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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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