2003, Licensing, Marketing and Treatment

Where is the drug discovery expertise happening in the UK?

Drug Discovery World

OCTOBER 16, 2023

The university aims to identify treatments for life-threatening anti-microbial diseases and metabolic disorders. Our research community of clinicians, clinical trialists, discovery scientists, and statisticians develop pioneering treatments for patients and ground-breaking discoveries in basic science.”

Drugs

Drugs Science Therapies Targeted Protein Degradation

BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. STOCKHOLM , Jan.

Disease

Disease Pharmaceutical Companies Licensing Licensing

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

MARCH 8, 2021

At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.

Trials

Trials Virus RNA Research Laboratories

PREA and Fixed-Dose Combinations: When Things Get Complicated

The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

Production

Production FDA Clinical Trials Compliance

U.S. FDA ACCEPTS FOR PRIORITY REVIEW

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. 5 Currently there is no cure or treatment for TBE, only management of symptoms.

FDA

FDA Vaccine Virus Clinical Trials

Blocked Transmission

Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. The man was in Hong Kong for kidney treatment. A company called LuminOre will soon bring copper-coated air ducts to the market. Read it on our website here. Credit: Alfred Mitchell, courtesy of Tom Ough.

Virus

Virus Hospitals Production Regulations

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

Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. For increased flexibility in bringing PIPs to market, a developer can also submit both. This action will address Louisiana Environmental Action Network v.

Regulations

Regulations Compliance Production Science

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

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials

Testimonials Doctors Production Laboratories

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. purchase, marketing, promotion, . . by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d

Vaccine

Vaccine FDA FDA Approval Pharmacy

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 397 (6th Cir.

FDA

FDA FDA Approval Testimonials Vaccine

Drug Discovery Digest

Where is the drug discovery expertise happening in the UK?

BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

Trending Sources

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

PREA and Fixed-Dose Combinations: When Things Get Complicated

U.S. FDA ACCEPTS FOR PRIORITY REVIEW

Blocked Transmission

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

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

Unimpressed Learned Intermediaries Defeat Warning Causation

A Texas Mess

The FDA and Feasible Alternative Designs

Stay Connected