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Life Sciences
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August 30, 2024
Fall IPO Pickup Could Be A Prelude For 2025 Recovery
More companies are preparing to go public after Labor Day, signaling a modest increase in initial public offerings that capital markets advisers say could presage a stronger recovery in 2025, assuming next year brings more clarity regarding interest-rate policy and the result of the presidential election.
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August 29, 2024
Pa. Justices To Examine Axing Of 'Red Book' Drug Pricing
The Supreme Court of Pennsylvania has agreed to review a decision tossing the "Red Book" pricing values used by the state's Bureau of Workers' Compensation to calculate reimbursement for prescription drug costs.
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August 29, 2024
Jury Clears Ore. Hospital That Implanted FDA-Flagged Mesh
A state jury cleared an Oregon hospital system and a surgeon of liability Wednesday over a patient's claims that prolapse mesh was implanted almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 29, 2024
Lannett Says Areva Reneged On Cancer-Drug Deal After Ch. 11
Lannett Pharmaceuticals hit generic-drug maker Areva Pharmaceuticals with a contract suit in Delaware's Court of Chancery on Thursday, accusing Areva of breaching their 2022 agreement that gave Lannett exclusive rights to distribute Areva's injectable anticancer drug after Lannett emerged from a prepackaged Chapter 11 bankruptcy.
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Seattle Biotech Can't Immediately Force Out LA Times Owner
Billionaire and Los Angeles Times owner Dr. Patrick Soon-Shiong will not be forced to recuse himself from a Seattle-based biotech research institute board while the nonprofit's breach-of-fiduciary duty lawsuit against him is pending, a Washington federal judge said on Thursday.
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Nektar Can't Get Docs It Says Show Lilly As 'Thieves, Liars'
A California federal judge Thursday rejected Nektar Therapeutics' request for internal Eli Lilly documents related to separate litigation as Nektar pursues allegations Eli Lilly ruined prospects for a drug the companies were developing together despite Nektar's counsel saying it would "expose Lilly for being thieves, liars."
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Jazz Hits Teva With Patent Suit Over Narcolepsy Drug
Teva Pharmaceuticals Inc. is infringing a patent for the narcolepsy drug Xywav, Jazz Pharmaceuticals Inc. said in a complaint filed in New Jersey federal court.
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August 28, 2024
Merck Must Face Class Claims In Vaccine Antitrust Suit
Merck cannot strike class claims in antitrust litigation over its rotavirus vaccine, a Pennsylvania federal judge ruled Wednesday, while also allowing the city of Baltimore to eliminate redundancies in its complaint.
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August 28, 2024
CyDex Says Bexson Breached Deal By Misusing Pharma IP
CyDex Pharmaceuticals hit Bexson Biomedical with a contract breach suit in Delaware Chancery Court accusing it of misusing a CyDex-designed molecule to develop unauthorized non-ketamine formulations, and subsequently filing a patent for those formulations, in violation of the parties' agreement.
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August 28, 2024
J&J Spinoff Beats Suit Over Tylenol 'Rapid Release' Labels
A New York federal judge tossed Tuesday a proposed class action accusing a Johnson & Johnson spinoff of misleading consumers by falsely claiming Tylenol's "Rapid Release" gelcaps relieved pain faster than alternative acetaminophen pills, finding the consumer's state claims are preempted by federal regulations.
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August 28, 2024
Lipitor Buyers Seek Final OK For $35M Deal In Antitrust Fight
End-payor plaintiffs asked a New Jersey federal judge Tuesday to give final approval of a $35 million settlement resolving their antitrust claims against Pfizer over the cholesterol medication Lipitor.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Calif. Couples Drop FujiFilm Suit Over Destroyed Embryos
California couples who sued a manufacturer of oil used in the in vitro fertilization process claiming the product killed their embryos are looking to drop their federal suit.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
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August 28, 2024
High Court Told Tyvaso Row Petition Based On 'False' Premise
A small pharmaceutical startup behind a drug that would compete with the blockbuster high blood pressure treatment Tyvaso says United Therapeutics is making a "fundamentally false" argument to the U.S. Supreme Court about why an appeals court rejected United Therapeutics' case.
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August 28, 2024
Regeneron Sues Sandoz Over Dozens Of Eye Drug Patents
Regeneron Pharmaceuticals Inc. has taken competing biomedical company Sandoz Inc. to New Jersey federal court with an extensive complaint asserting 46 patents and claiming Sandoz infringed them all with a biosimilar alternative to Regeneron's Eylea brand ophthalmic disorder drug.
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August 28, 2024
Biotech Biz Hid Risks Of Gene-Editing Trial, Investor Claims
Biotechnology firm Verve Therapeutics was hit with a proposed class suit alleging it misled investors about the risks associated with a clinical trial of an experimental gene-editing drug that was halted and caused the company's stock to tumble.
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August 27, 2024
Cherokee Nation's Opioid Suit Sent Back To State Court
An Oklahoma federal judge has adopted a magistrate judge's recommendation to send a Cherokee Nation opioid lawsuit against pharmaceuticals distributor Morris & Dickson back to state court, agreeing that the negligence case isn't predicated on a duty arising out of the federal Controlled Substances Act.
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August 27, 2024
USPTO Sued For Rejecting Blood Pressure Drug Patent
A small drug developer has hit the U.S. Patent and Trademark Office with a second lawsuit in Virginia federal court over the agency's latest rejection of the company's efforts to patent a different dosage of a drug the company markets to treat low blood pressure.
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August 27, 2024
NY Pension Funds Join Illumina Deal Suit Pile-On In Del.
New York state's retirement system and fund have added a new derivative suit to widening stockholder litigation over Illumina Inc.'s $8 billion reacquisition of cancer testing company Grail Inc. despite European Commission regulatory agency opposition.
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August 27, 2024
Fed. Circ. Won't Speed Up Apple Watch Ban Appeal
The Federal Circuit on Tuesday denied Apple Inc.'s request to expedite oral arguments in its appeal challenging the U.S. International Trade Commission's decision banning the tech giant from selling Apple Watches with a "blood oxygen" feature in the Masimo patent case.
Expert Analysis
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Firms Must Rethink How They Train New Lawyers In AI Age
As law firms begin to use generative artificial intelligence to complete lower-level legal tasks, they’ll need to consider new ways to train summer associates and early-career attorneys, keeping in mind the five stages of skill acquisition, says Liisa Thomas at Sheppard Mullin.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Tracking China's Push To Invalidate Foreign Patents
China’s increasing use of courts and administrative panels to nullify patents in strategically important industries, such as technology, pharmaceuticals and rare-earth minerals, raises serious concerns about the intellectual property rights of foreign businesses operating there, say Rajat Rana and Manuel Valderrama at Selendy Gay.
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Takeaways From Nat'l Security Division's Historic Declination
The Justice Department National Security Division's recent decision not to prosecute a biochemical company for an employee's export control violation marks its first declination under a new corporate enforcement policy, sending a clear message to companies that self-disclosure of misconduct may confer material benefits, say attorneys at Perkins Coie.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.