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 40

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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

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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 40

Immune Response Therapies Clinical Trials Treatment 40

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 52

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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 40

Science FDA Clinical Trials Clinical Pharmacology 40

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 40

Science Regulations International FDA 40

Codon

JUNE 2, 2025

” By 2003, collaborators had cultivated frog meat grown from cells, preceding the scientific and market interests in cultured meats. They saw their mission as “a pioneering collaboration that explores how tissue engineering can be used as a medium for artistic expression.” The result, taken collectively, was striking.

Engineering 65

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DrugBank

JUNE 18, 2025

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

Drug Development 52

Drug Development Clinical Trials Compliance Drugs 52

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 40

Clinical Trials Immune Response Trials Therapies 40

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 59

Biosimilars Licensing Licensing Production 59

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 40

Virus Trials Disease Hospitals 40

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 40

FDA Production Regulations Vaccine 40

Codon

NOVEMBER 1, 2024

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

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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 52

Disease Research Clinical Trials FDA 52

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 95

Disease Therapies Laboratories Treatment 95

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 52

Therapies Disease Treatment International 52

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.

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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 57

FDA Approval FDA Pharmacokinetics Licensing 57

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 59

Drugs Laboratories Science Clinical Trials 59

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 52

FDA Vaccine Virus Clinical Trials 52

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 95

Virus Vaccine RNA Trials 95

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 52

Therapies Compliance Treatment Small Molecule 52

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 52

Testimonials Production Vaccine Pharmaceuticals 52

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 64

Government FDA Pharmaceutical Companies Regulations 64

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 52

Production Trials International Government 52

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 59

FDA FDA Approval Testimonials Vaccine 59

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.”

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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 72

FDA Regulations Production Government 72

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. ,

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