SUBSCRIPTION

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.

FREE TRIAL
Legal Subscriptions

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.

Try Life Sciences Law & Industry Report now

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

To view additional stories from Life Sciences Law & Industry Report register for a free trial now.

Panelists Correctly Predict Court's Ruling That BPCIA Info Exchanges Aren't Mandatory
March 18
Practical Steps for Building a Strong Life Science Patent Portfolio Worth Billions of Dollars
March 19
Varmus Says New Field Offers Great Opportunities for Cancer Research
March 19
Novo Sees U.S. Price Gains Even With New Sanofi Insulin
March 19
House Approves Bill on Timely DEA Scheduling of New Medicines
March 18
Final Regulations Create ‘World's First' Risk-Based Regime for Pathogens, Toxins
March 18
Two Common Rule Changes in Effect Under Newborn Genetic Screening Law
March 18
Ignyta Acquires Four Oncology Development Programs From Teva
March 18
Enzo's $61M Infringement Award Tossed; Fed. Cir. Finds Error in Claim Construction
March 17
Appeals Court Revives Investor Suit Over FDA Rejection of New Drug Application
March 17
Court Says Former Enzo Executives Breached Agreement, Awards Nominal Damages
March 17
Nonprofits Invest in Biopharmas to Advance Standard of Care, Earn ROI, Speakers Say
March 17
Society for Science-Based Medicine Removed From Physician's Libel Suit
March 17
Court Finds Celsis's Cell Freezing Patent Invalid as Law of Nature, Cites Mayo, Alice
March 16
Considering ‘Therapeutic Context' Essential To Gauge R&D Productivity, FDA Official Says
March 16
Compliance With Requirement to Report Results to ClinicalTrials.gov Still Lacking
March 16
Single IRB, Engaged Patients May Lead To Improved Clinical Trials, Panelists Say
March 16
Big Companies Still Dominate Research Credit as Small Businesses Double Claims
March 16
Pittsburgh Health-Care Groups to Create Big Data Hub to Share Clinical Information
March 16
Workshop Set on Drug R&D Proposed Revisions
March 16
FDA Extends Comment Period On Combination Product Draft Guidance
March 13
DuPont Sues Monsanto to Enforce Gene-Gun Technology Royalties Award
March 13
Another Venture Investor Challenges Biopharma Patent in IPR Petition
March 12
23andMe to Turn DNA Data into Drugs; Recruits Genentech Executive to Help
March 12
FDA's Budget Request Will Help Ensure Medical Product Safety, Commissioner Says
March 12
Apple ResearchKit Sees Thousands Sign Up Amid Bias Criticism
March 12
Third Circuit Dismisses Investors' Lawsuit Over Failed Drug Approval
March 12
Alternative Way to Pay for Expensive New Drugs May Be Needed, RAND Says
March 12
Pharma Firm Shareholders Failed To Demonstrate Demand Futility
March 12
Wyoming Becomes Sixth State To Adopt Right-to-Try Legislation
March 12
Expert Panels Suggested as Way to Help FDA Include Biomarkers in Drug Approvals
March 11
Hamburg Commits to Full Agency Review Into Infections Linked to Medical Devices
March 11
FDA Releases Draft Guidance for Industry On Formal Meetings With Drug Sponsors
March 11
Pernix to Acquire Zohydro ER Pain Drug Franchise From Zogenix
March 11
Draft Interoperability Bill Would Replace ONC's Federal Advisory Groups
March 11
Makers of Failed Cancer Drug Win Dismissal of Securities Fraud Case
March 11
Va. Health Agency Launches Genetics Advisory Board
March 11
Report Makes Case for U.S. Biologics Law In TPP as Chief Negotiators Meet in Hawaii
March 10
Report Says Drug Costs Grew Last Year At Fastest Rate in More Than a Decade
March 10
Galapagos Evolves Into Target for Deal With Experimental Arthritis Drug
March 10
Court Denies Eli Lilly Summary Judgment In Genentech Antibody Noninfringement Suit
March 9
J&J Sues Celltrion Healthcare, Says Pending Biosimilar Infringes Patents
March 9
FDA's First Biosimilar Approval Greeted With Optimism; Naming, Pricing Still Issues
March 9
SCOTUS Denies Review in Tamiflu Challenge To Federal Circuit Double Patenting Ruling
March 9
State Right-to-Try Laws for Experimental Therapies Popular, but Effect Minimal
March 9
Investors Bet $100,000 Prices For Cancer Drugs Are Here to Stay
March 9
Biotech Stock Value Keeps Rising As Investors Worry ‘End Is Coming’
March 9
Apple's Health Research Kit Makes iPhone Users Test Subjects
March 9
Industry Groups Say More Work Needed by FDA on Biosimilar Policy
March 6
Novartis Wins Approval for Zarxio, First Biosimilar to Be Sold in U.S.
March 6
Third Circuit Tosses Investors' Lawsuit Over Failed Drug Approval
March 12
FDA Will Hold Personalized Medicine, Companion Diagnostics Workshop March 24
March 6
GAO: HHS Should Do More to Disseminate Comparative Effectiveness Research
March 6
Michigan Blues, U. Michigan Health System Launch Project on Genetic Testing Practices
March 6
AbbVie to Buy Pharmacyclics for $21 Billion, Including Blood Cancer Drug Imbruvica
March 5
FDA Approves Stem Cell Trial Involving AIDS
March 5
Senate Democrats' STRONG Patents Act Addresses Biopharma Fee Shifting Concerns
March 4
FDA Revises Draft Guidance on Imaging Data From Clinical Trials for Drugs, Biologics
March 4
Bristol-Myers Wins Early Approval Of Opdivo to Treat Lung Cancer
March 4
SEC Official Says FCPA Violations Involving Drug Companies Include Three Main Types
March 4
FDA's Budget Request Focuses on Essential Functions, Commissioner Tells House Panel
March 4
FDA to Hold Public Hearing in June On Regulatory Science Initiatives for Generics
March 4
FDA Advisory Panel to Hold Meeting On Pediatric-Focused Safety Reviews
March 4
FDA Accepts NDA for Parkinson's Drug, Grants Breakthrough Status to Cancer Drug
March 4
Natco Joins Gilead's Agreement With Indian Companies for Sovaldi
March 3
FDA Asks OMB to Approve Extension Of Two Forms Used in IND Applications
March 3
Will the Biosimilar Revolution Reach the U.S.?
March 3
CAFC Denies Promega's, LifeTech's Motions To Rehear DNA Identification Patent Case
March 2
European Patent Office Filings Up in 2014, Especially in Biotech, Medical Technology
March 2
Doctor Panel to Weigh Costs Of Hepatitis C Drugs in Guidelines
March 2
Gilead Avoids Billions in U.S. Taxes On $1,000-a-Pill Hepatitis C Drug
February 27
Australian High Court to Hear Myriad Gene Patent Case
February 27
Study Begins to Test Safety, Effectiveness Of ZMapp for Treating Ebola, NIH Says
February 27
CDC Considers Removing Six Pathogens From Select Agent List, Seeks Comment
February 27
Lee's Nomination for PTO Director Approved By Committee; Full Senate Confirmation Next
February 27
Alternative Simplified Credit Method Election For Research Credit OK on Returns, IRS Says
February 27
Demand Letter Abuse Legislation Will Return; Preemption of States' Efforts Top Issue
February 27
House Measure Would Exempt FDA User Fees From Sequestration
February 26
Senators Ask, ‘Who's in Charge?' Noting Flaws in U.S. Ebola Response
February 26
Implementation of Patent Term Statute In C.F.R. Found Permissible, Reasonable
February 26
Drug Breakthroughs Stir Payer Pushback at $5,000 a Month and Up
February 26
FDA Puts Embryonic Image Assessment Device Under Class II
February 26
Bioethics Panel's Ebola Brief Advises ‘Rigorous, Credible' Clinical Trial Design
February 26
PTAB Invalidates Genzyme, Duke Claims For Pompe Disease Enzyme Therapy
February 25
FDA Delays Advisory Panel Meeting On Celltrion's Biosimilar Remicade
February 25
Senate Measure Revives Effort To Make R&D Credit Permanent
February 25
FDA Accepts BLA for Kanuma, Grants Breakthrough Status to Glioblastoma Drug
February 25
Seattle Genetics Submits sBLA for Adcetris
February 25
FDA Official Outlines Goals for Oversight Of Next Generation Sequencing Tests
February 24
Consumer Group's Attempt to Challenge Stem Cell Patent Denied High Court Review
February 24
AMA: Policies to Promote Interoperability Critical to Success of 21st Century Cures
February 24
Cancer Drug Manufacturer Pharmacyclics Weighs Potential Sale, Sources Say
February 25
High Court Denies Review of Petitions, Leaves Federal Circuit AIA Rulings Intact
February 24
Reimbursement Delays Hinder Device Industry Innovation, Investor Says
February 24
Bristol-Myers Makes $1.6 Billion In Deals Boosting Cancer Pipeline
February 24
Dendreon's Cancer Drug Ultimately Goes For $495 Million to Valeant Pharmaceuticals
February 24
FTC Settlement Would Require Novartis to Divest Certain Cancer Drugs
February 24
New Drug Company Turing Pharma Launches, Acquires Three Retrophin Drugs
February 24
Novartis Asks Federal Court to Stop Pfizer From Selling Trumenba, Claims Infringement
February 23
FDA Set to Update Draft Guidance on Reactions to Cell, Tissue Transplants
February 23
Valeant's $10.1 Billion Salix Deal Seen as Bet on FDA Approval Decision
February 23
NGM, Merck Enter Agreement To Develop Biologic Therapies
February 23
Biotech Company CEO Pleads Guilty to DOJ Criminal Charges of Fraudulent Transfers
February 23
State House Approves ‘Right to Try’ Bill; Foundation Forms to Help Terminal Patients
February 23
23andMe Gains FDA Approval For First Genetic Test Kits
February 20
Experimental HIV Vaccine to Be Tested For Safety, Immune Response in South Africa
February 20
FDA, NIH Work Group to Develop Plan For Improving Study Subgroup Data
February 20
PTAB Growth, Patent Eligibility Guidance Updates Featured in Quarterly PPAC Meeting
February 20
‘Superbug' Spread Reveals Thin Pipeline Of Newest, Advanced-Stage Antibiotics
February 20
Senate Passes Bill for Pharmacist Substitutions of Biosimilar Drugs
February 20
Biogen Sues Neurobiogen Over Trademark, Claiming Name Is ‘Confusingly Similar'
February 19
FDA Announces Acting Director Of Office of Medical Policy
February 19
Mobile Health Tools are Essential For Precision Medicine, Verizon VP says
February 18
New NIH Advisory Panel Will Develop Million-Person Cohort for Obama Plan
February 18
Attorneys Must Know Antibody's Properties To Get Patent Approval in EU, Speaker Says
February 18
Those in Indian Clinical Trials Industry Look to Science-Based Regulation This Year
February 18
Congressional Research Service Reissues Report on Industry-Specific Patent Laws
February 18
Aetna Signs Pact to Offer Prevention Plans Based on Genes, Behavior, to Improve Health
February 18
Researchers Gear Up for Accreditation As Board Moves to Finalize Standards
February 18
FDA to Hold Conference in Indiana In June to Discuss Regulations
February 18
Illumina Scores Rare IPR Win as PTAB Declines to Invalidate Sequencing Claims
February 17
Myriad, GeneDx Settle Patent Dispute Over BRCA Screening, Ending Litigation
February 17
Rep. Brady Says Support Strong for Bill To Make Research Tax Credit Permanent
February 17
Apotex Says FDA Accepts Application For Biosimilar of Amgen's Neupogen
February 17
FDA Issues Guidance on Developing Drugs for Urinary Tract Infections
February 17
Canada Joins the Gene Patenting Debate
February 17
House Committee Approves Bill On Timely DEA Drug Scheduling
February 13
Investor Says Tax Inversion Rules Could Spur Mid-Size Pharma Deals
February 13
NIH Extends Comment Period For ClinicalTrials.gov Proposals
February 13
Investor Challenges MS Treatment Patent; BIO Claims Filing Abuses PTO IPR Process
February 12
Novartis Anti-Aging Drug Rapamycin Seen as Preventive Medicine
February 12
FDA Clinical Trial Warnings Aren't Published in Final Paper, Study Finds
February 12
FDA Seeks Comments on Development, Qualification of Biomarkers for Drugs
February 12
Hospital Associations Ask Judge To Throw Out PhRMA's 340B Lawsuit
February 12
Device Industry Group Seeks Policy Changes to Spur Innovation
February 11
Gilead's Hepatitis C Drug Patent Challenged by Medical Charity
February 11
FDA Issues Draft Guidance on Studies To Support Approval of Glaucoma Devices
February 11
Misuse of Health Data Should Draw Jail Sentence, Ethics Body Recommends
February 11
Investors Favor Novel Drug R&D, Oncology, Biologics, BIO Report Says
February 10
FDA Approves Expanded Use Of Genentech's Eye Drug Lucentis
February 10
Pfenex, Hospira Enter Agreement To Develop Biosimilar of Lucentis
February 10
Citing Potential March Release, Amgen Asks Court to Block Sales of Sandoz Biosimilar
February 9
Bioethics Commission Set to Endorse Adaptive Trials for Public Health Emergencies
February 9
Myriad Settles With Quest in Lawsuit On BRCA Testing Patent; One Suit Pending
February 9
FDA Issues Final Guidance for Industry On Abdominal Infection Drug Development
February 9
FDA Announces March 17 Panel Meeting For Celltrion's Remicade Biosimilar
February 9
Genetics Education for Health Professionals Can Improve Outcomes, IOM Report Says
February 9
Abiomed Kicks Shareholder Allegations It Made Misstatements About Key Product
February 9
President's Budget Request Includes $4.9 Billion in Total Resources for FDA
February 2
Hatch Stresses Intellectual Property Rights In Trans-Pacific Partnership Agreement
February 2
Court Prevents Former LabCorp Employee From Selling Embryo Testing Services
February 2
Court Finds Ricerca Liable Under Contract For Nordion's Litigation Costs, Expenses
February 2
New Rule Eases Personal Data Reporting To Hasten Access to Experimental Drugs
February 2
D.C. Final Rule Covers Transplant Reimbursement
February 2
White House Proposed Initiative Includes $215 Million for FY 2016, Rule Revisions
January 30
Senate Bill Would Require Penalized Pharma Companies to Invest in NIH, FDA
January 30
Senators Seek Comments on Report About Drug, Device Development
January 30
21st Century Cures Bill Likely to Pass, Would Shake Up Biomedical Landscape
January 30
Bipartisan Policy Center Launches Initiative to Modernize, Improve FDA
January 30
Senate Passes Bill to Give Terminally Ill Patients ‘Right to Try’ Experimental Treatments
January 30
Lessons Learned From IPR Proceedings in the Life Sciences
January 30
FDA Needs to Partner With Industry To Advance Medicine, Hamburg Says
January 29
Doctor Watson Will See You Now, If IBM Wins Fight With Congress
January 29
FDA's Standard Review Time for Drugs, Devices Shrinking, PwC Report Says
January 29
20 Percent of CDER-Approved Drugs in 2014 Were Personalized Medicines, Group Says
January 28
U.S. Biosimilars Companies Should Expect Hard Fight for Market Share, Attorney Says
January 28
Predictable Standards, Coverage Needed To Spur Development, Use of Genomic Tests
January 28
House Panel Releases Discussion Draft For 21st Century Cures Initiative
January 27
More Combination Drugs Would Receive Market Exclusivity Under Proposed House Bill
January 27
Board of Patient Outcomes Group Votes To Provide Funding for Two Obesity Studies
January 27
Growth of Non-HIPAA Regulated Health Data May Spark Major Changes, Attorney Says
January 27
Pfizer Earnings Forecast Falls Short On Patent Expiration, Currency Rates
January 27
FDA Warns Doctors Not to Use Certain Bone Grafts in Patients Under 18
January 27
Supreme Court Sends Three Cases Back To Federal Circuit in Light of Teva v. Sandoz
January 26
Gilead Expands Generic Sovaldi Pact To Add Investigational Combination Pill
January 26
Myriad, Invitae, Pathway, LabCorp Settle Myriad's Gene Screening Patent Litigation
January 26
Justices Set to Consider Petition on Standing To Appeal PTAB Decision at Federal Circuit
January 26
CBER Lists Blood, CGT Guidances Being Considered for 2015 Release
January 26
Pfizer $33 Billion Question Remains After It Sends Teva, Actavis Feelers
January 26
FDA Approves NPS's Natpara For Treating Hypoparathyroidism
January 26
FDA Looks to Improve Device Trials With New Guidance, Better IDE Process
January 26
FDA Asks for Input on Draft Guidance For Combination Product Manufacturing
January 26
FDA Appoints a Deputy Commissioner For Medical Products and Tobacco
January 26
Biotech Tax Credits, Stem Cell Study Grants Included in New Governor's Proposed Budget
January 26
Life Sciences Companies Must Mitigate Overseas Bribery, Corruption Risks, EY Says
January 23
FDA Approves Novartis's Vaccine Bexsero, For Serogroup B Meningococcal Disease
January 23
EMA Advises Suspension of 700 Drugs After Clinical Studies in India Questioned
January 23
Ebola Vaccine Trials May Face Limitations On Waning Epidemic; ZMapp Trials to Start
January 23
CIRM Revamps to Increase Efficiency, Speed Funding Approval, Official Says
January 23
Data Protection Standards for Genomics Lacking, Privacy Conference Speakers Say
January 23
Group to Offer Electronic Database For Sharing Cancer Treatment Data
January 22
Researchers Exert New Control On Genetically Modified Organisms
January 22
India's Proposed Amendments to the Drug and Cosmetics Act: Compensation for Injuries to Clinical Trial Participants and the Criminalization of Clinical Research
January 22
21st Century Cures Draft May Include One-Time Consent for Future Research
January 21
Obama Proposes Spending To Research Personalized Cures
January 21
Hepatitis C Clinical Trial Injury Claims Against Gilead May Proceed, Court Says
January 21
EMA Asks for Comments on Applying New EU Regulation to Clinical Trial Database
January 21
SCOTUS Goes Hybrid on Claim Construction; May Lead to Evidence Games Played at Trial
January 20