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Life Sciences
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September 13, 2024
SEC Fines Zymergen $30M Over Misleading Pre-IPO Claims
Now-shuttered biotechnology company Zymergen Inc. has agreed to pay a $30 million fine to settle U.S. Securities and Exchange Commission allegations that it misled investors in its initial public offering when it used "unsupported hype" about the market potential for its technology for foldable touch screens.
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September 13, 2024
Trio Of BigLaw Mergers Expected To Drive More Deal Talks
After months of a relatively steady pace of law firm mergers and acquisitions, the trio of proposed BigLaw tie-ups announced in recent days will likely spur more firms toward entertaining similar deal talks, experts say. Here, Law360 offers a snapshot of the proposed deals.
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September 13, 2024
Emergent BioSolutions Pays $40M To Settle COVID Vax Suit
Emergent BioSolutions has agreed to pay $40 million to settle a consolidated class action alleging it misled investors about how prepared it was to handle two high-profile deals to manufacture COVID-19 vaccines.
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September 13, 2024
Med Techs Settle Eyelid Cleaner Patent Spat
Two companies specializing in eyelid cleaning technology have reached a deal to settle their dispute in California federal court after the court refused to dismiss the infringement allegations.
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September 13, 2024
2 Life Sciences Cos. Start Trading After Raising $540M Total
Drug developers Bicara Therapeutics Inc. and Zenas BioPharma Inc. have debuted on the Nasdaq stock exchange in separate initial public offerings steered by a trio of law firms.
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September 13, 2024
Makers Of Paragard Say Time Ran Out On Claims In 236 Suits
Teva Pharmaceuticals and The Cooper Cos. pressed an Atlanta federal judge to pare back multidistrict litigation over alleged defects in the Paragard IUD by dismissing untimely claims across 236 complaints.
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September 13, 2024
Ex-DOJ Deputy In TikTok, Twitter Cases Joins Mayer Brown
A former leader of the U.S. Department of Justice's consumer protection arm who helped bring landmark privacy cases against TikTok and Twitter is jumping to Mayer Brown LLP, where he will focus on government investigations and enforcement actions.
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September 13, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen a football agent sue Chelsea FC after being cleared of allegations he threatened the club’s former director, an ongoing patent dispute between Amgen and Regeneron Pharmaceuticals, and a private school in Edinburgh suing Riverstone Insurance over compensation claims tied to historical abuse allegations made by former pupils. Here, Law360 looks at these and other new claims in the U.K.
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September 13, 2024
NHS Scotland Sues Accord, Allergan Over Drug Pricing
Scotland has sued Actavis and Allergan to recover the additional money they allegedly charged for hydrocortisone tablets used to treat a rare autoimmune disorder, the specialist antitrust tribunal said Friday after an appeals court reinstated price-fixing fines against the drugmakers.
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September 13, 2024
Former MilliporeSigma Patent Atty Joins Polsinelli In St. Louis
A patent expert and former in-house attorney with chemical and biotechnology company MilliporeSigma has joined Polsinelli PC's St. Louis office, continuing the law firm's expansion of its life sciences team.
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September 13, 2024
Ropes & Gray Helps Kohlberg Net $4.3B For 10th PE Fund
Kohlberg & Co., advised by Ropes & Gray, said Friday it has clinched its 10th flagship fund after raising $4.3 billion from limited partners, with plans to target investments in companies within areas including pharmaceuticals, healthcare and financial and compliance services.
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September 13, 2024
French Vaccine Maker Valneva Raises €61M In Private Placing
Vaccine manufacturer Valneva SE said Friday that it has successfully raised approximately €61.2 million ($67.9 million) by selling shares to investors, which it plans to use to fund projects.
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September 13, 2024
Alcon Loses European Patent Over Eye Imaging Tech
European officials have stripped Alcon Inc. of its protections over an eye-imaging device, ruling that the company's amended description of the technology's "ray tracing" process unlawfully broadened the patent.
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September 12, 2024
Wilson Sonsini Hires Tax Pro From Slaughter and May
Wilson Sonsini Goodrich & Rosati PC has recruited a tax specialist from Slaughter and May to its office in London to boost its strengths representing U.K. and European technology and life sciences companies that are expanding in the U.S. and globally.
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September 12, 2024
Faegre Drinker Adds White Collar Trio From Greenberg Traurig
Faegre Drinker Biddle & Reath LLP is building out its white collar team with former veteran prosecutors, announcing Wednesday it had added two partners and an associate from Greenberg Traurig LLP who will bolster its San Francisco and Philadelphia offices
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September 12, 2024
Mass Tort Boutique Leader On Sizing Up With Anapol Weiss
Nearly four years after leaving the corporate defense world to launch her own five-attorney plaintiffs' boutique, former Wilkinson Stekloff LLP founding partner Alexandra Walsh says she's looking forward to spending more time in the courtroom as her firm is absorbed by Philadelphia-based mass tort and personal injury firm Anapol Weiss. Here, Law360 Pulse speaks with Walsh about the decision to merge and about her move from the defense to the plaintiffs' bar.
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September 12, 2024
Greenberg Traurig Grows Health Team With Ex-NY Official
A former New York State Department of Health official has moved to the private sector with Greenberg Traurig LLP as the firm expands its healthcare and U.S. Food and Drug Administration practice.
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September 12, 2024
Stites & Harbison Eyes Conn. Office With Patent Team Pickup
Stites & Harbison PLLC is stretching beyond its established offices in the South and Midwest with a planned Connecticut location, thanks to the pickup of three patent attorneys and three patent agents formerly with Cantor Colburn LLP.
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September 12, 2024
Sullivan & Cromwell Guides Springer Nature's German IPO
German-British journal publisher Springer Nature said Thursday that it will aim to raise €200 million ($220 million) as it announced plans for an initial public offering in Frankfurt — what would be the first large European listing in the second half of the year.
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September 12, 2024
Sanofi Sets €320M Licensing Deal With US, French Biotechs
Pharmaceutical giant Sanofi SA said Thursday that it will pay up to €320 million ($353 million) to U.S. biotechnology group RadioMedix Inc. and French medicine developer Orano Med for an exclusive license for a radiation treatment for rare cancers.
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September 12, 2024
Danish Pharma Co. Is Entitled To VAT Reduction
A Danish pharmaceutical company's mandatory payments for value added tax should lower the company's taxable base, the European Court of Justice ruled on Thursday.
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September 11, 2024
Litigation Spending To Rise As Cases Grow More Aggressive
A substantial number of large companies are expecting to increase their litigation spending by double digits next year in the face of more complex and hard-fought cases — and they are more open to bringing in new legal talent to navigate the matters, according to a report released Thursday.
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September 11, 2024
Gender Care Hearing Centers On Ohio Bill Of Rights
Questions about potential conflicts between an Ohio gender care ban and a right to healthcare "freedom" enshrined in the state constitution dominated much of a Wednesday hearing in a state appellate court.
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September 11, 2024
Gov't Spent $236B In Fraud And Improper Payments In 2023
Federal agencies made $236 billion in improper payments in fiscal 2023, a drop of about $11 billion from the prior year, according to a report released Tuesday by the U.S. Government Accountability Office.
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September 11, 2024
Top Calif. Biz Bills Sitting On Gov. Newsom's Desk
Among the hundreds of bills awaiting California Governor Gavin Newsom's signature are a number that would create new guidelines for Golden State employers, healthcare industry players, as well as artificial intelligence labeling, textile recycling and increasing criminal penalties for corporate malfeasance by tens of millions of dollars.
Expert Analysis
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy
The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.
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Opinion
Unclear Intellectual Property Laws Are Stifling US Innovation
U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.
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The Fed. Circ. In June: More Liability For Generic-Drug Makers
The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.