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Life Sciences
Life Sciences Law360 provides breaking legal news and analysis on the pharmaceutical and medical device industry. Coverage includes high-stakes litigation and policy developments that affect life sciences companies, as well as licensing deals, mergers, and other corporate transactions.
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Latest News in Life Sciences
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May 13, 2024
USPTO Eyes Change To Patent Applicants' Disclaimer Practice
The U.S. Patent and Trademark Office is looking to add a requirement for patent applicants filing so-called terminal disclaimers in order to overcome rejections by patent examiners over obviousness-type double patenting, a move that lawyers and a former USPTO official say could change the agency's approach considerably, especially for patents covering brand-name drugs.
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May 13, 2024
Biogen Investors Seek Class Cert. In Alzheimer's Drug Suit
A proposed class of Biogen shareholders urged a Massachusetts federal court to certify their now-revived class action alleging the drugmaker made misleading statements about a deficient Alzheimer's drug, arguing it can sufficiently lead the suit with Block & Leviton LLP as class counsel.
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May 13, 2024
2nd Circ. Affirms Dismissal Of Bystolic Antitrust Suit
The Second Circuit issued its first decision under the high court's Actavis "pay for delay" ruling on Monday, affirming the dismissal of a case alleging that an AbbVie predecessor delayed competition for its hypertension treatment Bystolic through deals with several generic makers.
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May 13, 2024
SEC Says Biotech Co., Atty Should Pay $14M For Investor Lies
Federal securities regulators have said a Colorado biotech startup and two of its founders should pay more than $14 million in ill-gotten profits, including interest, for lying to investors about the company's financial position, arguing that the founders showed a "total disregard" for investors.
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May 13, 2024
Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
Areas of Coverage
- AGENCIES
- U.S. Consumer Product Safety Commission
- U.S. Food and Drug Administration
- U.S. Patent and Trademark Office
- U.S. International Trade Commission
- POLICY & REGULATION
- Affordable Care Act
- Federal Food, Drug, and Cosmetic Act
- Antitrust and consumer protection controls
- Drug and medical device lobbying
- State and international life sciences legislation and regulation
- ENFORCEMENT
- Drug and medical device recalls
- Drug safety actions
- Pay-for-delay investigations
- Merger reviews
- LITIGATION
- Patent disputes, including
- Abbreviated New Drug Application litigation
- Section 301 cases
- Product safety suits over drugs and medical devices, including off-label marketing and failure-to-warn claims
- Consumer litigation and class actions
- Fraud and compliance suits
- Antitrust disputes
- Labor and employment suits
- Shareholder and corporate governance disputes
- Bankruptcy proceedings
- TRANSACTIONS
- Mergers, acquisitions, and joint ventures
- Share buybacks and stock splits
- Private equity deals
- Patent-licensing agreements
- PROFILES
- Personnel moves
- Profiles of life sciences practice groups
Readership
- Life sciences lawyers at top law firms
- Corporate counsel and compliance officers at Fortune 1000 companies
- Executives and attorneys in the drug, biotechnology, and medical device industries
- Information experts at law firms, agencies, and companies
- Policymakers at federal and state agencies
- Judges and court staff across the U.S.
- Professors, students, and library staff at every accredited law school in the U.S.
- Attorney and law firm marketing professionals