PPD

FEBRUARY 22, 2023

The expected rebound of capital markets will drive a return-to-funding optimism. While volume and value from a deal perspective are down significantly, there is reason to remain optimistic that 2023 will see a rebound as the capital markets reopen, money comes off the sidelines, investors continue to be creative and M&As increase.

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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.

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The Pharma Data

JULY 29, 2021

Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD.

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The Pharma Data

JUNE 25, 2021

The FDA’s Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 BioArctic has no development costs for lecanemab in AD.

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Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. 2007 Jul;7(4):348–54. Brain Behav Evol. 2000 Jun;55(6):287–99. Scharfman HE. The Neurobiology of Epilepsy.

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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 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She has been a member of the board of directors and a member of the executive committee of the New York Biotechnology Association since 2007. She earned a BA from Durham University, U.K.,

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The Pharma Data

DECEMBER 28, 2020

Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application. Arch Gen Psychiatry , 2007 May; 64(5): 543-552. [link] . Accessed on Dec.

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Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Under DSHEA, manufacturers are responsible for ensuring their products are safe prior to release to the market. An NDI is defined as a dietary ingredient not marketed before October 15, 1994.

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The Pharma Data

MARCH 17, 2021

This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. In this trial, the median duration of exposure to KEYTRUDA was 10 months (range, 1 day to 2.2

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Therapies Treatment Disease Trials 52

The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. Bacterial Meningitis in the United States, 1998–2007. Clin Infect Dis.

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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.

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Agency IQ

MARCH 7, 2024

Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs. As AgencyIQ has previously discussed , the Tropical Disease PRV program was actually the first of FDA’s voucher programs, introduced in 2007 to incentivize the development of products to treat diseases (i.e.,

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FDA Packaging Science Drugs 40

The Pharma Data

MAY 7, 2021

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”. .

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Clinical Trials Regulations Trials Vaccine 52

Perficient: Drug Development

DECEMBER 19, 2024

Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Pumps & Pipes: A Convergence of Expertise Founded in 2007, Pumps & Pipes exemplifies Houstons unique position as a global hub for medicine, energy, and aerospace. Brain-controlled exoskeleton trials.

Hospitals 52

Hospitals Pharmaceuticals Research Science 52

Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met. Clinical trial agreement. If an MCA is required, does this clinical trial qualify for Medicare coverage?

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Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. For instance, a Johnson & Johnson vaccine failed in late-stage trials in 2023, and Merck ended its Ad5 HIV vaccine trial after data suggested an increased risk of HIV infection among recipients. percent.

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Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & and (2) suggesting that the Defendants can cross-examine [the expert] about this at trial. However, that do-over took a year and cost the defendant who knows how much money, headaches and heartburn. Fru-Con Inc. , 3d 734 (7th Cir.

Testimonials 52

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. While we know that a late-breaking holiday horror, such as T.H.

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Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2007 WL 2460776, at *6 (D. mentioned with approval an unappealed trial court ruling that, as to “strict liability,” a cellphone “app was not a product, and thus a products liability theory of recovery was not legally viable.” 2007 WL 218242, at *4 (N.D. Paragon 28, Inc.

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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.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

FEBRUARY 7, 2023

30, 2023), the plaintiff was implanted with the defendants inferior vena cava (“IVC”) filter in October 2007. (IVC 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.

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Drug & Device Law

OCTOBER 3, 2022

It was apparently uncontradicted that “on the week of [the] surgery in 2007, the MAUDE database. . . In a brief discussion, the Eighth Circuit did not even try to defend the district court’s ruling – instead it affirmed on harmless error: The MAUDE data suggesting the [device’s] success in 2007 does not refute any of [plaintiff’s] evidence.

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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. Without deciding whether 9(b)’s heightened pleading standards apply to a negligent misrepresentation claim, the court cited 2001 and 2007 Eastern District of Pennsylvania cases for a “degree of specificity” standard.

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Drug & Device Law

JUNE 6, 2022

One prescriber “testified that based on her review of all the post-approval data, at the time of trial, she believed the [risk] was still rare.” 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. 2007 WL 5861354, at *4 (C.D. 26, 2015); In re Plavix Product & Marketing Cases , 2017 WL 2882212, at *3 (Cal.

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Drug & Device Law

JUNE 2, 2022

If the draft Dobbs decision becomes the final decision, then preemption may take on an increasingly prominent role in combatting state laws designed to limit reproductive rights by, at least in part, limiting the use of medical products on the market pursuant to FDA decisions. 124 (2007), which would also be knocked out by Dobbs if it sticks.

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Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. Osmose Wood Preserving , 667 A.2d 2d 624, 636 (Md. Schultz, Inc. , 906, 909 (D.

Government 52

Government Production FDA Approval FDA 52

Drug & Device Law

MARCH 16, 2022

Nevertheless, the plaintiff argued that one of the pelvic mesh devices implanted in her in 2007 was not covered by the statute because such device had not received FDA 510(k) clearance at that time. The product had initially been marketed as a line extension of another product. Hence, the statute applied.

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