Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

The Pharma Data

NOVEMBER 10, 2020

On October 31, 2018 , Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Agency IQ

OCTOBER 6, 2023

This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

FDA 52

FDA Biosimilars Science Drugs 52

The Pharma Data

JANUARY 20, 2021

Much of the new recruitment has taken place at their new clinical and commercial manufacturing site in Warsaw, which began construction in 2018. Polpharma Biologics is a European biopharmaceutical company focused on the development and manufacture of biosimilar and novel biologic drugs. About Polpharma Biologics.

Biosimilars 52

Biosimilars Production Laboratories Drugs 52

DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

FDA Law Blog: Biosimilars

MAY 13, 2024

In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.” RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

FDA 111

FDA Production Trials Clinical Trials 111

The Pharma Data

APRIL 6, 2021

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

Regulations 52

Regulations Biosimilars Government Production 52

The Pharma Data

APRIL 8, 2021

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

Regulations 52

Regulations Biosimilars Government Production 52

The Pharma Data

JULY 15, 2021

. “By combining the expertise of the healthcare industry and the non-profit research community, we can carefully assess how biomedical data at this unprecedented scale is best utilized and hopefully accelerate the path from genetic discoveries towards novel therapeutics.”

Disease 52

Disease Biosimilars Government Treatment 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020.

FDA 115

FDA Production Marketing Regulations 115

FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

Drugs 45

Drugs Biosimilars Production Treatment 45

The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. So far, more than thirty company sponsored clinical studies covering more than fifteen indications have been conducted globally including in China and the United States.

Treatment 40

Treatment Clinical Trials Biosimilars Pharmaceutical Companies 40

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.

Biosimilars 40

Biosimilars FDA Production Treatment 40

FDA Law Blog: Biosimilars

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

Hospitals 59

Hospitals Nurses Compliance Pharmacy 59

Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

Science 40

Science FDA Biosimilars Production 40

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

FDA 64

FDA Regulations Science Marketing 64

The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.

FDA 40

FDA Clinical Trials Trials Treatment 40

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

FDA 69

FDA Laboratories Regulations Production 69

FDA Law Blog: Biosimilars

JULY 25, 2023

The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans. According to several studies, nitrosamines are a potentially potent carcinogen, depending on the length and depth of exposure. What is FDA doing about NDRSIs?

FDA 52

FDA International Regulations Production 52

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch passed away in April 2022), but Eli Mazour’s Clause8 podcast from October 2018 already covered that ground: see Henry Waxman – The Hatch-Waxman Act and a Life In Congress. So what should we do here on the FDA Law Blog to celebrate the 40th anniversary of Hatch-Waxman? We thought about an interview with Rep. Waxman (sadly, Sen.

FDA 59

FDA Drugs International Pharmaceuticals 59

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. 2018; 9: 1595. 2018; 10 (1): 34–45. 2018; 3: 60-9. The significant exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microliter support the U.S. Front Immunol. N Engl J Med.

Trials 52

Trials Production Clinical Trials Government 52

Agency IQ

JUNE 29, 2023

The notice specifically made mention of a 2018 draft guidance document, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, and noted that “it is not fully understood how consumers will interpret specific quantitative claims.”

FDA 40

FDA Drugs Regulations Production 40

Agency IQ

MARCH 1, 2024

history was in 2018-2019, totaling 35 days. It’s worth noting here that according to one drug sponsor , their application submitted “the day before the shutdown started” in 2018 was not able to be reviewed during the “lapse” period, meaning there is some sort of pre-shutdown deadline. What are the impacts for regulated industry?

Government 40

Government FDA Biosimilars Regulations 40

The Pharma Data

APRIL 7, 2023

In 2018, the FDA approved BRAFTOVI + MEKTOVI in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, CRC, and NSCLC.

FDA 40

FDA FDA Approval Small Molecule Drugs 40

The Pharma Data

APRIL 11, 2021

Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g., NHL is the most common hematologic malignancy and the tenth most common cancer worldwide, with about 510,000 new cases diagnosed in 2018. It accounts for about 250,000 deaths per year worldwide.

Treatment 52

Treatment Therapies Trials Disease 52

FDA Law Blog: Biosimilars

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. Here’s a breakdown of some of the more interesting highlights, statistics and graphics from the FY 2022 report.

FDA 52

FDA Licensing Licensing Laboratories 52

FDA Law Blog: Biosimilars

AUGUST 12, 2024

In February 2018, however, FDA issued a PTE decision determining that the testing phase for a NADA starts only once a Notice of Claimed Investigational Exemption (“NCIE”)—a written notification to FDA under an INAD of the sponsor’s intent to ship an investigational new animal drug—has been submitted.

FDA 59

FDA Regulations FDA Approval Drugs 59

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

Treatment 52

Treatment FDA Trials Disease 52

The Pharma Data

JULY 8, 2021

“By combining the expertise of the healthcare industry and the non-profit research community, we can carefully assess how biomedical data at this unprecedented scale is best utilized and hopefully accelerate the path from genetic discoveries towards novel therapeutics.”.

Disease 52

Disease Clinical Trials Government Research 52

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. 2018; 9: 1595. 2018; 141 (1): 110-116. Minimal clinically important difference for asthma endpoints: an expert consensus report.

Trials 40

Trials Production Clinical Trials Therapies 40

The Pharma Data

MAY 15, 2023

Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Prior to that, he worked in multiple executive business and finance roles for Philips and KPMG.

Science 40

Science Doctors Government Pharmaceuticals 40

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 As demonstrated by the statistics over the past five years (Table 2), the average number of Total Days (FDA Days + Industry Days) ranged from 127 to 159 calendar days. Average Number of Industry Days to MDUFA IV Decision 54.69

FDA 75

FDA Packaging Laboratories Engineering 75

The Pharma Data

DECEMBER 27, 2020

Following changes to our leadership team in late 2018 and early 2019, we have sought to transform Lineage into the preeminent allogeneic cell transplant company. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

Therapies 40

Therapies Clinical Trials Production Treatment 40

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

2018) , Arnold Partnership v. The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. Rogan , 246 F. 2d 460 (E.D. 2003) , and Biogen lnt’l v. Banner Life Sciences LLC, 956 F.3d 3d 1351 (Fed.

FDA Approval 59

FDA Approval FDA Production Therapies 59

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The FDA action converts the 2018 accelerated approval to full approval. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

Production 52

Production Clinical Trials International Small Molecule 52

The Pharma Data

FEBRUARY 8, 2021

price, patients switching to Toujeo ® and biosimilar glargine competition. to €189 million) reflecting recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition in several European countries. Full-year 2020 franchise sales were down 4.8%

Vaccine 52

Vaccine Production FDA Therapies 52