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Life Sciences Law & Industry Report

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

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OVERVIEW

EXPERT NEWS & COMMENTARY

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.


TRUSTED LEGAL ANALYSIS

Benefit from analysis and commentary by attorneys, government officials, and industry experts on emerging case law and government actions affecting the life sciences industry.

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POWERFUL RESEARCH FEATURES

Quickly locate news, cases, and more in this fully indexed, easily searchable service. The Report includes a company index to identify names in the news, as well as a fully-linked chart listing appeals filed and decisions rendered by the Federal Circuit Court on life science industry patents.


TOPICS COVERED

  • Antitrust
  • Biosimilars
  • Biotechnology
  • Bioterrorism countermeasures
  • Combination products
  • Conflict of Interest
  • Coverage and reimbursement policies
  • Data banks
  • Drug delivery
  • Emerging technologies
  • Food & Drug Administration
  • Fraud and abuse
  • Funding/financing
  • Genomic medicine
  • Health care regulations/compliance
  • Joint ventures
  • Licensing agreements
  • Mergers and acquisitions
  • Nanotechnology
  • Patents
  • Securities
  • Stem cells
  • Synthetic biology
  • Taxation
  • Technology transfer
  • Tissue banks/secondary research
  • Venture capital
Key Laws and Regulations
  • FDA Safety and Innovation Act
  • Federal Food, Drug, and Cosmetic Act
  • Project BioShield Act of 2004 and related laws
  • Social Security Act (Medicare/Medicaid)

SPECIFICATIONS

Product Structure

Notification: current reports providing news and developments.

Formats and Frequency

Print and Web notification formats are issued and available bi-weekly.


RECENT HEADLINES

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FDA Asserts Regulatory Authority Over Laboratory Developed Tests
July 31
Patent Trial and Appeal Board Is Focus Of House Subcommittee Oversight Hearing
July 31
NIH Common Fund Program to Search For More Genes That Respond to Drugs
July 31
BioMarin Sells Pediatric Priority Review Voucher to Regeneron for $67.5 Million
July 31
23andMe Receives $1.3 Million NIH Grant To Develop Database for Genetic Discovery
July 31
Report Says New Hep C Drugs Could Drive Medicare Spending Up Sharply
July 30
High Court to Hear Case in Oct. Challenging Federal Circuit's De Novo Claim Construction
July 30
AstraZeneca to Buy Almirall's Respiratory Medicine Franchise for Up to $1.22 Billion
July 30
Cancer Treatment Centers Sues AVAX For Contract Breach, Cancer Vaccines
July 29
Akamai v. Limelight Remanded to Fed. Cir. Panel That Denied Direct Infringement Claim
July 29
Combination Product Group Urges OMB To Release FDA Draft, to Start Dialogue
July 29
OHRP Compliance Director Supports Efforts to Streamline Incident Reporting
July 29
Industry Groups Ask CMS to Provide Education and Context for Sunshine Act Data
July 29
Agency Revises Draft Guidance On Regulatory Submission Formats
July 25
ATS Labs Acquires MicroTest Labs, Changes Name to Accuratus Lab Services
July 25
Senate Funding Bill Would Secure NIH's Budget Increases Through 2021
July 24
Reimbursement, Collaboration Highlighted At Workshop on Genetic Data in Health Care
July 24
Novartis Says Application for Biosimilar Version of Amgen Drug Accepted by FDA
July 24
Reimbursement, Regulatory Clarity Urged To Advance Use of Personalized Approach
July 23
Insurer for DTC Genetic Test Company Asks Court to Rule Against Covering Lawsuits
July 23
CDC Director Would Consider New Agency To Better Regulate Dangerous Pathogens
July 23
House Panel Hears About Barriers To Use of Medical Technology Advances
July 23
Boehringer Withheld Data on Dosing Of Blood Thinner Pradaxa, BMJ Says
July 23
FDA Approves Gilead's Zydelig For Treating Three Blood Cancers
July 23
New Law Allows Terminal Patients To Try Non-FDA Approved Treatments
July 23
Clinical Test Lab Settles Whistle-Blower Claims of Improper Billing for Genetic Tests
July 23
Research Consortia Can Speed New Drugs To Patients, Reducing Costs, Panelists Say
July 22
Failure to Validate Sunshine Data Accuracy Can Result in Heavy Fines, Consultant Says
July 22
Supreme Court Continues to Build Out Its Framework for Patent Eligibility in High-Tech and Life Sciences Sectors
July 22
White House OMB Issues Budget Priorities For Developing Biological Countermeasures
July 21
VC Investing Hits 13-Year High in Q2 2014; Biotech Second to Software, Report Says
July 21
HHS Issues Interpretation on Discount For Providers Under 340B Drug Program
July 21
AbbVie Becomes Biggest U.S. Company To Move HQ Overseas in $55 Billion Deal
July 21
Obama Administration, Senate Democrats Seek Urgent Curb on Offshore Inversion Deals
July 21
FDA Releases Curriculum to Aid Device Development, Regulatory Evaluation
July 21
Shareholders Sue, Claiming Prosensa Made False Statements About Biologic
July 21
FDA Releases Recall Enforcement Data Interface
July 21
Required Genome Screening in Clinical Trials Could Speed Medical Innovations to Patients
July 18
Governor Signs New Law to Prohibit Physician Self Referral to Clinical Labs
July 18
Study Touts Long-Term Benefits Of Innovation in Medical Technology
July 18
EU Court Adviser: OK to Deny Patents On Stem Cells for ‘Moral, Ethical' Reasons
July 18
Hawaii Case Against Bristol-Myers Returned To State Court Under Class Action Statute
July 18
Congress Must Act to Ensure Benefits Of Health IT Revolution, House Panel Told
July 17
Federal Policy on Stem Cell Study Funding Could Change With New Administration, Law
July 17
Don't Let FDA Regulate Lab Tests, Academics Tell White House OMB
July 17
InterMune Announces Breakthrough Status For Investigational IPF Drug Pirfenidone
July 17
Intuitive Surgical Avoids Lawsuit Filed by Investors Over Growth Projection
July 17
FDA Approves Ruconest to Treat Hereditary Angioedema Attacks
July 17
Government-Funded Research Lab Reels From Stem Cell Paper Fallout
July 17
Lawmakers Seek Answers in CDC Anthrax Incident; Frieden Promises Change in Culture
July 16
Groups Want CMS to Tackle Coding Issues, Definitions in Proposed Lab Fee Schedule
July 16
India Moves to Control Prices Of Diabetes, Cardiovascular Drugs
July 16
Pfizer to Pay at Least $225 Million For Generic Drug Developer InnoPharma
July 16
HHS Intends to Proceed With Interpretive Rule or Guidance on 340B Drug Discounts
July 15
FDA Seeks Comment on Consent Guidance Revised to Reflect New Regulations, Policy
July 15
Octapharma Says FDA Approves Octagam 10 Percent to Treat ITP
July 15
Mishandling Incidents Expose Workers To Anthrax, H5N1 Virus, CDC Report Finds
July 14
Insurers Review Reimbursement Policies For Orphan Drugs, Tufts Center Study Says
July 14
FDA Releases New Information After Webinar Had Technical Glitches
July 14
House Panel Hears Ways to Include Patients in Drug, Device Development
July 11
District Court Dismisses Investor Suit Against Pfizer, Executives Over Drug Trials
July 11
Senators Question Pricing Of Gilead's Hepatitis C Drug
July 11
Bill Targeting Patent Demand Letter Abuses Moved to Full House Commerce Committee
July 11
Government Approves New Stem Cell Law To Reinstate One Struck Down by High Court
July 11
Court Rules New Arthritis Drug Patent Result of ‘Insubstantial Tinkering,' Invalid
July 10
AbbVie Becomes Biggest U.S. Company To Move Domestic Address in $55 Billion Deal
July 21
House Panel Explores Ways to Improve Cost, Efficiencies in Clinical Trial Process
July 9
Sponsor May Have Informed Consent Duty, Court Says, Lets Negligence Claim Proceed
July 9
New Warnings Needed in Consent Process To Cover Animal Study Unknowns, Group Says
July 9
Drug Agency Issues New Regulations To Improve Conduct of Clinical Trials
July 9
Study Data-Sharing Policy Adoption Delayed Until October by EMA Board
July 9
SEC Assures Lawmaker of Scrutiny In Any Potential Allergan-Valeant Deal
July 9
AIA-Mandated Reports Long Overdue On Genetic Tests, Small Business Effects
July 9
Smallpox Discovered at NIH Storage Facility; CDC Testing Vials
July 9
Agency's Proposed IP-Antitrust Regulation Seen to Pose Risk of Compulsory Licensing
July 8
FDA Approves Novo Nordisk Drug For Treating Rare Bleeding Disorder
July 8
FDA Schedules Sept. 22 Public Meeting On Drugs for Bleeding, Platelet Disorders
July 8
TET Systems Suit Alleges CD Biosciences Infringed Its Patents on Gene Expression
July 7
U.S. IP Law Groups Support Overturning Federal Circuit's De Novo Claim Construction
July 7
New Specialty Drug Spotlights Costs, Effect on U.S. Health-Care System
July 7
Five Senators Seek to Dislodge Draft FDA Lab Test Guidance From OMB
July 7
FDA ‘Untitled’ Letter Faults Gilead For Sponsored Link About Viread
July 7
Physician Pay Rule Would Remove Some Sunshine Act Reporting Exemptions for CME
July 7
FDA Sets Sept. 26 Meeting to Discuss Pulmonary Fibrosis Drug Development
July 7
China's Fosun Pharmaceuticals Plans to Buy Israeli Device Makers
July 7
Hospira Completes Acquisition of Drug Manufacturing, R&D Facilities in India
July 7
Proposed FDA Quality Office Eyes Drug Manufacturing Metrics
July 3
Burrill Sued for Wrongful Termination Over Fund Mismanagement Allegations
July 3
New Data Show Sharp Increase In Biotech IPOs, Stock, M&A Values
July 3
Novartis's Japan Subsidiary, Ex-Employee Indicted for Publishing Manipulated Data
July 3
Myriad Countersues Counsyl in Bid To Enforce BRCA Testing Patents
July 3
Teva Files Another Citizen Petition To Slow Down Generics of Copaxone
July 3
FDA Releases Guidance for Industry On Developing Tropical Disease Drugs
July 3
FDA Requests Comments on Guidance For Biologic Manufacturing Arrangements
July 3
China's Commerce Ministry Releases Information on Drug Industry's Growth
July 3
PTO Seeks Suggestions on Changing Rules For PTAB Patent Challenge Trial Proceedings
July 2
UC Rescinds Policy That Restricted Direct Investment in Tech Start-ups
July 2
Pharmacies, Health Insurers, Others Ask FDA To Use Same Names for Biologics, Biosimilars
July 2
National Academies Report Says Research Offers Benefits, New Measures Required
July 2
Stiefel Laboratories Had Duty to Disclose Ongoing Merger Talks, 11th Cir. Affirms
July 2
Genentech to Acquire Breast Cancer Drug Company Seragon for Up to $1.7 Billion
July 2
AbbVie's Patents Asserted Against Centocor's Stelara Psoriasis Treatment Ruled Invalid
July 1
Fraud Suit Over Delcath's Failed Cancer Therapy Survives Challenges
July 1
U.S. Leads in Genomic Patent Filings While FDA Reviews Are Faster, Reports Say
July 1
Clinton Says National Policy, State Support Could Keep Biotechs, Drug Advances in U.S.
July 1
Biological Targets Partnership Is Like 21st Century Moon Mission, BIO Told
July 1
FDA Warns Drug Companies: Social Media Data Can Be Reportable
July 1
Agency Issues Draft Strategic Priorities That Will Guide Actions Through 2018
July 1
PTO's Mayo/Myriad Eligibility Guidance May Chill New Drugs, Diagnostics, Panel Says
June 30
Lighting Ballast Adds to Teva's Challenge To No-Deference Claim Construction Standard
June 30
Federal Funding of Nanotech Research Leads to Significant Gains, Report Says
June 30
Mass. Proposed Rule Would Reduce BRCA Payment
June 30
Joint Pharmaceutical Venture Clears EU Review
June 30
Rader Gives Last Speech as Judge, Asks BIO Attendees to Work With CAFC
June 27
Claims Sent for Arbitration In Suits Over 23andMe's Test Kits
June 27
Drugmaker Had Duty to Disclose Ongoing Merger Talks, 11th Cir. Affirms
July 2
FDA Releases Draft Strategic Priorities That Will Guide Agency Through 2018
July 1
Rader Gives Last Speech as Judge, Asks BIO Attendees to Work With CAFC
June 27
BGOV Insight: Proposed FDA Quality Office Eyes Drugmaking Metrics
July 3
Governor Signs Bill Establishing Statewide Vaccination Program
June 27
EY Industry Report Says Biotech Needs New R&D Model Despite Strong 2013 Growth
June 26
PTO May Change New Eligibility Guidance; Told to ‘Push Back’ Against High Court
June 25
House Passes Reauthorization to Require Newborn Screening Tests, Expand Program
June 25
Canada Proposes Regulations to Require Licenses for Use of Human Pathogens, Toxins
June 25
Collaboration, Notification Essential For Biosimilar Safety, BIO Panel Says
June 25
FDA Draft Proposes No Regulation Of Medical Device Data Systems
June 25
Endo Reaches Agreement to Acquire Generic Company Dava for $575 Million Cash
June 25
Battelle/BIO 2014 Report Highlights Bioscience Industry as Job Generator
June 24
Cert Petition Questions Safe Harbor In Drug Patent Infringement Case
June 24
Witnesses Tell House Panel of Need For Accuracy in a Digital Health World
June 24
FDA Issues Final Guidance on Use Of Nanotechnology in Regulated Products
June 24
Massachusetts Governor Signs Biosimilars Bill Including Patient Notification
June 24
23andMe Resubmits FDA Application For Direct-to-Consumer Genetic Testing
June 23
FDA Again Approves Avian Flu Diagnostic Under Emergency Use Authorization
June 23
FDA Approves Antibiotic Sivextro To Treat Adults With Skin Infections
June 23
Advocacy, Industry Groups Urge Reforms To FDA's Guidance Development Process
June 23
FDA Issues Guidance for IND, BLA Applicants On Environmental Assessment Requirements
June 20
Return of Individual Genome Study Results, Stem Cell Therapies Covered in NAP Books
June 20
Spanish Supreme Court Reverses Stem Cell Regulations, Saying Law Is Needed
June 20
Mere Implementation of Abstract Idea With Computer Affirmed Not Patent Eligible
June 19
Neuroscientist Says NIH Funding Squeeze Causing ‘Crisis' in Biomedical Enterprise
June 19
Gene Mutations That Lower Heart Attack Risk May Spur New Drugs, NEJM Studies Suggest
June 19
After Court Ruling, HHS Says It Will Move Forward With 340B Orphan Drug Rule
June 19
FDA Releases Draft Guidance for Industry On Developing Antibiotics for Gonorrhea
June 19
State's Life Sciences Industry Tops in U.S. In Jobs per Capita, University Report Says
June 19
Health-Care Regulator Releases New Clinical Trial Compliance Guidance
June 19
Fed. Cir. Remands Abraxis's PTA Appeal Same Day PTO Issues New PTA Guidance
June 18
FDA Updates Magnetic Resonance Device Guidance
June 18
NIH to Help Small Business Grantees With Commercialization in New Pilot Program
June 18
OncoGenex Inventors Appeal Rejection By PTAB of Squamous Cell Cancer Therapy
June 17
Energy and Commerce White Paper Seeks Input on Digital, Personalized Health Care
June 17
FDA Releases Two Draft Guidances On Social Media for Drug, Device Industry
June 17
FDA Will Start Posting Customer Satisfaction Ratings, Based on Survey
June 17
Report: U.S. Spends Less on Medical Technology Than Other Health Services
June 17
Myriad Sues Pathway in Latest Lawsuit Involving Breast Cancer Testing Patents
June 16