The Pharma Data

NOVEMBER 15, 2020

Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004.

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New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). Indeed, flavopiridol, a non-selective pan-CDK inhibitor that targets CTD kinases, has demonstrated efficacy for the treatment of chronic lymphocytic leukemia (CLL), but suffers from a poor toxicity profile (Lin et al.,). Inhibitors of CDK7 are currently being developed for the treatment of cancer.

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Drug Target Review

JUNE 21, 2023

4 For the treatment of rare genetic disorders especially, drugs with genetically supported targets are more than twice as likely to be approved 5 , thereby indicating genetics and genomics can empower companies to develop better drugs. 2004 Feb 6;303(5659):808-13. Global mapping of the yeast genetic interaction network. PMID: 14764870.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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The Pharma Data

APRIL 28, 2021

OSAKA, Japan, April 28, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories. About Takeda Pharmaceutical Company Limited.

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. There remains a significant need for new treatments with improved activity and tolerability to prevent or treat organ transplant rejection and to treat autoimmune conditions, including systemic lupus erythematosus, rheumatoid arthritis and multiple sclerosis.”. CHATHAM, N.J.,

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The Pharma Data

AUGUST 19, 2021

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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The Pharma Data

JULY 23, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MARCH 22, 2021

The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S. In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.

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Agency IQ

JUNE 16, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims. 2020) (LEAN).

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New Drug Approvals

APRIL 5, 2025

It is used as a ‘conditioning’ treatment to clear the bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells. [9] TREOSULFAN C 6 H 14 O 8 S 2 MW 278.29 9] It belongs to the family of drugs called alkylating agents. [9] 9] Efficacy was evaluated in MC-FludT.14/L

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New Drug Approvals

APRIL 14, 2025

PATENT Arena Pharmaceuticals, Inc.WO2023172685 Arena Pharmaceuticals, Inc., 2] As of October 2024, bexicaserin is in phase 3 clinical trials for treatment of developmental disabilities. [1] 1] [3] It is being developed by Longboard Pharmaceuticals. [1] 1] [3] It is being developed by Longboard Pharmaceuticals. [1]

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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. The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2004) and related cases.

Regulations 40

Regulations Compliance Production Government 40

Codon

FEBRUARY 23, 2025

million by 2004. government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. For more than two decades, the U.S.

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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.” 2004) (pre- Tincher product liability case; “assessment of the dangers of unfair prejudice and confusion of the issues are procedural matters that govern in a federal court notwithstanding a state policy to the contrary”); Kelly v.

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Drug & Device Law

DECEMBER 11, 2023

Merrell Dow Pharmaceuticals, Inc., In other cases with similar facts, courts have found that healthcare defendants are not necessary or indispensable parties in a products liability claim against a medical device or pharmaceutical manufacturer. Knoll Pharmaceutical Co. Knoll Pharmaceutical Co. Alfonzo-Larrain , 490 U.S.

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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

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. Medicis Pharmaceutical Corp. , 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. Graphic Process 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. 2004 WL 2827710, at *6 (Del. 15, 2004); Goodridge v. 15, 2004); Goodridge v. Miles , 414 P.3d 3d 680, 689 (Ariz. 2d 498 (Del.

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Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2004); and Hackett v. 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. . . . McNeil Consumer & Specialty Pharmaceuticals , 672 F.3d

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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 See Ehlis v.

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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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