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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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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
Expanding Medical Research Opportunities: Proposed 21st Century Cures Act Offers Increased Access to Health Information
February 18
FDA to Hold Conference in Indiana In June to Discuss Regulations
February 18
MDL Panel to Hear Arguments On Consolidating Benicar Suits
February 18
FDA Expands Revlimid's Indication, Grants Fast Track to Opioid Overdose Drug
February 18
FDA Announces Acting Director Of Office of Medical Policy
February 18
Hatch-Waxman Litigation Update
February 18
AstraZeneca Appeals After Generics Win Key Ruling on Pediatric Asthma Drug Patent
February 17
Apotex Says FDA Accepts Application For Biosimilar of Amgen's Neupogen
February 17
FDA to Hold March Meeting, Reopen Comment Docket on Generic Label Proposal
February 17
Chicago Psychiatrist Pleads Guilty To Accepting Kickbacks From Drug Firms
February 17
Takeda Ordered to Pay $3.6M In Pennsylvania Actos Case
February 17
Government Clarifies Criminal Penalties For Importers of Unregistered Medicines
February 17
More Generics of Celebrex Receive Full Approval Following Court Action
February 13
District Court Nixes Teva Request to Restore Original Injunction in Generic Copaxone Case
February 13
FDA Releases Five Draft Documents Related to Drug Compounding, Repackaging
February 13
FDA Issues Guidance on Developing Drugs for Urinary Tract Infections
February 13
CMS Announces New Performance-Based Medicare Payment Model for Oncology Care
February 13
FDA Approves Eisai's Lenvima For Treating Differentiated Thyroid Cancer
February 13
FDA Oversight of Devices Improving; Global Safety, Drug Shortages Still a Risk
February 13
Rules for Drugmakers Under Development On Mandatory Reporting of Drug Shortages
February 13
AstraZeneca Pays $7.9M to Resolve Pharmacy Benefit Kickback Allegations
February 12
Bayer Lacks Standing for Claim Based On Mexican Trademark; TTAB Reversed
February 12
Hospital Associations Ask Judge To Throw Out PhRMA's 340B Lawsuit
February 12
House Committee Approves Bills On Rx Drug Abuse, Timely DEA Scheduling
February 12
FDA Seeks Comments on Development, Qualification of Biomarkers for Drugs
February 12
FDA Issues Draft Guidance to Help Sponsors Developing Drugs for Alcoholism
February 12
Court Rejects Challenge to DAB Refusal To Accept Untimely Overpayment Appeal
February 12
FDA Warns Oregon Pharmacy About Violations Involving Production
February 12
Pacira Resolves FDA Warning Letter On Promotional Materials for Exparel
February 12
Hospira Recalls Multiple Lots Of Pain Drug Due to Particulates
February 12
FDA-EMA Joint Initiative Could Signal End of FDA GMP Inspections in EU
February 12
Gilead's Hepatitis C Drug Patent Challenged by Medical Charity
February 11
With Court Mandate, Decision Now Moves To FDA on Approving Celebrex ANDAs
February 10
President's Budget Request Seeks $4.9 Billion in Total Resources for FDA
February 2
Obama Proposes Allowing Medicare To Negotiate Prescription Drug Prices
February 2
WLF Urges Supreme Court to Review California County's Drug Disposal Ordinance
February 2
FDA Approves First-in-Class Glyxambi To Treat Adults with Type 2 Diabetes
February 2
FDA Approves Shire's Vyvanse To Treat Binge-Eating Disorder
February 2
Senate Bill Would Require Penalized Pharma Companies to Invest in NIH, FDA
February 2
Mylan to Buy Famy Care Women's Health Units for $800 Million
February 2
Medicaid Policy on Hepatitis C Meds Aims To Align Clinical Needs With Budget Realities
February 2
Senate Passes Bill to Give Terminally Ill Patients ‘Right to Try’ Treatments
February 2
Modafinil Buyers' Reverse Payments Case Survives Dismissal in District Court
January 30
Obama to Propose $215 Million To Fund ‘Precision Medicine' Initiative
January 30
U.S. Biosimilars Companies Should Expect Hard Fight for Market Share, Attorney Says
January 30
Ranbaxy Will Sell Off Antibiotic Assets To Complete Deal With Sun Pharmaceuticals
January 30
Senators Seek Comments on Report About Drug, Device Development
January 30
Bipartisan Policy Center Launches Initiative to Modernize the FDA
January 30
FDA's Standard Review Time for Drugs, Devices Shrinking, PwC Report Says
January 30
U.S. Prescription Drug Prices Rose 10.9 Percent in 2014, Report Says
January 30
FDA Approves Combo Drug Evotaz For Treating HIV-1 Infection in Adults
January 30
FDA Expands Approved Use of Imbruvica For Rare Form of Non-Hodgkin Lymphoma
January 30
AIDS Patients Face Price Discrimination In Some ACA Plans, Harvard Study Finds
January 30
Endo Completes Acquisition Of Auxilium Pharmaceuticals
January 30
J&J Knew Risperdal Caused Breast Growth in Boys, Ex-FDA Head Says
January 30
Court Dismisses Pair of Lawsuits Against Sanofi Over MS Medication
January 30
Drug Company Didn't Have Duty To Disclose Dispute With Business Partner
January 30
Ninth Circuit Affirms Dismissal of Suit By Shareholders Over Weight-Loss Drug
January 30
Boehringer, Amneal Agree to End Aggrenox Dispute, Begin Confidential Licensing Pact
January 28
U.S. FDA Imposes Ban on Indian Drug Manufacturer IPCA Laboratories
January 28
Board of Patient Outcomes Group Approves Developing Funding Call for Obesity Studies
January 28
20 Percent of CDER-Approved Drugs in 2014 Were Personalized Medicines, Group Says
January 28
Standards Group Approved to Certify Apps For e-Prescribing of Controlled Substances
January 28
FDA Grants Orphan Status To Drugs for Pancreatic, Lung Cancer
January 28
Amgen, Onyx Submit sNDA For Multiple Myeloma Drug Kyprolis
January 28
Drugmaker Wants Permission to Deny Samples
January 28
U.K.’s NICE Should Oversee Apps In Mobile Health, Digital Specialist Says
January 28
Pharmaceutical Firms Can Build Trust Through Twitter Conferences, Speaker Says
January 28
Hatch-Waxman Litigation Update
January 28
High Court Denies Mylan, Sandoz Attempt To Expedite Remand in Copaxone Case
January 27
FDA Says Ranbaxy Gave Up Generic Nexium Exclusivity; Ranbaxy Seeks Quick Ruling
January 27
House Panel Releases Draft Language on 21st Century Cures
January 27
Takeda, Colcrys Investors Appeal Ruling Upholding FDA's Approval of Competing Drug
January 27
Petition Cites Splintered Federal Circuit Obviousness Ruling on BMS's Hepatitis Drug
January 27
More Combination Drugs Would Receive Market Exclusivity Under Proposed House Bill
January 27
Pitts Will Reintroduce House Bill On Timely DEA Scheduling of New Drugs
January 27
FDA Approves Generic Version Of Lamictal Orally Disintegrating Tablets
January 27
FDA Approves New Strength Of Novo Nordisk's Norditropin FlexPro
January 27
Owner of Turkish Wholesaler Sentenced To Prison Term in Missouri Imports Case
January 27
Court Shrinks FCA Claims Against Drug Company, Allows Off-Label Theory to Proceed
January 26
Supreme Court Sends Three Cases Back To Federal Circuit in Light of Teva v. Sandoz
January 26
HHS Announces Plans to Tie Medicare Payments to Quality
January 26
Gilead Expands Generic Sovaldi Pact To Add Investigational Combination Pill
January 26