The Pharma Data

MARCH 5, 2021

Food and Drug Administration (FDA) approved Actemra ® /RoActemra ® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. 1-3 SSc affects about 2.5

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The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . 42/40 ratio, brain amyloid by PET and treatment Low values of plasma A?42/40

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The Pharma Data

OCTOBER 20, 2020

8 months in similar patients with metastatic breast cancer in the third line setting without BriaCell’s treatment; Additional overall survival data will be presented at the 2020 San Antonio Breast Cancer Symposium®, December 9 – 11. Overall Survival of 13. BERKELEY, Calif. and VANCOUVER, British Columbia, Oct.

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The Pharma Data

DECEMBER 15, 2020

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. About Critical Path Institute. There is currently no known cure for any type of diabetes.

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New Drug Approvals

SEPTEMBER 8, 2024

5 On August 14, 2024, seladelpar was granted accelerated approval by the FDA for the treatment of primary biliary cholangitis, 6 which is a condition associated with aberrant bile acid metabolism. 2007.05.007 Drug Discovery, Johnson and Johnson Pharmaceutical Research and Development, LLC, 8 Clarke Drive, Cranbury, NJ 08512, USA Scheme 1.

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Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . Last year, Pfizer opened a $68.5 million facility in Durham North Carolina to support the company’s gene therapy capabilities.

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Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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The Pharma Data

APRIL 27, 2021

Roche announces five new intended uses for key cardiac biomarkers to help identify cardiovascular risk, better diagnose patients and support early treatment. Early diagnosis and treatment can contribute to saving or improving people’s lives and could help healthcare systems save money.

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The Pharma Data

NOVEMBER 25, 2020

A new website takeironseriously.com has been launched to educate individuals and healthcare professionals on the symptoms of iron deficiency, demonstrate the ease of diagnosis and encourage people to seek treatment to protect their health. Vifor Pharma Group is a global pharmaceuticals company. 12 June 2018. Am J Clin Nutr.

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New Drug Approvals

SEPTEMBER 7, 2024

Refer to WO 2004101742 A2, US 2005/0143320 Al, US 2006/0014821 Al, US 2009/0137818 Al, WO 2013049382 A2, WO 2013166319 A1, WO2018042343, WO2018023054, WO 2022013684, WO 2021252644, WO2022020711, WO 2022020242, US 11,174,231 B1, US 11,124,497 B1, WO 2005113580, and WO2006061714). Patent CN114524821A. WO2023177854 [link] Example 15.

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The Pharma Data

NOVEMBER 2, 2020

Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with triple-class refractory multiple myeloma.

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Codon

APRIL 9, 2024

In response to the precipitous rise in incidence, governments on both sides of the Pacific began a systematized search for antimalarial treatments. Over the course of 12 years, the Walter Reed Army Institute of Research (WRAIR) screened more than 250,000 compounds in search of an efficacious treatment.

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The Pharma Data

SEPTEMBER 2, 2021

Interim analysis of patient engagement and adherence assessment indicates ability of Enerzair Breezhaler optional digital companion (sensor and app) in supporting patient engagement and treatment adherence 6. Woehrle et al. Details: Oral Presentation, 7 September, 14:45-16:15 CEST. About Enerzair ® Breezhaler ® in the European Union (EU).

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Agency IQ

FEBRUARY 2, 2024

In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. Predictive biomarkers enable the identification and selection of patients who are more likely to benefit from a specific treatment and would achieve a better clinical outcome in response to a specific treatment.

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The Pharma Data

AUGUST 31, 2021

The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region,” said Professor Glenda Gray, President and Chief Executive Officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol Chair.

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Metabolite Tales Blog

MARCH 1, 2023

9 The evidence here is that treatment with P450 inhibitors removed the toxic effects seen in the compounds of interest. 2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 11 Figure 11 Pyrazoles – more stable to oxidative cleavage? 2017, 30, 1, 13–37 [link] 2a Drug Metab. 1980, 8, 34-38 [link] 4 J.

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The Pharma Data

NOVEMBER 26, 2020

“When we get market approval for Sedaconda, we can exclusively launch the treatment inhaled sedation in Europe. The treatment consists of our drug Sedaconda, which is then approved for administration only via our medical device AnaConDa. This information was brought to you by Cision [link].

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SugarCone Biotech

MAY 28, 2019

A study, published in 2005, suggested that chloroquine could prevent SARS (the older virus) from infecting cells kept in culture. [2] It appears to also be true of the approval of aducanumab for the treatment of Alzheimer’s Disease (AD). In contrast, a weak hypothesis generates predictions that fail more often than not. Stay tuned. [1]

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Vaccine Clinical Trials Virus Science 52

Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. These technical corrections consist of corrections of typos, incorrect regulatory citations, and small oversights. On September 14, 2018, the U.S.

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Agency IQ

JUNE 16, 2023

Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims. The proposed revisions, the first since the FARR was promulgated in 2005 (70 FR 18074), clarify aspects of the initial rules and add provisions to address additional sources of particulate matter.

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Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

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Drug & Device Law

DECEMBER 4, 2023

Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.” The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows. Senju Pharmaceutical Co. ,

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Drug & Device Law

JUNE 1, 2023

Accord Arizona State Hospital/Arizona Community Protection & Treatment Center v. Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. 2005); In re Doe , 981 P.2d Miles , 414 P.3d 3d 680, 689 (Ariz. Klein , 296 P.3d 3d 1003, 1009 (Ariz. Gastro-Intestinal Center, Inc. ,

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Drug & Device Law

JANUARY 15, 2024

at 526 (citation omitted). “[R]esearch and innovation in medical equipment and treatment would be inhibited.” Janssen Pharmaceuticals, Inc. , 2d 439 (2005): [A]t the time this [product] was sold, it complied with all safety standards. Cafazzo therefore refused to expand strict liability. [B]efore 2d at 1013-14. 3d 709 (Pa.

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Drug & Device Law

MAY 30, 2022

That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d at *3 (emphasis original). Hoffman-LaRoche, Inc. , 2d 806, 817 (5th Cir.

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d

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Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d Luitpold Pharmaceuticals, Inc. , An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . .

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