XTalks

APRIL 21, 2023

Life science startups face unique challenges given the highly regulated and complex nature of the industry. Prioritize scientific rigor: The foundation of any life science startup is the scientific research behind its technology or product.

Life Science 98

Life Science Trials Production Regulation 98

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Data will unlock clinical and economic value in Europe’s challenging landscape.

Life Science 111

Life Science Development Research Production 111

Outsourcing Pharma

JUNE 7, 2023

With generative AI continuing to create a buzz, OSP took the opportunity to speak to Indegene, a digital-first, life sciences commercialization company that helps biopharmaceutical, emerging biotech and medical device companies develop products.

Life Science 86

Life Science Production Development Regulation 86

pharmaphorum

OCTOBER 6, 2020

But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good use within their regulatory functions. Adopting intelligent automation could help organisations realise disruptive benefits that are above and beyond the tangible gains of cost, quality and productivity improvements.

Regulation 114

Regulation Life Science Production HR 114

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

Regulation 98

Regulation Drugs Manufacturing Production 98

XTalks

MARCH 30, 2022

Should companies and regulators share more information about the steps being taken to address the issue of drug impurities? The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines.

Life Science 93

Life Science Manufacturing FDA Approval Drugs 93

Outsourcing Pharma

JANUARY 29, 2024

The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.

Life Science 98

Life Science Licensing Licensing Medicine 98

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

Regulation 97

Regulation Marketing Sales Branding 97

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 ”).

Regulation 98

Regulation Medicine Generic Drugs Containment 98

Outsourcing Pharma

MARCH 21, 2024

Merck set to invest over â300 million in new production center in South Korea.

Life Science 83

Life Science Production Regulation Marketing 83

pharmaphorum

MAY 6, 2022

The PING Conference 2022 is back in person this year, with opportunities to network face-to-face with people from right across the life sciences ecosystem. Hear about how the UK is leading the way in what has been described as the ‘Golden Age for Life Sciences Innovation’ and the opportunities arising from this from leading experts.

Life Science 52

Life Science Genome Genomics Production 52

Cloudbyz

AUGUST 13, 2024

In the rapidly evolving landscape of life sciences, the need for robust, efficient, and compliant pharmacovigilance (PV) solutions has never been greater. In this blog, we’ll explore how these solutions are transforming pharmacovigilance and why they are becoming the go-to choice for forward-thinking life sciences companies.

Life Science 52

Life Science Compliance Drugs Marketing 52

Cloudbyz

SEPTEMBER 11, 2024

This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device.

Development 104

Development Regulation Production Life Science 104

Pharmaceutical Technology

MAY 24, 2023

Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients. CGT trials operate with much lower volumes of manufactured final product. The labeling process of the final product is earlier than that for traditional trials.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

pharmaphorum

OCTOBER 7, 2020

By having an effective complaint management system, life science organizations have a better chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring complaint trends over time and having a complaint program improves the customer’s experience with your products.

Production 52

Production Life Science Regulation Marketing 52

XTalks

JANUARY 4, 2023

In the era of increasing awareness of environmental, social and governance (ESG) policies, life science companies are starting to take notice of their benefits. ESG policies can be advantageous for small to mid-sized business-to-business (B2B) life science companies in a number of ways. Conclusion.

Life Science 52

Life Science Branding Marketing Regulation 52

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

BioPharma Reporter

AUGUST 14, 2023

Teknova, a producer of life science reagents, has opened a new GMP-certified production facility which it claims will enable bioprocessing and gene therapy companies to get into the clinic faster.

Reagent 98

Reagent Gene Therapy Life Science Manufacturing 98

XTalks

DECEMBER 18, 2024

The most common form of CAH, 21-hydroxylase deficiency, disrupts hormone production, leading to cortisol deficiency and an overproduction of androgens. This imbalance causes a variety of health issues, including abnormal growth, early puberty, infertility and life-threatening adrenal crises.

Genetics 116

Genetics Hormones Trials Drugs 116

pharmaphorum

OCTOBER 12, 2022

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory. Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in.

Compliance 105

Compliance Manufacturing Life Science Production 105

BioPharma Reporter

JULY 3, 2023

Donaldson, a provider of filtration products and solutions, has acquired Univercells Technologies, a producer of biomanufacturing solutions for cell and gene therapy research, development, and commercial manufacturing, to broaden its life sciences reach.

Gene Therapy 93

Gene Therapy Life Science Gene Manufacturing 93

pharmaphorum

DECEMBER 24, 2020

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

Vaccination 126

Vaccination Vaccine Regulation Life Science 126

XTalks

JULY 5, 2022

Employee retention and motivation is a challenge that all life science companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company.

Life Science 52

Life Science Compliance Packaging Packaging 52

pharmaphorum

SEPTEMBER 8, 2021

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. ” Fewer staff will therefore be asked to cover more ground with fewer resources, all whilst operating under a pay freeze, they claim.

Regulation 105

Regulation Life Science Medicine Production 105

pharmaphorum

JANUARY 8, 2021

IHD – or Instant Health Data – will be used by the EMA to carry out data analyses and examine medicinal product utilisation, answer questions about safety and efficacy, and understand how treatments perform in real-world settings, said the Boston, US-based company.

Life Science 105

Life Science Medicine Clinical Trials Clinical Trials 105

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 130

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

Vaccination 105

Vaccination Vaccine Development Life Science 105

Pharma in Brief

NOVEMBER 20, 2023

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.

Production 52

Production Cosmetics Regulation Branding 52

BioTech 365

OCTOBER 19, 2020

Food and Drug Administration to provide an update on the Agency’s Comprehensive Plan for Tobacco and Nicotine Regulation WILLIAMSVILLE, N.Y., NYSE American: XXII), a leading plant-based, life science … Continue reading → 19, 2020 (GLOBE NEWSWIRE) — 22nd Century Group, Inc.

Regulation 40

Regulation Life Science Production Drugs 40

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).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. The Medicinal Products Annex.

Production 119

Production Medicine Marketing Regulation 119

Pharmaceutical Commerce

JULY 27, 2023

Drug safety database can now be used by life sciences organizations that are looking to develop, manufacture, and market regulated products in the country.

Life Science 52

Life Science Regulation Manufacturing Production 52

XTalks

FEBRUARY 18, 2025

The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Biosimilars are biological products highly similar to an already FDA-approved reference product, with no clinically meaningful differences in terms of safety, purity and potency.

Insulin 59

Insulin FDA Approval Production Hormones 59

Outsourcing Pharma

SEPTEMBER 17, 2020

The US agency continues to issue advice for life-sciences professionals engaged in work related to the virus, and keep an eye out for fraudulent products.

Life Science 69

Life Science Production Regulation Marketing 69

Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). b) of the Regulations. Link: Health Canada, Notice: Application of the definition of Canadian Reference Product (January 26, 2024)

Production 52

Production Generic Drugs Drugs Bioequivalency 52

XTalks

NOVEMBER 23, 2021

The investment will go towards expanding Biovectra’s existing production facility in Charlottetown, the capital of PEI. Additional production would be performed at other facilities for final packaging. Additional production would be performed at other facilities for final packaging.

Manufacturing 98

Manufacturing Vaccination Vaccine Drugs 98