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.

Life Science 97

Life Science Vaccination Vaccine Pharmacy 97

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 96

Packaging Packaging Containment Production 96

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.”.

Drugs 83

Drugs Clinical Trials Clinical Trials Doctor 83

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.

Drugs 101

Drugs Packaging Packaging Containment 101

Pharmaceutical Technology

MAY 24, 2023

Cold chain requirements for CGT are highly stringent and most often at the cryogenic level (below -150 Celsius), which requires the use of specialized containers filled with liquid nitrogen (dewars) and particular shippers requiring specific logistics expertise. This is a primary factor for the staggeringly high unit cost of CGT.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

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

Vaccination 104

Vaccination Vaccine Production Manufacturing 104

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.

Clinical Trials 73

Clinical Trials Clinical Trials Life Science Trials 73

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

XTalks

SEPTEMBER 5, 2024

” Opzelura (ruxolitinib), which contains 1.5 Opzelura works by inhibiting the JAK-STAT pathway, a critical regulator of inflammation in the immune system. As eczema can vary in severity, not all patients respond to the same treatment regimen.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Containment 52

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.

Containment 98

Containment Production Contamination Marketing 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

pharmaphorum

DECEMBER 15, 2022

Co-chaired by Lord James O’Shaughnessy and Professor Mike Bewick, former deputy national medical director of NHS England (present online), the NHS Innovation and Life Sciences Commission Report launch took place at One Great George Street, Westminster, on 12th December 2022. The UK as a powerhouse of research.

Life Science 93

Life Science Medicine Clinical Trials Clinical Trials 93

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.

DNA 97

DNA Gene Gene Silencing Genome 97

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?

Insulin 98

Insulin Hormones FDA Approval Sales 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 communication of this press release in certain countries may constitute a violation of local laws and regulations.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

XTalks

OCTOBER 29, 2024

The Role of AI in Enhancing Digitized Protocols Clinical protocols are often lengthy, complex documents—traditionally delivered as PDFs—that contain detailed information. “It does make the humans doing the work much more efficient, and that’s where you start seeing these time savings start to add up,” Matthew explained.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

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.

Gene Therapy 81

Gene Therapy Gene Trials Clinical Trials 81

Pharma in Brief

SEPTEMBER 5, 2023

If classified instead as edible cannabis, Jolts would exceed the THC content per immediate container permitted by the Cannabis Regulations. Organigram classified Jolts as cannabis extract in notices of new cannabis product to Health Canada.

Production 52

Production Compliance Containment Regulation 52

The Pharma Data

AUGUST 18, 2020

The drug repositioning pillar builds on Johnson & Johnson’s ongoing partnership with the prestigious Rega Institute at KU Leuven in Belgium, where a team of scientists are screening molecule libraries containing thousands of existing compounds to determine if they have potential as COVID-19 treatments.

Development 52

Development Research Containment Production 52

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.

Production 105

Production Medicine Marketing Regulation 105

The Pharma Data

FEBRUARY 22, 2021

It will be applied broadly, fairly and in compliance with all applicable employment laws and regulations worldwide and across all management teams in Bayer.”. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. About Bayer. Capital expenditures amounted to 2.9

Life Science 52

Life Science Compliance Development Containment 52

The Pharma Data

OCTOBER 21, 2020

This Announcement Contains Inside Information for the Purposes of Article 7 of Regulation (EU) No 596/2014. This press release contains forward-looking statements. This communication does not contain an offer or constitute any part of an offer to the public within the meaning of sections 85 and 102B of FSMA or otherwise.

Containment 40

Containment Regulation Marketing Sales 40

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.

Gene Therapy 93

Gene Therapy Gene Protein FDA Approval 93

XTalks

DECEMBER 2, 2022

Additionally, Rebyota could contain food allergens, which poses an unknown risk for food allergen-related adverse reactions. Despite being classified as investigational by the FDA and hence loosely regulated, fecal microbiota transplants (FMT) performed through a colonoscopy or upper endoscopy are often used to treat CDI.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

MAY 17, 2024

Lilly said it discovered some products claiming to be compounded tirzepatide medicines that contained bacteria, high impurity levels, different chemical structures and different colors than Mounjaro or Zepbound. “In In at least one instance, the product was nothing more than sugar alcohol,” said Lilly.

Sales 52

Sales FDA Approval Pharmacy Production 52

XTalks

MAY 4, 2021

These modifications regulate gene expression without altering 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.

DNA 52

DNA Gene Gene Silencing Genome 52

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.

Gene Therapy 52

Gene Therapy Life Science Production Clinical Development 52

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.

FDA Approval 94

FDA Approval Development Containment Licensing 94

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.

Development 40

Development Protein Regulation Drugs 40

The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. ABOUT TAURIGA SCIENCES INC. Tauriga Sciences, Inc. TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives. NEW YORK, NY, Dec. Provisional Patent Application No.

Life Science 52

Life Science Manufacturing Development Production 52

The Pharma Data

NOVEMBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. ABOUT TAURIGA SCIENCES INC. . Tauriga Sciences, Inc. TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives. NEW YORK, NY, Nov.

Life Science 52

Life Science Production Cosmetics Manufacturing 52

XTalks

MARCH 10, 2023

Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

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. “I’m not an anti-vaxxer, but….” Suddenly people were comparing the length of approval processes in the UK, Europe, and the US.

Research 52

Research Clinical Trials Clinical Trials Vaccination 52

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.

Containment 111

Containment Bacteria Marketing Production 111

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.

Containment 40

Containment Regulation Marketing Development 40

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

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.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59