FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity.

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The Pharma Data

APRIL 6, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

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The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. Research for the guide was based on 1,000s of interviews and surveys completed by law firm partners active in the market.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

MAY 18, 2021

By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

In an interview with the Blog , FDLI wants to recognize the efforts of Chris Perkins, Gabe Lindman and Emma Dardis of Washington, DC-based marketing agency Model B, for their amazing work. Plus, the burgundy was kicked up a notch to a cherry red.

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The Pharma Data

OCTOBER 27, 2020

Commenting on his appointment, Parag Agarwal said, “Dr Reddy’s is driven by its purpose, high governance standards, a robust strategy and strong leadership. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . With AMSP, countries don’t have to search the market for supplies.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. Men in Black from the PTO’s PTE branch might have gotten to us. Lehman , No. 95-650-A (E.D.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

In other words, a violative manufacturer not only pays penalties, but is also compelled to continue marketing the drug in Minnesota (at a reduced price). For now, we will continue to monitor the law, its future implementing regulations, and any legal challenges as they develop.

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The Pharma Data

MAY 15, 2023

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022. Gallen (HSG), Switzerland.

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The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

SEPTEMBER 17, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

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The Pharma Data

JANUARY 26, 2021

Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. This extension does not include potential pediatric exclusivity. 2,3 In the U.S.,

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the FDA has appropriated funding through January 19.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Accordingly, make sure your CRO fosters the use of data so that you’re poised for market access early in the game.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The CMS regulation (unlike the statute) would expansively define a “misclassification” to include, not only misclassifying the drug category (e.g.,

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The Pharma Data

SEPTEMBER 16, 2020

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

SEPTEMBER 20, 2020

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen will record sales in the U.S.

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The Pharma Data

JULY 8, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. The organisation has over 150 dedicated members of staff, based in multiple locations across the UK. Source link: [link].

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The Pharma Data

DECEMBER 21, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen will record sales in the U.S.

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The Pharma Data

OCTOBER 29, 2020

Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. Marketable securities. Received U.S. Germany & Japan. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences.

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