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Consumer Drugs
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ISSN (Print) 1530-1206
Published by Informa plc

[9 journals]

US FDA's First-Ever Countrywide Import Alert For Drugs Bans
Mexican Hand Sanitizers
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  Abstract: Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy. Related Stories
  One Prediction For US FDA Under Biden: More Advisory Committees
  Campaign Against Woodcock’s US FDA Commissioner Bid Has Begun
  Yescarta Becomes Japan’s Second Approved CAR-T
  PubDate: Fri, 29 Jan 2021 18:46:53 GMT
US FDA Questions Valisure’s Zantac Carcinogenicity Findings
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  Abstract: As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab?s test made nitrosamine levels appear high. Related Stories
  Pink Sheet Podcast: Aduhelm OIG Review, COVID-19 Vaccine Approval Sprint, Adcomm Drought
  Blow For Industry As GSK-Teva ‘Skinny Label’ Decision Upheld
  Pink Sheet Podcast: Aduhelm OIG Review, COVID-19 Vaccine Approval Sprint, Adcom Drought
  PubDate: Wed, 02 Oct 2019 23:00:16 GMT
Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports
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  Abstract: Majority opinion by Federal Circuit upheld International Trade Commission?s decision and denied as moot Amarin?s petition for order to compel... Related Stories
  Recent And Upcoming FDA Advisory Committee Meetings
  Australian Drug Industry Lays Out Wishlist As Elections Near
  What Lies Beneath: Chinese Pharma Tycoon Alleged Paying Millions In Stanford Admission Scandal
  PubDate: Thu, 02 May 2019 20:57:22 GMT
Australian Competition Watchdog Probes GSK/Pfizer Consumer Health JV
Proposal
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  Abstract: Assessing how closely GSK?s OTC brands including Panadol compete with Pfizer?s Robitussin and other OTC brands is the aim of investigation... Related Stories
  Gene Therapy Manufacturing Make-Or-Buy Options Weighed
  UK MHRA Clarifies No Deal Brexit Plans For PIPs
  WHO?s Human Genome Editing Standards Must Not Impact Somatic Cell Research
  PubDate: Mon, 04 Mar 2019 23:56:33 GMT
Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus
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  Abstract: Moberg had been expanding its OTC portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine... Related Stories
  Gene Therapy Manufacturing Make-Or-Buy Options Weighed
  UK MHRA Clarifies No Deal Brexit Plans For PIPs
  WHO?s Human Genome Editing Standards Must Not Impact Somatic Cell Research
  PubDate: Fri, 15 Feb 2019 15:38:46 GMT
Pfizer Consumer Health True To Form Pending Move To JV With GSK
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  Abstract: Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK... Related Stories
  PhRMA Muscles In With Post-Brexit Trade Deal Wish List
  Recent And Upcoming FDA Advisory Committee Meetings
  UK: Funding For Second Kymriah Indication After Talks And Price Cut
  PubDate: Thu, 31 Jan 2019 16:10:30 GMT
Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates
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  Abstract: Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its... Related Stories
  EU Consults On Revised Guide For Orphan Drug Designation
  MMV/DNDi Offer 400 Compounds in ‘Pandemic Response Box’
  Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption
  PubDate: Wed, 30 Jan 2019 18:54:40 GMT
Poland Kick Starts 2019 With Three Rx-To-OTC Switches
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  Abstract: Clotrimazole, pyrantel, and ciclopirox olamine have been switched from prescription-to-OTC status by Poland?s national drug regulator. Related Stories
  Fremanezumab Among Latest EU Drug Hopefuls While Patients Speak Up On Pacritinib
  UK Inquiry Schedules Public Hearing On Availability Of Vertex’s Orkambi
  Former Purdue Chairman Sought To Shadow Opioid Sales Reps, Massachusetts AG Suit Says
  PubDate: Sun, 27 Jan 2019 16:05:09 GMT
Dr. Kade Enters OTC Dermatology Space With Sirius Acquisition
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  Abstract: German firm Dr. Kade moves into the OTC dermatology category with an all-share acquisition of Sirius, which owns and markets... Related Stories
  UK Committee Urges Clarity On No-Deal Brexit Medicine Supplies
  Recent And Upcoming FDA Advisory Committee Meetings
  ChemoCentryx/Vifor Change Tack On EU Avacopan Filing
  PubDate: Thu, 24 Jan 2019 14:43:16 GMT
US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch
Proposals
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  Abstract: Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing... Related Stories
  Biosimilar Vs. Biosimilar: Coherus Sues Amgen For Infringing Adalimumab Formulation Patents
  FDA Refines Guidance On Immunogenicity Testing
  UK Committee Urges Clarity On No-Deal Brexit Medicine Supplies
  PubDate: Mon, 21 Jan 2019 07:58:17 GMT
FDA's OTC Naloxone Model Labels Confirmed In CONFER Study
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  Abstract: Participants in US FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed... Related Stories
  Pharmacists to get new substitution powers to tackle Brexit shortage risk
  Financial Penalties Scope Widened Under New EU Regulation
  Singapore Reveals Phase-In Plans For eCTD
  PubDate: Mon, 21 Jan 2019 07:56:01 GMT
Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo,
Troubles Analysts
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  Abstract: Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated... Related Stories
  PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny
  Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth
  UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre
  PubDate: Fri, 18 Jan 2019 15:48:50 GMT
Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth
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  Abstract: "Probably the worst offense" among Perrigo?s problems is that before appointing President and CEO Murray Kessler in November, it had... Related Stories
  PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny
  Irish $1.9bn Tax Bill ?Out Of Nowhere? Perplexes Perrigo, Troubles Analysts
  UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre
  PubDate: Fri, 18 Jan 2019 15:47:07 GMT
House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A
Question Mark
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  Abstract: With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action... Related Stories
  EU ATMP Developers Missing Out By Failing To Use Advice On Offer
  Industry Welcomes Mandatory eCTD In Australia, But With Caveats
  J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy?s In China, And Investor Sentiment Shifts
  PubDate: Thu, 10 Jan 2019 16:56:25 GMT
EllaOne Firm Endorses UK Reproductive Rights Group's Push For OTC
Sales Of Emergency Contraceptives
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  Abstract: EllaOne manufacturer HRA Pharma supports British Pregnancy Advisory Service?s call to scrap mandatory consultations for emergency contraceptives by switching the medicines... Related Stories
  EU ATMP Developers Missing Out By Failing To Use Advice On Offer
  Industry Welcomes Mandatory eCTD In Australia, But With Caveats
  J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy?s In China, And Investor Sentiment Shifts
  PubDate: Tue, 08 Jan 2019 17:05:34 GMT
Burt’s Bees Hopes Third Time’s A Charm In Oral Care With
P&G As Provider
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  Abstract: Clorox and Procter & Gamble embarked on a strategic licensing partnership to market Burt’s Bees toothpastes, available now in mass... Related Stories
  EU ATMP Developers Missing Out By Failing To Use Advice On Offer
  Industry Welcomes Mandatory eCTD In Australia, But With Caveats
  J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy?s In China, And Investor Sentiment Shifts
  PubDate: Mon, 07 Jan 2019 18:18:29 GMT
Bayer Consumer Chief Identifies 'Root Causes' Of Slump, Initiates
Growth 'Fix'
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  Abstract: Bayer?s Consumer Health chief Heiko Schipper hopes a focus on innovation and a leaner portfolio will help return business to... Related Stories
  New UK Drug Assessment Routes Among Latest Measures For No-Deal Brexit
  Recent And Upcoming FDA Advisory Committee Meetings
  EU Court Ruling Puts Pressure On Orphan Drug Developers
  PubDate: Thu, 20 Dec 2018 14:51:00 GMT
HRA Pharma Reveals Big Growth Ambition: Become Top 10 OTC Player
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  Mon, 17 Dec 2018 10:35:29 GMT
Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers
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  Abstract: Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety... Related Stories
  New UK Drug Assessment Routes Among Latest Measures For No-Deal Brexit
  Recent And Upcoming FDA Advisory Committee Meetings
  EU Court Ruling Puts Pressure On Orphan Drug Developers
  PubDate: Fri, 14 Dec 2018 15:59:08 GMT
Crown Labs Spreads Out, GSK Narrows Focus In OTC Skin Care Brand Deal
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  Abstract: GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna... Related Stories
  New UK Drug Assessment Routes Among Latest Measures For No-Deal Brexit
  Recent And Upcoming FDA Advisory Committee Meetings
  EU Court Ruling Puts Pressure On Orphan Drug Developers
  PubDate: Thu, 06 Dec 2018 16:17:09 GMT

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