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

Regulations Clinical Trials Production Disease 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.

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FDA Production Regulations Vaccine 40

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

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.

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Immune Response Therapies Clinical Trials Treatment 40

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.

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FDA Vaccine Virus Clinical Trials 52

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.

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FDA Approval FDA Treatment Therapies 52

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

The Pharma Data

MARCH 8, 2021

Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases.

Trials 69

Trials Virus RNA Research Laboratories 69

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

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

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Clinical Development Pharmaceuticals Clinical Trials Trials 52

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 52

Clinical Trials Production Disease Hospitals 52

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

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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DNA RNA Molecular Biology Laboratories 105

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 International Trials Government 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

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.

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FDA FDA Approval Testimonials Vaccine 59

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.

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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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Production Testimonials Trials Marketing 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.”

International 59

International Marketing Trials Production 59

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).

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Government FDA Pharmaceutical Companies Regulations 64