XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

Development 111

Development Trials Clinical Trials Clinical Trials 111

Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The UDI was FDA’s risk-based approach to regulate the hundreds (possibly thousands) of illegal drugs that remain on the U.S.

Development 130

Development Production Drugs Marketing 130

XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

Regulation 94

Regulation Hormones Containment Packaging 94

WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. If the objectives of the study contain a health claim the substance being studied will be considered a drug and the FDA likely will require an IND.

Regulation 52

Regulation Research Production Compliance 52

pharmaphorum

SEPTEMBER 2, 2020

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. In July, Gilead’s Veklury (remdesivir) became the first drug cleared by EU regulators to treat symptoms in patients hospitalised with COVID-19.

Regulation 53

Regulation Containment Medicine Drugs 53

The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

Regulation 52

Regulation Compliance Contamination Marketing 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Finding the best commercial packaging suppliers in contract marketing.

Packaging 130

Packaging Packaging Marketing Containment 130

Drug Discovery World

DECEMBER 6, 2022

As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. At times, this proved a major roadblock during Covid-19, where similar datasets contained unexplained differences and inconsistencies. Pre-specification of effect size .

Development 98

Development Drugs Vaccination Vaccine 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

Marketing 130

Marketing Compliance Doctors Doctor 130

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. Timely intervention is imperative to contain and mitigate potential impact.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

Drug Discovery World

NOVEMBER 14, 2022

A collaboration between PerkinElmer’s SIRION Biotech business and the Centre for Genomic Regulation (CRG) agreed to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas. . Find out more: Collaboration to develop AAV vectors for diabetes gene therapy .

Development 52

Development Gene Therapy Drugs Gene 52

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

Manufacturing 40

Manufacturing Development Production Containment 40

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

Cosmetics 64

Cosmetics Production Compliance Regulation 64

Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Pharmaceutical Technology

MAY 24, 2023

The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development 75

Development Regulation Medicine Containment 75

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

Clinical Trials 126

Clinical Trials Clinical Trials Trials Regulation 126

FDA Law Blog

AUGUST 21, 2023

830(e)(1)(B)(i). “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that may be marketed in the U.S. 21 U.S.C. § 21 U.S.C. § 830(e)(1)(B)(i).

Pharmacy 52

Pharmacy Regulation Sales Production 52

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

FDA Law Blog

MAY 25, 2022

Shuren identified in the Agency’s November 2015 “Public Health Evidence for FDA Oversight of Laboratory Developed Tests” ( here ). Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests.

Regulation 40

Regulation Genetics In-Vitro Development 40

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness 2 ,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.

Clinical Development 52

Clinical Development Medicine Development 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. extractables and leachables).

Packaging 98

Packaging Packaging Containment Production 98

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R. Design controls (21 C.F.R.

Compliance 98

Compliance Marketing Regulation Development 98

Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. The influence of these microbiomes extends to children as well.

Clinical Trials 65

Clinical Trials Clinical Trials Regulation Bacteria 65

The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

XTalks

OCTOBER 13, 2023

The magic lies in its patented De-Sugaring technology developed by NTFC. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Impressively, this sugar free cranberry juice retains every bit of the fruit’s nutritional value. Sugar is ubiquitous.

Containment 105

Containment Production Marketing Branding 105

FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. OTC products are also susceptible; testing has revealed nitrosamines in heartburn remedies containing ranitidine.

Containment 52

Containment Manufacturing Regulation Drugs 52

The Pharma Data

OCTOBER 26, 2020

This work complements the Company’s own development work currently being undertaken. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure. [link]. .

Development 40

Development Antibody Engineer Production 40

The Pharma Data

NOVEMBER 23, 2020

EVOTEC TO SUPPORT RAPPTA IN DEVELOPING SMALL MOLECULES THAT REACTIVATE PP2A, A KEY TUMOR SUPPRESSOR. THE COLLABORATION LEVERAGES EVOTEC’S ONCOLOGY EXPERTISE AND INTEGRATED DRUG DISCOVERY AND DEVELOPMENT PLATFORM. This is the perfect combination of expertise to translate these discoveries to the clinic.”

Development 40

Development Protein Regulation Containment 40

Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

RNA 65

RNA In-Vivo In-Vitro DNA 65

The Pharma Data

NOVEMBER 2, 2020

The biotechnology production development program commenced in October 2020 with completion expected in September 2021. “Our goal is the development of precise and predictable psychedelic drug formulations for clinical study and therapeutic use.” “Psychedelic agents are a promising new class of therapeutic drug.

Production 52

Production Development Drug Delivery Drugs 52

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Antibody 40

Antibody Development Licensing Licensing 40

The Pharma Data

NOVEMBER 9, 2020

Psilocybin, mescaline, LSD, MDMA, DMT and other psychedelic compounds added to exclusive dealing agreement for the development of psychedelic-based therapeutics. Dr. Löbenberg with respect to exclusive commercial development rights under his cannabis licences and to related intellectual property. The Company and Prof.

Development 40

Development Drugs Drug Delivery Production 40

The Pharma Data

AUGUST 18, 2020

Johnson & Johnson statement on the launch of new CARE (Corona Accelerated R&D in Europe) consortium, Europe’s largest, multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19. The reader is cautioned not to rely on these forward-looking statements.

Development 52

Development Research Containment Production 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. Aflibercept is a key treatment in ophthalmology. Disclaimer.

Clinical Development 40

Clinical Development Medicine Development Production 40

XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. The Environmental Working Group (EWG) identified several food products containing this chemical, such as Entenmann’s Coconut Crunch Donuts and Sara Lee Honey Glazed Buns.

Hormones 52

Hormones Containment Production Cosmetics 52