Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Biosimilars Drug Pricing Compounding Drug Development 100

STAT

SEPTEMBER 26, 2023

Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

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Drug Pricing Biosimilars Drug Development 315

European Pharmaceutical Review

NOVEMBER 9, 2023

In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade.

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Express Pharma

JULY 3, 2023

How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?

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Biosimilars Drug Development Generic Medicine Diabetes 79

Express Pharma

MAY 24, 2023

The sixth edition of the Pharma Project & Portfolio Management was held at Fairfield by Marriott near the Mumbai International Airport from April 26-28, 2023. The day concluded with the delegates solving an exciting case study by Tahseen Rana on the drug development process while dealing with the pandemic and timelines!

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Biosimilars Communication Drug Development 81

European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 99

European Pharmaceutical Review

NOVEMBER 6, 2023

million in 2023, with a predicted compound annual growth rate (CAGR) of 4.1 Demand for cell lines “in drug development , vaccine production, and therapeutic research is surging”, setting the market up for significant expansion, Ghosh noted. Total cell line product sales are expected to reach $3,124.4

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Biosimilars Compounding Vaccines Drug Development 85

Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. By 2022, that time was nearly cut in half, at nine to 12 months, and even shorter development timelines are expected in the next few years.

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Biosimilars Vaccines Drug Development Diabetes 52

European Pharmaceutical Review

FEBRUARY 20, 2024

Other key influences helping the upstream bioprocessing market expand include drug development, antibody manufacturing, as well as a higher need for cell therapy research.

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Process Improvement Biosimilars Drug Development 79

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. is the largest dedicated food and drug law firm in the country.

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FDA Law Blog: Biosimilars

DECEMBER 20, 2023

Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually. At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings.

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Biosimilars Drug Development 59

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

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Biosimilars Drug Pricing Drug Development 130

FDA Law Blog: Biosimilars

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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Drug Development 59

FDA Law Blog: Biosimilars

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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Drug Development Immunity Immunization 98

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. She is an oncologist/hematologist and at the time she retired from FDA on July 29, 2023, she was the Director of the CDER Office of Immunology and Inflammation (OII) in the Office of New Drugs (OND).

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FDA Law Blog: Biosimilars

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023.

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Drug Development 59

FDA Law Blog: Biosimilars

MARCH 13, 2024

10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,968,453 (November 29, 2023) Pursuant to 37 C.F.R. 10,544,220 (the ‘220 patent). Appendix D.

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Documentation Drug Development 59

FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

117-328 (2022) (see our FDORA summary and analysis here ).

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Hospitals Drug Development 52

PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

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Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

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Labelling Drug Development 40

FDA Law Blog: Biosimilars

JUNE 27, 2023

Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) Valentine , as a 2023 Rising Star. James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. HP&M’s Kurt R. Gibbs Paul M. Hyman Alan M. Mullen Frank J.

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Drug Development Pharmaceutical Manufacturing 81

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

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Documentation Vaccines Drug Development 59

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Packaging Documentation Labelling Communication 59

Safe Biologics

OCTOBER 10, 2023

Department of Health and Human Services​ Clip 2: Drug Developer Discusses Impacts on R&D – Steven Potts, PhD, MBA – View clip Clip 3: Innovation and Patient Access – Andrew Spiegel, Esq. director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

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Biosimilars Drug Pricing Drug Development 130

European Pharmaceutical Review

OCTOBER 27, 2022

Ahead of the world’s largest pharma event, CPHI Frankfurt – hosted at the Frankfurt Messe (1-3 November, 2022) – part i of the CPHI Annual Report looks ahead at the opportunities for biologics outsourcing and contract manufacturing organisastions (CMOs) in 2023. In the report some 50.4 percent in 2021).

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Biosimilars Vaccines Drug Development 81

PharmaShots

FEBRUARY 27, 2023

Some of their thoughts are: Mr. Mekala Rao (Chairman – Technology Global PHT Expo & Summit – 2023 and President – Atachi Systems, USA) – “motivation to attend Global PHT is to understand the cultural gap in the production of innovative medicine, healthcare systems between eastern and western world.

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Biosimilars Diabetes Packaging Hospitals 40

FDA Law Blog: Biosimilars

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” By James E. Valentine & Charles D.

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Drug Development 64

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Documentation Labelling Drug Development 59

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Drug Development Documentation Labelling Medical Records 64

FDA Law Blog: Biosimilars

APRIL 23, 2023

Tobolowsky & David B.

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Documentation Drug Development 49

Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year.

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