SUBSCRIPTION

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.

FREE TRIAL
Legal Subscriptions

OVERVIEW

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.

Try Pharmaceutical Law & Industry Report now

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

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

Context Remains a Concern as CMS Open Payments Data Release Nears
June 26
Third Circuit Sides With FTC On Antitrust Scrutiny of Drug Patent Deals
June 26
Unions' Complaint Targets Product Switch That Delayed Generic of Asacol
June 26
House Lawmakers Still Hopeful Of ‘Cures' Bill Vote in Early July
June 26
FDA Seeks Comment on Whether Drug Products Containing CFCs Are Essential
June 26
Dr. Reddy's Recalls Generic Drugs For Wrong Potency, Solubility, FDA Says
June 26
Allergan Sues Over Investment Firm's IPR Patent Challenge, Alleges Extortion
June 26
DaVita Finalizes $450 Million Settlement in Medication Waste Case
June 26
First Trials Set for August In Cymbalta Withdrawal Suits
June 26
Canada's Drug Shortage Rules Go Beyond U.S. Regulations
June 26
Australian Parliament Lowers Drug Subsidies, Eases Path for Biosimilars
June 26
Pain Medication Prescriber Pleads Guilty To Receiving Kickbacks in Medicare Case
June 24
Noven's ADHD Patch May Cause Permanent Loss of Skin Color
June 24
Pharmacy Groups Ask FDA to Delay Drug Tracking Requirement for Dispensers
June 24
FDA Approves New Indication for Fycompa, Grants Orphan Status to Other Products
June 24
Hatch-Waxman Litigation Update
June 24
FDA Releases Guidance for Industry On Filling Injectable Drugs, Biologics
June 24
FDA Seeks Comments on Study of Hearing And Direct-to-Consumer Drug TV Ads
June 24
FDA Warns South Carolina Company About Drug Manufacturing Violations
June 24
Court Says Generic Drugmaker Stated Monopolization Claim Against Otsuka
June 24
Complaint Against Novartis Targets Delay in Availability of Generic Gleevec
June 24
Providers Ask Congress to Improve Medicare Coverage for Those With Chronic Illnesses
June 24
Pfizer Revival of Celebrex Patent in Vain As Federal Circuit Affirms Double Patenting
June 23
CBO Puts ‘Cures' Cost at $106 Billion, Even as Part D Offset Disappears
June 23
Generic, Branded Industry Groups Want Changes to Proposed Rule on ANDAs
June 23
Reintroduced House Bill Would Prevent Use of REMS to Delay Generic Drugs
June 23
Texas Enacts Biologic Substitution Law; Notification Provision Expires in 2019
June 23
Over 1,400 Pharmacies Submit Questionable Medicare Claims in 2014, HHS Agency Finds
June 23
FTC Amicus Brief Filed in First Circuit Argues Illegal Reverse Payments Not Limited to Cash
June 22
After Tax Inversion, Drugmaker Mylan Questions FTC's Foreign Treatment
June 22
Supreme Court Rejects Apotex's Bid To Revisit Inequitable Conduct Standard
June 22
FDA Approves Intravenous Antiplatelet Drug To Prevent Clots in Coronary Arteries
June 22
Cancer Drug Costing $9,200 Has Zero Benefit, Rating Scale Shows
June 22
House Delays 21st Century Cures Proposal to Address Insurers' Objections
June 19
FDA Releases Guidance for Industry On Size, Shape of Generic Tablets, Capsules
June 19
Outcome in Teva v. Sandoz Copaxone Dispute Unaffected by High Court Guidance
June 19
House Appropriations Subcommittee Approves FDA FY 2016 Funding Bill
June 19
Ruling Finding Celgene's Abraxane Doesn't Infringe Cephalon's Paclitaxel Patent Upheld
June 19
Device Center Leader Asks If FDA Should Develop User Fee Goals for Combo Products
June 19
FDA Takes Action Against Websites Selling Unapproved Rx Drugs, Devices
June 19
Court Approves $1.2 Billion Settlement In Provigil Case Between FTC and Teva
June 19
Mallinckrodt's Questcor Reportedly Facing Multistate Antitrust Probe
June 19
Judgment Against Novartis Reversed In Lawsuit Alleging Harm From Clozaril
June 19
Court Kills Whistle-Blower Suit Against Gilead Alleging FDA Quality Violations
June 19
Proposed Competition Bureau Guidance Addresses Patent Litigation Settlements
June 19
Russian Health-Care Agency's Permits For Imported Drugs End Under New Law
June 19
Inspire Pharmaceuticals to Pay $6M In Eye Treatment Off-Label Marketing Case
June 17
21st Century Cures Author Pushing For Floor Vote; FDA Official Praises Bill
June 17
IPR Patent Challenges Faster Than Courts, But Panelists at BIO Question Their Fairness
June 17
Teva's $24 Million Nexium Settlement Gets Approval
June 17
FDA Releases Guidance for Industry On Naming Drug Products Containing Salts
June 17
Allergan to Purchase Kythera Biopharmaceuticals for $2.1 Billion
June 17
FDA Launches Website for Rx Drug Risk Evaluation and Mitigation Strategies
June 17
FDA Warns Tennessee Pharmacy About Violations in Producing Sterile Drugs
June 17
FDA Grants Orphan Designation To PNP's Gedeptin, Other Drugs
June 17
Health Canada Raises Data Integrity Concerns on Italian, Chinese Manufacturers
June 17
Hatch-Waxman Litigation Update
June 17
HHS Issues Proposed Rule On 340B Drugmaker Penalties
June 16
Upton Expects House Vote on ‘Cures' Bill Soon, but More Work Necessary
June 16
Drug Companies Turning To Social Media Sites for Marketing
June 16
FDA Says Potiga's Labeling Adequately Manages Risks
June 16
FDA Approves Zomig Nasal Spray For Migraines in Older Pediatric Patients
June 16
FDA Warns Drugs Marketed By Texas Company Could Be Contaminated
June 16
Veloxis Submits Revised Labeling For Envarsus XR to FDA for Approval
June 15
FDA Has Failed to Meet Commitments Under Generic User Fee Program, Industry Says
June 15
FDA to Work With Online Patient Forum to Mine Drug Safety Data
June 15
Pilot Programs Needed to Test Ways To Pay for High-Cost Drugs, Analyst Says
June 15
Actavis Changes Global Name to Allergan; U.S., Canadian Generic Units Remain Actavis
June 15
Biotech Sets Financial Records in 2014, Nears $1 Trillion Market Cap, Report Says
June 15
Wrongful Promotion of Generic Drug May Be Viable Recovery Theory in 5th Cir.
June 15
GSK Illegally Promoted Zofran Off-Label For Treating Pregnancy Nausea, Suit Says
June 15
Insurers Face HIV Drug Copay Limits, Anti-Bias Review for Florida Health Plans
June 15
Merck KGaA Purchase of Sigma-Aldrich Wins Authorization by European Commission
June 15
Canadian Appellate Court Rules For Allergan in Generic Eye Drop Case
June 15
Cephalon, Generic Drugmakers Win Denial Of Class Certification in Modafinil Case
June 12
Drug Industry Criticizes FDA's Response To Company on Off-Label Statements
June 12
House Judiciary Committee Moves Patent Bill Forward, Battle Over Fee Shifting Looms
June 12
FDA Mistakenly Widened Approved Indication Of Vanda's Hetlioz, Public Citizen Tells Agency
June 12
FDA Releases Draft Guidance on Assessing How Drugs Taken by Fathers Affect Embryos
June 12
Novartis Gets FDA Approval For Blood-Disorder Treatment Promacta
June 12
Pfizer Wins Second Trial Over Zoloft, Birth-Defect Link
June 12
Insurers: Drugmakers Have ‘Blank Check' On Pricing, System Not Sustainable
June 12
House Republican Calls for More Transparency in 340B Drug Program
June 12
Advocacy Group Concerned Over Drug Pricing Implications in Pacific Trade Deal
June 10
Amgen Cholesterol Drug Wins FDA Panel Backing for Some Patients
June 10
Sanofi Cholesterol Drug Gets Partial Backing From FDA Advisers
June 10
Drug Firms Could Speed Muscular Dystrophy Treatments Thanks to Guidance, Groups Say
June 10
Study Finds Medicare Coverage of Opioids Decreasing, Particularly Abuse Deterrents
June 10
FDA Warns Texas Pharmacy Of Violations in Producing Sterile Drugs
June 10
FDA Grants Breakthrough Status To Systemic Sclerosis Drug, Enzyme Therapy
June 10
New Florida Law Gives Patients ‘Right to Try’ Unapproved Treatments
June 10
Hatch-Waxman Litigation Update
June 9
FDA Tells Drugmaker Amarin It Doesn't Have Concerns About Bulk of Off-Label Statements
June 9
PhRMA's Attack on New Patent Transfer Rule Under Hart-Scott-Rodino Act Fails
June 9
White House Finishes Its Review Of 340B Drugmaker Penalties Rule
June 9
Class Action Complaint Hits Actavis, Generic Drugmakers on Namenda
June 9
Counsel's Corner: Smart Approach to FDA May Lead to Faster Decisions, Savings
June 9
Teva Subsidiary Cephalon Can't Dodge False Claims Lawsuit on Cancer Drug
June 9
Patient Coalition Urges FDA to Replace Guidance Language on Biosimilar Labeling
June 9
Mylan Expands Recall of Injectable Medications Due to Particulate Matter
June 9
Medical Device, Drug Data Project Will Soon Play Larger Role at FDA
June 8
What You Need to Know About the ‘21st Century Cures’ Bill
June 8
Breakthrough Drugs to Cost Government $50 Billion Over Decade, Insurers Say
June 8
India Rejects Abraxis Cancer Drug Patent for Lack of Inventive Step
June 8
AbbVie Asks FDA to Require Biosimilar Label To List Differences From Reference Biologic
June 5
Female Libido Drug Nears Approval With FDA Advisory Panel's Backing
June 5
Appeals Court Again Says Watson's Lialda Generic Not Likely to Infringe
June 5
After Lengthy Delay, DEA Takes Action On GE Healthcare's Radiopharmaceutical
June 5
Senate Panel OKs Patent Litigation Bill That Diverges From House Counterpart
June 5
House Democrats Seek Stronger Warnings In Labeling for Immediate-Release Opioids
June 5
Charity Group's Proposed Patient Assistance Wouldn't Lead to Sanctions, IG Opinion Says
June 5
Cardinal Health Intends to Acquire Harvard Drug Group for $1.12 Billion
June 5
Cymbalta Users Try Again for Class Status; Eli Lilly Allegedly Hid Withdrawal Risk
June 5
Insurers: Drugmakers Have ‘Blank Check' On Pricing, System Isn't Sustainable
June 12
Alabama Joins List of States Allowing ‘Right to Try’ Unapproved Treatments
June 5
Survey Says Indian Drugmakers Grappling With Data Integrity Issues
June 5
Federal Circuit Struggles With BPCIA Language as Amgen Seeks Zarxio Delay
June 3
Watchdog, Consumer Groups Say ‘Cures' Bill Could Lower Certain Drug Approval Standards
June 3
Court Reaffirms Generic of Suprep Would Infringe Braintree's Patent
June 3
FDA Draft Guidance Could Restrict Access To Repackaged Avastin, Senators Say
June 3
FDA Warns Three Pharmacies About Violations Involving Production
June 3
FDA Accepts BLA for Anthrax Rx, Grants Orphan Designations to Other Products
June 3
FDA Approves Generics of ADHD Drug Intuniv, Birth Control Pill Seasonique
June 3
Halozyme Enters Global Collaboration, License Agreement With AbbVie
June 3
FDA Approves New Indication for Qudexy XR
June 3
Hatch-Waxman Litigation Update
June 3
Tyco's Restoril Case Not Objectively Baseless, But Citizen Petition Suggests Antitrust Injury
June 2
Female Libido Drug's Safety Questioned by U.S. Regulatory Staff
June 2
FDA Extends Comment Period for Draft Memo With States on Rx Compounding
June 2
FDA Requests Notice From Stakeholders Of Intent to Participate in GDUFA Meetings
June 2
FDA Warns Czech Drug Company About Violations in Making Ingredients
June 2
Hepatitis Cruise, India Trips Among Plans to Save on $1,000 Pill
June 2
Purdue Pharma to Face Whistle-Blower Lawsuit After Supreme Court Denial
June 1
Solicitor General Supports Allergan in Latisse Unfair Competition Case Against Athena
June 1
‘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