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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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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
PTO Patent Eligibility Guidance Round Two: Better Than First; Commenters Want More
March 31
Explain Nature-Based Claim Patentability Using Science, Attorneys Suggest at ABA
March 31
FDA Issues Guidance on Requesting Critical Path Innovation Meetings
March 31
Court Revisits, Reaffirms Opinion Claims For Cell-Freezing Method Are Natural Law
March 31
Governor Signs ‘Right to Try' Bill For Phase I Investigational Products
March 31
Hamburg Expresses Pride in Stronger FDA, Worries About Funding, Unfunded Mandates
March 30
PTO 3-Part Plan to Revise PTAB Procedures Favors Patent Owners, May Balance Scales
March 30
FDA Might Revise Guidance on Data in INDs From Early Trials With Live Organisms
March 30
FDA Encourages Applicants to Use WHO Drug Dictionary in Submissions
March 30
Teva Will Purchase Auspex, Maker of Nervous System Drugs
March 30
FDA Denies Amgen's Petition to Require BPCIA Information Exchange Compliance
March 27
Genzyme Not Liable for Alleged Harm Caused by Shortage of Fabrazyme
March 27
Ebola Vaccines to Enter Final Testing Stage After Success in Mid-stage Trials, NIH Says
March 27
White House Plan to Fight Superbugs Promotes Research on New Antibiotics
March 27
U.S. Image as Innovation Nation Burnished by Surge in R&D Spending
March 26
From Pills That Snitch to Xbox Sensors, Novartis Goes High Tech
March 26
Amgen's Iceland DNA Quest Scans Nation's Genes for Disease Clues
March 26
CER's Impact on Health-Care Decisions Is Three Years Away, According to Webinar
March 26
FDA Seeks Comment on Reporting Provisions In Guidance for Data Monitoring Committees
March 26
Practitioners Warn New L-1B Guidance May Not Be All Good News for Businesses
March 26
Utah Final Rule Eases Controlled Substance Research
March 26
CIRM Proposes Rule on Conflicts of Interest
March 26
Court Dismisses Professor's Claims He Invented Patents for Concerta to Treat ADD
March 25
FDA Approves Anthrasil to Treat Anthrax When Used With Other Drugs
March 25
Merck's Melanoma Drug Trial Stopped Early After Improvements Seen Over BMS Product
March 25
Orphan Status Granted to Treatments For Multiple Myeloma, Other Conditions
March 25
Stakeholders Say Single IRB, Registries Could Cut Drug Development Costs
March 24
Faster FDA Spurs Breakthroughs As New Drug Approvals Surge
March 24
House Democrats Back Extender Renewals With Offsets in Budget Substitute Amendment
March 24
Alzheimer's Therapy Debate Revived Even as Biogen's Drug Trial Advances
March 24
Governor Signs Right-to-Try Legislation On Early Access to Unapproved Therapies
March 24
FDA Issues Final Guidance on Gauging Need For Environmental Assessment in INDs, BLAs
March 24
Work Starts on Improved Anthrax Vaccine That Would Require Fewer Doses, HHS Says
March 24
FDA Issues Guidance on Electronic Submission of Lot Reports for BLAs
March 24
FDA Releases Report on CDER's Drug Safety Regulatory Science Needs, Priorities
March 24
Bill Would Require FDA to Expedite Review of Drugs Approved in Europe
March 24
District Court Dismisses Investor Lawsuit Against Drugmaker Aveo
March 24
Woodcock Says Precision Medicine Effort Reinforces Existing FDA Programs
March 23
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