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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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House Lawmakers Still Hopeful Of ‘Cures' Vote in First Week of July
June 26
NIH Funding Would Increase Under Bills Approved by House, Senate Appropriators
June 26
FDA Seeks Projects to Integrate Collection Of Electronic Health Records, Trial Data
June 26
Context Remains a Concern as CMS Open Payments Data Release Nears
June 26
AHRQ Funds Centers to Support Patient-Centered Outcomes Research
June 26
Allergan Sues Over Investment Firm's IPR Patent Challenge, Alleges Extortion
June 25
Australian Parliament Lowers Drug Subsidies, Eases Path for Biosimilars
June 25
FDA Releases Guidance for Industry On Filling Injectable Drugs, Biologics
June 24
Intellectual Property Rights Are Challenge For Peru in Upcoming TPP Negotiations
June 24
Zimmer Divests Some Medical Devices As Purchase of Biomet Moves Forward
June 24
High Court's No Post-Patent Royalty Ruling Stalls Medical Discovery, Commercialization
June 23
Precision Medicine's Benefits Overstated By Proponents, JAMA Viewpoint Suggests
June 23
CBO Puts ‘Cures' Cost at $106 Billion, Even as Part D Offset Disappears
June 23
Biobetters: The Advantages and Challenges of Being Better
June 23
Verizon, Intel Announce Support for House ‘Cures' Bill, But Provider Groups Still Wary
June 23
Texas Enacts Biologic Substitution Law; Notification Provision Expires in 2019
June 23
Health-Tracking Wristband by Google Could Ease Research Data Collection
June 23
Minnesota Audit Calls for Faster Reporting Of Adverse Events by University Psych Dept.
June 23
Supreme Court Rejects Apotex's Bid To Revisit Inequitable Conduct Standard
June 22
NIH Issues Plan to Fix Systemic Issues At Research Drug Prep Section, Pharmacy
June 22
Drug Costing $9,200 Scores Zero On Cancer Doctor Value Scale
June 22
Senate Bill Seeks More Efficient Approach to Device Reviews at FDA
June 22
‘Voice of Patient,' Bull Market Bubble, BIO's Name Change Among Meeting Topics
June 22
Device Center Leader Asks If FDA Should Develop User Fee Goals for Combo Products
June 22
FDA to Focus on Companion, Complementary Diagnostics in Forthcoming LDT Framework
June 19
Class Action Suit Filed Against J&J's DePuy For Implant of Unapproved System in Trials
June 19
Privacy Principles for Precision Medicine Under Development by Advisory Panel
June 19
House Delays 21st Century Cures Proposal to Address Insurers' Objections
June 18
Outcome in Teva v. Sandoz Copaxone Dispute Unaffected by High Court Guidance
June 18
Biotech Patent Eligibility Chaos Spurs Proposals for Section 101 Amendments
June 18
Health-Care Research Agency Would Die In Republican Plan Approved by House Panel
June 18
NIH Seeking Personal Health Data From 1 Million Participants for Initiative
June 18
House Appropriations Subcommittee Approves FDA FY 2016 Funding Bill
June 18
Ruling Finding Celgene's Abraxane Doesn't Infringe Cephalon's Paclitaxel Patent Upheld
June 18
FDA's Woodcock Says 21st Century Cures Would Help Spur Needed Agency Changes
June 17
Investors Will Seek Long-Term Value As Biotech Mergers Heat Up, Pyott Says
June 17
IPR Patent Challenges Faster Than Courts, But Panelists at BIO Question Their Fairness
June 17
Antibody Patent Filers Advised to Adapt To AbbVie; Claim Structure, Not Function
June 17
Clinical Research Data Sharing Increasing But Risks to Patients Must Be Recognized
June 17
FDA Releases Draft Guidance On Investigational Device Exemptions
June 17
Rare Disease Patent Filings Up, Report Says, But Antibiotics May Lose Another Decade
June 16
Upton Expects House Vote on ‘Cures' Bill Soon, but More Work Necessary
June 16
Lawmaker ‘Nervous' About Cures Bill, Says Senate to Offer New Health IT Proposals
June 16
FDA Looking at Class II Device Trials To See if Greater Scrutiny Is Needed
June 16
Collaborating to Predict, Prevent Problems Can Spur Advances, Burrus Tells Drug Group
June 16
Officials Describe U.S. Role in ‘Incredible' Global Ebola Response, Cite Lessons Learned
June 16
Pilot Programs Needed to Test Ways To Pay for High-Cost Drugs, Analyst Says
June 16
U. Minn. Regents Approve Plan Limiting Compensation From Research Sponsors
June 16
Biotech Sets Financial Records in 2014, Nears $1 Trillion Market Cap, Report Says
June 15
FDA Approves St. Jude Medical's Deep Brain Stimulation Device for Movement Disorders
June 15
Consumers Suing 23andMe Over Testing Kits Must Arbitrate Individually, Not as a Class
June 15
Merck KGaA Purchase of Sigma-Aldrich Wins Authorization by European Commission
June 15
Federal Circuit Affirms Patent Ineligibility of Sequenom's Prenatal Test Methods
June 12
House Judiciary Committee Moves Patent Bill Forward, Battle Over Fee Shifting Looms
June 12
House Committee Draft Bill Would Change Regulation of Diagnostic Tests
June 12
Genzyme Appeals Patent Board's Invalidation Of Pompe Disease Patents to Federal Circuit
June 12
Committee Chairmen Ask GAO to Investigate Questionably Canceled Biothreat Contract
June 12
21st Century Cures Author Pushing For Floor Vote; FDA Official Praises Bill
June 17
Lawmaker ‘Nervous' About Cures Bill, Says Senate Will Make New Health IT Proposals
June 16
Drug Industry Criticizes FDA's Response To Company on Off-Label Statements
June 12
FDA Issues Final Guidance for Designing Early-Stage Gene Therapy Toxicity Studies
June 12
Insurers: Drugmakers Have ‘Blank Check' On Pricing, But System Isn't Sustainable
June 12
HHS Contracts to Develop Rapid Ebola Test
June 12
FDA Releases Draft Guidance on Assessing How Drugs Taken by Fathers Affect Embryos
June 12
Though Extenders Is Top Priority, It May Languish Until End of Year, Lawmaker Says
June 12
Biotech CEOs Among Highest-Paid U.S. Executives on Cancer Cures
June 11
Patient Data Registries Can Ease Research But Must Be Interoperable, Less Fragmented
June 10
India Fines GSK, Sanofi for Collusion On Tender to Supply Meningitis Vaccine
June 10
AICPA Urges IRS to Provide Clear Way To Fix Mischaracterizations of R&E Costs
June 10
Drug Firms Could Speed Muscular Dystrophy Treatments Thanks to Guidance, Groups Say
June 10
New Florida Law Gives Patients ‘Right to Try’ Unapproved Treatments
June 10
PhRMA's Attack on New Patent Transfer Rule Under Hart-Scott-Rodino Act Fails
June 9
New $500 Million Fund Pushes Biotech Closer to Record in Venture Investing
June 9
Patient Coalition Urges FDA to Replace Guidance Language on Biosimilar Labeling
June 9
FDA Tells Drugmaker Amarin It Doesn't Have Concerns About Bulk of Off-Label Statements
June 9
Medical Device, Drug Data Project Will Soon Play Larger Role at FDA
June 9
Breakthrough Drugs to Cost Government $50 Billion Over Decade, Insurers Say
June 9
Will State Action on Biosimilars Thwart Anticipated Savings for Private and Government Health Care Programs?
June 9
CAFC Denies Enzo's Request That It Revisit Decision Vacating $61M Infringement Verdict
June 8
Newborn Screening Law Could Hamper Important Research, NIH Staff Say in JAMA
June 8
What You Need to Know About 21st Century Cures Bill
June 8
Regulatory Agenda Includes Updates On Combo Products, Labeling Rules
June 8
Survey Says Indian Drugmakers Grappling With Data Integrity Issues
June 8
India Rejects Abraxis Cancer Drug Patent for Lack of Inventive Step
June 8
Hedge Funds Seeking Insider Advantage By Filing Patent Cases, Senator Tells SEC
June 5
Senate Panel OKs Patent Litigation Bill That Diverges From House Counterpart
June 5
House Republicans' Obamacare Repeal Bill Would Provide $15 Billion Increase for NIH
June 5
Government Says No Sanctions for Subsidies Offered to Recruit Subjects for Device Study
June 5
ACUS Recommends Publishing Previously Undisclosed ‘Pending' Rules
June 5
Court Strikes Physician's Defamation Claims Over Blogs on Use of Enbrel for Alzheimer's
June 5
AbbVie Asks FDA to Require Biosimilar Label To List Differences From Reference Biologic
June 4
NIH Suspends Drug Making Section After Finding Contaminated Drug Vials
June 4
EC Backs Animal Testing Ban in Theory But Says Not Currently Practical
June 4
Alabama Joins List of States Allowing ‘Right to Try’ Unapproved Treatments
June 4
Federal Circuit Struggles With BPCIA Language as Amgen Seeks Zarxio Delay
June 3
Precision Medicine Has Potential to Spur Health System Changes Beyond Initiative
June 3
Groups Say ‘Cures' Bill Could Lower Some Drug Approval Standards
June 3
Pharmacy Benefit Managers Object To Medicare Offsets in ‘Cures’ Bill
June 3
Court OKs Dendreon Reorganization Plan That Lays Out Shareholder Payments in Sale
June 3
Halozyme Enters Global Collaboration, License Agreement With AbbVie
June 3
Greater Access to Medicare Claims Data Part of Effort to Spur Tech Innovation
June 2
Biotech IPOs Set Records in 2014 But Misuse Could Chill Industry Investing
June 1
Soaring Cost, Toxic Effects Drive Race for Cancer Tests
June 1
NIH Mulls Design Challenges, Requests Feedback on Precision Medicine Study Design
June 1
First Cancer Trial in Precision Medicine Likely to Begin Enrolling Patients in July
June 1
House Leader Says Vote Possible In Mid-June on 21st Century Cures Bill
May 29
Big Pharma, Insurers Negotiate As Drug Costs Spiral Upwards
May 29
Kite Pharma on Cusp of Breakthrough In Cancer Immunotherapy, CEO Says
May 29
House Committee Examining FDA's Use of Untitled Letters
May 29
Merix Can't Escape Jury Verdict Freeing Supplier From Liability for Tainted Placebo
May 29
OIG Issues Updates for FY 2015 Work Plan, Including New Review of Part D Program
May 29
Nevada Governor Signs ‘Right to Try’ Law Giving Terminally Ill Access to Study Drugs
May 29
Colorado Governor Approves Tax Refund For Clean Tech, Medical Device Companies
May 28
Supreme Court Vacates, Remands Cisco; Mobile Device Case Affects Life Sciences
May 27
Dozens of Genes in Breast Cancer Tests Have Tenuous Link to Risk, Report Says
May 27
What You Need to Know About the ‘21st Century Cures’ Bill
June 8
Merix Can't Escape Jury Verdict Freeing Supplier from Liability for Tainted Placebo
May 29
Nevada Becomes Latest State to Enact ‘Right to Try’ Law for Terminally Ill Patients
May 29
Illumina Once Again Sues Ariosa, Says Harmony Prenatal Test Infringes Patent
May 20
Science and Technology Policy Office Asks For Views on Unifying Study of Microbiomes
May 20
Panelists Emphasize Patient Access To Biosimilars, Improved Patient Outcomes
May 20
Biopharmas Affected as Federal Circuit Affirms ‘Single Entity' Infringement Rule
May 19
FDA No Longer Trumps Common Rule In Latest 21st Century Cures Legislation
May 19
Biosimilars, Biologics Should Have Same Nonproprietary Name, Hospira Official Says
May 19
NAS, IOM Jump Into Controversy, Launch Major Human Gene Editing Initiative
May 18
Adaptive Trials May Be Used to Approve Devices, FDA Says in Draft Guidance
May 18
Court Stays CTE Global's Validity Suit On Novozymes' Digestive Treatment Patents
May 18
Public Citizen Asks OHRP to Investigate Research at UMinn, Reverse Decision
May 18
Tufts Study Says Over Next Five Years, Investing in Personalized Medicine Will Grow
May 18
Sidley Austin Partner to Become Deputy Director in FDA's Device Center
May 18
Portman, 10 Others Press for 12 Years Of IP Exclusivity for Biologics in Agreement
May 15
Collaborative Ebola R&D Sped to Success, Could Hurt Ongoing Trials, WHO Official Says
May 15
Congressman Says Patient Participation Is Key to Personalized Medicine
May 15
New Member Added to PCORI Standards Committee
May 14
21st Century Cures Legislation Approved By House Health Panel Without Changes
May 14
Release of Newest Version of Cures Legislation Sets Stage for Markup
May 13
Newest Cures Legislation Would Overhaul Federal Health IT, Data Exchange Efforts
May 13
Hepatitis C, Cancer, Compounded Drugs Driving Increase in Rx Costs, Report Says
May 13
Sen. Alexander Begins Investigation Into Agencies' Use of Regulatory Guidance
May 13
Rare Pediatric Disease Voucher for Genetic Disorder Drug, Fast Track for Cancer Drug
May 13
CIRM Aims to Increase Attractiveness Of Loan Program by Converting Grants
May 13
Minnesota Governor Signs Bill Allowing Terminally Ill to Try Investigational Drugs
May 13
Senate May Delay ‘Cures' Vote to Fall, Behind House Goal of Summer Floor Vote
May 12
FDA Enzyme Replacement Draft Guidance Covers First-Time Testing in Humans
May 12
FDA Issues Revised Draft Q&A Guidance For Biosimilar Product Development
May 12
Washington Governor Signs Biosimilars Bill With Pharmacist Notification Requirements
May 12
Tennessee Becomes Latest State To Adopt Right-to-Try Measure
May 12
House Panel Set to Hold May 14 Markup of 21st Century Cures Proposal
May 11
PTO Extends Deadline to Comment On Enhanced Patent Quality Initiative
May 11
FDA Approves Bayer's Avelox For Treating Patients With Plague
May 11
Georgia Governor Signs Legislation On Interchangeable Biological Drugs
May 11
Biogen Can't Challenge Interference Ruling By PTAB in District Court, Fed. Cir. Finds
May 8
Tippers in Martoma Insider Case Received Personal Benefit, DOJ Argues
May 8
Device Innovations Need Fresh Regulatory Approach, FDA's Shuren Says
May 8
Drugmaker Amarin Asks Court to Protect Free Speech Right to Discuss Off-Label Use
May 8
Blood-Testing Startup Theranos Hires Clinton Adviser as Counsel
May 8
Hearing Brings Stakeholders Together On Senate Version of Patent Litigation Bill
May 8
Brand, Generic Companies Establish Forum To Expand Patient Access to Biosimilars
May 7
Groups Praise FDA's Combination Product Draft Guidance, Want Some Changes
May 7
House Bill Would Provide Tax Incentives To Encourage Early Stage Research Investing
May 7
Analysis Shows Massachusetts Device Sector Number Two in Venture Capital Funding
May 7
Cures Legislation Will Aid Drug, Device Companies' Bottom Line, Ex-FDA Official Says
May 6
Federal Agencies Pressed for Specifics On Precision Medicine at Senate Hearing
May 6
Dutch Biotech Concern Dodges Investor Suit Over Phase III Trial
May 6
Patient Groups Express Concerns to FDA About Biosimilar Advisory Committee Process
May 6
EU-Wide Patent Regime Survives Spain's Legal Challenge; Expected to Begin in 2016
May 6
AbbVie Sells $16.7 Billion of Bonds In Third-Largest Debt Deal of 2015
May 6
Fed. Cir.'s Stay of Sandoz Biosimilar Release Shows Desire to Get First BPCIA Ruling Right
May 6
Breakthrough Status for Leukemia Drug, Orphan Status for Several Other Products
May 6
Amgen Wins Order Blocking Sandoz Neupogen Biosimilar Pending Appeal
May 5
FDA Device Official Says Final Guidance On Lab-Developed Tests Unlikely in 2015
May 5
Success of Gene Therapy to Treat Blind Appears to Wane With Time, Studies Find
May 5
Regado to Pay Parexel $5M to Settle Suit Over Study That Ended With Patient's Death
May 5
FDA Withdraws 47 Draft Guidances For Drug, Device and Blood Products
May 5
Three Areas of Patent Trolling Behavior, Can Four Bills Become One?
May 4
Two Years After SG Said Wait, Standard For Inequitable Conduct Back at High Court
May 4
FDA Doesn't Have LDT Oversight Authority, Would Lose Court Challenge, Panelists Say
May 4
DVC's Negligence Claim Against Lonza Dismissed, Breach Claim to Be Amended
May 4
When Adult Data for Devices May Be Used For Children Topic of FDA Draft Guidance
May 4
Gilead's Gaffe Leads Drugmakers To Pledge More Openness on Price
May 4
Bayer Enters Agreement With Isis To Develop Investigational Thrombosis Drug
May 4
Former PTO Director Says Challenges To Drug Patents Before PTAB Increasing
May 4
Former PTO Official Predicts ‘Opportunists' Will Continue to Challenge Drug Patents
May 4
New Member Added to PCORI Standards Committee
May 4
Brand, Generic Firms Establish Forum To Expand Patient Access to Biosimilars
May 7
BIO, PhRMA Criticize Senate Measure For Not Fixing IPR Proceeding Abuses
May 1
Cures Legislation Needs More Work, Energy and Commerce Panel Says
May 1
Official Says FDA to Work With Congress, Others to Address Gaps in Cures Legislation
May 1
More Final Guidance Needed From FDA, Republican Senators Say
May 1
Average Biotech Licensing Up 73 Percent To $58.7 Million in 2014, MoFo Report Says
May 1
Teva Infringed License, Must Return Proneuron's IP Rights, Court Rules
May 1
China's Record on IP Rights Top Among USTR Concerns in Special 301 Report
May 1
Sanofi Diabetes Drug Sales Drop After Lantus Gets Price Cut in U.S.
May 1
Georgia Governor Signs Bill On Biosimilar Drug Substitutions
May 11
FDA Approves Raplixa to Help Control Bleeding During Surgery
May 1
EHRs, Fitness Trackers Freed From Federal Oversight in Draft House Bill
April 30
Ethics, Safety Issues Mean NIH Won't Fund Gene Editing With Human Embryos
April 30
Amgen's Melanoma Immunotherapy Wins Backing of FDA Advisers
April 30
U.K. Bioscience Lobby Unveils Vision To Create Third Global Cluster by 2025
April 30
House Panel Releases Second Draft Of 21st Century Cures Legislation
April 29
NIH Would Get $10 Billion Boost by 2020 Under New House 21st Century Cures Draft
April 29
PTO Director Cites Theranos CEO As Example of Benefits of Patenting
April 29
Investors Should Urge Gilead to Disclose Risks of Setting High Prices, ISS Says
April 29
Hearing Brings Stakeholders Together On Senate Version of Patent Litigation Bill
May 7
Need for Speed Defines Race Between Gilead, Achillion for Hepatitis C Therapy
April 29
Chimps Give Way to ‘Humans on Chips' As Drugmakers Seek Lower Testing Costs
April 29
Fed. Cir. on Nautilus Remand: We Still Say These Patent Claims Aren't Indefinite
April 28
Stakeholders File Opposing Briefs to CAFC On BPCIA Info Exchange, Notice Provisions
April 28
FDA Releases Three Final Guidances For Industry on Developing Biosimilar Drugs
April 28
Too Many New Mandates Could Overwhelm FDA, Top Regulator Cautions Senate Panel
April 28
Regulating Personalized Medicine
April 28
Agency's New Drug Marketing Code Requires Physician Payment Reporting
April 28
FDA, CMS Create Joint Task Force On Oversight of Laboratory-Developed Tests
April 27
FDA Reviewers Question Benefit Of Amgen's T-Vec Melanoma Drug
April 27
Bill on Breakthrough Approvals For Devices Divides Stakeholders
April 27
Drop in Basic Research Funding Causing ‘Innovation Deficit' in U.S., Report Says
April 27
IRS Rules Simplifying Controlled-Group Research Tax Credit Allocation Amended
April 27
Court Denies Whistle-blower New Trial On Claims Biotech Falsified Grant Reports
April 24
Celsis In Vitro Appeals Ruling That Cell Freezing Storage Claims Are Invalid
April 23
‘Right-to-Try' Mandate Could Lead to Delays In Drug Approvals, Merck Execs Say in JAMA
April 23
Bass Expands Drug Patent Fight As Celgene, Shire Make Five Targets
April 23
Cochlear Asks Appeals Court to Throw Out Finding It Infringed Hearing Implant Claim
April 23
FDA Doesn't Have LDT Oversight Authority, Would Lose Court Challenge, Panelists Say
May 4
International, Multicenter Clinical Trials Can Be Authorized Under New Regulations
April 23
U.S. Biodefense Preparedness Worse After Budget Cuts, Panelists Tell Hearing
April 22
Use of Non-U.S. Clinical Trial Data For IDEs Covered in FDA Draft Guidance
April 22
New FDA Guidance on Lung Cancer Drugs Allows More Options in Outcome Measures
April 22
Court Says Denial of ‘Experimental Coverage' For Dying Woman Legal but ‘Monstrous'
April 21
Color Genomics Offers Gene Test For Breast Cancer Priced at $249
April 21
Roche's Experimental Breast-Cancer Drug Challenges Merck in Immunotherapy Race
April 21
FDA Seeks Comments on Interim Assessment Of Drug Review Transparency Program
April 21
Diagnostics Companies, Inserm Team Up To Make Cancer-Causing Mutation Database
April 21
FDA Approving More Drugs, Combating Opioid Abuse, Acting Commissioner Says
April 21
FDA's Office of Chief Counsel Working To Implement New Authorities, Official Says
April 21
Drugmakers Reaping Rewards From Deals Signal M&A Boom Will Last
April 21
Panelists Say Precision Medicine Revolution Is Changing Medical Practice Weekly
April 20
FDA Asks Genervon to Release All Study Data for Experimental ALS Drug
April 17
Medicare Coverage Proposed for Cervical Cancer Screening With HPV Tests
April 17
NIH Issues First Grants to Identify Antibiotic-Resistant Pathogens Faster
April 10
Natco Takes Patent Blitz Honed In India to U.S. Pharma Market
April 10
More Than 240 New Drugs In Development For Blood Cancers, PhRMA Report Says
April 10
AbbVie Spared Humira Royalties, CAFC Affirms Trust's RA Patent Invalid
April 9
Forced Labor Claims of Serb Researchers With H-1B Visas May Proceed, Court Says
April 9
EU Adopts New Safety Standards For Human Tissue, Cell Donations
April 9
Teva Mulls Next Move as Mylan's Perrigo Bid Jolts Drugmakers
April 9
Court Won't Require Removal of Blogs That Physician Said Caused Him Harm
April 9
PTO Reviews Eligibility Guidance Changes, Downplays New Streamlined Analysis Option
April 8
Novartis Will Pay Juno $12M Plus to Settle Cancer Treatment Patent, Contract Disputes
April 8
Novartis Wins FTC Final Approval Of Acquisition of Certain GSK Drugs
April 8
Governor Signs Bill Allowing Biologic Drug Substitutions
April 8
‘Research-Ready Culture' Among Patients Said Needed to Foster Their Participation
April 8
Spending More on Cancer Care Yields Better Outcomes, Researcher Says
April 8
Data Sharing, E-Labeling Initiatives Aim to Enhance Clinical Trials Process
April 8
Novo Nordisk Sues Baxter Over Validity While Preparing to Launch Hemophilia Drug
April 7
InVivo Therapeutics Avoids Would-Be Securities Class Suit Over Press Releases
April 7
Enzo Life Sciences Sues Hologic, Says Prostate, STI Tests Infringe
April 7
IPXpharma Sues Millennium Again, Says Velcade Infringes Its Patent
April 7
Bristol to Buy Stake in Uniqure, Maker of $1 Million Gene Therapy
April 7
Shire ‘Confident’ in Fighting Hayman After Victory Over Actavis
April 7
H-1B Workers Boost Wages, Jobs, Economy, Council Asserts in ‘Primer' on Visa Program
April 7
Patient-Centered Outcome Fee Increases 4 Percent for Policies Ending Before Oct. 1
April 7
J&J's Ethicon Announces New Use Approved by FDA for Evarrest Patch
April 7
FDA Releases Interim Report on Program To Enhance Drug Review Transparency
April 6
Former FDA Leader Hamburg Named Institute of Medicine's Foreign Secretary
April 6
Governor Signs Bill for Doctor Notification When Biosimilar Drugs Dispensed
April 6
Baxter International, Johnson & Johnson Settle Infringement Suit Over Baxter's Floseal
April 3
More Stringent CLIA Regulation of LDTs, Not FDA Oversight, Advised at IOM Workshop
April 3
IRS Eliminates Extra Math in Allocating Controlled-Group Research Tax Credit
April 3
FDA Releases Interim Report on Program To Enhance Drug Review Transparency
April 3
Hedge Fund Manager Targets Shire In Two New Drug Patent Challenges
April 2
CMS Releases Documents on Paying For Biosimilars in Medicare, Medicaid
April 1
Patent Reform Bill Provisions Would Hurt Investment in Life Sciences, Executives Say
April 1
Quintiles, Quest Diagnostics Joint Venture To Offer Clinical-Trial Services to Drugmakers
April 1
Biases in Publication, Reporting Overstate Anxiety Drug Study Outcomes, Analysis Finds
April 1
Court Says Plaintiff Owes Attorneys' Fees In Suit Over Patent It Knew It Didn't Own
April 1
Pharma's Comeback Deals Keep Drug M&A on Track to Reach Records
April 1
AbbVie Deutschland and Unknown Embodiments: Has the Written Description Requirement for Antibodies Gone Too Far?
April 1