FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59

Drugs Production Licensing Licensing 59

The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

Vaccination 52

Vaccination Vaccine Medicine Trials 52

The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. 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

pharmaphorum

NOVEMBER 16, 2020

EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role. Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). Emer Cooke.

Regulation 64

Regulation Medicine Vaccination Vaccine 64

pharmaphorum

JANUARY 17, 2022

As such, the UK will no longer be part of the EU free market. Eric Noehrenberg, Vice President and Global Head of Market Access and Goverment Affairs, Corcym. Discuss the impact on UK parallel trade following Brexit, through the eyes of regulators, the pharmaceutical industry and academics. Market Access. Distribution.

Packaging 52

Packaging Packaging Marketing Regulation 52

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###. Today, the U.S.

Contamination 52

Contamination Production Cosmetics Packaging 52

pharmaphorum

JANUARY 27, 2023

Even if underlying inflation levels ease off compared to last year – and there are some encouraging initial market signals – it’s important to focus on the areas that actually drive production costs for the industry. The same goes for many commodities used in the production process for key medicines, from solvents through to packaging.

Medicine 105

Medicine Production Marketing Packaging 105

pharmaphorum

JANUARY 18, 2022

The global pre-filled syringes market was valued at $1139.6 Assess the evolving regulatory landscape for pre-filled syringes and discuss approaches to work with regulators as guidance is updated. Primary Packaging material designers. Secondary packagers. Who should Attend: Drug-delivery developers. Drug developers.

Drug Delivery 52

Drug Delivery Production Drug Delivery Systems Packaging 52

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

Roots Analysis

OCTOBER 5, 2023

Presently, polymers are employed in various fields, including agricultural, aircraft, automotive, consumer science, medicine, packaging, and sports. Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses.

Manufacturing 40

Manufacturing Drug Delivery Systems Drug Delivery Packaging 40

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.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

Pharma in Brief

AUGUST 3, 2023

Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature.

Production 52

Production Drugs Manufacturing Clinical Trials 52

pharmaphorum

APRIL 11, 2022

Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. At Janssen, we strive to improve access to our innovative medicines and vaccines and achieve the best possible outcomes for patients across the world.

Medicine 115

Medicine Clinical Trials Clinical Trials Development 115

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

DECEMBER 14, 2020

The IND covers the development of Rabeximod in Covid-19 and other indications, such as rheumatoid arthritis, and is a prerequisite for a future validation of the company’s five recent patent applications in the US market. “Filing an IND with the FDA is an important step in the clinical development of Rabeximod. . About Cyxone.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Development Drugs 52

Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. require market authorization holders to meet post-marketing regulatory requirements; and.

Vaccination 98

Vaccination Vaccine Drugs Manufacturing 98

The Pharma Data

MAY 14, 2021

When you drink, the liver has to work to remove the alcohol from the blood instead of regulating blood sugar. I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST!

Production 52

Production Packaging Packaging Insulin 52

The Pharma Data

OCTOBER 26, 2020

For 20 years, Novasep has acquired experience in developing and manufacturing a wide range of viral vectors through its sites in Belgium: AAV, Adenovirus, Lentivirus, HSV, VEEV, VSV…, for cell & gene therapy, immunotherapy, vaccination and other therapies from process development to cGMP production. Source link.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

RNA 40

RNA Vaccination Vaccine Development 40

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

pharmaphorum

MAY 26, 2022

The challenge for regulators and pharma companies is that safety and efficacy data from an RCT may not always translate to the real world ‘effectiveness’ of a medicine (how efficacious the drug is in patients once marketed) which is governed by these complex intrinsic and extrinsic factors.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Medicine 143

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. • Anthrax Vaccines. Adjusted Net Income (1). .

Production 52

Production Manufacturing Vaccination Vaccine 52

Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

Genome 244

Genome Genomics Medicine Gene Therapy 244

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations.

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Sales Manufacturing FDA Approval Life Science 98

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Research Vaccines. COVID-19 Research Vaccines.

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. Our Commitment to Access. Antimycobacterials: rifampin.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Profit growth is expected to be underpinned by a combination of strong revenue growth from new vaccines and specialty medicines, improving operational performance and benefits from the transformation.

Sales 52

Sales Vaccination Vaccine Production 52

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Research Vaccines. FDA Emergency Use Authorization Statement.

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

MAY 14, 2021

Their waists got smaller… They also saw an improvement in fat-regulating hormones. A little over a month later… A package arrived at my door… I ripped open the box as fast as I could. And serves as your body’s “master regulating switch.” When the package gets dropped off at your door….

Production 52

Production Insulin Packaging Packaging 52

The Pharma Data

JANUARY 21, 2021

ViiV Healthcare is the marketing authorization holder for CABENUVA. CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Janssen is the marketing authorization holder for EDURANT ® in the U.S. In the U.S.,

FDA Approval 52

FDA Approval RNA Drugs Containment 52

The Pharma Data

MAY 15, 2021

So much so that studies have shown your brain can regulate force production without you ever having to move a muscle. Which is why I’ve made a publishing deal: we could test this low cost offer in a few places, and if it does well we keep it on the market and go wide with it. They understand that your mind drives your movement.

Production 52

Production Packaging Packaging Development 52

The Pharma Data

MAY 13, 2021

Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. Not to mention – no other solution on the market offers the healing properties of red light bio-energetic imprinting – even though they cost much more than MindBody Matrix.

Pharmacy 52

Pharmacy Production Doctors Doctor 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This includes the rising number of biologic drugs on the market, which are mostly administered parenterally.

Contamination 130

Contamination Packaging Packaging Manufacturing 130

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. That would sound better from a marketing perspective. Dr. Wood doesn’t care very much about slick marketing…. So go ahead and choose your discounted package of HB5 right now….

Hormones 52

Hormones Insulin Production Packaging 52

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine. The price of that prize is incalculable.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92