FDA Law Blog: Biosimilars

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

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The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . This is because they did not have access to essential medicines needed for treatment.

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FDA Law Blog: Biosimilars

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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The Pharma Data

MARCH 5, 2021

To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.

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The Pharma Data

JANUARY 26, 2021

The PRESECO study aims to determine the efficacy of Avigan as an early treatment for COVID-19 patients with mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions. Dr. Reddy’s operates in markets across the globe.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

Immediate-Release and High Dosage Opioids The government’s expert asserted that opiate prescriptions alone can create a “therapeutic duplication” red flag when two separate immediate release opioids are prescribed in their highest strength version. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), 21 C.F.R. §§ 1306.04(a),

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The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.

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The Pharma Data

SEPTEMBER 17, 2020

Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. About IBRANCE® (palbociclib) 125 mg tablets and capsules.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. The government asserted additional allegations that are outside our scope.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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The Pharma Data

AUGUST 3, 2021

The FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The European Commission granted marketing authorization for Jardiance ® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). Humira net revenues were $3.907 billion , an increase of 6.9

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the FDA has appropriated funding through January 19.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The CMS regulation (unlike the statute) would expansively define a “misclassification” to include, not only misclassifying the drug category (e.g.,

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The Pharma Data

JULY 8, 2021

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. The organisation has over 150 dedicated members of staff, based in multiple locations across the UK. Source link: [link].

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The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. The primary efficacy endpoint was the annualized asthma exacerbation rate during the 52-week treatment period.

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The Pharma Data

SEPTEMBER 16, 2020

Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it.

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The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment. ” Amgen Webcast Investor Call Amgen?will

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The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. All aspects of the collaboration are under the oversight of joint governing bodies.

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recent Events.

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The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The study included an active control arm where patients were treated with dupilumab, a biologic treatment administered by subcutaneous injection.

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The Pharma Data

MAY 14, 2021

Biogen’s experimental eye treatment fails to meet study goal ( Reuters ) ( Endpoints ). Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities ( Scrip ). EU Go Ahead For Standards Needed For New Medtech Regulations ( MedtechInsight ). In Focus: International.

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Agency IQ

JULY 28, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 27, 2023 11:49 AM CDT Big-picture things to watch in Q3 A rush of things for FDA to do as we approach the end of the fiscal year: The government operates on a Fiscal Year that begins on October 1 each year and ends on September 30. government by October 1.

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The Pharma Data

MAY 3, 2021

Sarepta’s more potent Duchenne treatment shows promise, greater toxicity, in small study ( STAT ) ( Endpoints ). Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ).

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The Pharma Data

MAY 17, 2021

Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). Desperate for treatment, Covid ‘long haulers’ push for 9/11-style health registry ( Politico ). BioPharmaDive ).

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