbria Inc. Dr. Prener serves on the Boards of Directors of several life science companies, Rubius Therapeutics, Kaleido Bioscience and Renovacor. Dr. Prener holds a Ph.D.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. NEW YORK, NY, Dec. DISCLAIMER — Forward-Looking Statements.

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The Pharma Data

APRIL 26, 2021

Offer Memorandum, Position Statement and further information This announcement contains selected, condensed information regarding the Offer and does not replace the Offer Memorandum and/or the Position Statement. Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. The company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment. NEW YORK, NY, Nov.

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pharmaphorum

JANUARY 27, 2021

Corners have been cut,” “The vaccine contains fetuses,” “It’s Thalidomide all over again”, all demonstrate a lack of public knowledge and awareness about how trials are conducted in the present day. Thalidomide was marketed during the late-1950s and early-1960s in the UK and was later found to cause birth defects in unborn babies.

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Drug Discovery World

MARCH 7, 2023

DDW Editor Reece Armstrong takes a look at Qatar’s drug discovery and life sciences market, exploring how the country is utilising innovative technologies in its approach to healthcare. The Middle East represents one of the world’s most lucrative markets for pharmaceuticals.

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XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

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XTalks

NOVEMBER 9, 2023

Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. The staggering billion-dollar figures reflect a growing obesity drug market that is projected to reach $100 billion by 2030, according to Goldman Sachs Research.

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The Pharma Data

NOVEMBER 23, 2020

Although PP2A is a key tumour suppressor and has a critical function regulating protein de-phosphorylation and tumour growth, it has to-date been very difficult to target pharmaceutically. Rappta Therapeutics is backed by blue-chip investors Advent Life Sciences, Novartis Venture Fund, Novo Holdings and a family office.

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries.

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