Mylan Archives - Medical Design Sourcing

FDA approves first interchangeable Humira biosimilar to Humira

Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales.

Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar.

First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and plaque psoriasis.

The FDA decided to grant interchangeable status to Cyltezo based on Phase 3 randomized VOLTAIRE-X clinical trial.

FDA allows interchangeable biosimilars to be substituted for the reference product without the prescriber modifying the prescription.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of …

Former top IT person at Mylan pleads guilty to insider trading

A former information technology (IT) executive at Mylan today pleaded guilty to conspiracy to commit securities fraud and aiding in the preparation of a false tax return.

Dayakar Mallu, who at the time of the fraud served as VP of global operations information technology at Mylan, admitted to the charges in court in the Western District of Pennsylvania, according to a U.S. Dept. of Justice news release.

Between 2017 and 2019, Mallu conspired with others to trade the securities of Mylan — the maker of the EpiPen — ahead of corporate announcements concerning drug approvals, financial earnings and a merger. Mallu placed trades in the company’s securities and shared trading profits with his co-conspiratory through cash transactions in India, with the trading resulting in more than $8 million in unrealized profits and losses avoided.

According to the DOJ release, Mallu ultimately realized net profits and losses avoided totaling more than $4.2 million as…

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Kansas Distric Court rules in favor of Mylan in EpiPen class action

Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action.

Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO statute, including claims asserted against former Mylan CEO Heather Bresch.

Get the full story at our sister site, Drug Delivery Business News.

DTW Podcast: CEO Johnson on entrepreneurship, upcoming MedtechColor Pitch Contest; Krum handicaps medtech Q4

In this episode of the DeviceTalks Weekly Podcast, Angelique Johnson, CEO of MEMstim, shares her “accidental entrepreneur” story and how it has enabled her the help others pursuing the same dream. Also, Johnson, co-founder of MedtechColor, an organization seeking to further the advancement of people of color in the medical device industry, details the group’s goals and invites entrepreneurs of color to apply for the group’s Pitch Contest.

The deadline is Feb. 5. Go to medtechcolor.org for more information.

Truist Securities Managing Director Kaila Krum answers questions about medtech’s Q4 performance, diving deeper on Stryker and other companies.

Krum also shares details on a survey conducted by the research team that sought to answer the question – when will hospitals start seeing elective patients again.

Pharma Editor Brian Buntz returns to tell his story of his 10-days wearing a continuous glucose monitor from Dexcom. Buntz wrote about the exp…

DTW Podcast: CEO Johnson on entrepreneurship, upcoming MedtechColor Pitch Contest; Krum handicaps medtech Q4

In this episode of the DeviceTalks Weekly Podcast, Angelique Johnson, CEO of MEMstim, shares her “accidental entrepreneur” story and how it has enabled her the help others pursuing the same dream.

Also, Johnson, co-founder of MedtechColor, an organization seeking to further the advancement of people of color in the medical device industry, details the group’s goals and invites entrepreneurs of color to apply for the group’s Pitch Contest.

The deadline is Feb. 5. Go to medtechcolor.org for more information.

Truist Securities Managing Director Kaila Krum answers questions about medtech’s Q4 performance, diving deeper on Stryker and other companies.

Krum also shares details on a survey conducted by the research team that sought to answer the question – when will hospitals start seeing elective patients again.

Pharma Editor Brian Buntz returns to tell his story of his 10-days wearing a continuous glucose monitor from Dexcom. Buntz wrote …

Mylan must face EpiPen racketeering lawsuit

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device.

Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers (PBMs) —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market. The cases were consolidated in August.

Get the full story on Drug Delivery Business News.

Mylan must face EpiPen racketeering lawsuit

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device.

Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers (PBMs) —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market. The cases were consolidated in August.

Mylan and the PBM defendants filed separate motions to dismiss for failure to state a claim. The PBMs also argued that Rochester Drug and Dakota Drug have not alleged plausible racketeering claims, that the claims are time-barred, and that the claims against the PBMs’ corporate parents should be…

Gilead licenses remdesivir production to 5 generic drugmakers

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

Get the full story on our sister site, MassDevice.

Gilead licenses remdesivir production to 5 generic drugmakers

(Image from Gilead Sciences)

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.

Remdesivir is an intravenous drug that…