FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. to maintain its gold standard of pharmaceutical quality. By Kalie E.

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Drug Target Review

DECEMBER 11, 2024

For small- and medium-sized pharmaceutical companies, outsourcing represents a strategic leap forward, offering a gateway to unparalleled expertise and cutting-edge analytical technologies. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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Drug Target Review

APRIL 5, 2024

For example, a CDMO with deep sequencing knowledge and a proprietary cell line will achieve significantly better performance than CDMOs that license third-party technologies. Finding the right CDMO may require significant time and company resources, but CLD sits at the heart of biologics development.

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Drug Target Review

AUGUST 9, 2024

Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 3 Patient compliance is a critical but complex challenge, with contributing factors reaching beyond just drug formulation. What is drug formulation?

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FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval.

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Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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The Pharma Data

DECEMBER 28, 2020

is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary. An import license is necessary for any intellectual property or equipment used during the trial.

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PPD

JULY 9, 2024

Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. And it enables careful motoring of quality and compliance key performance indicators (KPIs), along with greater opportunity to apply time- and cost-saving process improvements.

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The Pharma Data

DECEMBER 20, 2020

We are excited to work with BetterLife to build out our product line and conduct further R&D to develop an exciting IP portfolio surrounding LSD based pharmaceutical treatments,” said Transcend CEO, Justin Kirkland. Both companies have similar values and complementary strengths, which make this a strong corporate and cultural fit.”.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs. What is an excipient?

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The Premier Consulting Blog

NOVEMBER 8, 2022

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. About Collegium Pharmaceutical, Inc.

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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The Pharma Data

OCTOBER 18, 2020

About AVEO Pharmaceuticals, Inc. Crist brings more than twenty years of oncology sales experience in both launch-stage and late-stage companies, building commercial organizations and developing high performing sales force teams. Crist served as general manager, hematology oncology U.S. Mr. Crist holds a B.S. from Florida State University.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

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The Pharma Data

DECEMBER 14, 2020

is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. About BetterLife Pharma Inc. BetterLife Pharma Inc.

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Molecule Blog

MARCH 17, 2023

The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceutical research and discovery. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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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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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. BOSTON –(BUSINESS WIRE)–Oct.

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Agency IQ

JUNE 29, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. from the E.U. on February 1, 2020 started a year-long transition period; The E.U.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. Source: Alexion Pharmaceuticals, Inc. The acquisition will be immediately core earnings-accretive and value-enhancing, and is aligned with stated capital-allocation priorities. CAMBRIDGE, England & BOSTON –(BUSINESS WIRE)–Dec. AstraZeneca contacts.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Audits and Compliance Monitoring: Using its discretionary authority under 42 U.S.C. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit. Final Guidance at 15.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. Moreau, CEO of Algernon Pharmaceuticals. About Algernon Pharmaceuticals Inc. . Moreau CEO Algernon Pharmaceuticals Inc. VANCOUVER, British Columbia, Dec. This is another important step for the Company,” said Christopher J. Christopher J.

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Drug Target Review

SEPTEMBER 7, 2023

Author Bio: Keir Loiacono Keir Loiacono brings nearly 20 years of transactional experience from the biotech, pharmaceutical and medtech industries. A patent lawyer by training, Keir represented companies of various sizes in all stages of transactions, including licensing and M&A. a public, clinical-stage oncology company.

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The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” The Swiss Agency for Therapeutic Products (Swissmedic) has demanded that license holders check suppliers more rigorously when importing finished medicinal products from outside the European Union. . EMA Report. .

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DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

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Agency IQ

JUNE 2, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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The Pharma Data

AUGUST 6, 2020

announced that the companies submitted the Biologics License Application (BLA) to the U.S. In June, the company and Acceleron Pharma Inc. announced the European Commission (EC) approved Reblozyl (luspatercept) for the treatment of transfusion-dependent anemia in adult patients with myelodysplastic syndromes (MDS) or beta thalassemia.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. to $6.93 (1)% to 2% Amortization of intangible assets.47

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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