The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S

Clinical Development

Drug Target Review

JULY 24, 2024

For example, “From now on, assume we are talking about human-only clinical trials without considering our previous conversation.” As a business executive at IBM Research in New York, Dr Singh led the go-to-market for IBM Watson Genomics Analytics. Raminderpal earned his PhD in semiconductor modelling in 1997.

Clinical Trials

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

The Pharma Data

JANUARY 18, 2021

The company’s common shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825). The company is based in Paris, France, and Cambridge, Massachusetts. Disclaimer This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts.

Regulations

The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 mmol/kg) for CNS imaging. mmol/kg weight. “At

Clinical Trials

The Pharma Data

NOVEMBER 9, 2020

The primary endpoint of the trial is recommended phase II dose (RP2D); the secondary endpoints are objective response rate (ORR), safety and feasibility, and body-kinetics; and the exploratory endpoints are survival outcomes, duration of response, and biomarkers of response.

Immune Response

The Pharma Data

DECEMBER 15, 2020

Klisyri will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch. Mr. Peter Guenter, CEO of Almirall, stated, “We are delighted to partner with Athenex to market Klisyri in the U.S. Founded in 2003, Athenex, Inc.

FDA Approval

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.

Science

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA.

Science

The Pharma Data

OCTOBER 19, 2020

Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. About NANOBIOTIX: www.nanobiotix.com.

Clinical Trials

FDA Law Blog: Biosimilars

AUGUST 29, 2024

2117 (2024) was released, that landmark decision “ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment ‘right of trial by jury’ in all ‘suits at common law.’” And like its predecessor bills, S.

Biosimilars

The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

Virus

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

The Pharma Data

JULY 22, 2021

Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Biogen Inc.

Disease

Drug Target Review

NOVEMBER 30, 2023

On my return to Europe, I took a position at Nestlé as Head of the Research Centre, where I led the scientific development of several highly innovative health promoting food products from laboratory to market. Then I was approached to co-found AC Immune in 2003. COVID-19 has shown the revolutionary impact of vaccines.

Disease

The Pharma Data

MAY 5, 2021

The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. About lupus nephritis Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease. N Engl J Med.

Therapies

The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

FDA

BioPharma Drive: Drug Pricing

AUGUST 8, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Q&A Inside AstraZeneca’s long-term strategy in lung cancer Decades-long research has yielded a strong and growing franchise built around drugs for a genetic form of lung cancer.

Clinical Trials

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 506 (N.Y.

FDA

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

Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work. and (2) suggesting that the Defendants can cross-examine [the expert] about this at trial. Bairnco Corp. ,

Testimonials

Drug & Device Law

FEBRUARY 7, 2023

Today’s decision involves the defendant’s motion in limine to exclude evidence of adverse events associated with an earlier filter and of the company’s marketing and communications related to those adverse events. From 2003 to 2005, the defendant marketed its first-generation retrievable IVC filter. separate filters on trial.”

International

Drug & Device Law

AUGUST 26, 2022

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. 2003) (“[C]ourts are to assist the plaintiff by allowing jurisdictional discovery unless the plaintiff’s claim is ‘clearly frivolous.’ ”).” Atrium Medical Corp. , — F. 3d –, 2022 WL 3357485 (E.D. Step Two, S.A. ,

Production

Drug & Device Law

JANUARY 30, 2023

Mensing , 564 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Moran , 536 U.S. Walsh , 538 U.S.

FDA

Drug & Device Law

NOVEMBER 16, 2023

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. The trial court ordered JAMA to produce a privilege log and copies of the documents for in camera review. GlaxoSmithKline , 2023 IL App (1st) 221666 (2003).

Government

LifeSciVC

MAY 28, 2025

Further, the pace of fast follower drugs is striking relative the past: according to PhRMAs recent report on innovation , the average time for a drug class to have three FDA approvals in it went from ~15 years in 1990-2003 to ~2 years in 2013-2021. Market competition between startups happens very quickly, and often intensely.

Production

New Drug Approvals

APRIL 27, 2025

octane-8,1′-azolidin-1-ium]-3-yl 2-hydroxy-2,2-diphenylacetate;chloride FDA 2024, Cobenfy 9/26/2024, To treat schizophrenia Press Release Drug Trials Snapshot Trospium chloride is a muscarinic antagonist used to treat overactive bladder. [3] 12] Chemistry Anticholinergic drugs used to treat overactive bladder were all amines as of 2003.

FDA Approval

Drug Target Review

APRIL 30, 2025

For instance, a drug discovery project might simultaneously need to work with molecular structure graphs, protein interaction networks and clinical trial outcome data. As a business executive at IBM Research in New York, Dr Singh led the go-to-market for IBM Watson Genomics Analytics.

Drugs

Drug Target Review

APRIL 9, 2025

Preclinical and early clinical data A key question in vaccine development is how well a vaccine performs in preclinical and early-stage human trials. In a high-risk challenge study, they vaccinated the transgenic mice against SARS-CoV-1 – the virus behind the 2003 outbreak with a 50 percent mortality rate.

Virus

Drug Target Review

MARCH 26, 2025

4 Shortly after, testosterone pellets hit the market, followed by injectable ester forms. Cannot use the same patch site for 7 days, due to blistering 9 , 13 Gel AndroGel 2003 Ease of use, non-invasive, less skin irritation compared to patches. Sigilon uncovers possible reason behind haemophilia A trial hold. Endocr Connect.

Therapies