Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 April 2013)

Regulatory Reconnaissance (1 April 2013)

Posted 01 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. All eyes in the industry are on India today, where the Supreme Court has ruled that Novartis' patent on Glivec/Gleevec is invalid, paving the way for cheaper generic competitors and perhaps a sea change in the way companies approach the 1.2 billion-person country.

In the US, the WSJ reports Omontys had early side effects that foreshadowed its recall, the regulatory battle over compounding heats up, FDA posts the warning letter it sent to Impax last week, Teva's Quartette NDA gets FDA approval, PhRMA touts pre-approval benefits of drug products, Covidien wins a huge lawsuit against J&J, FDA looks to get their UDI proposal off the ground, industry pans FDA's home-use draft guidance, companies look to avoid regulations by getting into the supplement business, and an FDA study into biomarkers for drug-induced liver injury looks to get off the ground.

Abroad, South Africa is urged to adopt compulsory licenses for some patented drugs, Indian companies need to give six months' notice before stopping production of a drug, the UK's NHS has massive changes coming into effect today, Otsuka files for regulatory approval for a new TB drug in Japan, and Korean and Chinese regulatory changes seem to be unlikely to affect drugs and devices in the short term.

Five in Focus:

  1. Novartis loses landmark India patent case on Glivec (The Ruling) (Backup Ruling) (Reuters) (Novartis) (Scrip) (BioSpectrum) (Financial Times) (NYTimes) (Reuters) (NYTimes)
  2. After fungal meningitis outbreak, agencies do battle with pharmacies (NBC)
  3. Indian Companies will need to give 6 months notice to stop essential drugs (Economic Times)
  4. Covidien wins $177M from Johnson & Johnson's Ethicon Endo-Surgery in ultrasound scalpel spat (Mass Device) (MDDI) (Fierce Medical Devices) (Covidien)
  5. With Top Lines Drooping, Firms Reach for Vitamins With Eye on Avoiding Regulatory Oversight (WSJ)

US

Pharmaceuticals/Biotechnology
  • Anemia Drug Omontys Had Early Side Effects (WSJ)
  • After fungal meningitis outbreak, agencies do battle with pharmacies (NBC)
  • FDA Posts Impax Laboratories' Form 483 (FDA)
  • FDA Approves New Drug Application (NDA) for Teva's Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy (Teva) (Med City News)
  • Tris Pharma Gets FDA Approval for Three New Formulations of Anti-Allergy Drug Paglic (Caribinoxamine Maleate) (FDA) (NDA #022556)
  • Par Pharma Gets New ANDA Approvals for Exforge (Amlodipine Besylate and Val Sartan) (FDA) (ANDA # 090011 / 090144)
  • Lupin Pharma Gets New ANDA Approval for Birth Control Product Jencycla (Norethindrone) (FDA) (ANDA #091323)
  • Navinta Gets ANDA Approved for Peripheral Vasodilator Drug Hydralazine Hydrochloride (FDA) (ANDA #202938)
  • Dr. Reddy's launches generic acne drug (Drug Store News)
  • Years Before Approval, New Medicines Still Offer Benefits (PhRMA)
  • Janssen Submits Simeprevir NDA (Drug Discovery and Development)
  • Audio Posted for FTC v. Actavis Supreme Court Case (Oyez Project)
  • Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture (FDA Law Blog)
  • BioCryst Pharmaceuticals Provides Update Regarding Peramivir (Business Wire)
Medical Devices
  • Covidien wins $177M from Johnson & Johnson's Ethicon Endo-Surgery in ultrasound scalpel spat (Mass Device) (MDDI) (Fierce Medical Devices) (Covidien)
  • FDA Solicitation Looks to Start Getting UDI Proposal Off the Ground (FDA)
  • Scope Of FDA's Home-Use Device Draft Guidance Is Too Broad, Industry Says (The Gray Sheet) ($)
  • FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says (The Gray Sheet) ($)
  • Jerry Fishman, Analog Devices CEO, Dead at 67 (Xconomy)
  • The U.S. military's miracle scanner detects brain hematomas (CNN Money)
  • Class 1 Recall: Nurse Alarm System That, in Rare Instances, Doesn't Sound Alarm (FDA)
  • U.S. to reexamine health effects of cellphone radio waves (Reuters)
  • FCC Chair's Departure Could Impact Progress on mHealth Initiatives (FDA News)
  • Kips Bay rises on FDA trial approval, despite losses in sales and revenue (Mass Device)
  • ResMed takes aim at APEX Medical over respiratory device patents (Mass Device)
Assorted
  • With Top Lines Drooping, Firms Reach for Vitamins With Eye on Avoiding Regulatory Oversight (WSJ)
  • Are GMP Violations The "Next Hot Thing" In False Claims Act Litigation? (The Pink Sheet) ($)
  • ACRP and IISRA to merge (Center Watch)
  • FDA Office of Special Health-Office that Administers Medwatch-Changes Name to Office of Health and Constituent Affairs (FDA)
  • FDA Looking for Tech to Get its "Study of Translational Biomarkers for Drug-Induced Liver Injury with Next-Generation Sequencing" Off the Ground (FDA)
  • Another FDA Solicitation Calls for DNA Sequencer to Help FDA Study Biomarkers to Advance Personalized Medicines (FDA)
  • Massachusetts Looks to Amend Rules for Prescription Drug Adverse Event Reporting (Scout)
  • Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers (FDA)
  • U.P.S. Will Forfeit $40 Million Over Illegal Drug Shipments (NYTimes) (WSJ)
  • FDA Lawyer Concedes Difficulty in Meeting FSMA Deadlines (Food Product Design)
  • Va. Gov. McDonnell on two-way street with chief executive of struggling life sciences company (Washington Post)
  • More Diagnoses of Hyperactivity in New C.D.C. Data (NYTimes)
Government and Budget
Meetings and Events This Week
  • 4 April 2013: Hamburg to Deliver Keynote to 2013 National Rx Drug Abuse Summit (NRxDA Summit)
  • 4 April 2013: NIH's Francis Collins to Appear on Stephen Colbert's 'The Colbert Report' (Colbert Nation)
  • 5 April 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)

International

  • Novartis loses landmark India patent case on Glivec (The Ruling) (Backup Ruling) (Reuters) (Novartis) (Scrip) (BioSpectrum) (Financial Times) (NYTimes) (Reuters) (NYTimes)
  • South Africa Urged to Adopt Compulsory Licenses as Well (Med India)
  • Indian Companies will need to give 6 months notice to stop essential drugs (Economic Times)
  • EU Parliament Considers More Stringent Medical Device Regulations (The Gray Sheet) ($)
  • Biosimilars: Is The Game About To Change In Europe? (The Pink Sheet) ($)
  • Five ways the NHS is changing starting today (BBC)
  • Expert Indian panel on FDC meets stakeholders to get their suggestions on guidance document (PhramaBiz)
  • Novartis, Retracted Papers And A Big-Selling Drug (Pharmalot)
  • Promotion of Chinese, Korean Drug Authorities to Ministry Level Not Likely to Impact Drug Policy (FDA News) ($)
  • Otsuka's novel TB drug filed in Japan (Scrip) ($)
  • India: Delay in setting up separate DCGI for Ayush affects regulatory mechanism (PharmaBiz)
  • India's Glenmark Hits Merck By Launching Copy Of Patented Januvia In A Move That May Alter The DPP4 Diabetes Market (PharmAsia News) ($)

General Regulatory and Interesting Articles

  • How one startup is fighting counterfeit drugs in developing countries - one cellphone at a time (Med City News)
  • BioCenturyTV Interviews George Church on a New Neuron Mapping Project (BioCentury)
  • The Real World of Cost-Benefit Analysis: Thirty-Six Questions (and Almost as Many Answers) (Cass Sunstein)
  • GERD label makes parents more likely to want medicine (Reuters) (Med Page Today)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.


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