The Pharma Data

DECEMBER 13, 2020

Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The biosimilar is a collaboration between Amgen and Allergan, which was formed when Allergan was Watson Pharmaceuticals in December 2011.

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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.

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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.

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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.

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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.

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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).

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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 ).

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FDA Law Blog: Biosimilars

JUNE 23, 2024

This information was widely publicized, and we are aware that industry practice evolved whereby pharmacies would deliver or dispense to practitioner’s office in certain cases including those discussed above. However, two events conspired to undermine this prior guidance.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy, FDA News Release (June 25, 2018). (DEA FDA had not approved an NDA or ANDA for cannabis for any indication in 2016.

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Drug Discovery World

OCTOBER 20, 2022

Similarly, biosimilars are expected to grow. In 2018, for instance, Tohoku University signed a partnership agreement with Phillips Japan, a subsidiary of Dutch multinational Phillips, to conduct joint research in the field of healthcare.

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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.

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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”).

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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.

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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?

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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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”).

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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.

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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.”

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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 ).

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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.”

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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?

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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.

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FDA Law Blog: Biosimilars

SEPTEMBER 24, 2023

The nearly $7 billion window covering industry was well aware of the dangers of dangling cords and put industry standards in place in 2018 and updated them in 2022. Circuit Court of Appeals described in a recent opinion as an “aggressive timeline for industry compliance.” However, as the D.C.

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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.

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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]

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FDA Law Blog: Biosimilars

MARCH 14, 2023

Attorney General Jeff Sessions rescinded the Cole Memorandum and all prior DOJ guidance on marijuana enforcement in January 2018.) Cole, Deputy Attorney General, Memorandum for All United States Attorneys (Aug. 29, 2013), 3.

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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.

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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.

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FDA Law Blog: Biosimilars

JUNE 19, 2023

Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here ). Whether we will actually see a proposed rule in August is more than a little uncertain, however.

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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.

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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.

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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.

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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.

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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.”.

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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.

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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.

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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.

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