FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

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The Pharma Data

JUNE 17, 2022

As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL 2 and Hyrimoz HCF. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

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Advarra

JULY 5, 2022

When returned directly to participants, aggregate results should be packaged and communicated in user-friendly formats, such as in newsletters or web pages constructed with readability and health literacy principles in mind. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Initial doses are expected to be limited as manufacturing ramps up.

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The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. The FDA also granted a second meeting for review. The agency encouraged further review of the data for potential reference as a historical control.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling. . § 314.94(a)(8)(iv),

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Advarra

JULY 19, 2022

A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Could you please confirm?

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The Pharma Data

MAY 15, 2021

The product is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. After you fill in your information and confirm your package will be shipped for free right to your doorstep as soon as possible. Dentitox Pro is non-GMO and safe.

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The ChEMBL-og

JUNE 13, 2023

ChEMBL database version ChEMBL 33 release notes _ # This version of the database, prepared on 31/05/2023 contains: 2,399,743 compounds (of which 2,372,674 have mol files) 3,051,613 compound records (non-unique compounds) 20,334,684 activities 1,610,596 assays 15,398 targets 88,630 documents BioAssay Data Sources: Number Assays: Number Compound Records: (..)

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The Pharma Data

JANUARY 6, 2021

” AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks. Source: AstraZeneca.

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The Pharma Data

DECEMBER 8, 2020

Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages. Series D funds will be used to accelerate reimbursement coverage for its three commercial products. .

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Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Six years later with the reauthorization of several FDA-industry user fee programs in 2012, Congress took the opportunity to set a series of policy changes into motion. However, the proposed rule sat in limbo for years without ever being finalized.

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The Pharma Data

MAY 16, 2021

Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

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The Pharma Data

MAY 13, 2021

After all my requirements were 100% met, we finally had the final product: Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards.Met Slim Pro capsules are non-GMO and safe. Safe: processed under strict sterile standards with regularly disinfected equipment.

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Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

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Agency IQ

JANUARY 19, 2024

The FDA CRL cited inspection findings that arose from a “multi-sponsor inspection of a third-party, contract manufacturing organization” which involved the monoclonal antibody drug substance for lebrikizumab. The clinical package, safety and label were not affected. However, BeiGene announced that it is seeking approval in the U.S.

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Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Drug labeling : Labeling for the imported drug product must be consistent with the current required U.S.

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Broad Institute

MAY 16, 2024

But FDA-approved forms of the most commonly used vehicle for packaging and delivering these therapies to target cells, adeno-associated viruses (AAVs), aren’t able to efficiently cross the blood-brain barrier at high levels and deliver therapeutic cargo.

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The Pharma Data

MAY 13, 2021

Every capsule is manufactured in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV.

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The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ ® (upadacitinib) [Package Insert]. 14 In August 2019 , RINVOQ received U.S. ClinicalTrials.gov. Accessed on April 20, 2021. North Chicago, Ill. AbbVie Inc. .

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The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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Agency IQ

JULY 26, 2024

Prior to CARES Act reforms, FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as they adhered to pre-set terms under the monograph. On the other hand, data, information and comments to a proposed or final order should use the OTC Monographs@FDA portal.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

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The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. XmAb is a registered trademark of Xencor, Inc.

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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