2012, Biosimilars and Pharmaceuticals

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order , 77 Fed.

Pharmacy

Pharmacy Government Treatment Compliance

The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

APRIL 16, 2024

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir. MJM-22-977 (Dist.

Drugs

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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

The Pharma Data

DECEMBER 13, 2020

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

Treatment

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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

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Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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.

FDA

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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

JANUARY 24, 2021

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

FDA

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CMS Definition of “New Formulation” Upheld in Federal Court

FDA Law Blog: Biosimilars

APRIL 3, 2023

Vanda Pharmaceuticals, Inc. This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). MJM-22-977 (Dist.

Drugs

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New Sandoz Board of Directors appointed

The Pharma Data

MAY 15, 2023

Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. He also served on 2 Boards of Directors at Takeda Pharmaceuticals between 2013 and 2015 and Britannia Industries, India, between 2000 and 2008. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

Science

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Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

FDA

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Biogen Files New Drug Application for Aducanumab in Japan

The Pharma Data

DECEMBER 9, 2020

million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012). is a leading global pharmaceutical company headquartered in Japan. According to the Health, Labor and Welfare Ministry, it is estimated approximately 4.6 About Eisai Co., Eisai Co.,

Clinical Trials

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

FDA

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

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Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Biosimilars

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Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

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. [See from the E.U. excluding Northern Ireland) as of January 1, 2021.

International

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Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Now it is up to the Council to provide their position.

Regulations

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Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

.: Hands-on training course Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/03/2024 EUCOPE’s Life Science Lectures – Episode Five (Joint Clinical Assessments) Webinar/Seminar ( OPEN ) EUCOPE 6/04/2024 6/04/2024 EUDAMED, the pathway to compliance Webinar/Seminar ( OPEN ) Team Person Responsible for Regulatory Compliance (TEAM-PPRC) 6/04/2024 6/04/2024 News (..)

Regulations

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Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations

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Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations

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Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics.

Regulations

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

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Roche reports good half-year results

The Pharma Data

JULY 21, 2021

Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. Sales in the Pharmaceuticals Division were CHF 22 billion, a decrease of 3%. Outlook confirmed for 2021.

Biosimilars

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA

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Article EMA Thank You What we expect European regulators to do in December 2023

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Expected Action Description of action Original Deadline Pharmaceuticals – changes to marketing authorisations (review of EU rules) [E.U.] Q2 2022 E.U.

Regulations

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Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). for multiple violations observed during an inspection that occurred eight months ago.

FDA

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

Trending Sources

CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

CMS Definition of “New Formulation” Upheld in Federal Court

New Sandoz Board of Directors appointed

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Biogen Files New Drug Application for Aducanumab in Japan

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Amgen Reports Second Quarter 2021 Financial Results

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Article EMA Thank You What we expect European regulators to do in July 2024

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in May 2024

Article EMA Thank You What we expect European regulators to do in March 2024

Article EMA Thank You What we expect European regulators to do in April 2024

Article EMA Thank You What we expect European regulators to do in August and September 2024

Roche reports good half-year results

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Article EMA Thank You What we expect European regulators to do in December 2023

Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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