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Life Sciences
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April 03, 2024
Genmab Builds Oncology Portfolio With $1.8B Deal
Danish biotechnology company Genmab announced Wednesday that it would acquire private cancer drugmaker ProfoundBio for $1.8 billion in cash, a move set to beef up Genmab's oncology portfolio and position the company as a competitor to other biotech companies that have made similar deals in the antibody drug conjugate space in recent months.
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April 03, 2024
McDermott Adds Ex-Baker McKenzie Tax Pro In Chicago
The former chair of Baker McKenzie's Chicago tax practice group has joined McDermott Will & Emery LLP and will work as a partner in the firm's Chicago office, McDermott said Wednesday.
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April 03, 2024
Hospital Workers' Vax Free Speech Suit Falls Flat At 6th Circ.
The Sixth Circuit backed the dismissal of two workers' claims that a children's hospital violated their constitutional rights when it rejected their religious objections to a COVID-19 vaccine mandate, saying Wednesday they failed to show the hospital was a government actor.
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April 03, 2024
Pharma Exec, Cousin Cop To Insider Trading On Kodak Loan
A pharmaceutical company's executive and his cousin on Wednesday pled guilty to trading on information they acquired through the company's partnership with Eastman Kodak Co. about a government loan the photography giant was set to receive during the COVID-19 pandemic.
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April 02, 2024
Alaska Judge Tosses Opioid Nuisance Case Against Pharmacies
Retail pharmacies including Walgreens Co. and Walmart Inc. have escaped a suit brought by Alaska in state court over their role in the opioid epidemic after a judge found the state's public nuisance claims were a "bridge too far."
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April 02, 2024
9th Circ. To Hear Ex-Theranos Execs' Criminal Appeals In June
The Ninth Circuit has set oral arguments in former Theranos CEO Elizabeth Holmes' high-stakes appeal of her criminal securities fraud conviction and 11-year prison sentence for June 11 — the same day the panel is scheduled to hear arguments in convicted ex-Theranos executive Ramesh "Sunny" Balwani's appeal.
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April 02, 2024
Lupin Scores Win In Rosacea Patent Fight With Galderma
A judge has found that Galderma failed on its allegations that Lupin infringed a pair of its patents that cover a rosacea drug, saying "Galderma has a theory but no proof."
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April 02, 2024
Theseus Investor Seeks Appraisal After Concentra Merger
A fund invested in clinical-stage biopharmaceutical company Theseus Pharmaceuticals Inc. has petitioned Delaware's Court of Chancery for an appraisal of the investor's 250,000 shares following Theseus' $4.05 per-share consolidation in February with Concentra Biosciences LLC.
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April 02, 2024
Teva Has Remedy For Generic EpiPen Takings, Colo. Says
Colorado's attorney general urged the Tenth Circuit to toss a Teva Pharmaceuticals lawsuit challenging a state epinephrine auto-injector affordability program, arguing in an opening brief that the company already has an avenue to get compensation for the alleged taking of its property.
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April 02, 2024
Fed. Circ. Seems Ready To Revive Amarin's Skinny Label Suit
A Federal Circuit panel seemed wary Tuesday of a Delaware federal judge's decision to throw out Amarin Pharma Inc.'s infringement suit over Hikma Pharmaceuticals USA Inc.'s limited-use version of the blockbuster cardiovascular drug Vascepa, suggesting the district court may have been too hasty.
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April 02, 2024
Mich. Warns PFAS Ruling Could Fuel More Agency Challenges
Michigan has warned the state's high court that an appellate decision invalidating PFAS drinking water limits could pave the way for future litigants to attack state regulations by pointing to imperfect cost estimates, urging the court to revive the PFAS rules.
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April 02, 2024
NM Medical Cannabis Insurance Row To Stay In Federal Court
The federal court is the proper place for a proposed class action seeking to make Blue Cross and Blue Shield and other insurers cover medical cannabis, a New Mexico federal judge has ruled, rejecting objections by patients who said the state's high court will eventually need to get involved.
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April 02, 2024
Daiichi Gets Award Nixing Seagen Cancer Drug Claims OK'd
A Washington federal judge has refused to revive U.S. biotech company Seagen Inc.'s claims seeking billions of dollars in damages in a dispute with Japanese drugmaker Daiichi Sankyo Co. Ltd. over cancer drug patents, ruling that an arbitrator who tossed the claims did not disregard the law.
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April 02, 2024
McCarter & English's Client Contract Win Heads To Mediation
The law firm McCarter & English LLP will hold settlement talks in June with an ex-client who has already lost a jury trial over $2 million in unpaid legal bills and potentially faces $3.6 million in punitive damages after an anticipated decision by Connecticut's highest court, a federal magistrate judge ruled Tuesday.
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April 02, 2024
Feds Seek Leniency For UK Billionaire Lewis In Trading Case
Prosecutors have told a Manhattan federal judge that 87-year-old British billionaire Joe Lewis should serve less than 18 months in prison after he pled guilty to insider trading, citing his age and health and arguing he "has otherwise lived a law-abiding life."
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April 02, 2024
Acorda Therapeutics Hits Ch. 11, Plans $185M Drug Sale
Neurological disorders drugmaker Acorda Therapeutics Inc. filed for Chapter 11 protection in New York bankruptcy court, with plans to sell its assets to another pharmaceutical company for $185 million.
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April 01, 2024
Inotiv Can't Toss Investor Suit Over Feds' 'Puppy Mill' Probe
Medical research services provider Inotiv Inc. must face a proposed investor class action accusing it of failing to disclose that subsidiaries it acquired had come under investigations by the U.S. Department of Justice for animal welfare and smuggling violations, an Indiana federal judge ruled while lamenting the "appalling" mistreatment of beagles that investigators had found.
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April 01, 2024
Pharma Co. Beats Investor Suit Over Wrinkle Drug Approval
A California federal judge has dismissed a lawsuit from the investors of Revance Therapeutics Inc. accusing it and several executives of concealing quality control concerns that eventually led the U.S. Food and Drug Administration to deny the company a license for its wrinkle injectable, saying the defendants may not have known the approval timeline they presented was unattainable.
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April 01, 2024
Apple, Intel Again Lose Fintiv APA Challenge In Calif. Court
A California federal judge on Sunday ended Big Tech's coordinated challenge to Patent Trial and Appeal Board precedent that allows its judges to discretionarily deny patent reviews based on how proposed reviews overlap with related litigation in other forums.
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April 01, 2024
Optical Co. Beats Investor Suit Over Pandemic Staffing Levels
A Georgia federal judge has permanently tossed an investor suit accusing National Vision of failing to disclose issues with its staffing levels during the pandemic, saying the investors did not adequately plead that any of the challenged statements allegedly made by the optical company were false or misleading.
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April 01, 2024
'Unreliable' Theory Dooms City's Acthar Antitrust Cert. Bid
The city of Rockford has presented "unreliable" damages evidence that cannot warrant giving class treatment to its claim that pharmacy benefits manager Express Scripts engaged in a scheme to fix prices for the seizure medication Acthar, an Illinois federal judge has said.
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April 01, 2024
Fed. Circ. Revives Challenges To J&J Schizophrenia Drug
A Federal Circuit panel on Monday gave generics-makers Teva Pharmaceuticals USA Inc. and Viatris Inc. a new chance to prove that a patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna is invalid, saying a lower court used an "erroneously rigid" analysis when rejecting their challenge.
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April 01, 2024
Catching Up With Delaware's Chancery Court
Last week, Delaware's Court of Chancery saw a $42.5 million settlement, dismissal of two big suits with two more remanded back, and new cases from shareholders of Walt Disney, Donald Trump's Truth Social, Rivian Automotive and BarkBox.
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April 01, 2024
Ex-Pharma Co. Exec Denies Signing Noncompete Deal
The former director of government sales for a pharmaceutical company asked the North Carolina Business Court on Friday to knock out a breach of contract claim in a lawsuit that alleges he took trade secrets to a competitor, arguing the company has no valid noncompete agreement to back it up.
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April 01, 2024
J&J Opted To 'Deny' Talc-Cancer Link, Jury Told
Johnson & Johnson opted to "deny, deny, deny" evidence linking its baby powder to ovarian cancer and continued to market it as safe to use, an attorney for the widower of a longtime baby powder user who died from cancer told jurors in Sarasota, Florida, on Monday.
Expert Analysis
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Series
ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.
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Trending At The PTAB: Administrative Procedure
A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.
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Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits
Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.
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ITC Ban On Apple Watch Could Still Be Reversed
The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.
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Incontinence Drug Ruling Offers Key Patent Drafting Lessons
In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.