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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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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.

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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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Drugmaker's Fraud on PTO Means Firm Can't Use Patent Strength, Litigation Risk Defenses
July 30
$84.5M Abbott Labs Verdict Stands; Insurer Must Pay for Italian Drug Recall
July 30
Fast Track for Seizure Treatment; Orphan Status for Bayer's Adempas
July 30
AstraZeneca to Buy Almirall's Respiratory Medicine Franchise for Up to $1.22 Billion
July 30
FDA Approves Third Indication For Regeneron's Eye Drug Eylea
July 30
Two Zometa Plaintiffs May Go to Trial; Novartis Wins Judgment in Third Case
July 30
House Approves Bill Intended To Combat Prescription Drug Abuse
July 30
Perrigo Files Application For Generic Version of Topicort
July 30
Report Says New Hep C Drugs Could Drive Medicare Spending Up Sharply
July 30
Infringement Case Against Purdue Stayed, Pending IPR Decisions on Depomed Patents
July 29
Beneficiaries in Part D ‘Doughnut Hole' Got Average $819 in Manufacturer Discounts
July 29
Industry Groups Ask CMS to Provide Education and Context for Sunshine Act Data
July 29
FDA Denies Requests for New Rule On Therapeutic Equivalence Decisions
July 29
PBMs Seek High Court Review of Ruling That Upheld California Price Reporting Law
July 29
Two Compounders Receive Warnings Based on FDA Inspectors' Findings
July 29
FDA Inspects Impax Facility in Taiwan, Issues Form 483 With 10 Observations
July 29
Harkin Urges HHS to Move Forward With Proposed 340B ‘Mega’ Regulation
July 29
Researchers Say New, Costly Drugs Spur Affordability Concerns but Offer Benefits
July 29
Revive Lexapro Marketing Lawsuit, California Parents Tell First Circuit
July 29
OIG Wouldn't Impose Sanctions For Direct Sale of Rx Drug to Patients
July 28
FDA Requires Additional Information For Approval of Pain Drug Zalviso
July 28
FDA Approves Antibiotic Acticlate To Treat Severe Acne, Other Infections
July 28
FDA Expands Imbruvica's Approved Use After Breakthrough Designation
July 28
Agency Revises Draft Guidance On Regulatory Submission Formats
July 25
FDA Seeks Comments on Reserving Proprietary Names for Pharmaceuticals
July 25
Google Targeted in State Crackdown on Illicit Drug Ads, Content
July 25
After Suing, Perrigo Says FDA Updates Equivalent Rating for Its Testosterone Gel
July 25
Little Expansion of Orphan Drug Exemption In IRS Rules on ACA Prescription Drug Fee
July 25
GSK's Flonase Allergy Spray Gets Approval to Switch to an OTC Drug
July 25
Guilty Plea Announced for Smuggler Of Turkish Version of Cancer Drug to U.S.
July 25
Novartis Says Application for Biosimilar Version of Amgen Drug Accepted by FDA
July 24
FDA Approves Purdue's Extended-Release Opioid With Abuse-Deterrent Properties
July 24
Advocacy Groups, Waxman Call for Policy Changes to Achieve Medicare Drug Savings
July 23
Generic Drug Savings Thwarted By Safety Program Misuse, New Study Says
July 23
House Panel Hears About Barriers To Use of Medical Technology Advances
July 23
Unique Pharmaceuticals Recalls Potentially Contaminated Drugs, Suspends Compounding
July 23
FDA Approves Gilead's Zydelig For Treating Three Blood Cancers
July 23
New Law Allows Terminal Patients To Try Non-FDA Approved Treatments
July 23
Three Compounders Receive Warnings Based on FDA Inspectors' Findings
July 23
FDA Denies Antares Pharma's Petition, Says Timing of Competitor's Filing Controls
July 23
FDA Approves Ryanodex for Treating Hyperthermia Triggered by Anesthesia
July 23
FDA Releases Recall Enforcement Data Interface
July 23
Failure to Validate Sunshine Data Accuracy Can Result in Heavy Fines, Consultant Says
July 22
Group Asks FDA to Update Label, Add Black Box Warning to J&J Antibiotic Levaquin
July 22
OIG: Some Part B Drug Manufacturers Not Fully Reporting Sales Pricing Data
July 22
From Allergan to BMS: Are We Forgetting the Lessons of History?
July 22
India Announces Program to Reward Whistle-Blowers for Reporting Fake Drugs
July 22
Doctor Whose Medical License Enabled Illegal Imports of Drugs Sentenced to Prison
July 22
HHS Issues Interpretation on Discount For Providers Under 340B Drug Program
July 21
Judge Enjoins Actavis From Selling Generic Gralise Until Court Can Issue Opinion in Case
July 21
FDA to Study Teens' Perceptions Of Prescription Drug Advertising
July 21
House Republicans Target FDA Proposed Generic Drug Labeling Rule
July 18
AbbVie to Purchase Shire, Move Legal Address to Reduce Taxes
July 18
CMS Limits Prior Authorization Policy For Drugs for Beneficiaries in Hospice
July 18
‘Untitled’ Letter Faults Kapvay Maker For Lack of Risk Information in Phone Script
July 18
Mylan Wins as Court Won't Let GSK Continue Supplying Apotex With Paroxetine for Generic
July 18
InterMune Announces Breakthrough Status For Investigational IPF Drug Pirfenidone
July 18
Dignity Health Pays $1.55M to Resolve Mishandling of Controlled Substances
July 18
FedEx Indicted for Shipping Drugs for Illegal Pharmacies
July 18
Prescription Drug Misuse Declining, But Still Prevalent in U.S., Study Says
July 18
Hawaii AG Case Against Bristol-Myers Sent Back to State Court Under CAFA
July 18
Drive to Add FDA Officials in India Delayed by Departures of Leaders
July 18
FDA Approves Ruconest to Treat Hereditary Angioedema Attacks
July 18
FDA Rejects Group's Call for Tougher Controls on Testosterone Products
July 16
Expanding Medicaid Eligibility Must Be Top ACA Priority, Waxman Tells Conferees
July 16
Industry Stakeholders Oppose OIG Efforts to Expand Exclusion Authority
July 16
FDA Grants Breakthrough Status To IPF Treatment From Boehringer Ingelheim
July 16
Companies Say Connecticut AG Investigates Pricing of Generic Digoxin
July 16
Pfizer to Pay at Least $225 Million For Generic Drug Company InnoPharma
July 16
No Learned Intermediary Defense In Lexapro Wrongful Death Lawsuit
July 16
India Moves to Control Prices Of Diabetes, Cardiovascular Drugs
July 16
HHS Intends to Proceed With Interpretive Rule or Guidance on 340B Drug Discounts
July 15
FDA Warning Letters Target Italian Manufacturer, Kansas Compounder
July 15
Octapharma Says FDA Approves Octagam 10 Percent to Treat ITP
July 15
Court Nixes RICO Claims Against Merck, But Allows Other Copay Coupon Claims
July 15
Massachusetts Governor Signs Bill On Compounding Pharmacy Safety
July 15
Iowa's High Court Allows Reglan Lawsuit Against Generic but Not Branded Company
July 15
Plaintiff Loses Metoclopramide Appeal; Dissent Would Certify Branded Liability Issue
July 15
Indirect Purchasers, Warner Chilcott Settle Generic Doryx Delay Claims for $8 Million
July 15
Indian Generic Drugmaker Ranbaxy Settles Fraud Allegations With Oregon AG
July 14
Insurers Review Reimbursement Policies For Orphan Drugs, Tufts Center Study Says
July 14
Mylan to Add Abbott Labs' Generic Drugs Unit, Cut Tax Rate
July 14
FDA Asks Texas Pharmacy to Recall Potentially Contaminated Drug Products
July 14
Pharmacist Sentenced to 37 Months, Fined $1 Million for Illegal Narcotics Sales
July 14
Brazil's Exemption of 174 Drugs From Two Taxes Will Drive Down Prices
July 14
FDA Releases New Information After Webinar Had Technical Glitches
July 14
Senators Question Pricing Of Gilead's Hepatitis C Drug
July 11
FDA Releases Two Draft Guidances On Prior Approval Supplements, ANDAs
July 11
FDA Advisory Committees to Discuss Testosterone Replacement Therapy
July 11
District Court Dismisses Investor Suit Against Pfizer, Executives Over Drug Trials
July 11
House Panel Hears Ways to Include Patients in Drug, Device Development
July 11
Giving Cancer Doctors Lump-Sum Payments Slashes Costs, Study Finds
July 11
Senators Take Issue With FDA Proposed Rule To Allow Destruction of Imported Drugs
July 11
Court Rules New Arthritis Drug Patent Result of ‘Insubstantial Tinkering,' Invalid
July 11
EU Closes Investigation of Generic Pharmaceutical Companies in France
July 11
FDA Issues Draft Guidance for Industry On Submitting Drug Sample Information
July 11
Court Bars Massachusetts From Enforcing Restriction on Zohydro ER Prescriptions
July 9
EU Fines Servier, Generic Makers Over Delayed Hypertension Drug
July 9
Mylan Launches Generic Version of Micardis
July 9
FDA Grants Priority Review to Pain Drug, Breakthrough Status to Leukemia Drug
July 9
Reverse Payments After Actavis: Fifteen Cases to Follow
July 9
SEC Assures Lawmaker of Scrutiny In Any Potential Allergan-Valeant Deal
July 9
Celebrex Purchasers File Lawsuits Over Generic Delay for Arthritis Drug
July 9
Canadian Court Invalidates Patent for Reflux Drug Nexium
July 9
FDA Schedules Sept. 22 Meeting On Drugs for Bleeding, Platelet Disorders
July 8
UCB, Dermira Enter Licensing Agreement To Develop Cimzia for Psoriasis Indication
July 8
FDA Denies Horizon's Petition On Generic Versions of Vimovo
July 8
FDA Approves Novo Nordisk Drug For Treating Rare Bleeding Disorder
July 8
FDA ‘Untitled’ Letter Faults Gilead For Sponsored Link About Viread
July 7
Valeant, Precision Dermatology Will Sell Acne Treatments in $475 Million Merger
July 7
Zogenix Plans to Submit Application For Abuse-Deterrent Version of Zohydro ER
July 7
FDA Schedules Sept. 26 Meeting On Pulmonary Fibrosis Drug Development
July 7
Physician Pay Rule Would Remove Some Sunshine Act Reporting Exemptions for CME
July 7
Impax Labs Says Connecticut AG Investigating Pricing of Generic Digoxin
July 16
Federal Court Orders Par Pharmaceutical To File Answers in Unlawful Marketing Action
July 7
Hospira Completes Acquisition of Drug Manufacturing, R&D Facilities in India
July 7
China's Fosun Pharmaceuticals Plans to Buy Israeli Device Makers
July 7
FDA Reopens Comments Period on Ways To Prevent, Deter Abuse of Opioid Pain Drugs
July 7
Yabao, Eli Lilly Enter Partnership To Develop Diabetes Treatment
July 7
Teva Files Another Citizen Petition To Slow Down Generics of Copaxone
July 3
Medicaid Officials Developing Policy For Use of $1,000-Per-Pill Hepatitis C Drug
July 3
Pharmacies, Health Insurers, Others Ask FDA To Use Same Names for Biologics, Biosimilars
July 3
FDA Releases Guidance for Industry On Developing Tropical Disease Drugs
July 3
FDA Seeks Comments on Guidance Provisions For Biologic Manufacturing Arrangements
July 3
FDA Approves Beleodaq to Treat Rare, Aggressive Form of Non-Hodgkin Lymphoma
July 3
Rite Aid to Pay $498,000 Over Failure To Conduct Prescription Drug Consultations
July 3
Warning Duty Limited to Prescribing Doctor; Evidence Curtailed in Florida Aredia Case
July 3
Court Excludes Plaintiffs' Expert in Zoloft Litigation; Causation Opinion Not Reliable
July 3
Design Defect, Consumer Claims Axed In Wrongful Death Suit Involving Tysabri
July 3
Genentech to Acquire Breast Cancer Drug Company Seragon for Up to $1.7 Billion
July 3
China's Commerce Ministry Releases Information on Drug Industry's Growth
July 3
New Specialty Drug Puts Spotlight On Costs, Impact on Health-Care System
July 3
BGOV Insight: Proposed FDA Quality Office Eyes Drugmaking Metrics
July 3
FDA Releases Several Policy Documents On Expectations for Drug Compounders
July 1
AbbVie's Patents Asserted Against Centocor's Stelara Psoriasis Treatment Ruled Invalid
July 1
PTO's Mayo/Myriad Eligibility Guidance May Chill New Drugs, Diagnostics, Panel Says
July 1
Lighting Ballast Adds to Teva's Challenge To No-Deference Claim Construction Standard
July 1
FDA Warns New Jersey Compounder About Deficiencies for Making Sterile Drugs
July 1
Lawmakers Pass Bill to Toughen Rules for Compounding Pharmacies
July 1
Fraud Suit Over Delcath's Failed Cancer Treatment Survives Challenges
July 1
Bristol-Myers Voluntarily Recalls Six Lots Of Blood Clot Drug Coumadin for Injection
July 1
Consumers Who Used Generic Pain Drug Propoxyphene Lose Appeal
July 1
Breakthrough Status for Leukemia Drug; Upsher-Smith Launches Qudexy XR
July 1
Part D Pays 32 Percent More Than Medicaid for Drugs, Report Finds
July 1
Actavis Completes Deal To Purchase Forest Laboratories
July 1
Transcept, Paratek Sign Definitive Merger Agreement
July 1
ANI Acquires Application for Lithobid
July 1
Justices Seek Government's View In Case Allowing ‘Failure-to-Update' Claims
June 30
Orexo Sues Actavis Over Generic Application for Opioid Dependence Drug
June 30
FDA Approves Allergan's Ozurdex, Issues Complete Response Letter for Semprana
June 30
GlaxoSmithKline, Theravance Submit sNDA Seeking Approval of Breo Ellipta for Asthma
June 30
FDA Grants Breakthrough Therapy Status To Antidote for Blood Thinner Pradaxa
June 30
FDA to Drug Companies: Social Media Data Can Be Reportable
June 30
First-to-File Rule Means Only One Relator Shares in Qui Tam Proceeds
June 30
FDA Releases Draft Strategic Priorities That Will Guide Agency Through 2018
June 30
CAFA's ‘Tried Jointly' Language Won't Get Supreme Court Review
June 30
FDA Approves MannKind's Inhaled Insulin Product for Adult Diabetics
June 27
Novartis Loses as District Court Says Generic Exelon Patch Won't Infringe
June 27
FDA Advisory Committee Votes Against Accelerated Approval for AstraZeneca Drug
June 27
FDA Warns Against Using Lidocaine For Teething Pain, Adds Boxed Warning
June 27
Ranbaxy's Ohm Unit Receives FDA Approval for Generic Diovan
June 27
Pharmacist Has Duty to Correctly Advise Customer About Nonprescription Drug
June 27
Indian Companies Form Coalition To Promote Access to Generic Drugs
June 27
Software Maker May Be Held Liable For Negligent Undertaking in Drug Lawsuit
June 27
OIG Says Lab Processing, Registry Arrangements May Violate Anti-Kickback Law
June 27
Republican Lawmakers Want Examination Of Costs of Proposed Generic Labeling Rule
June 27
MedPAC Urges CMS to Suspend Policy On Drug Payments for Hospice Enrollees
June 27
Drug Distributor Settles for Failure To Report Suspicious Oxycodone Orders
June 27
Guilty Pleas in Unapproved Drug Case Involving Kentucky Clinic
June 27
ACA Fee on Branded Drugs Properly Implemented by IRS, Inspector General Says
June 27
Illinois Becomes Third State Granting Prescribing Authority to Psychologists
June 27
Canadian Court Grants Allergan's Request to Prohibit Generic Eye Drop
June 27
Drug, Hospital Industry Groups Lobby Supreme Court on FCA Penalties
June 26
Collaboration, Notification Essential For Biosimilar Safety, BIO Panel Says
June 25
FDA Finds No Clear Evidence of Increased Heart Risks for Diabetics Taking Olmesartan
June 25
Omnicare Will Pay $124M to Settle Kickback Allegations, DOJ Says
June 25
FDA Seeks Comments on Proposed Collection Of Information for Generic Drug Applicants
June 25
FDA Requires Additional Clinical Data For Approval of Basilea's Ceftobiprole
June 25
FDA Grants Orphan Status to Drug That Treats Rare Neuromuscular Disorder
June 25
Endo Reaches Agreement to Acquire Generic Company Dava for $575 Million Cash
June 25
eRx Market Analysis Shows Significant Growth Globally in Wake of Federal Initiatives
June 25
Shire Wins District Court Ruling Upholding Patents on Vyvanse
June 25
Counsel's Corner: Integrating FDA Law With Intellectual Property Law
June 25
ANI Pharmaceuticals Acquires Application for Lithobid
July 1
SCOTUS Seeks U.S. Government's View In Case Allowing ‘Failure-to-Update' Claims
June 30
Drug Distributor Settles for Failure To Report Suspicious Oxycodone Orders
June 27