2018, Licensing and Packaging - Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Noema Pharma raises CHF54 million in Series A financing round led by Sofinnova Partners and Polaris Partners

The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

Licensing

Licensing Licensing Packaging Production

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

FDA

FDA Drugs Production Licensing

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. The clinical package, safety and label were not affected. 2023 saw the review of 17 orphan medicines, compared to an annual average of 20.6

Biosimilars

Biosimilars FDA Production Treatment

Deliberate Dysentery

Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months.

Vaccine

Vaccine Trials Disease Virus

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. As an example, in 2018 the FDA requested a recall of a specific medical food product (Limbrel; Primus Pharmaceuticals, Inc.)

Therapies

Therapies Science FDA Production

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. What’s next? Stay tuned.

FDA

FDA Biosimilars Science Production

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

What happens when a drug is not stored in its original container or within a licensed facility? All of the evidence discussed thus far pertains to drugs that have been stored in ideal conditions and within the original container by a licensed facility. Enter the beyond-use date.

Science

Science FDA Packaging Production

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Proposed Rule Stage National Primary Drinking Water Regulations: Consumer Confidence Report Rule Revisions 2040-AG14 June 2023 The America’s Water Infrastructure Act (AWIA) of 2018 was enacted on October 23, 2018. On March 23, 2018, the President signed into law the “Fair Agricultural Reporting Method Act” or the “FARM Act.”

Regulations

Regulations Compliance Production Science

Unblock My Hormones And Start Burning Fat TODAY With HB5

The Pharma Data

MAY 13, 2021

Additionally, in a 2018 study, published in the journal Phytotherapy Research…. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Once you’ve selected your package…. Then click on whichever of the packages is best for you.

Production

Production Packaging Doctors Research

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

In response to the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), we worked with the World Health Organization (WHO), U.S. The safety and efficacy of Inmazeb was established through the 681-patient PALM Trial, a randomized, multicenter, controlled trial initiated in 2018 in the DRC.

FDA Approval

FDA Approval FDA Production Vaccine

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2018), rejected a purported duty to modify an electronic product component to disable product use while the user was driving. Ocwen Loan Servicing, LLC , 2018 WL 6599901, at *5 (D. 17, 2018), the court held that a mortgage “is not tangible personal property” as required by the Magnuson Moss Act. 2018), cert. 18 §7001.

Production

Production International Trials Government

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2018 WL 1071290, at *3 (N.D. Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d See Allain v.

Testimonials

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Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Noema Pharma raises CHF54 million in Series A financing round led by Sofinnova Partners and Polaris Partners

Trending Sources

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Deliberate Dysentery

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Unblock My Hormones And Start Burning Fat TODAY With HB5

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

How the Fifty States View Electronic Data as a “Product”

Unimpressed Learned Intermediaries Defeat Warning Causation

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