Biopharma Lawsuit Tracker 2023: Alexion-Portola, Liquidia, and Others Under Scrutiny

 Between the hotly debated Inflation Reduction Act, tightening Federal Trade Commission regulation and ongoing patent battles, biopharma legal news is abundant.

Here, we debut our new, exclusive Biopharma Lawsuit Tracker. Follow along as we keep you up to date on who’s headed to court and why, and let BioSpace be your news source for industry lawsuits through 2023. 

June

June 30:

• Following a lawsuit filed by the FTC in May aiming to block a multi-billion-dollar merger between Amgen and Horizon, the companies have filed a counter suit against the FTC claiming the original suit is unconstitutional, Law360 reported on June 30. “The FTC’s case is wholly novel and impossibly speculative,” the companies wrote, according to Endpoints News.

June 29:

• Alexion-Portola faced Securities and Exchange Commission (SEC) insider trading charges against a pharmaceutical executive, doctors and individuals involved in an alleged scheme surrounding the deal, as reported by several outlets. According to the SEC, Joseph Dupont, a former vice president at Alexion and member of the company's acquisitions team, is accused of initiating the tip-off. The charges, filed in the U.S. District Court for the Southern District of New York, assert that Dupont knowingly or recklessly shared confidential information about the acquisition with his close friends, who then passed it along to other associates.

• Liquidia intends to defend itself against a potential new patent related to United Therapeutics' treprostinil for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD) in response to an SEC filing. The two companies have been locked in an ongoing legal dispute over the drug. Liquidia stated in its SEC filing that United Therapeutics had received a notice of allowance for its patent application, which broadly covers the treatment of PH-ILD using an inhaled form of treprostinil. This notice indicates that the U.S. Patent and Trademark Office has determined that United Therapeutics is entitled to the patent.

June 23:

• The Amgen-Horizon deal saw more scrutiny as six states joined the FTC in requesting the District Court of the Northern District of Illinois grant a preliminary injunction against the acquisition. This injunction would remain in effect while the FTC prepares an administrative complaint and until decisions are made regarding the complaint.

June 21:

• PhRMA, Merck and Bristol-Myers Squibb have jointly filed a lawsuit against the federal government concerning the price-setting provisions outlined in the IRA. The lobbying group and the two pharmaceutical companies have come together in their legal action, claiming that the legislation violates the U.S. Constitution.
• Novo Nordisk initiated lawsuits against medical spas, wellness and weight loss clinics and pharmacies. The lawsuits allege that these establishments have been advertising and selling products containing semaglutide, the active ingredient found in Novo Nordisk's diabetes medications Ozempic and Rybelsus, as well as the weight loss injection Wegovy.

June 20:

• Sanofi announced that an arbitration tribunal from the International Chamber of Commerce had dismissed a claim made by Boehringer Ingelheim. The claim was related to legal responsibilities associated with the ranitidine-based product Zantac.
• BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 countries.

June 19:

• Bristol Myers Squibb (BMS) filed a lawsuit against the Biden administration. The lawsuit contends that an upcoming Medicare drug negotiation program via the IRA infringes upon the First and Fifth Amendments of the U.S. Constitution.

June 15:

• AbbVie initiated a lawsuit alleging patent infringement by China-based BeiGene regarding their new blood cancer drug, Brukinsa (zanubrutinib). The lawsuit claims that Brukinsa infringes on AbbVie’s patent for Imbruvica (ibrutinib), a drug developed in collaboration with Janssen and AbbVie’s Pharmacyclics. Imbruvica received FDA approval in 2014 as a therapy for chronic lymphocytic leukemia.

June 12:

• The U.S. Chamber of Commerce has filed a lawsuit in federal court against the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). The lawsuit challenges the constitutionality of the drug price negotiation program outlined in the IRA.

June 9:

• Pharmacies and drug manufacturers Allergan and Teva Pharmaceuticals, along with retail chains CVS, Walgreens, and Walmart,have agreed to pay state and local governments an additional $18.75 billion to resolve lawsuits accusing them of fueling the opioid epidemic.

• After a two-month trial, Walgreens agreed to pay $500 million settlement to the state of New Mexico for failing to recognize abuse of opioid prescriptions.

June 8:

• Eli Lilly and Takeda were hit with a class action suit accusing the pharmaceutical companies of racketeering, certified by a California Federal Judge. The allegations stem from the companies' purported failure to disclose the risk of bladder cancer associated with their diabetes drug, Actos (pioglitazone), during its marketing.

June 7:

• Promosome filed individual lawsuits against Moderna and Pfizer. The lawsuits allege that both companies infringed upon patent protections associated with mRNA technology. In the filings presented to the Southern District Court of California, Promosome asserted that its affiliated scientists made a breakthrough in 2009. They reportedly discovered a method for enhancing protein expression by making minor modifications to mRNA. This is the latest in a growing number of patent suits over the COVID mRNA vaccines.

June 6:

• Merck initiated a lawsuit against the Biden administration in the U.S. District Court for the District of Columbia. The lawsuit challenges the IRA’s constitutionality, encompassing provisions related to drug price negotiation.

https://www.biospace.com/article/biospace-lawsuit-tracker-2023-alexion-portola-liquidia-and-others-under-scrutiny/

How To Create a Fake News Cycle

 Despite the best efforts of the mainstream media to pillory him as an anti-vaccine conspiracy theorist, Robert F. Kennedy Jr. is having a moment. A recent poll from CNN of all places showed him earning 20% of Democratic primary voters – and that was before his Joe Rogan interview and shirtless push-up video went viral. Kennedy’s support only confirms the titanic loss of trust between voters and mainstream media.

Except for those in the business, few people understand the inner workings of the media world. As a doctor and lifelong Democratic voter who pulled the lever for Biden in 2020, I had no clue. Prior to COVID-19, I trusted that what I was reading represented the truth. My experience running the Front Line COVID-19 Critical Care Alliance (FLCCC) quickly disabused me of that idea.

The first wave hit in December 2020, when I testified in the Senate that corticosteroids were saving my COVID patients’ lives. My recommendations weren’t just ignored – they were attacked, and I was personally ridiculed as a fraud and Trump puppet. My life and career were upended. I felt forced to resign my faculty position. It was cold comfort when a few months later, a large study confirmed my testimony and government agencies added steroids to the standard of care for COVID patients.

I struggled to make sense of it through much of 2021. The Biden administration and the mainstream media single-mindedly pushed untested vaccines even as the FLCCC accumulated more and more evidence that cheap, generic medicines could stop COVID. As I detailed in my new book, “The War on Ivermectin,” simply presenting evidence that doctors were using the medicine to treat and prevent COVID around the world was a dog whistle for the mob.

After this crash course in media manipulation, I was much savvier and learned to spot the tactics. When in September 2021 Rachel Maddow tweeted a local news story to her 10 million followers about Oklahoma hospitals being overrun with ivermectin overdoses, I knew it was fake news.  

The report quoted a doctor claiming that patients overdosing on ivermectin were backing up rural hospitals. Supposedly people coming to the ER with serious injuries – even gunshot wounds – could not access care. The story was laundered through countless media outlets and blue checks, who were already skeptical of ivermectin because of its association with Trump and his supporters. In their eyes, a bunch of MAGA lunatics overdosing on “horse de-wormer” were killing grandma.

Six days later, the hospital where the doctor worked confirmed that the story was a total fabrication. There were no ivermectin overdoses – none – and the doctor hadn’t worked at the hospital in more than two months.

This was easily the sloppiest and most brazen hit job the media pulled during the pandemic. But Rolling Stone’s coverage took the cakes. The outlet used a photo portraying people lined up outside wearing winter clothes – wrong season. As the saying goes, “A lie is halfway round the world before the truth has got its boots on.” To this day, Rolling Stone still hasn’t taken the story down. It simply changed the headline and slapped on a disclaimer.

The whole debacle presents a neat lesson in how to create a fake news cycle. It goes like this.

Step one: Identify a public tool, such as poison control centers, that are easy to manipulate. These organizations have a public hotline and email address that anyone can use to report a problem. The reports are logged as “adverse events,” but they are not easily confirmed and typically will be tabulated for public records whether or not they have been verified. This is exactly what happened with the Oklahoma story. The local poison control center was deluged with fake calls from people claiming they overdosed on ivermectin.

Step two: Deploy “independent,” seemingly credible voices to validate and embellish the false claims. Doctors are among the most trusted professionals, but having a medical degree doesn’t make you an honest broker. Many doctors struggle to earn a living practicing medicine, and sadly some – like the Oklahoma ER doc – will stoop to industry or political hit jobs if it pays the bills. And doctors willing to go on the record expressing concern about a health scare – ivermectin overdoses – are all a reporter needs for a juicy scoop.

Step three: Coordinate with institutional allies to add legitimacy – FDA, American Medical Association, and GAVI (The Vaccine Alliance) – to add credibility and fan the flames with outraged public statements and targeted ad buys. Reporters can pose questions to their representatives at televised briefings, which carried more significance during the pandemic.

Finally, step four: Activate the echo chamber in mainstream and social media. Twitter influencers who live and play in the Acela corridor can talk to each other in the green rooms of cable news studios and glitzy Beltway gatherings. They can pat each other on the back for exposing the crazies and conspiracy theorists.

The pharmaceutical company didn’t invent this playbook, though it used it effectively to wage war on ivermectin and rake in more than $30 billion dollars from COVID vaccines. Tobacco, energy, chemicals, and other industries have deployed these same tactics to neutralize competition and preserve market control.

Big business has been gaming the system for a long time, but the rise of social media has turned once respected media institutions into clickbait machines easily manipulated by industry. With Americans locked in their homes and constantly primed to accuse each other of killing grandma, the pandemic rapidly accelerated this trend and gave pharma – and its media allies – strong motive and ample opportunity. 

From masks and lockdowns to vaccines and remote learning: Time and again, solutions touted by the media oversold and underdelivered. We may never know how many lives were lost because of the tactics used to suppress ivermectin, but we know we can’t trust the media. That explains RFK Jr.’s rise – and it’s why I wouldn’t bet against him.

Pierre Kory, M.D., is president and chief medical officer of the Front Line COVID-19 Critical Care Alliance and author of "The War on Ivermectin: The Medicine that Saved Millions and Could Have Ended the Pandemic."

https://www.realclearpolitics.com/articles/2023/07/05/how_to_create_a_fake_news_cycle_149447.html

MAGA Declaration of Independence: Taking on the ‘woke’ partisan mob

 When in the course of human events, a “woke” partisan mob, in collaboration with Wall Street globalists, social media oligarchs, and a propagandist corporate media, seizes the reins of power, it becomes necessary for the people most victimized to throw these rascals out. To this end, we hold these truths to be self-evident:

American taxpayers are entitled to a fair return on the investments they make through tax payments and sound governance. They must not be treated as instruments of a Marxian redistribution of income to advance leftist causes. A country in which only a minority of its citizens pay income taxes is now inviting abuses of the “woke” mob.

The American economy is endowed with abundant natural resources, ample capital, and a superbly skilled workforce, and American citizens are entitled to high productivity, low inflation, rising real wages and prosperous growth. This can be achieved only through substantial investment on U.S. shores, secure domestic supply chains, strategic energy dominance, and fiscal responsibility.

Instead, the “woke” mob has delivered virulent stagflation, falling productivity and real wages, fragile supply chains, offshore production, and a crushing debt burden on future generations.

America’s borders must be secure for safety as well as economic and national security. Open borders such as those being delivered by the “woke” mob increase crime, catalyze drug and child trafficking by unscrupulous cartels, allow the penetration of our interior by enemies ranging from Islamic terrorists to Chinese agent provocateurs, and facilitate the entry of undocumented, illiterate aliens who will unfairly compete with Black and brown Americans for blue-collar jobs while driving down wages.

American citizens have the right to move about freely and choose their own forms of medical care. Instead, the “woke” mob has subjected the citizenry to unwarranted lockdowns and experimental medical injections under the false rubric of “safe and effective vaccines” while denying citizens access to alternative safe and effective therapeutics.

America’s schools must be dedicated to preparing our children for a fiercely competitive global environment with a laser focus on the modern-day version of reading, writing and arithmetic. Instead, the “woke” mob and its teachers union cadres indoctrinate our children while exposing them to pornography, gender dogma and revisionist history.

American voters are entitled to fair elections in which only legal votes are counted. The “woke” mob’s elimination of even the most basic safeguards, such as signature match on ballots, combined with the shadowy use of practices such as illegal drop boxes and ballot harvesting, have made a mockery of what was once the most admired democracy in the world.

American citizens must have the full protection of the rights set forth in the Constitution. In violation of the First Amendment, the “woke” mob’s cancel culture, as enforced by employers, social media oligarchs and the corporate media, abridges free speech and denies the right of the American people to assemble in the digital square.

In violation of the Fourth Amendment, the FBI now regularly violates the rights of people to be secure in their homes. Under White House leadership, the Department of Justice and FBI use raids and coercion to silence American citizens who challenge “woke” dogma. Concerned parents are being unfairly branded as “domestic terrorists” simply for speaking up at school board meetings.

The American judicial system must blindly deliver equal justice under the law. Instead, the “woke” mob has weaponized our law enforcement agencies and courts to deny citizens the right to run for political office while burdening members of the minority party with unwarranted lawsuits, indictments, legal fees, and other such “lawfare” costs.

The U.S. military must focus on combat readiness to best protect this nation. The sons and daughters of America’s working classes asked to protect this country must not be used as cannon fodder in endless wars that position America as the world’s policeman.

Instead, a “woke” Pentagon is more interested in being politically correct than in protecting America from its enemies. After finally ending a seemingly endless war in Afghanistan in the most humiliating and dangerous of ways, the “woke” mob itself is now pushing this nation toward a new endless war in Ukraine, one already draining the American arsenal and making us easier prey for existential threats such as China and Iran.

Whenever any form of government becomes so destructive, it is the duty of each of us in the American nation to alter that government. In today’s America, the next best chance for voters to do so is in the 2024 presidential and congressional elections. On today’s Capitol Hill, the next best chance for a House Republican majority to right these wrongs is right now.

• Peter Navarro served as manufacturing czar and chief China strategist in the Trump White House. This column originally appeared at www.peternavarro.substack.com.

https://www.washingtontimes.com/news/2023/jul/4/maga-declaration-of-independence-taking-on-woke-pa/

Just – Evotec awarded second contract from U.S. DoD under accelerated antibodies program

 

• JUST – EVOTEC BIOLOGICS WILL SUPPORT THE DOD WITH RAPID, COST-EFFICIENT DEVELOPMENT OF SAFE, EFFICACIOUS MABS TARGETING ORTHOPOXVIRUSES
• PROJECT INCLUDES EXISTING ANTIBODY DEVELOPMENT, ANTIBODY DISCOVERY, AND AI-DRIVEN DE NOVO ANTIBODY DESIGN OF THERAPEUTIC CANDIDATES
• EVOTEC WILL PROVIDE PRE-CLINICAL AND CLINICAL TRIAL SERVICES

Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that the U.S. Department of Defense (“DOD”) has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 74 m for the rapid development of monoclonal antibody (“mAb”)-based drug product prototypes targeting orthopoxviruses.

Under the contract, Just – Evotec Biologics will develop drug product prototype(s) from discovery through the execution of Phase I first-in human (“FIH”) clinical trials. Discovery activities will include both discovery of new mAbs using AI-driven de novo antibody design and evaluation of existing mAbs. To enable rapid development, Just – Evotec Biologics will further leverage its technology platform, J.DESIGN, with activities including molecular optimisation, cell line and process development, and culminating in intensified continuous manufacturing at Just – Evotec Biologics’ advanced development and manufacturing facility - J.POD Redmond, WA (USA). In addition, Evotec will leverage its pre-clinical and clinical biologics development capabilities. The rapid, cost-efficient development of mAb product protypes will yield an accelerated supply of safe and efficacious mAb medical countermeasures (“MCMs”) for use against orthopoxviruses.

\https://www.marketscreener.com/quote/stock/EVOTEC-SE-436047/news/Just-ndash-Evotec-Biologics-awarded-second-contract-from-U-S-Department-of-Defense-under-accelera-44266868/

Rikers inmate dies of overdose, DOC staffers facing suspension

 A Rikers Island inmate locked up on burglary charges died of an overdose — and jail staffers are facing discipline following “violations” in their response, corrections officials said Tuesday.

Felix Taveras, 40, complained of pain while being held in Anna M. Kross Correctional Facility around 11:55 p.m. Monday and was taken to the clinic for medical care, a spokesman for the city’s Department of Correction said.

Law enforcement sources said Narcan was administered multiple times.

Taveras was later transported to Elmhurst Hospital, where he died of an overdose just before 1:30 a.m., the agency said.

“Based on preliminary departmental review, procedural violations were discovered and suspensions will be issued,” a spokesman said but did not provide details of the offenses.

Taveras was arrested on March 28 in connection to a burglary on Staten Island and held on $30,000 bail, according to jail and court records.

The DOC spokesman said the death is under investigation and notifications have been made to all appropriate agencies, including Rikers’ federal monitor and the Board of Correction.

The 40-year-old man died late Thursday of an apparent overdose.

Matthew McDermott
The monitor admonished the agency in May for failing to alert the watchdog of multiple dangerous incidents in a timely manner as is required by court orders.

The death marks at least the fourth in-custody death this year, on the heels of a particularly deadly 2022, when 19 inmates died behind bars.

The DOC no longer issues press releases when an inmate dies in custody as part of a significant shift in policy earlier this year, which led to two deaths initially going unreported.

The president of the Correction Officer’s Benevolent Association, Benny Boscio, defended the officers Tuesday, saying they shouldn’t be blamed for “circumstances beyond their control.”

“We are damned if we do, damned if we don’t, while the inmates violate the rules and regulations with impunity,” Boscio added. 

The union did not respond to questions asking what rules were allegedly violated or how many corrections officers potentially face discipline. 

https://nypost.com/2023/07/04/rikers-inmate-dies-of-overdose-doc-staffers-facing-suspension/