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Life Sciences
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May 01, 2024
AI Is Top Of Mind For Companies — And Securities Regulators
As references to artificial intelligence in securities filings soar, attorneys say companies must ground their disclosures in fact and be upfront about risks posed by AI in order to avoid the wrath of regulators, who promise to crack down on misleading claims.
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May 01, 2024
J&J Proposes $6.5B Deal To End Ovarian Cancer Claims
Johnson & Johnson said Wednesday it is proposing a prepackaged reorganization plan for its talc unit that will pay out $6.5 billion to resolve claims that its talc-based baby powder caused ovarian cancer, if a supermajority of claimants agree to the plan.
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April 30, 2024
Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue
The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.
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April 30, 2024
Judge Strikes Parts Of NC Law Restricting Abortion Drug
A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.
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April 30, 2024
Tech. Orgs Deny Being 'Apple's Puppets' In Watch Ban Fight
A group of technology industry groups claimed they are "not Apple's puppets" as they seek to back the company in its Federal Circuit appeal of the U.S. International Trade Commission's ban on imports of Apple Watch models capable of monitoring blood oxygen levels.
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April 30, 2024
Chase Can't Escape Medical Services Co.'s Defamation Suit
A Florida federal judge refused Monday to toss a suit by a medical services company accusing JPMorgan Chase Bank NA of destroying its business by adding it to a "blacklist," canceling its transactions and falsely telling its business partners that sanctions typically applied to violators of international laws or human rights statutes caused the cancellations.
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April 30, 2024
Pharmacyclics Can't Score Fees After Imbruvica Patent Win
Delaware's top federal judge on Tuesday told AbbVie's Pharmacyclics LLC unit that it was "also guilty of vexatious conduct" and had no standing to seek legal fees after it won a patent infringement suit against generic-drug rivals over its branded blockbuster cancer drug Imbruvica.
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April 30, 2024
Amgen Cuts Deal To End Bone Drug IP Suit Against Sandoz
A New Jersey federal judge has signed off on a deal that would end a suit where Amgen accused Sandoz of infringing patents on treatments for bone cancer and bone problems.
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April 30, 2024
SEC Fines 3 Men For Insider Trading On Zogenix Buyout
The U.S. Securities and Exchange Commission reached deals Tuesday totaling more than $170,000 with three men accused of trading shares of biopharmaceutical company Zogenix Inc. based on insider information.
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April 30, 2024
BCBS Says Federal Drug Law Preempts NM Medical Weed Row
A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.
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April 30, 2024
Pfizer Can't Slip COVID-19 Vax Suit, Texas Tells Court
The Texas attorney general told a federal judge not to let Pfizer Inc. out of its suit accusing the pharmaceutical company of misleading the public about its COVID-19 vaccine, arguing the suit was properly pled under state law in a brief filed Monday.
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April 30, 2024
Drug Company Can't Escape Texas Counties' Opioid MDL
A Texas appeals court on Tuesday declined to cut loose a New Jersey-based pharmaceutical manufacturer from Texas multidistrict litigation over opioid addiction in the state, finding that the counties of Dallas and Bexar have demonstrated that it's made deliberate moves toward the Texas market.
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April 30, 2024
3rd Circ. Preview: Kavanaugh Classmate Takes On HuffPost
The Third Circuit's May lineup will find the court weighing HuffPost's battle with an allegedly libeled former classmate of U.S. Supreme Court Justice Brett Kavanaugh and claims by consumers alleging they bought defective Bayer antifungal medicine.
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April 30, 2024
Judge Tosses LTL's Suit Over Article Linking Talc To Cancer
A New Jersey federal judge on Tuesday tossed a suit from the bankrupt talc unit of Johnson & Johnson accusing three doctors of damaging its business through a medical journal article it claimed was backed by "junk science," ruling that the doctors having served as expert witnesses in the Garden State is not enough to show that the court has jurisdiction over its claims.
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April 30, 2024
FTC Continues To Target 'Junk' Drug Patents
Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.
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April 30, 2024
Vaxart Investors Want Sanctions Over Deleted Texts
A group of Vaxart investors asked a California federal judge to issue sanctions against Armistice Capital LLC, which previously controlled Vaxart and allegedly sold $267 million worth of its Vaxart shares at inflated prices, saying the hedge fund and its executives purposely deleted text messages integral to the investors' claims.
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April 30, 2024
Feds Endorse Easing Marijuana Status In Big Policy Shift
Federal drug enforcers will recommend loosening restrictions on cannabis for the first time since the drug was made federally illegal decades ago, the U.S. Department of Justice announced Tuesday.
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April 30, 2024
Don't Miss It: McDermott, Paul Weiss Lead Month's Hot Deals
A lot can happen in the world of mergers and acquisitions over the course of a month. Here, Law360 recaps the deals you may have missed, including transactions helmed by McDermott and Paul Weiss.
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April 30, 2024
Medical Device Biz Hologic To Buy UK Rival For $310M
Hologic Inc. has agreed to buy Endomagnetics Ltd., a developer of breast cancer surgery technology, for approximately $310 million, as the U.S. medical company moves to expand its presence in the women's health sector.
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April 29, 2024
Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims
A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.
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April 29, 2024
Judge Rejects 2 Challenges To Medicare Drug Price Talks
A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.
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April 29, 2024
Sandoz Says Biopharma Biz Added 'Poison' To Market
More than $160 million separate generic-drug maker Sandoz Inc. and biopharmaceutical firm United Therapeutics Corp. in their estimates of damages suffered by Sandoz when the other company effectively blocked the sale of Sandoz's generic version of a hypertension medication, according to opening statements Monday during a bench trial in New Jersey federal court.
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April 29, 2024
Mistrial Called In $86M Stent Patent Case Against Medtronic
An $86 million case in Texas over stents sold by medical device giant Medtronic has ended in a mistrial after U.S. District Judge Alan Albright was notified that a juror didn't want to budge on a position that was at odds with the rest of the jurors.
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April 29, 2024
Boehringer Accused Of Monopolizing Inhaler Product Market
Boehringer Ingelheim Pharmaceuticals has manipulated the U.S. patent and drug approval system to unlawfully block makers of generic inhaler medications, health and welfare funds claimed in a lawsuit filed Monday in Connecticut federal court, arguing that the "availability of generics has tangible cost and life-saving effects."
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April 29, 2024
Pharma Co. Hit With Investor Suit Over Liver Drug Trials
Biopharmaceutical company Akero Therapeutics and three of its executives were hit with a proposed class action in California federal court alleging they made misleading statements about the patient population in a clinical trial for its liver disease treatment.
Expert Analysis
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Expediting Psychedelics Approvals In The US And Canada
Accelerated regulatory pathways for psychedelics in the U.S. and Canada play a pivotal role in the progression of drugs, devices and novel therapies toward commercialization, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
Playing Competitive Tennis Makes Me A Better Lawyer
My experience playing competitive tennis has highlighted why prioritizing exercise and stress relief, maintaining perspective under pressure, and supporting colleagues in pursuit of a common goal are all key aspects of championing a successful legal career, says Madhumita Datta at Lowenstein Sandler.
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Series
The Pop Culture Docket: Judge Djerassi On Super Bowl 52
Philadelphia Court of Common Pleas Judge Ramy Djerassi discusses how Super Bowl 52, in which the Philadelphia Eagles prevailed over the New England Patriots, provides an apt metaphor for alternative dispute resolution processes in commercial business cases.
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Reverse Merger Tips For Biotechs After SEC's Recent Actions
Several recent U.S. Securities and Exchange Commission developments could limit the viability of reverse mergers for biotech companies, and will require additional creativity and analysis for private companies looking to go public, say attorneys at Orrick.
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Opinion
Proposed Rule Misses The Mark On Improving MDLs
The Advisory Committee on Civil Rules' recently proposed rule on multidistrict litigation would provide some guidance for courts on managing MDLs — but without any requirement for the early vetting of claims, it is particularly unhelpful for defendants in pharmaceutical and product liability cases, say attorneys at Crowell & Moring.
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Taking A Closer Look At Fed. Circ. Claim Construction Split
An empirical analysis of a year's worth of claim construction decisions from the Federal Circuit and four key district court jurisdictions shows that these constructions vary in material ways depending on the analysis' source, and this body of case law would benefit from clarification by the Federal Circuit itself, say attorneys at WilmerHale.
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The 7th Circ.'s Top 10 Civil Opinions Of 2023
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.
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Employee Experience Strategy Can Boost Law Firm Success
Amid continuing business uncertainty, law firms should consider adopting a holistic employee experience strategy — prioritizing consistency, targeting signature moments and leveraging measurement tools — to maximize productivity and profitability, says Haley Revel at Calibrate Consulting.
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Series
Competing In Triathlons Makes Me A Better Lawyer
While practicing law and competing in long-distance triathlons can make work and life feel unbalanced at times, participating in the sport has revealed important lessons about versatility, self-care and perseverance that apply to the office as much as they do the racecourse, says Laura Heusel at Butler Snow.
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Parsing The USPTO's Guidelines For Assessing Enablement
Ryan Hagglund at Loeb & Loeb details the U.S. Patent and Trademark Office's recent guidelines for assessing enablement principles set forth in the U.S. Supreme Court's 2023 Amgen v. Sanofi decision, including how the guidelines can apply to all fields of technology.
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.