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Life Sciences Law & Industry Report

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What this service is:

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative, and legal issues.

What it helps you do:

  • Become familiar with the global, billion-dollar life sciences industry -- defined as the use of advanced and emerging technologies to develop solutions that enhance human health and combat disease.
  • Understand how rapid expansion of the industry has spurred both government and private efforts to encourage research, reward innovation, fund supporting infrastructure, and protect the public.
  • Be thoroughly informed of federal, state, and major international legislation, regulations, policies, and standards concerning the life sciences industry -- everything from biotechnology to patents to counterterrorism.
  • Find out about newly issued court and administrative decisions affecting the life sciences, as well as current government enforcement activity, pending litigation, and settlements.
  • Get essential details on Congressional hearings, bills, and amendments that may have an impact on the industry.
  • Consider the views of practicing attorneys, government regulators, and other experts in Analysis & Perspective articles.
  • Consult just one convenient source for information on the myriad legal and business issues affecting the life sciences.
  • Quickly locate news, cases, and more in this fully indexed, easily searchable service.
  • Benefit from objective, unbiased news equally useful to lawyers, business executives, regulators, directors of research, and institutions.
  • Stay ahead of the information curve -- the scope of the Report will expand along with the life sciences industry, with every advance in technology.
Product Structure

Notification: current reports providing news and developments

Formats and Frequency

Print and Web notification formats are issued and available biweekly.

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  • Antitrust
  • Bioinformatics
  • Biotechnology
  • Bioterrorism countermeasures
  • Clinical research
  • Combination products
  • Collaborative agreements
  • Coverage and reimbursement policies
  • Data banks
  • Drug delivery
  • Emerging technologies
  • Food & Drug Administration
  • Fraud and abuse
  • Funding/financing
  • Genomic medicine
  • Government contracting
  • Health care regulations/compliance
  • Information technology
  • Intellectual property
  • Joint ventures
  • Licensing agreements
  • Mergers and acquisitions
  • Nanotechnology
  • Patents
  • Pharmaceuticals
  • Pharmacogenomics
  • Sales and marketing
  • Securities
  • Stem cells
  • Taxation
  • Technology transfers
  • Therapeutic proteins
  • Tissue banks/secondary research
  • Venture capital
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July 31, 2014
  • FDA Asserts Regulatory Authority Over Laboratory Developed Tests
  • Patent Trial and Appeal Board Is Focus Of House Subcommittee Oversight Hearing
  • NIH Common Fund Program to Search For More Genes That Respond to Drugs
  • BioMarin Sells Pediatric Priority Review Voucher to Regeneron for $67.5 Million
  • 23andMe Receives $1.3 Million NIH Grant To Develop Database for Genetic Discovery
July 30, 2014
  • Report Says New Hep C Drugs Could Drive Medicare Spending Up Sharply
  • High Court to Hear Case in Oct. Challenging Federal Circuit's De Novo Claim Construction
  • AstraZeneca to Buy Almirall's Respiratory Medicine Franchise for Up to $1.22 Billion
July 29, 2014
  • Cancer Treatment Centers Sues AVAX For Contract Breach, Cancer Vaccines
  • Akamai v. Limelight Remanded to Fed. Cir. Panel That Denied Direct Infringement Claim
  • Combination Product Group Urges OMB To Release FDA Draft, to Start Dialogue
  • OHRP Compliance Director Supports Efforts to Streamline Incident Reporting
  • Industry Groups Ask CMS to Provide Education and Context for Sunshine Act Data
July 25, 2014
  • Agency Revises Draft Guidance On Regulatory Submission Formats
  • ATS Labs Acquires MicroTest Labs, Changes Name to Accuratus Lab Services
July 24, 2014
  • Senate Funding Bill Would Secure NIH's Budget Increases Through 2021
  • Reimbursement, Collaboration Highlighted At Workshop on Genetic Data in Health Care
  • Novartis Says Application for Biosimilar Version of Amgen Drug Accepted by FDA
July 23, 2014
  • Reimbursement, Regulatory Clarity Urged To Advance Use of Personalized Approach
  • Insurer for DTC Genetic Test Company Asks Court to Rule Against Covering Lawsuits
  • CDC Director Would Consider New Agency To Better Regulate Dangerous Pathogens
  • House Panel Hears About Barriers To Use of Medical Technology Advances
  • Boehringer Withheld Data on Dosing Of Blood Thinner Pradaxa, BMJ Says
  • FDA Approves Gilead's Zydelig For Treating Three Blood Cancers
  • New Law Allows Terminal Patients To Try Non-FDA Approved Treatments
  • Clinical Test Lab Settles Whistle-Blower Claims of Improper Billing for Genetic Tests
July 22, 2014
  • Research Consortia Can Speed New Drugs To Patients, Reducing Costs, Panelists Say
  • Failure to Validate Sunshine Data Accuracy Can Result in Heavy Fines, Consultant Says
  • Supreme Court Continues to Build Out Its Framework for Patent Eligibility in High-Tech and Life Sciences Sectors
July 21, 2014
  • White House OMB Issues Budget Priorities For Developing Biological Countermeasures
  • VC Investing Hits 13-Year High in Q2 2014; Biotech Second to Software, Report Says
  • HHS Issues Interpretation on Discount For Providers Under 340B Drug Program
  • AbbVie Becomes Biggest U.S. Company To Move HQ Overseas in $55 Billion Deal
  • Obama Administration, Senate Democrats Seek Urgent Curb on Offshore Inversion Deals
  • FDA Releases Curriculum to Aid Device Development, Regulatory Evaluation
  • Shareholders Sue, Claiming Prosensa Made False Statements About Biologic
  • FDA Releases Recall Enforcement Data Interface
  • AbbVie Becomes Biggest U.S. Company To Move Domestic Address in $55 Billion Deal
July 18, 2014
  • Required Genome Screening in Clinical Trials Could Speed Medical Innovations to Patients
  • Governor Signs New Law to Prohibit Physician Self Referral to Clinical Labs
  • Study Touts Long-Term Benefits Of Innovation in Medical Technology
  • EU Court Adviser: OK to Deny Patents On Stem Cells for ‘Moral, Ethical' Reasons
  • Hawaii Case Against Bristol-Myers Returned To State Court Under Class Action Statute
July 17, 2014
  • Congress Must Act to Ensure Benefits Of Health IT Revolution, House Panel Told
  • Federal Policy on Stem Cell Study Funding Could Change With New Administration, Law
  • Don't Let FDA Regulate Lab Tests, Academics Tell White House OMB
  • InterMune Announces Breakthrough Status For Investigational IPF Drug Pirfenidone
  • Intuitive Surgical Avoids Lawsuit Filed by Investors Over Growth Projection
  • FDA Approves Ruconest to Treat Hereditary Angioedema Attacks
  • Government-Funded Research Lab Reels From Stem Cell Paper Fallout
July 16, 2014
  • Lawmakers Seek Answers in CDC Anthrax Incident; Frieden Promises Change in Culture
  • Groups Want CMS to Tackle Coding Issues, Definitions in Proposed Lab Fee Schedule
  • India Moves to Control Prices Of Diabetes, Cardiovascular Drugs
  • Pfizer to Pay at Least $225 Million For Generic Drug Developer InnoPharma
July 15, 2014
  • HHS Intends to Proceed With Interpretive Rule or Guidance on 340B Drug Discounts
  • FDA Seeks Comment on Consent Guidance Revised to Reflect New Regulations, Policy
  • Octapharma Says FDA Approves Octagam 10 Percent to Treat ITP
July 14, 2014
  • Mishandling Incidents Expose Workers To Anthrax, H5N1 Virus, CDC Report Finds
  • Insurers Review Reimbursement Policies For Orphan Drugs, Tufts Center Study Says
  • FDA Releases New Information After Webinar Had Technical Glitches
July 11, 2014
  • House Panel Hears Ways to Include Patients in Drug, Device Development
  • District Court Dismisses Investor Suit Against Pfizer, Executives Over Drug Trials
  • Senators Question Pricing Of Gilead's Hepatitis C Drug
  • Bill Targeting Patent Demand Letter Abuses Moved to Full House Commerce Committee
  • Government Approves New Stem Cell Law To Reinstate One Struck Down by High Court
July 10, 2014
  • Court Rules New Arthritis Drug Patent Result of ‘Insubstantial Tinkering,' Invalid
July 09, 2014
  • House Panel Explores Ways to Improve Cost, Efficiencies in Clinical Trial Process
  • Sponsor May Have Informed Consent Duty, Court Says, Lets Negligence Claim Proceed
  • New Warnings Needed in Consent Process To Cover Animal Study Unknowns, Group Says
  • Drug Agency Issues New Regulations To Improve Conduct of Clinical Trials
  • Study Data-Sharing Policy Adoption Delayed Until October by EMA Board
  • SEC Assures Lawmaker of Scrutiny In Any Potential Allergan-Valeant Deal
  • AIA-Mandated Reports Long Overdue On Genetic Tests, Small Business Effects
  • Smallpox Discovered at NIH Storage Facility; CDC Testing Vials
July 08, 2014
  • Agency's Proposed IP-Antitrust Regulation Seen to Pose Risk of Compulsory Licensing
  • FDA Approves Novo Nordisk Drug For Treating Rare Bleeding Disorder
  • FDA Schedules Sept. 22 Public Meeting On Drugs for Bleeding, Platelet Disorders
July 07, 2014
  • TET Systems Suit Alleges CD Biosciences Infringed Its Patents on Gene Expression
  • U.S. IP Law Groups Support Overturning Federal Circuit's De Novo Claim Construction
  • New Specialty Drug Spotlights Costs, Effect on U.S. Health-Care System
  • Five Senators Seek to Dislodge Draft FDA Lab Test Guidance From OMB
  • FDA ‘Untitled’ Letter Faults Gilead For Sponsored Link About Viread
  • Physician Pay Rule Would Remove Some Sunshine Act Reporting Exemptions for CME
  • FDA Sets Sept. 26 Meeting to Discuss Pulmonary Fibrosis Drug Development
  • China's Fosun Pharmaceuticals Plans to Buy Israeli Device Makers
  • Hospira Completes Acquisition of Drug Manufacturing, R&D Facilities in India
July 03, 2014
  • Proposed FDA Quality Office Eyes Drug Manufacturing Metrics
  • Burrill Sued for Wrongful Termination Over Fund Mismanagement Allegations
  • New Data Show Sharp Increase In Biotech IPOs, Stock, M&A Values
  • Novartis's Japan Subsidiary, Ex-Employee Indicted for Publishing Manipulated Data
  • Myriad Countersues Counsyl in Bid To Enforce BRCA Testing Patents
  • Teva Files Another Citizen Petition To Slow Down Generics of Copaxone
  • FDA Releases Guidance for Industry On Developing Tropical Disease Drugs
  • FDA Requests Comments on Guidance For Biologic Manufacturing Arrangements
  • China's Commerce Ministry Releases Information on Drug Industry's Growth
  • BGOV Insight: Proposed FDA Quality Office Eyes Drugmaking Metrics
July 02, 2014
  • PTO Seeks Suggestions on Changing Rules For PTAB Patent Challenge Trial Proceedings
  • UC Rescinds Policy That Restricted Direct Investment in Tech Start-ups
  • Pharmacies, Health Insurers, Others Ask FDA To Use Same Names for Biologics, Biosimilars
  • National Academies Report Says Research Offers Benefits, New Measures Required
  • Stiefel Laboratories Had Duty to Disclose Ongoing Merger Talks, 11th Cir. Affirms
  • Genentech to Acquire Breast Cancer Drug Company Seragon for Up to $1.7 Billion
  • Drugmaker Had Duty to Disclose Ongoing Merger Talks, 11th Cir. Affirms
July 01, 2014
  • AbbVie's Patents Asserted Against Centocor's Stelara Psoriasis Treatment Ruled Invalid
  • Fraud Suit Over Delcath's Failed Cancer Therapy Survives Challenges
  • U.S. Leads in Genomic Patent Filings While FDA Reviews Are Faster, Reports Say
  • Clinton Says National Policy, State Support Could Keep Biotechs, Drug Advances in U.S.
  • Biological Targets Partnership Is Like 21st Century Moon Mission, BIO Told
  • FDA Warns Drug Companies: Social Media Data Can Be Reportable
  • Agency Issues Draft Strategic Priorities That Will Guide Actions Through 2018
  • FDA Releases Draft Strategic Priorities That Will Guide Agency Through 2018
June 30, 2014
  • PTO's Mayo/Myriad Eligibility Guidance May Chill New Drugs, Diagnostics, Panel Says
  • Lighting Ballast Adds to Teva's Challenge To No-Deference Claim Construction Standard
  • Federal Funding of Nanotech Research Leads to Significant Gains, Report Says
  • Mass. Proposed Rule Would Reduce BRCA Payment
  • Joint Pharmaceutical Venture Clears EU Review
June 27, 2014
  • Rader Gives Last Speech as Judge, Asks BIO Attendees to Work With CAFC
  • Claims Sent for Arbitration In Suits Over 23andMe's Test Kits
  • Rader Gives Last Speech as Judge, Asks BIO Attendees to Work With CAFC
  • Governor Signs Bill Establishing Statewide Vaccination Program
June 26, 2014
  • EY Industry Report Says Biotech Needs New R&D Model Despite Strong 2013 Growth
June 25, 2014
  • PTO May Change New Eligibility Guidance; Told to ‘Push Back’ Against High Court
  • House Passes Reauthorization to Require Newborn Screening Tests, Expand Program
  • Canada Proposes Regulations to Require Licenses for Use of Human Pathogens, Toxins
  • Collaboration, Notification Essential For Biosimilar Safety, BIO Panel Says
  • FDA Draft Proposes No Regulation Of Medical Device Data Systems
  • Endo Reaches Agreement to Acquire Generic Company Dava for $575 Million Cash
June 24, 2014
  • Battelle/BIO 2014 Report Highlights Bioscience Industry as Job Generator
  • Cert Petition Questions Safe Harbor In Drug Patent Infringement Case
  • Witnesses Tell House Panel of Need For Accuracy in a Digital Health World
  • FDA Issues Final Guidance on Use Of Nanotechnology in Regulated Products
  • Massachusetts Governor Signs Biosimilars Bill Including Patient Notification
June 23, 2014
  • 23andMe Resubmits FDA Application For Direct-to-Consumer Genetic Testing
  • FDA Again Approves Avian Flu Diagnostic Under Emergency Use Authorization
  • FDA Approves Antibiotic Sivextro To Treat Adults With Skin Infections
  • Advocacy, Industry Groups Urge Reforms To FDA's Guidance Development Process
June 20, 2014
  • FDA Issues Guidance for IND, BLA Applicants On Environmental Assessment Requirements
  • Return of Individual Genome Study Results, Stem Cell Therapies Covered in NAP Books
  • Spanish Supreme Court Reverses Stem Cell Regulations, Saying Law Is Needed
June 19, 2014
  • Mere Implementation of Abstract Idea With Computer Affirmed Not Patent Eligible
  • Neuroscientist Says NIH Funding Squeeze Causing ‘Crisis' in Biomedical Enterprise
  • Gene Mutations That Lower Heart Attack Risk May Spur New Drugs, NEJM Studies Suggest
  • After Court Ruling, HHS Says It Will Move Forward With 340B Orphan Drug Rule
  • FDA Releases Draft Guidance for Industry On Developing Antibiotics for Gonorrhea
  • State's Life Sciences Industry Tops in U.S. In Jobs per Capita, University Report Says
  • Health-Care Regulator Releases New Clinical Trial Compliance Guidance
June 18, 2014
  • Fed. Cir. Remands Abraxis's PTA Appeal Same Day PTO Issues New PTA Guidance
  • FDA Updates Magnetic Resonance Device Guidance
  • NIH to Help Small Business Grantees With Commercialization in New Pilot Program
June 17, 2014
  • OncoGenex Inventors Appeal Rejection By PTAB of Squamous Cell Cancer Therapy
  • Energy and Commerce White Paper Seeks Input on Digital, Personalized Health Care
  • FDA Releases Two Draft Guidances On Social Media for Drug, Device Industry
  • FDA Will Start Posting Customer Satisfaction Ratings, Based on Survey
  • Report: U.S. Spends Less on Medical Technology Than Other Health Services
June 16, 2014
  • Myriad Sues Pathway in Latest Lawsuit Involving Breast Cancer Testing Patents
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