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.

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
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