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

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

XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.

Packaging 64

Packaging Packaging Production In-Vitro 64

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

FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or. Finally, SB 343 provides that resin identification code numbers (e.g.,

Packaging 52

Packaging Packaging Containment Production 52

FDA Law Blog

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Drugs 59

Drugs Production Licensing Licensing 59

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

SEPTEMBER 13, 2022

The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”. “The

Bacteria 98

Bacteria Packaging Packaging Production 98

XTalks

FEBRUARY 13, 2024

Such developments have led to a more vigilant stance against deceptive marketing practices, pushing for transparency and honesty in food advertising. The complaint highlighted that these drinks did not contain any of the advertised mango, açaí berry or passion fruit.

Marketing 59

Marketing Containment Production Packaging 59

XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

Containment 96

Containment Hormones Contamination Packaging 96

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Integrated analytical services for pharmaceuticals.

Development 130

Development Production Manufacturing Vaccination 130

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. c) Other policy developments. The courts also had a busy year in 2021.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is your advice for approaching the regulatory strategy?

Packaging 52

Packaging Packaging Drugs Containment 52

pharmaphorum

NOVEMBER 17, 2021

The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. Daniel Latham, Head Connected Health Product Development, Novartis. Louise Place, Director, Devices, GSK.

Drugs 52

Drugs Drug Delivery Engineer Production 52

XTalks

APRIL 14, 2021

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. 1, FD&C Blue No.

Regulation 94

Regulation Production Branding Cosmetics 94

The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Below are newsworthy items compiled by HealthDay staff: U.K. Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Shane Erickson Inc.

Contamination 52

Contamination Vaccination Vaccine Pharmacy 52

XTalks

JUNE 27, 2023

Developing countries face additional challenges due to their limited technical capacity to identify instances of food fraud. Mislabeling: False information is intentionally placed on the packaging or label, misleading consumers about the product’s true nature. Mitigating the risks associated with food fraud can be a complex task.

Production 97

Production Branding Manufacturing Packaging 97

Pfizer

APRIL 26, 2023

We’ve pioneered solutions to distribution and storage requirements In the last few months alone, Pfizer has developed cutting-edge packaging and storage solutions to meet the needs of the varied locations that will be distributing the vaccine - whether they are in a major cites or rural towns.

Vaccination 52

Vaccination Vaccine Manufacturing Containment 52

Drug Discovery World

MARCH 29, 2023

Antibiotic development According to Politico, the European Medicines Agency is investigating a chronic shortage in antibiotics across Europe, where almost every country is reporting gaps in supplies – 25 out of the 27 EU countries have reported local shortages, the agency’s Chief Medical Officer, Steffen Thirstrup, told a press briefing 6.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

DECEMBER 14, 2020

a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. STOCKHOLM , Dec. 15, 2020 /PRNewswire/ — Cyxone (publ.),

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Development Drugs 52

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. By Adrienne R. Draft Guidance at 8.

Containment 40

Containment Cosmetics Packaging Packaging 40

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Regulation 45

Regulation Production Cosmetics Sales 45

The Pharma Data

JANUARY 5, 2021

Lattice Biologics develops and manufactures biologic products to domestic and international markets. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction. and internationally.

Engineer 40

Engineer Manufacturing Production Marketing 40

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Trulicity (Dulaglutide) Trulicity sales in 2022: $7.439 billion Company/Developer: Eli Lilly & Co.

Sales 52

Sales Insulin FDA Approval Drugs 52

FDA Law Blog

SEPTEMBER 20, 2021

Valentine — Few FDA publications are as eagerly anticipated in the drug development world as the twice-a-decade PDUFA Reauthorization Performance Goals and Procedures (hereinafter the “goals letter”). Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Development 52

Development Gene Therapy Production Drugs 52

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

Pfizer

JANUARY 27, 2023

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

JANUARY 6, 2021

We would like to thank the regulators for their swift and decisive actions and our partner, Serum Institute of India, for its substantial contribution to this global effort.”. We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. FDA Emergency Use Authorization Statement. 08.11.2022.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Production 40

Production Compliance Manufacturing Regulation 40

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. Business Development/Other Developments. Research and development expenses increased 20 percent to $1.673 billion, or 24.8 on a non-GAAP basis.

Antibody 52

Antibody Sales Production Development 52

pharmaphorum

JANUARY 30, 2023

Though the shortages have been more widely reported in more economically developed countries, the reality is that supply is likely limited globally. The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics.

Medicine 104

Medicine Production Manufacturing Regulation 104

The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

Production 52

Production Manufacturing Vaccination Vaccine 52

Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

JUNE 18, 2021

vice president and head, global oncology development, AbbVie. VENCLYXTO/VENCLEXTA is being developed by AbbVie and Roche. VENCLYXTO is being developed by AbbVie and Roche. Concomitant use of preparations containing St. After a median follow-up of more than four years (52.4 months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]);

Medicine 40

Medicine HR Trials Production 40

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com.

Drugs 69

Drugs Licensing Licensing Containment 69