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Pharmaceutical Law & Industry Report ®

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What this service is:

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

What it helps you do:

  • Follow major actions at the federal and state level that focus on intellectual property/patent issues, drug pricing and reimbursement, FDA oversight, and Federal Trade Commission antitrust enforcement.
  • Keep current with marketplace news on the forces behind escalating costs and the responses from the public and private sectors.
  • Understand how health plans, pharmacy benefit managers, and employers develop and apply drug cost-containment strategies and modifications to health plan benefits.
  • Stay tuned in with "hot links" to important full-text documents on the Web, such as Federal Register notices, court decisions, and government reports.
  • Save hours of reading time with analytical articles on emerging case law and current litigation by practicing attorneys.
  • Rely on reporting that is objective and independent, as well as timely.
Product Structure

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, cumulating annually. Web current reports are archived to 1/17/2003, with archive coverage of Pharmaceutical Law & Policy Report since 7/12/2001. E-mail summaries, providing the highlights and table of contents for each report, with URLs to full text articles and documents are also available.

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  • Reforms to Hatch-Waxman Act
  • Fraud and abuse investigations
  • FDA regulation of drug company advertising and marketing
  • FTC antitrust enforcement actions
  • Growth of generic drugs
  • State Medicaid formularies
  • Biotechnology patents
  • Medicare drug benefit debate
  • Drug pricing lawsuits by states and consumers
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July 25, 2014
  • FDA Seeks Comments on Reserving Proprietary Names for Pharmaceuticals
  • Agency Revises Draft Guidance On Regulatory Submission Formats
  • Google Targeted in State Crackdown on Illicit Drug Ads, Content
  • After Suing, Perrigo Says FDA Updates Equivalent Rating for Its Testosterone Gel
  • Little Expansion of Orphan Drug Exemption In IRS Rules on ACA Prescription Drug Fee
  • GSK's Flonase Allergy Spray Gets Approval to Switch to an OTC Drug
  • Guilty Plea Announced for Smuggler Of Turkish Version of Cancer Drug to U.S.
July 24, 2014
  • Novartis Says Application for Biosimilar Version of Amgen Drug Accepted by FDA
  • FDA Approves Purdue's Extended-Release Opioid With Abuse-Deterrent Properties
July 23, 2014
  • Advocacy Groups, Waxman Call for Policy Changes to Achieve Medicare Drug Savings
  • Generic Drug Savings Thwarted By Safety Program Misuse, New Study Says
  • House Panel Hears About Barriers To Use of Medical Technology Advances
  • Unique Pharmaceuticals Recalls Potentially Contaminated Drugs, Suspends Compounding
  • FDA Approves Gilead's Zydelig For Treating Three Blood Cancers
  • New Law Allows Terminal Patients To Try Non-FDA Approved Treatments
  • Three Compounders Receive Warnings Based on FDA Inspectors' Findings
  • FDA Denies Antares Pharma's Petition, Says Timing of Competitor's Filing Controls
  • FDA Approves Ryanodex for Treating Hyperthermia Triggered by Anesthesia
  • FDA Releases Recall Enforcement Data Interface
July 22, 2014
  • Failure to Validate Sunshine Data Accuracy Can Result in Heavy Fines, Consultant Says
  • Group Asks FDA to Update Label, Add Black Box Warning to J&J Antibiotic Levaquin
  • OIG: Some Part B Drug Manufacturers Not Fully Reporting Sales Pricing Data
  • From Allergan to BMS: Are We Forgetting the Lessons of History?
  • India Announces Program to Reward Whistle-Blowers for Reporting Fake Drugs
  • Doctor Whose Medical License Enabled Illegal Imports of Drugs Sentenced to Prison
July 21, 2014
  • HHS Issues Interpretation on Discount For Providers Under 340B Drug Program
  • Judge Enjoins Actavis From Selling Generic Gralise Until Court Can Issue Opinion in Case
  • FDA to Study Teens' Perceptions Of Prescription Drug Advertising
July 18, 2014
  • House Republicans Target FDA Proposed Generic Drug Labeling Rule
  • AbbVie to Purchase Shire, Move Legal Address to Reduce Taxes
  • CMS Limits Prior Authorization Policy For Drugs for Beneficiaries in Hospice
  • ‘Untitled’ Letter Faults Kapvay Maker For Lack of Risk Information in Phone Script
  • Mylan Wins as Court Won't Let GSK Continue Supplying Apotex With Paroxetine for Generic
  • InterMune Announces Breakthrough Status For Investigational IPF Drug Pirfenidone
  • Dignity Health Pays $1.55M to Resolve Mishandling of Controlled Substances
  • FedEx Indicted for Shipping Drugs for Illegal Pharmacies
  • Prescription Drug Misuse Declining, But Still Prevalent in U.S., Study Says
  • Hawaii AG Case Against Bristol-Myers Sent Back to State Court Under CAFA
  • Drive to Add FDA Officials in India Delayed by Departures of Leaders
  • FDA Approves Ruconest to Treat Hereditary Angioedema Attacks
July 16, 2014
  • FDA Rejects Group's Call for Tougher Controls on Testosterone Products
  • Expanding Medicaid Eligibility Must Be Top ACA Priority, Waxman Tells Conferees
  • Industry Stakeholders Oppose OIG Efforts to Expand Exclusion Authority
  • FDA Grants Breakthrough Status To IPF Treatment From Boehringer Ingelheim
  • Companies Say Connecticut AG Investigates Pricing of Generic Digoxin
  • Pfizer to Pay at Least $225 Million For Generic Drug Company InnoPharma
  • No Learned Intermediary Defense In Lexapro Wrongful Death Lawsuit
  • India Moves to Control Prices Of Diabetes, Cardiovascular Drugs
  • Impax Labs Says Connecticut AG Investigating Pricing of Generic Digoxin
July 15, 2014
  • HHS Intends to Proceed With Interpretive Rule or Guidance on 340B Drug Discounts
  • FDA Warning Letters Target Italian Manufacturer, Kansas Compounder
  • Octapharma Says FDA Approves Octagam 10 Percent to Treat ITP
  • Court Nixes RICO Claims Against Merck, But Allows Other Copay Coupon Claims
  • Massachusetts Governor Signs Bill On Compounding Pharmacy Safety
  • Iowa's High Court Allows Reglan Lawsuit Against Generic but Not Branded Company
  • Plaintiff Loses Metoclopramide Appeal; Dissent Would Certify Branded Liability Issue
  • Indirect Purchasers, Warner Chilcott Settle Generic Doryx Delay Claims for $8 Million
July 14, 2014
  • Indian Generic Drugmaker Ranbaxy Settles Fraud Allegations With Oregon AG
  • Insurers Review Reimbursement Policies For Orphan Drugs, Tufts Center Study Says
  • Mylan to Add Abbott Labs' Generic Drugs Unit, Cut Tax Rate
  • FDA Asks Texas Pharmacy to Recall Potentially Contaminated Drug Products
  • Pharmacist Sentenced to 37 Months, Fined $1 Million for Illegal Narcotics Sales
  • Brazil's Exemption of 174 Drugs From Two Taxes Will Drive Down Prices
  • FDA Releases New Information After Webinar Had Technical Glitches
July 11, 2014
  • Senators Question Pricing Of Gilead's Hepatitis C Drug
  • FDA Releases Two Draft Guidances On Prior Approval Supplements, ANDAs
  • FDA Advisory Committees to Discuss Testosterone Replacement Therapy
  • District Court Dismisses Investor Suit Against Pfizer, Executives Over Drug Trials
  • House Panel Hears Ways to Include Patients in Drug, Device Development
  • Giving Cancer Doctors Lump-Sum Payments Slashes Costs, Study Finds
  • Senators Take Issue With FDA Proposed Rule To Allow Destruction of Imported Drugs
  • Court Rules New Arthritis Drug Patent Result of ‘Insubstantial Tinkering,' Invalid
  • EU Closes Investigation of Generic Pharmaceutical Companies in France
  • FDA Issues Draft Guidance for Industry On Submitting Drug Sample Information
July 09, 2014
  • Court Bars Massachusetts From Enforcing Restriction on Zohydro ER Prescriptions
  • EU Fines Servier, Generic Makers Over Delayed Hypertension Drug
  • Mylan Launches Generic Version of Micardis
  • FDA Grants Priority Review to Pain Drug, Breakthrough Status to Leukemia Drug
  • Reverse Payments After Actavis: Fifteen Cases to Follow
  • SEC Assures Lawmaker of Scrutiny In Any Potential Allergan-Valeant Deal
  • Celebrex Purchasers File Lawsuits Over Generic Delay for Arthritis Drug
  • Canadian Court Invalidates Patent for Reflux Drug Nexium
July 08, 2014
  • FDA Schedules Sept. 22 Meeting On Drugs for Bleeding, Platelet Disorders
  • UCB, Dermira Enter Licensing Agreement To Develop Cimzia for Psoriasis Indication
  • FDA Denies Horizon's Petition On Generic Versions of Vimovo
  • FDA Approves Novo Nordisk Drug For Treating Rare Bleeding Disorder
July 07, 2014
  • FDA ‘Untitled’ Letter Faults Gilead For Sponsored Link About Viread
  • Valeant, Precision Dermatology Will Sell Acne Treatments in $475 Million Merger
  • Zogenix Plans to Submit Application For Abuse-Deterrent Version of Zohydro ER
  • FDA Schedules Sept. 26 Meeting On Pulmonary Fibrosis Drug Development
  • Physician Pay Rule Would Remove Some Sunshine Act Reporting Exemptions for CME
  • Federal Court Orders Par Pharmaceutical To File Answers in Unlawful Marketing Action
  • Hospira Completes Acquisition of Drug Manufacturing, R&D Facilities in India
  • China's Fosun Pharmaceuticals Plans to Buy Israeli Device Makers
  • FDA Reopens Comments Period on Ways To Prevent, Deter Abuse of Opioid Pain Drugs
  • Yabao, Eli Lilly Enter Partnership To Develop Diabetes Treatment
July 03, 2014
  • Teva Files Another Citizen Petition To Slow Down Generics of Copaxone
  • Medicaid Officials Developing Policy For Use of $1,000-Per-Pill Hepatitis C Drug
  • Pharmacies, Health Insurers, Others Ask FDA To Use Same Names for Biologics, Biosimilars
  • FDA Releases Guidance for Industry On Developing Tropical Disease Drugs
  • FDA Seeks Comments on Guidance Provisions For Biologic Manufacturing Arrangements
  • FDA Approves Beleodaq to Treat Rare, Aggressive Form of Non-Hodgkin Lymphoma
  • Rite Aid to Pay $498,000 Over Failure To Conduct Prescription Drug Consultations
  • Warning Duty Limited to Prescribing Doctor; Evidence Curtailed in Florida Aredia Case
  • Court Excludes Plaintiffs' Expert in Zoloft Litigation; Causation Opinion Not Reliable
  • Design Defect, Consumer Claims Axed In Wrongful Death Suit Involving Tysabri
  • Genentech to Acquire Breast Cancer Drug Company Seragon for Up to $1.7 Billion
  • China's Commerce Ministry Releases Information on Drug Industry's Growth
  • New Specialty Drug Puts Spotlight On Costs, Impact on Health-Care System
  • BGOV Insight: Proposed FDA Quality Office Eyes Drugmaking Metrics
July 01, 2014
  • FDA Releases Several Policy Documents On Expectations for Drug Compounders
  • AbbVie's Patents Asserted Against Centocor's Stelara Psoriasis Treatment Ruled Invalid
  • PTO's Mayo/Myriad Eligibility Guidance May Chill New Drugs, Diagnostics, Panel Says
  • Lighting Ballast Adds to Teva's Challenge To No-Deference Claim Construction Standard
  • FDA Warns New Jersey Compounder About Deficiencies for Making Sterile Drugs
  • Lawmakers Pass Bill to Toughen Rules for Compounding Pharmacies
  • Fraud Suit Over Delcath's Failed Cancer Treatment Survives Challenges
  • Bristol-Myers Voluntarily Recalls Six Lots Of Blood Clot Drug Coumadin for Injection
  • Consumers Who Used Generic Pain Drug Propoxyphene Lose Appeal
  • Breakthrough Status for Leukemia Drug; Upsher-Smith Launches Qudexy XR
  • Part D Pays 32 Percent More Than Medicaid for Drugs, Report Finds
  • Actavis Completes Deal To Purchase Forest Laboratories
  • Transcept, Paratek Sign Definitive Merger Agreement
  • ANI Acquires Application for Lithobid
  • ANI Pharmaceuticals Acquires Application for Lithobid
June 30, 2014
  • Justices Seek Government's View In Case Allowing ‘Failure-to-Update' Claims
  • Orexo Sues Actavis Over Generic Application for Opioid Dependence Drug
  • FDA Approves Allergan's Ozurdex, Issues Complete Response Letter for Semprana
  • GlaxoSmithKline, Theravance Submit sNDA Seeking Approval of Breo Ellipta for Asthma
  • FDA Grants Breakthrough Therapy Status To Antidote for Blood Thinner Pradaxa
  • FDA to Drug Companies: Social Media Data Can Be Reportable
  • First-to-File Rule Means Only One Relator Shares in Qui Tam Proceeds
  • FDA Releases Draft Strategic Priorities That Will Guide Agency Through 2018
  • CAFA's ‘Tried Jointly' Language Won't Get Supreme Court Review
  • SCOTUS Seeks U.S. Government's View In Case Allowing ‘Failure-to-Update' Claims
June 27, 2014
  • FDA Approves MannKind's Inhaled Insulin Product for Adult Diabetics
  • Novartis Loses as District Court Says Generic Exelon Patch Won't Infringe
  • FDA Advisory Committee Votes Against Accelerated Approval for AstraZeneca Drug
  • FDA Warns Against Using Lidocaine For Teething Pain, Adds Boxed Warning
  • Ranbaxy's Ohm Unit Receives FDA Approval for Generic Diovan
  • Pharmacist Has Duty to Correctly Advise Customer About Nonprescription Drug
  • Indian Companies Form Coalition To Promote Access to Generic Drugs
  • Software Maker May Be Held Liable For Negligent Undertaking in Drug Lawsuit
  • OIG Says Lab Processing, Registry Arrangements May Violate Anti-Kickback Law
  • Republican Lawmakers Want Examination Of Costs of Proposed Generic Labeling Rule
  • MedPAC Urges CMS to Suspend Policy On Drug Payments for Hospice Enrollees
  • Drug Distributor Settles for Failure To Report Suspicious Oxycodone Orders
  • Guilty Pleas in Unapproved Drug Case Involving Kentucky Clinic
  • ACA Fee on Branded Drugs Properly Implemented by IRS, Inspector General Says
  • Illinois Becomes Third State Granting Prescribing Authority to Psychologists
  • Canadian Court Grants Allergan's Request to Prohibit Generic Eye Drop
  • Drug Distributor Settles for Failure To Report Suspicious Oxycodone Orders
June 26, 2014
  • Drug, Hospital Industry Groups Lobby Supreme Court on FCA Penalties
June 25, 2014
  • Collaboration, Notification Essential For Biosimilar Safety, BIO Panel Says
  • FDA Finds No Clear Evidence of Increased Heart Risks for Diabetics Taking Olmesartan
  • Omnicare Will Pay $124M to Settle Kickback Allegations, DOJ Says
  • FDA Seeks Comments on Proposed Collection Of Information for Generic Drug Applicants
  • FDA Requires Additional Clinical Data For Approval of Basilea's Ceftobiprole
  • FDA Grants Orphan Status to Drug That Treats Rare Neuromuscular Disorder
  • Endo Reaches Agreement to Acquire Generic Company Dava for $575 Million Cash
  • eRx Market Analysis Shows Significant Growth Globally in Wake of Federal Initiatives
  • Shire Wins District Court Ruling Upholding Patents on Vyvanse
  • Counsel's Corner: Integrating FDA Law With Intellectual Property Law
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