FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

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STAT

JANUARY 8, 2024

Cure Ventures , a Boston-based venture capital firm founded in 2021 by a trio of veteran biotech investors, has brought in two former executives from Sage Therapeutics to prepare them for investing in neuroscience startups. Continue to STAT+ to read the full story…

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pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

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pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

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pharmaphorum

MARCH 1, 2021

In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in France. Compassionate access is for off-label treatments that aren’t in development for an indication. Yet there are still challenges to be worked through in 2021.

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STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

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pharmaphorum

JULY 9, 2021

The updated label for Aduhelm (aducanumab) says it should only be used in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, according to an update from the drug’s developers. Katie Porter (@RepKatiePorter) July 6, 2021. Now, it has backtracked on that decision.

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pharmaphorum

JANUARY 14, 2021

This has, of course, been more recently challenged in Europe by second wave infections and new lockdowns, but this masks more fundamental and as yet unresolved challenges for 2021’s commercial model, which could be defined by environment divergence and the need to achieve impact. From 2021 onwards, this will change. Pharma pivots East.

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Eye on FDA

JULY 19, 2021

But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. Of the 153, only 33 of them were translated into Spanish.

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Safe Biologics

DECEMBER 19, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.

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Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

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Pharmaceutical Technology

MAY 12, 2023

According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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pharmaphorum

NOVEMBER 19, 2020

Earlier this year Gilead added a lenacapavir arm to its planned prevention study in women at risk of HIV – which is being carried out to expand the label for Descovy after it was approved with a narrower PrEP indication than Truvada last year. billion and $3 billion of Gilead’s HIV sales last year.

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Labelling 86

STAT

OCTOBER 4, 2023

Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. The treatment, which is called Lumakras and made by Amgen, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. Now, Amgen needs to prove it works.

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Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. Consultation on the draft guidance document is open until May 7, 2021. Consultation on the draft guidance document is open until May 7, 2021. Background and scope.

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pharmaphorum

JANUARY 12, 2021

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

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Eye on FDA

JANUARY 9, 2022

In that respect, 2021 was not a banner year. One of them involved the more serious Warning Letter action, possibly because the product associated with that communication had a Boxed Warning in its label. The Numbers: Looking first at the quantity of enforcement, the numbers were low.

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European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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Pharmaceutical Technology

JANUARY 23, 2023

However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021.

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Express Pharma

NOVEMBER 8, 2023

Due to their novel mechanisms of action, and positive efficacy and safety profiles, these therapies are expected to improve treatment rates and drive growth within the class II-V MG market*, especially within the treatment refractory segment, in which patients fail to respond to two or more off-label treatments.

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European Pharmaceutical Review

FEBRUARY 8, 2023

Research from data and analytics company GlobalData shows that the use of CD19 chimeric antigen receptor T-cell (CAR-T) agents for blood cancer is set to significantly increase between 2021-2031. GlobalData predicts Bristol-Myers Squibb’s Breyanzi and Gilead’s Yescarta are set to have high annual sales in the forecast period.

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European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

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Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. A 2021 survey of 401 U.S state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. It is also opposed by the majority of physicians, in the U.S.

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pharmaphorum

JULY 1, 2021

The two firms are collaborating to create a unique, end-to-end labeling solution tailored for medical device organizations. Wokingham, United Kingdom — 22 nd June 2021 — Labeling software specialist PRISYM ID has joined the Siemens Digital Industries Software Solution Partner Program.

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Labelling 52

Drug Channels

OCTOBER 3, 2023

CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived! This month, nine biosimilar versions of adalimumab launched in the U.S.

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European Pharmaceutical Review

NOVEMBER 10, 2022

Medicines Discovery Catapult (MDC) released a report 2 on complex medicines in 2021, proposing narrowing the definition to: ‘medicines requiring the application of novel technologies for their delivery and targeting of drugs, through the modification of an active pharmaceutical ingredient (API) or formulation, or a novel delivery route’.

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pharmaphorum

JUNE 22, 2021

Labelling software firm has implemented six new software systems in the last few months in a sign that the market is now rebalancing after the upheavals of the last 12 months. The first few months of 2021 have been extremely busy for us as it is clear that the legacy of COVID-19 has focused people’s minds.

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Express Pharma

JANUARY 4, 2024

The Indian pharma industry is on a solid growth trajectory, surging from $40 billion in 2021 to an estimated $130 billion in 2030, with a steady double-digit CAGR for the next 10 years. In addition to meeting strong domestic demand, the Indian pharmaceutical industry is well poised as a robust contributor to the growing global market.

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pharmaphorum

MAY 10, 2021

Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

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Pharma Marketing Network

APRIL 15, 2021

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.

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pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

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pharmaphorum

JUNE 10, 2021

The latest version of the PRISYM 360 cloud-based labeling solution has achieved certification for the GS1 standards utilized by the medical device and life science industries. GS1 oversees a system of globally recognized open standards for unique identifiers that can be used throughout the supply chain to enhance traceability.

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Pharmaceutical Technology

JULY 20, 2022

While the label expansion will likely increase avenues for patients to access the antiviral, Ganio adds one caveat: due to burnout and turnover seen across the healthcare field, including pharmacy staff, there are going to be sites that just don't have the resources to dedicate a pharmacist to do some of this work.

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European Pharmaceutical Review

JANUARY 18, 2023

In 2021, Peter Kohut, Director of Drug Safety at Arriello shared with EPR how European medical cannabis market lacks a common regulatory framework. “… there is a lack of standardisation in the manufacturing of medical cannabis products , their ingredients and labelling.”.

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pharmaphorum

OCTOBER 14, 2022

It was first approved for five-year contraception back in 2000, and had that extended to seven years in 2021. Now, the label says it “should be removed or replaced after eight years at the latest,” according to Bayer.

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Labelling 59

European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. in November 2021. The primary endpoint assessed in this study was RBC-TI for 12 weeks, with a mean haemoglobin increase ? The company will also discuss results with health authorities.

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Pharmaceutical Business Review

OCTOBER 17, 2023

This single arm, multicentre, open label study evaluated Minjuvi along with lenalidomide in adults with relapsed or refractory DLBCL. Knight also signed a supply and distribution agreement with Incyte in September 2021 for the exclusive distribution of pemigatinib (Pemazyre) and tafasitamab in Latin America.

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