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Pharmaceutical Law & Industry Report

Bloomberg BNA's Pharmaceutical Law & Industry Report® helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries.

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EXPERT NEWS & COMMENTARY

Get in-depth news coverage of wide-ranging developments affecting the pharmaceutical industry, from patent litigation to economic issues to fraud prevention. Follow major actions at the federal and state level focusing on intellectual property/patent issues, drug pricing and reimbursement, FDA oversight, and Federal Trade Commission antitrust enforcement. 


TRUSTED LEGAL ANALYSIS

Save hours of reading time with analytical articles on emerging case law and current litigation by practicing attorneys. Understand how health plans, pharmacy benefit managers, and employers develop and apply drug cost-containment strategies and modifications to health plan benefits.

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TIMESAVING TOOLS

Access anti-fraud and antitrust enforcement activity of the Federal Trade Commission (FTC), HHS Office of Inspector General (OIG), and state attorneys general and quickly link to important online documents, such as Federal Register notices and court decisions.


TOPICS COVERED

  • Drug patent litigation
  • Drug pricing lawsuits brought by states and consumers
  • FDA oversight of new drug approvals
  • Fraud and abuse investigations
  • FTC antitrust enforcement
  • Generic drugs
  • Health-plan pharmacy benefits
  • Medicare drug benefit
  • Medicare/Medicaid coverage, reimbursement,
  • payment policies
  • Product safety and liability
  • Regulation of drug company advertising and marketing

SPECIFICATIONS

Notification: current reports providing news and developments.

Formats and Frequency

Web notification is published continually. 
Print notification is available weekly. Print current reports are indexed every six months, culminating annually. Web current reports are archived to 01.17.2003, with archive coverage of Pharmaceutical Law & Policy Report since 07.12.2001. 
E-mail summaries, providing the highlights and table of contents for each report, with URLs to full text articles and documents are also available.


RECENT HEADLINES

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‘Cures' Bill Released for Markup; Maintains Increases for NIH, but No New FDA Money
May 19
Federal Circuit Affirms ‘Single Entity' Infringement Rule, Will Affect Biopharmas
May 19
Biosimilars, Biologics Should Have Same Nonproprietary Name, Hospira Official Says
May 19
Actavis Met With DOJ to Discuss Resolving Probe of Warner Chilcott's Rx Sales Tactics
May 19
FDA Warns Certain Type 2 Diabetes Drugs May Cause High Levels of Blood Acids
May 19
FDA Approves Janssen's Invega Trinza, Three-Month Injection for Schizophrenia
May 19
FDA Approves Labeling Update About Recurrence Rate for Endo's Xiaflex
May 19
FDA Warns Two Pharmacies About Violations Involving Production
May 19
Family Health-Care Costs Increased 6.3 Percent in 2015, Milliman Report Finds
May 19
FDA Grants Orphan Designation To AbbVie's Humira, Other Drugs
May 19
E-Rx for Controlled Substances Grows but Only Among Few Doctors
May 19
Claims Must Fail Against Branded Maker, Despite Alabama Court Ruling, Wyeth Says
May 19
Government to Let Pharmacies Offer Discounted Pharmaceuticals
May 19
Hatch-Waxman Litigation Update
May 19
No High Court Review in Lawsuit Involving Generic Drug Label Update
May 18
FDA to Hold Public Meeting in July On Using Naloxone for Opioid Overdoses
May 18
Endo Will Purchase Par Pharma For $8B Amid Hunt for More Deals
May 18
FDA Approves Baxter's Facility in Spain For Making Sodium Chloride Injection
May 18
Injunction Against Indian Generic Maker In Sitagliptin Case Meant to Speed Things Up
May 18
21st Century Cures Legislation Approved By House Health Panel Without Changes
May 15
Clinical Study Countering Skelaxin Concerns Falls Within Hatch-Waxman Act's Safe Harbor
May 15
Teva No Longer Barred From Launching Generic of Warner Chilcott Osteoporosis Rx
May 15
PharMerica to Pay $31.5 Million To Settle Controlled Substances Allegations
May 15
CVS Settles Illegal Prescription Drug Allegations in Two Florida Stores for $22M
May 15
Tufts Study Says Over Next Five Years, Investing in Personalized Medicine Will Grow
May 15
FDA Approves Migraine Drug Treximet For Use in Certain Pediatric Patients
May 15
Patient Coalition Calls on CMS To Reject Discriminatory Health Plans
May 15
Portman, 10 Others Press USTR on TPP For 12 Years of IP Exclusivity for Biologics
May 15
Drugmakers Need Incentives to Develop New Generation of Antibiotics, U.K. Report Says
May 15
Russian Authorities Revise Rules For Price Controls for Medicines
May 15
Release of Newest Version of Cures Legislation Sets Stage for Markup
May 13
California Ruling in Pay for Delay Case May Create Headaches for Drug Companies
May 13
Sen. Alexander Begins Investigation Into Agencies' Use of Regulatory Guidance
May 13
As Second Open Payments Release Date Nears, Industry Feels Increased Burdens
May 13
California Top Court Poised to Decide Daimler Jurisdiction Issue in Plavix Case
May 13
FDA Submits Proposed Surveys on Generic Pill Appearance to OMB for Clearance
May 13
Hepatitis C, Cancer, Compounded Drugs Driving Increase in Rx Costs, Report Says
May 13
Trial Court Dismisses RICO Claims In Lawsuit Over Risperdal Injury
May 13
Rare Pediatric Disease Voucher for Genetic Disorder Drug, Fast Track for Cancer Drug
May 13
ANI Pharmaceuticals Acquires Rights To Testosterone Gel Product From Teva
May 13
Governor Signs Legislation Allowing Terminally Ill to Try Investigational Drugs
May 13
Hatch-Waxman Litigation Update
May 13
Meijer Sues Ranbaxy, Says Drugmaker ‘Mucked Up’ FDA Generic Rx Approvals
May 12
Senate May Delay ‘Cures' Vote to Fall, Behind House Goal of Summer Floor Vote
May 12
AndroGel Makers Can't Compel FTC to Hand Over All Data Underlying Published Studies
May 12
Governor Signs Biotech Drug Bill With Pharmacist Notification Language
May 12
Vertex Cystic Fibrosis Combination Wins Backing of FDA's Advisers
May 12
Tennessee Becomes Latest State To Adopt Right-to-Try Measure
May 12
FDA Issues Revised Draft Q&A Guidance For Biosimilar Product Development
May 12
FDA to Hold Public Meeting On Next Version of PDUFA
May 12
Federal Circuit Affirms ‘Single Entity' Infringement Rule, Will Impact Biopharmas
May 19
No High Court Review in Lawuit Involving Generic Drug Label Update
May 18
No FDA Approval Yet for J&J's Application Seeking to Expand Invega Sustenna's Label
May 12
House Panel Set to Hold May 14 Markup of 21st Century Cures Proposal
May 11
J&J Among Drug Companies Getting Chicago's Opiates Suit Tossed
May 11
HHS Says Alzheimer's Drug Switch Could Cost Programs Billions
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
Governor Signs Legislation On Interchangeable Biological Drugs
May 11
Drugmakers Subject to Antitrust Scrutiny For Patent Deals Under California Ruling
May 8
AstraZeneca Patent on Pulmicort Respules Invalid, Appeals Court Says
May 8
FTC's AndroGel Reverse Payment Suit Doomed by Lack of Cash Payment
May 8
Drugmaker Amarin Asks Court to Protect Free Speech Right to Discuss Off-Label Use
May 8
Hearing Brings Stakeholders Together Behind Senate Version of Patent Litigation Abuse Bill
May 8
Abuse of Pain Pills Fuels Virus's Spread, Confounding Regulators
May 8
Groups Praise FDA's Combination Product Draft Guidance, Want Some Changes
May 8
Brand, Generic Firms Establish Forum To Expand Patient Access to Biosimilars
May 8
Tippers in Martoma Insider Case Received Personal Benefit, DOJ Argues
May 8
New York City Clinic Owner Convicted Of Running $165M Oxycodone Ring
May 8
Instruction to ‘Tell Your Doctor' of Pain Doesn't Induce Infringing Use of Drug
May 6
Court's Amgen Biosimilar Order Shakes Up Game or Prolongs Suspense, Attorneys Say
May 6
Patient Groups Express Concerns to FDA About Biosimilar Advisory Committee Process
May 6
Cures Legislation Will Aid Drug, Device Companies' Bottom Line, Ex-FDA Official Says
May 6
Court Further Whittles State Law Claims In Lidoderm Pay-for-Delay Litigation
May 6
Diabetes Drugs Compete With Prices That Rise in Lockstep
May 6
FDA to Hold Advisory Panel Meeting On Sprout's Drug to Boost Female Libido
May 6
White House OMB Begins Review Of ‘Omnibus’ Guidance on Rx Discounts
May 6
Breakthrough Status for Leukemia Drug, Orphan Status for Several Other Products
May 6
Canadian Regulator Aims to Clarify Listings of Combination Drug Patents
May 6
Actos Makers Face Reverse Payment Suit
May 6
New Member Added to PCORI Standards Committee
May 6
Hatch-Waxman Litigation Update
May 6
Trial Court Tosses RICO Claims In Lawsuit Over Risperdal Injury
May 13
Minnesota Governor Signs Bill Allowing Terminally Ill to Try Investigational Drugs
May 13
Amgen Wins Order Blocking Sandoz Neupogen Biosimilar Pending Appeal
May 5
OIG: Government Inspections of Generic Drug Manufacturers Improve, but Work Remains
May 5
Gilead Dodges Claims That Hep C Drug Prices Violate ACA's Anti-Discrimination Provision
May 5
FDA Official Says Drug Shortages Declined ‘Significantly' in Recent Years
May 5
FDA Withdraws 47 Draft Guidances For Drug, Device, Blood Products
May 5
DaVita Prepared to Pay Estimated $495M to Settle False Claims Lawsuit
May 5
Tygacil Warning Claims Survive Dismissal, But Fraud Not Sufficiently Pleaded
May 5
High Court Stays Out of Baraclude Patent Case Over Use of ‘Unexpected Results'
May 4
Two Years After Government Said Wait, Inequitable Conduct Standard Back at Court
May 4
Express Scripts Subsidiary to Pay $60M In Settlement for Novartis Kickback Scheme
May 4
Drug and Device Enforcement Trends to Watch
May 4
Apotex's Complaint Over Eye Drug Stays Alive in Delaware Federal Court
May 4
Governor Signs Legislation On Biosimilar Drug Substitutions
May 11
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
Gilead's Gaffe Leads Drugmakers To Pledge More Openness on Price
May 4
FDA Approves Cough, Cold Drug From Vernalis, Tris Pharma
May 4
FDA Warns California Pharmacy Of Violations in Producing Sterile Drugs
May 4
Bayer Enters Agreement With Isis To Develop Investigational Thrombosis Drug
May 4
FTC Official Says Third Circuit Reverse Payments Ruling Due Out ‘Any Day Now'
May 1
Attorney Says Calif. Cipro Case May Cause States to Scrutinize Drug Patent Settlements
May 1
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
FDA, CMS Officials Outline Efforts to Combat Opioid Abuse
May 1
More Final Guidance Needed From FDA, Republican Senators Say
May 1
Amgen's Melanoma Immunotherapy Wins Backing of FDA Advisers
May 1
GlaxoSmithKline Wins FDA Approval To Sell Breo Only to Adults With Asthma
May 1
FDA Approves Raplixa to Help Control Bleeding During Surgery
May 1
Sanofi Diabetes Sales Drop After Lantus Gets Price Cut in U.S.
May 1
Acid Reflux, Blood Pressure Drugs Top CMS Lists on Part D Spending, Usage
May 1
Teva Infringed License, Must Return Proneuron's IP Rights, Court Rules
May 1
U.K. Bioscience Lobby Unveils Vision To Create Third Global Cluster by 2025
May 1
House Panel Releases Second Draft Of 21st Century Cures Legislation
April 29
FDA Approves First Generics Of Antipsychotic Drug Abilify
April 29
Reverse Payments Not Limited To Cash, FTC Commissioner Says
April 29
Need for Speed Defines Race Between Gilead, Achillion for Hepatitis C Therapy
April 29
Merck Receives Another FDA Letter Rejecting Sugammadex Injection
April 29
Double-Chin Injectable Drug From Kythera Wins FDA Approval
April 29
Cigna's Mail-Order Plan for Specialty Drugs Alleged to Discriminate Against HIV Patients
April 29
Fast Track for Fabry Disease Drug; Priority Review for Hepatitis C Drug
April 29
Spectrum Sues to Undo FDA Approval Of ‘Carved-Out' Generic Version of Fusilev
April 28
FDA Releases Three Final Guidances For Industry on Developing Biosimilar Drugs
April 28
HRSA Moves Closer to Creating Drug Ceiling Price Website for 340B Program
April 28
TWi, Takeda Settle Patent Litigation Over Generic Version of Dexilant
April 28
Stakeholders File Opposing Briefs to CAFC On BPCIA Info Exchange, Notice Provisions
April 28
Too Many New Mandates Could Overwhelm FDA, Top Regulator Cautions Senate Panel
April 28
Takeda Said to Agree to Pay $2.3 Billion To Settle Thousands of Actos Cases
April 28
GPhA Urges FDA to Adopt Alternative To Proposed Generic Drug Labeling Rule
April 28
India's Wockhardt Recalls Some Drugs From U.S. Market
April 28
Watchdog Agency Strengthens Pharmaceuticals Marketing Code
April 28
Justices Again Deny Review in Suit Alleging Generic Drugmaker Didn't Update Label
April 27
Senate, House Democrats Urge FDA To Adopt Proposed Generic Labeling Rule
April 27
Personal Jurisdiction in Hatch-Waxman Cases Uncertain After Daimler
April 27
Lawmakers Seek Transition Period For Medicaid Rx Reimbursement
April 27
Impax, CorePharma Merger May Proceed With Divestitures
April 27
Citing OIG Report, Florida Senator Calls for Medicare-Medicaid Rebate Parity
April 27
House Panel Members Continue to Seek Ways to Prevent Rx Drug, Heroin Abuse
April 24
FDA Approves Cyramza for Use In Certain Colon Cancer Patients
April 24
‘Right-to-Try' Mandate Could Lead to Delays In Drug Approvals, Merck Execs Say in JAMA
April 24
Bass Expands Drug Patent Fight As Celgene, Shire Make Five Targets
April 24
Suits: Xarelto Marketed as ‘One Size Fits All'; No Disclosure on Lack of Reversal Agent
April 24
Canadian Court Upholds Invalidation Of Viiv's Patent for HIV Drug Kivexa
April 24
Suboxone Maker Must Continue Fighting Direct Purchaser Product Hopping Claims
April 22
FDA Starts Reauthorization Process For Generic Drug User Fee Program
April 22
Teva Bid for Mylan Sparks Worries Of Rising Generic Drug Prices
April 22
Roche's Experimental Breast-Cancer Drug Challenges Merck in Immunotherapy Race
April 22
FDA Grants Breakthrough Status to Lung Cancer Drug, Fast Track for Hepatitis Drug
April 22
FDA Tentatively Approves Generic Of Bystolic; Approves Generic of Kenalog
April 22
FDA Grants Orphan Status to Drugs That Treat Lymphoma, Ovarian Cancer
April 22
Nonobviousness of AzaSite Patents Upheld, Sandoz Generic Version Would Infringe
April 10
AbbVie Spared Humira Royalties, CAFC Affirms Trust's RA Patent Invalid
April 10
Court Finds Purdue's Patent on Reformulated Abuse-Resistant Painkiller OxyContin Invalid
April 10
FDA Chided for Delaying Tactics in Abilify Case; Agency Ordered to Supplement Record
April 10
Merck Sues Apotex, Alleging Nasonex Patent Infringement
April 10
FDA Warns Galena of Violations At Manufacturing Facility in Oregon
April 10
Teva Mulls Next Move as Mylan's Perrigo Bid Jolts Drugmakers
April 10
Astrazeneca's Diabetes Drug May Raise Death Risk, FDA Analysis Says
April 10
More Than 240 New Drugs In Development For Blood Cancers, PhRMA Report Says
April 10
Pfizer Assailed at Opening Of Zoloft Birth Defect Risk Trial
April 10
Natco Takes Patent Blitz Honed In India to U.S. Pharma Market
April 10
Baxter Voluntarily Recalls Intravenous Solutions Due to Potential Particulate Matter
April 10
Rising Prices of Rx Drugs Unsustainable, Consumer Groups, NAMD, Others Say
April 10
State Repeals Rule Requiring Drugmakers To Report Annual Spending on Advertising
April 10
Vermont Governor Calls on Maker Of Naloxone to Halt Spike in Pricing
April 10
Indian Foreign Trade Watchdog Begins Using Drug Tracking System With Bar Codes
April 10
Drugmakers Can Hike Prices Of 509 Essential Medicines in India
April 10
Federal Circuit Lifts Injunction on Sandoz Sales of Generic Copy of Spectrum's Fusilev
April 8
OMB Reviewing Penalty Proposal For 340B Drug Discount Program
April 8
Novartis Wins FTC Final Approval Of Acquisition of Certain GSK Drugs
April 8
FDA Grants Two Breakthrough Designations to Hepatitis C Drug
April 8
FDA Warns Two N.Y. Pharmacies Of Drug Compounding Violations
April 8
Gilead Submits Application to FDA For Fixed-Dose Combination HIV Drug
April 8
Senators Request Increased Funding For HHS to Combat Rx Drug Abuse
April 8
‘Research-Ready Culture' Among Patients Said Needed to Foster Their Participation
April 8
Electronic Drug Alert Program Improves Patient Safety in ACOs, Study Finds
April 8
No Preemption in Lexapro Suicide Case, But Defendant Wins Judgment on Causation
April 8
Drug Manufacturer Glenmark to Pay $25 Million in Resolving Case With Texas
April 8
Governor Signs Bill Allowing Biologic Drug Substitutions
April 8
Governor Signs New Law Clarifying State Authority to Investigate PBM Pricing
April 8
FDA Approves Perrigo's Generic of Exalgo
April 8
Hatch-Waxman Litigation Update
April 8
AstraZeneca $76M Win in Prilosec Patent Infringement Case Affirmed by Fed. Cir.
April 7
Court Refuses to Dismiss Prolensa Patent Suit Over Jurisdictional Issues
April 7
Novo Nordisk Sues Baxter Over Validity While Preparing to Launch Hemophilia Drug
April 7
FDA Warning Letter Finds Problems At Hospira Manufacturing Plant in Italy
April 7
IPXpharma Sues Millennium Again, Says Velcade Infringes its Patent
April 7
Drugmaker Dodges Off-Label FCA Claims, But Kickback, Conspiracy Claims Stick
April 7
Drugstore Chain Files Antitrust Complaint Over Solodyn Competition
April 7
Shire ‘Confident’ in Fighting Hayman After Victory Over Actavis
April 7
Patient-Centered Outcome Fee Increases 4 Percent for Policies Ending Before Oct. 1
April 7
Prior Relationship With Drugmaker Disqualifies Plaintiffs' Expert in Some Areas
April 7
Tennessee Physician Sentenced To 28 Months in Prison for Fraud
April 7
FDA Issues Guidance on Submitting Revisions to Risk Plans for Drugs
April 6
FDA Issues Notices on Two Companies’ Pediatric Priority Review Vouchers
April 6
Former FDA Leader Hamburg Named Institute of Medicine's Foreign Secretary
April 6
Benicar Suits Head for New Jersey; Plaintiffs Say Drug Causes GI Problems
April 6
Governor Signs Bill for Doctor Notification When Biosimilar Drugs Dispensed
April 6
Teva Settles Classes' Generic Delay Allegations Over Nexium for $24 Million
April 3
Two Pharma Companies Win Dismissal Of FCA Off-Label Marketing Claims
April 3
Teva Launches New Drugs, Sells Dialysis Unit in Line With Restructuring
April 3
FDA Releases Interim Report on Program To Enhance Drug Review Transparency
April 3
Hedge Fund Manager Targets Shire In New Drug Patent Challenges
April 3
FDA Submits Study on Impact of Price Comparisons in Rx Drug Ads to OMB
April 3
FDA's Panel on Anti-Infective Drugs Renamed Antimicrobial Drugs Advisory Panel
April 3
Contacts Insufficient for General Jurisdiction, District Court Says; Case Transferred
April 3
Brazil's Annual Readjustment Of Prices Labeled Insufficient by Industry
April 3
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
Court Finds Purdue Patents on Sleep Drug Intermezzo Invalid for Obviousness
April 1
FDA Releases Guidance on Evaluation, Labeling of Abuse-Deterrent Opioids
April 1
Strengthening Pending and Future Application Portfolios in Advance of Potential Attack in AIA Proceedings
April 1
J&J Units Settle False Ad Suit With GSK; Settlement Over Flonase Ads Confidential
April 1
Takeda Said to Offer $2.2 Billion To Settle Actos Cancer Risk Litigation
April 1
Pharma's Comeback Deals Keep Drug M&A on Track to Reach Records
April 1
Unsealed FCA Case Alleges Kickbacks by Drugmaker Teva
April 1
FDA Accepts Supplemental Application For Kyprolis, Grants Priority Review
April 1
FDA Grants Orphan Status to Treatments For Lymphoma, Hepatitis D, Hypertension
April 1
Oncologist Pleads Guilty to Dispensing Foreign, Misbranded Drugs to Patients
April 1
State Proposes Amended Regulations On Drug Compounding for Pharmacies
April 1
Mylan, Sandoz Launch Generics of Exforge
April 1
Hatch-Waxman Litigation Update
April 1
Daiichi's Creative Use of Disclaimer Can't Stop Apotex's Pursuit of Generic Benicar
March 31
Court Won't Stay Atelvia Patent Invalidity Ruling, but Temporarily Stops Generic Launch
March 31
Public Citizen Asks FDA to Stop Off-Label Promotions of Diabetes Drugs
March 31
FDA Issues Guidance on Requesting Critical Path Innovation Meetings
March 31
FDA Approves Jadenu Tablets For Treating Chronic Iron Overload
March 31
Federal Law Doesn't Bar Claims Against Maker of Withdrawn Generic Drug
March 31
Merck Can't Evade False Claims Act Case Over Off-Label Drug Marketing
March 31
Court Won't Reconsider Finding of ‘Large And Unjustified' Payment in Modafinil Case
March 31
Governor Signs Right-to-Try Bill For Phase I Investigational Products
March 31
High Court Denies Review in Another Case Alleging Generic Maker Didn't Update Label
March 30
Hamburg Expresses Pride in Stronger FDA, Worries About Funding, Unfunded Mandates
March 30
FDA Strengthens Warnings on Allergic Reactions With Anemia Drug Feraheme
March 30
FDA Releases Draft Guidance On Near Infrared Analytical Procedures
March 30
FDA Issues Complete Response Letter For Adamis Pharma's Epinephrine Product
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
Director of Generics Office on Leave; Peters to Serve as Acting Director
March 30
EC Reverses Course, Approves Germany's Drugmaker Rebate Exemptions
March 30
FDA Denies Amgen's Petition to Require BPCIA Information Exchange Compliance
March 27
Otsuka Sues FDA Over Abilify Decision, Says Agency Actions Violated APA
March 27
FDA's Proposed Generic Drug Labeling Rule Would Cause Confusion, Industry Groups Say
March 27
House Panel Members Seek Ways To Prevent Rx Drug, Heroin Abuse
March 27
Genzyme Not Liable for Alleged Harm Caused by Shortage of Fabrazyme
March 27
Aetna to Lower Costs for Most HIV Drugs After Group's Complaint
March 27
CER's Impact on Health-Care Decisions Three Years Away, Stakeholders Say
March 27
GlaxoSmithKline Wins Summary Judgment In Bone-Fracture Suit Involving Avandia
March 27
Court Dismisses Three of Four Counts Filed Over State's Zohydro Restrictions
March 18
Court Likely to Rule BPCIA Information Exchanges Not Mandatory, Attorneys Say
March 18
What Conclusions Should Be Drawn From Senator Markey's Queries To Pharmacy Chains Regarding Accessible Prescription Drug Label Practices?
March 18
Novo Sees U.S. Price Gains Even With New Sanofi Insulin
March 18
DEA Issues Nationwide Alert on Fentanyl As Threat to Health and Public Safety
March 18
FDA Approves Cholbam to Treat Rare Bile Acid Synthesis Disorders
March 18
Orphan Status Granted to Treatments For Hypertension, Cancer, Other Conditions
March 18
Ignyta Acquires Four Oncology Development Programs From Teva
March 18
Hatch-Waxman Litigation Update
March 18
Appeals Court Revives Investor Suit Over FDA Rejection of New Drug Application
March 17
Public Citizen Sues FDA Over Wheat Gluten in Medications
March 17
Litigation Over Eye Drug AzaSite Against Mylan Settled, InSite Vision Says
March 17
House Approves Bill on Timely DEA Scheduling of New Medicines
March 17
OIG Says Sandoz Will Pay $12.6M To Settle Drug Pricing Allegations
March 16
Merck Anticipates Another FDA Letter Rejecting Sugammadex Injection
March 16
Price of New Cholesterol Drugs Seen as Key for Amgen, Sanofi
March 16
Gov. Cuomo Signs Bill Delaying New York's E-Prescription Requirement
March 16
Federal Circuit Bars Copies of Pulmicort Respules Pending Outcome of Astra's Appeal
March 13
Another Venture Investor Challenges Biopharma Patent in IPR Petition
March 13
Federal Court Enters Permanent Injunction Against Texas Drug Compounding Pharmacy
March 13
FDA's Budget Request Will Help Ensure Medical Product Safety, Commissioner Says
March 13
FDA Extends Comment Period On Combination Product Draft Guidance
March 13
FDA Approves Pediatric Indication For Bipolar Disorder Drug Saphris
March 13
Public Citizen Again Asks HHS to Withdraw FDA Draft Guidance on Drug Risk Information
March 13
Drugmakers Turn Heat on Insurers By Backing Copay Limits in States
March 13
Hospira Recalls One Lot of Lactated Ringer's Irrigation Due to Mold Contamination
March 13
Third Circuit Tosses Investors' Lawsuit Over Failed Drug Approval
March 13
India Revokes Boehringer Lung Drug Patent On Opposition From Generic Maker Cipla
March 13
New Strategies for Venue in Hatch-Waxman Litigation
March 11
Special Master Assigned to Review Reckitt Benckiser Suboxone Documents for Privilege
March 11
Pfizer Executive Suggests ‘Creative’ Financing for Costly Drugs
March 11
Alternative Way to Pay for Expensive New Drugs May Be Needed, RAND Says
March 11
Wyoming Becomes Sixth State To Adopt Right-to-Try Legislation
March 11
Galapagos Evolves Into Target for Deal With Experimental Arthritis Drug
March 11
Pernix to Acquire Zohydro ER Pain Drug Franchise From Zogenix
March 11
Expert Panels Suggested as Way to Help FDA Include Biomarkers in Drug Approvals
March 11
Sanctions Imposed on Seattle Law Firm For ‘Bad Faith' Pursuit of Thalidomide Cases
March 11
Treanda Injection Shouldn't Be Used With Certain Devices, FDA Warns
March 11
Drugs for Lymphoma, Pulmonary Fibrosis, Lou Gehrig's Disease Gain Orphan Status
March 11
Makers of Failed Cancer Drug Succeed in Dismissing Securities Case
March 11
Pharma Firm Shareholders Failed To Demonstrate Demand Futility
March 11
Indian Patent Office Rejects Bayer's Bid to Patent New Form of Cancer Rx
March 11
Court Dismisses Pharmacy's Antitrust Claims
March 11
ANI Buys Generic Flecainide Acetate From Teva
March 11
Mylan Launches Generic Subutex Sublingual Tablets
March 11
Hatch-Waxman Litigation Update
March 11
FDA's First Biosimilar Approval Greeted With Optimism; Naming, Pricing Still Issues
March 10
FDA Releases Draft Guidance for Industry On Formal Meetings With Drug Sponsors
March 10
Discovery's Web Page Misbrands Surfaxin, FDA Says in ‘Untitled' Letter
March 10
PCORI Has Awarded Over $670M To Fund Research, GAO Finds
March 10
FDA Warning Letter to Novacyl Targets Manufacturing Practice Problems
March 10
Drug Costs Grew Last Year At Fastest Rate in Decade, Report Says
March 10
FDA Approves Unituxin for Pediatric Patients With High-Risk Neuroblastoma
March 10
Attorney Can't Pursue FCA Action Pro Se Without Retaining Local Counsel
March 10
Kidney Drugmaker Tengion Goes to Initial Bidder RegenmedTX in Trustee's Private Sale
March 10
Report Makes Case for U.S. Biologics Law In TPP as Chief Negotiators Meet in Hawaii
March 10
New Laws Enacted to Regulate Prices of Medical Devices, Medicines
March 10
Justices Deny Review in Tamiflu Challenge To Federal Circuit Double Patenting Ruling
March 9
Appeals Court Temporarily Bars Sandoz From Launching Generic Fusilev Product
March 9
J&J Sues Celltrion Healthcare, Says Pending Biosimilar Infringes Patents
March 9
FDA Updates Label for Chantix On Alcohol Interaction, Seizure Risks
March 9
Kythera Says FDA Advisers Endorse Injectable Double Chin Treatment
March 9
Investors Bet $100,000 Prices For Cancer Drugs Are Here to Stay
March 9
Industry Groups Say More Work Needed by FDA on Biosimilar Policy
March 6
Novartis Wins Approval for First Biosimilar to Be Sold in U.S.
March 6
The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs
March 6
Ranbaxy Appeals Preliminary Injunction Loss Over Generic Nexium, Valcyte to D.C. Circuit
March 6
In Win for Teva, Court Finds Patent Claims on Osteoporosis Rx Atelvia Invalid
March 6
State Right-to-Try Laws for Experimental Therapies Popular, but Effect Minimal
March 6
FDA Seeks Comments by May 8 On Bioequivalence Recommendations
March 6
FDA Establishes Public Docket For Comments on Drug Compounding
March 6
Comment Period Extended for Proposal On Electronic Drug Prescribing Information
March 6
News Article Nixes FCA Claims Against Drug Company Under Public Disclosure Bar
March 6
FTC Requires Divestitures of Generic Drugs In Acquisition of CorePharma by Impax Labs
March 6
FDA Approves Astellas's Antifungal Drug Cresemba
March 6
GAO: HHS Should Do More to Disseminate Comparative Effectiveness Research
March 6
DEA Needs to Take Steps to Better Manage Drug Shortages, GAO Report Says
March 6
GlaxoSmithKline Judgment Affirmed; Paxil Plaintiff's Claims Time-Barred
March 6
Couple's Testosterone Product Suit Goes Back to Alabama State Court
March 6
Brazil Using New Methodology For Drug Price Readjustment
March 6
AbbVie to Acquire Pharmacyclics For Approximately $21 Billion
March 5
Senate Democrats' STRONG Patents Act Addresses Biopharma Fee Shifting Concerns
March 4
FDA's Budget Request Focuses on Essential Functions, Commissioner Tells House Panel
March 4
Bristol-Myers Wins Early Approval To Use Opdivo for Lung Cancer
March 4
FDA to Hold Public Hearing in June On Regulatory Science Initiatives for Generics
March 4
FDA Launches First Mobile App Containing Drug Shortage Information
March 4
SEC Official Says Drug Firm FCPA Violations Involve Three Main Categories of Misconduct
March 4
FDA Accepts NDA for Parkinson's Drug, Grants Breakthrough Status to Cancer Drug
March 4
New Jersey Accutane Plaintiffs in Peril After Experts Barred for Poor Science
March 4
Hatch-Waxman Litigation Update
March 4
FDA Requires Label Changes For Rx Testosterone Products
March 3
Outside Counsel Contingency-Fee Contract OK'd in Opioid Fraudulent Marketing Case
March 3
Lawmakers Question Amphastar Over Increasing Price of Naloxone
March 3
Whistle-Blower Can Allege False Claims Occurring After Employment Ended
March 3
California High Court Hears Argument on Pay-for-Delay Case
March 3
Tennessee Medical Practice Settles Case Involving Unapproved Drug Imports
March 3
FDA Warns Kansas Pharmacy About Violations Involving Production
March 3
FDA Advisory Panel to Hold Meeting On Pediatric-Focused Safety Reviews
March 3
Ranbaxy Loses Bid to Block Other Firms' Nexium, Valcyte Generic Products
March 2
Doctor Panel to Weigh Costs Of Hepatitis C Drugs in Guidelines
March 2
FDA in Complete Response Letter Rejects New Use for Exparel
March 2
Natco Joins Gilead's Agreement With Indian Companies for Sovaldi
March 2
Pfizer's Sales Tactics Related To Lipitor Survive Court Challenge
March 2
State Legislature Approves Delay in E-Prescription Requirement
March 2
District Court Issues New Order In Fusilev Case With Correct Patent
February 27
Implementation of Patent Term Statute In C.F.R. Permissible and Reasonable
February 27
Dentist Claims Allergan Inked Anticompetitive Pact to Bar Direct Competition to Botox
February 27
Sanofi Gains FDA Approval For Successor to Top-Selling Lantus
February 27
Second U.S. Company Recalls Drugs Due to Sterility Issues at Indian Manufacturer
February 27
FDA Warns About Risks of Sharing Multi-Dose Diabetes Pen Devices
February 27
Drug Breakthroughs Stir Payer Pushback at $5,000 a Month and Up
February 27
Gilead Avoids Billions in U.S. Taxes On $1,000-a-Pill Hepatitis C Drug
February 27
FDA Approves Antibiotic Avycaz For Treating Complicated Infections
February 27
House Bill Would Exempt FDA User Fees From Sequestration
February 27
Medicare's Drug Substitution Policy Saved $13 Million From 2013-2014, HHS OIG Says
February 27
FDA Delays Advisory Panel Meeting On Celltrion's Biosimilar Remicade
February 26
FDA Denies Two Citizen Petitions Seeking to Delay Generics of Fusilev
February 25
Court Finds Maine's Foreign Pharmacy Law Unconstitutional, Preempted by Federal Law
February 25
Outlook for 2015: Antitrust Litigation In the Pharma Industry—More Than Just Actavis Progeny
February 25
California High Court Prepares For Arguments on Reverse Payments
February 25
Pfizer Withdraws Case Against Mayne Pharma Over Version of Tikosyn
February 25
Cancer Drug Manufacturer Pharmacyclics Weighs Potential Sale
February 25
FDA Warns Arkansas Sterile Drug Facility About Manufacturing Problems
February 25
FDA Accepts BLA for Kanuma, Grants Breakthrough Status to Glioblastoma Drug
February 25
J&J Wins Risperdal Verdict Cut But Must Pay $136M, S.C. Court Says
February 25
J&J Told to Pay $2.5 Million In Risperdal Boy Breast Trial
February 25
Court Enters Judgment Against Loestrin Buyers
February 25
Beneficiaries Saved $15 Billion on Rx Drugs
February 25
Seattle Genetics Submits sBLA for Adcetris
February 25
FDA Accepts sNDA for Pfizer's Rapamune
February 25
Hatch-Waxman Litigation Update
February 25
Bristol-Myers Makes $1.6 Billion In Deals Boosting Cancer Pipeline
February 24
Sagent Recalls Drug After FDA Finds Violations at Indian Manufacturing Facility
February 24
High Court Denies Review of Petitions, Leaves Federal Circuit AIA Rulings Intact
February 24
Mylan Signs Exclusive Agreement To Distribute Sovaldi, Harvoni in India
February 24
Consumer Group Urges FDA To Ban Antifungal Drug Ketoconazole
February 24
TWi to Sell Generic Versions Of Megace ES, Lidoderm in U.S.
February 24
Appeals Court Affirms Dismissal Of Pharmacist's False Claims Case
February 24
Claims Preempted in Branded Drug Suit; Maker Couldn't Unilaterally Change Label
February 24
New Drug Company Turing Pharma Launches, Acquires Three Retrophin Drugs
February 24
Federal Circuit Affirms Court Ruling That Generic Trizivir Didn't Infringe
February 23
Sandoz Scores Win in Suit Over Generic Fusilev; Court Says Spectrum Patent Obvious
February 23
Dendreon's Cancer Drug Ultimately Goes For $495 Million to Valeant Pharmaceuticals
February 23
FTC Settlement Would Require Novartis to Divest Certain Cancer Drugs
February 23
Valeant's $10.1 Billion Salix Deal Seen as Bet on FDA Decision
February 23
FDA Approves Farydak For Treating Multiple Myeloma
February 23
FDA Grants Seven Years of Market Exclusivity To Eagle's Hyperthermia Drug Ryanodex
February 23
Teva Pursues U.S. Injectables Market With New Product Launches
February 23
FDA Approves Pediatric Indication For Meda's Allergy Drug Dymista
February 23
NGM, Merck Enter Agreement To Develop Biologic Therapies
February 23
Utah House Approves ‘Right to Try’ Bill; Foundation Forms to Help Terminal Patients
February 23
Chief Executive, Pharmacist Plead Guilty To Rebranding, Restocking Medications
February 23
FTC May Get Access to More Documents Related to Drugmakers' ‘Pay for Delay' Deal
February 20
Surescripts Opens Campaign to Encourage More e-Prescribing of Controlled Substances
February 20
FDA Tentatively Approves Hospira's Antibiotic Daptomycin
February 20
Senate Passes Bill for Pharmacist Substitutions of Biosimilar Drugs
February 20
Report Says New York Medicaid Failed to Maximize Available Drug Rebates
February 20