FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. Before 1983, only 38 orphan drugs had received U.S.

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The Pharma Data

DECEMBER 30, 2020

That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. Most Read Today. Source link.

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The Pharma Data

JUNE 18, 2021

June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. IRVINE, Calif. Experience the interactive Multimedia News Release here: [link] . Each story is unique. Each story is unique.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. Specifically, after 2 to 4 weeks of treatment with this combination of two correctors and a potentiator, such patients experienced about a 10 percentage point improvement in forced expiratory volume in 1 second (FEV1), which is a key measure of lung capacity.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2016 March 4. [5]

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 was submitted on December 8, 2016 (Docket No.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved. While that remains a tremendous challenge, this new method could help to bring the goal of discovering many more precise and effective cancer treatments within better reach.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. At the time of that publication risdiplam was also in clinical trials for the treatment of SMA patients.

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. Over time, the frequency of resistance gene variants in the population will continue increasing because only the bacteria lacking those variants will die with treatment.

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The Pharma Data

FEBRUARY 13, 2022

Current treatment options in this age group are primarily topical steroids, which can be associated with safety risks and may impair growth when used long-term. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years).

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The Pharma Data

JUNE 18, 2021

Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17 , including findings from the informCLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN ® )-recommended regimens for CLL/SLL.

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The Pharma Data

AUGUST 30, 2021

Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. Parents and caregivers are challenged to find safe and effective treatment options,” said John Reed, M.D., In 2016, the U.S.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

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Codon

JUNE 18, 2024

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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The Pharma Data

SEPTEMBER 15, 2020

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment. Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Publication of the full IMPACT study findings is pending.

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The Pharma Data

DECEMBER 21, 2020

21 December 2020 — AstraZeneca’s Tagrisso ( osimertinib ) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. 0.23; p<0.0001).

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FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; 21 U.S.C. §

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. EINSTEIN-Jr.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE. for use in pediatric patients.

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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 FDA will follow these procedures for both agency-initiated operations (e.g.,

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Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. Read AgencyIQ’s analysis of that case here. ]

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc.

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The Pharma Data

SEPTEMBER 10, 2021

If approved for this indication, we believe MYFEMBREE has the potential to redefine care for women with endometriosis as an effective, one pill, once-a-day treatment option.”. We look forward to potentially bringing this important new treatment option to women with endometriosis.”. In the U.S., About MYFEMBREE®.

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Broad Institute

NOVEMBER 6, 2024

For some patients, this treatment results in striking and long-lasting remission — but for a subset, it triggers complications ranging from mild rash to potentially deadly brain and heart inflammation. At that point in 2016, we knew very little about these conditions. He had total, complete remission, which is so incredible.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children. It has also been approved for newborns of mothers who have tested positive for Ebola. during the 2014 to 2016 epidemic. In 2019, the FDA approved an Ebola vaccine, Merck’s Ervebo. “We

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FDA Law Blog: Biosimilars

MAY 5, 2024

Scheduling Under the CSA Substances in schedule I of the CSA have a high potential for abuse, no currently accepted medical use in treatment in the U.S., Those in schedule III have a potential for abuse less than schedule I or II substances, have a currently accepted use in treatment in the U.S., 21 U.S.C. § 21 U.S.C. § 53,688 (Aug.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). 115, 125 (2016).

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Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. Danco Labs.,

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Drug & Device Law

SEPTEMBER 7, 2023

For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use. 115 (2016), eight years after Levine , there is no such presumption in express preemption either. Last week, the district court in GenBioPro, Inc. There was more.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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Drug & Device Law

MAY 11, 2023

Its staff has a broad view tied to public health considerations, available drug and non-drug treatment options, data that may not be publically available, and decades of experience with the subject matter. 330, 339 (2016), and Clapper v. That all matters because judges lack that expertise, broad view, and experience. Brief at 11 n.1.

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Drug & Device Law

APRIL 20, 2023

Back when the Dobbs decision had been leaked but not yet issued, we offered that the decision would open the door to a range of challenges to FDA-approved drugs for medical abortion and emergency contraception, along with a wide range of other regulated medical products. Are you with us?

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