The Pharma Data

MARCH 8, 2021

At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.

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Perficient: Drug Development

JANUARY 25, 2024

This is a disappointing reversal for payers, as the 2010 results showed a nine-point gain compared to the 2003 figure. Understand the role consumers want you to play In the past, we’ve seen payers provide detailed information on common conditions and treatments covered by their health plans.

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The Pharma Data

NOVEMBER 11, 2020

McChesney is the founder and chief executive officer of Cloaked Therapeutics and Arbor Therapeutics, through which he has drawn on more than five decades of research in natural products chemistry to identify and develop novel cancer treatments. In 2009, he established Ironstone Separations Inc.,

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The Pharma Data

OCTOBER 19, 2020

In February 2020, the United States Food and Drug Administration granted the regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

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The Pharma Data

MARCH 26, 2021

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. The CHMP’s positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis.”.

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The Pharma Data

NOVEMBER 9, 2020

Additionally, the vast majority of patients only receive a temporary benefit or no benefit from ICIs, as they either develop resistance to the treatment during the course of therapy or are non-responsive to the treatment altogether (only 15%-20% of patients respond, according to published data). Next Steps in Immunotherapy.

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The Pharma Data

MAY 5, 2021

GlaxoSmithKline plc (GSK) today announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE).

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The Pharma Data

JULY 22, 2021

NOTE: ADUHELM TM (aducanumab-avwa)injection 100 mg/mL solutionis indicated for the treatment of Alzheimer’s disease. 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. Biogen Inc.

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The Pharma Data

OCTOBER 1, 2021

Currently, the quality dose for all marketed GBCAs, including gadobutrol and gadoterate, is 0.1 Safety was evaluated by analyzing the frequency of treatment-emergent adverse events (TEAE). The administration of GBCAs during MRI helps physicians answer critical medical questions within the diagnosis and monitoring of disease.

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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. The trials assessed change in nasal congestion score over one week of treatment. Both trials showed no difference between phenylephrine and placebo.

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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. By then, many neurons have died, and cannot be replaced.

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The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

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Production FDA Clinical Trials Compliance 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. 2003) , and Biogen lnt’l v. Patent Nos. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed.

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The Pharma Data

FEBRUARY 25, 2021

Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature. 5 Currently there is no cure or treatment for TBE, only management of symptoms. 2003 Dec 12;22(2):217-23.

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. The man was in Hong Kong for kidney treatment. A company called LuminOre will soon bring copper-coated air ducts to the market. Read it on our website here. Credit: Alfred Mitchell, courtesy of Tom Ough.

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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

MARCH 29, 2024

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act on May 20, 2003, and subsequently amended on July 13, 2006. Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal.

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Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C. 2020) (LEAN).

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The Pharma Data

APRIL 25, 2021

We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. 2003; vol 143:S127-S132. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. Pediatrics. 2020;146(1):e20193611. Leader S., J Pediat r ics.

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The Pharma Data

MAY 13, 2021

What I learned on the DVDs was the missing link when it comes to evaluation and eventual treatment of my clients planning for patients with muscular dysfunctions.”. ll see, and treatment strategies from some top notch names in our industry: Mike Robertson, Bill Hartman, Eric Beard, Rick Kaselj, Kevin Yates, and Dean Somerset.”.

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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 Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. section 7412(d)(6).

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Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. For increased flexibility in bringing PIPs to market, a developer can also submit both. This action will address Louisiana Environmental Action Network v.

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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.

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Science Regulations International FDA 40

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.

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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. at *3 (emphasis original). Hoffman-LaRoche, Inc. , 2d 806, 817 (5th Cir. 1992) (applying Mississippi law). 692, 694 (5th Cir. Another recent decision is Hubbard v.

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Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. purchase, marketing, promotion, . . by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d

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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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Drug & Device Law

DECEMBER 11, 2023

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. 2003 WL 27423681, at *4 (N.D. 2003 WL 27423679, at *3 (N.D. Ohio July 11, 2003) (same), reconsideration denied , 2003 WL 27423680 (N.D. Zimmer, Inc.

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