Pharma in Brief

AUGUST 5, 2020

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. GENVOYA is a designated “innovative drug” in respect to TAF pursuant to the data protection provisions of the Food and Drug Regulations , CRC, c 870 ( Data Protection Regulations ). Background. Minister of Health’s Decision.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Regulation Compliance Medicine Manufacturing 52

Pharma in Brief

JULY 7, 2021

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until January 1, 2022. The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices.

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Regulation Medicine Containment Life Science 52

pharmaphorum

FEBRUARY 25, 2022

The past two years have shone a spotlight on the UK life sciences industry. These efforts, as Nadhim Zahawi rightly said when he was Vaccines Minister, have led to the life sciences and pharma industry becoming a UK national treasure. An industry that will forever play a greater role in our everyday lives.

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Life Science Vaccination Vaccine Pharmacy 98

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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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. The integrity of container closures is critical to drug safety. Sagent Pharmaceuticals Inc. This was also associated with a risk of loss of sterility.

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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.

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BioTech 365

OCTOBER 22, 2020

This Announcement Contains Inside Information for the Purposes of Article 7 of Regulation (EU) No 596/2014 LONDON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Abcam plc (AIM: ABC) (“Abcam”), a global leader in the supply of life science research tools, announces … Continue reading →

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XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. the PMS Product ). In that case, Manson J. Knowledge of influence.

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pharmaphorum

MAY 24, 2021

Savana’s Dr Ignacio Medrano explains how machine learning and natural language processing technology is opening up huge amounts of previously-inaccessible real-world evidence (RWE) for pharma and regulators. One problem is that most RWE is contained in inflexible, siloed databases. It’s just not in that particular database.”.

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The Pharma Data

NOVEMBER 10, 2020

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. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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Life Science Clinical Trials Clinical Trials Trials 40

XTalks

AUGUST 16, 2022

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. 1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.

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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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Regulation Drugs Vaccination Vaccine 52

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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Clinical Trials Clinical Trials Life Science Trials 89

XTalks

AUGUST 3, 2021

Johnson and Johnson has faced thousands of lawsuits over its iconic baby powder, which people claim the company knew for decades contained asbestos. Talc and asbestos are often found together in nature, which is why mined talc can contain the carcinogen.

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Pharma in Brief

OCTOBER 29, 2020

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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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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Life Science Regulation Medicine Drugs 52

XTalks

MAY 4, 2021

These modifications regulate gene expression without changing the sequence or structure of DNA. Related: 2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences. It’s a great tool for controlling gene expression.”. pyogenes dCas9.

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DNA Gene Gene Silencing Genome 98

pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. The TCA mentions medicinal products only fleetingly in its main body, but contains a specific Medicinal Products Annex. Andrew has broad experience over thirty years working in the life sciences and other sectors.

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Pharma in Brief

JULY 28, 2020

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations ( CSP Regulations ). JULUCA ® is a fixed-dose combination ( FDC ) drug product containing the medicinal ingredients dolutegravir and rilpivirine ( JULUCA ).

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Production Containment Drugs Regulation 52

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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XTalks

NOVEMBER 9, 2022

GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion. Accordingly, the diabetes drug market is expected to balloon from $29.81 billion in 2021 to $61.6 billion by 2030. What Are GLP-1 Agonists?

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Pharma in Brief

JANUARY 7, 2024

Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. As we reported , the export regulations first issued as an interim order in November 2020, in response to the FDA publishing the US Importation Rule in October 2020. 01.014.13).

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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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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.

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XTalks

APRIL 24, 2023

Early and ongoing engagement with regulators greatly helps clinical development planning. Scientific advice meetings with regulators help ensure the trial design and gene therapy manufacturing will meet regulatory expectations. As a result, there are several EU regulations and directives to follow.

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Gene Therapy Gene Trials Clinical Trials 95

XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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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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Regulation Manufacturing Drugs Medicine 52

Pharma in Brief

JULY 5, 2021

The Federal Court of Appeal ( FCA ) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations , the “second person” ( i.e. , generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation ( NOA ).

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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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Pharma in Brief

JUNE 9, 2021

of the Food and Drug Regulations (the Data Protection Provisions ). The dispute arose due to two concurrent New Drug Submissions ( NDSs ) filed by different drug manufacturers for products containing amifampridine. Catalyst ) filed an NDS for FIRDAPSE, which contains amifampridine. Background.

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Containment Production Compliance Drugs 52

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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Gene Therapy Gene Manufacturing Production 52

XTalks

JUNE 28, 2023

It is injected into a patient’s muscle tissue. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile.

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Gene Therapy Gene Protein FDA Approval 98

Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. Subsection 5(1) is DIN-specific.

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Marketing Drugs Regulation Compliance 52

Pharma in Brief

MARCH 21, 2022

Also reported was Health Canada’s intention to introduce transition regulations, which would have ended the expedited IO authorization pathway but extended current IO authorizations so that industry could meet therequirements for converting their IO approvals to medical device licenses under the Medical Devices Regulations (the Regulations ).

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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 ). OPSUMIT® is a tablet containing macitentan. Background. Janssen Inc. Janssen Inc. Sandoz Canada Inc. Sandoz ) sought approval for a generic macitentan product.

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