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Featured Stories


Dems' 'Better Deal' Would Create Drug Price Gouging 'Enforcer'

Plan would empower new agency to investigate and potentially fine drug manufacturers that make unjustified price increases.

Pricing Debate Legislation Policy

AbbVie AndroGel Jury Verdict Targets 'Low T' Promotion

In first bellwether trial in testosterone replacement therapy litigation, jury issues $150m verdict against AbbVie for fraudulent misrepresentation of AndroGel.

BioPharmaceutical Policy Legal Issues

FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed

Head of US FDA's Office of Pharmaceutical Quality says agency doesn't want pharmaceutical companies to know just how they will be inspected under the emerging standardized 'NIPP' approach, lest they use that knowledge to game the process.

Compliance Manufacturing Quality

Rydapt set for EU approval after Novartis addresses CHMP concerns

Novartis’s new kinase inhibitor, Rydapt (midostaurin), for the treatment of AML and mastocytosis, could have got the thumbs up for EU approval in June but the committee that makes the decision, the European Medicines Agency’s CHMP, had concerns about the application. The CHMP has now issued a positive opinion for the orphan drug and formal EU approval is in sight.

Europe Approvals ImmunoOncology
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Policy & Regulation Explore this Topic

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Rydapt set for EU approval after Novartis addresses CHMP concerns

Novartis’s new kinase inhibitor, Rydapt (midostaurin), for the treatment of AML and mastocytosis, could have got the thumbs up for EU approval in June but the committee that makes the decision, the European Medicines Agency’s CHMP, had concerns about the application. The CHMP has now issued a positive opinion for the orphan drug and formal EU approval is in sight.

Europe Approvals ImmunoOncology

Latest From Regulation

Vanda And Nektar Persevere With Fanapt And Onzeald In EU

The two products that the European Medicines Agency’s key scientific committee, the CHMP, decided last week should not be approved in the EU were Vanda’s schizophrenia treatment Fanaptum (iloperidone), and Onzeald (etirinotecan pegol), a potentially new treatment for breast cancer with brain metastases from Nektar/Daiichi Sankyo Europe. The companies want the CHMP to look again at the negative opinions they received.

Regulation Approvals

Consumer Health Weekly Trademark Review July 18, 2017

Compiled from the Official Gazette of the U.S. Patent and Trademark Office] for [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) trademarks registered and published for opposition.

Consumer Trademarks

EMA Reviewing Guide To Support New Genome Editing Technologies, CAR-T Cell Therapies

The European Medicines Agency is updating its five-year old guideline on drugs containing genetically modified cells to factor in rapid scientific developments in relation to gene editing technologies, and the development of promising new cancer immunotherapies, such as CAR-T cells.

Regenerative Medicine Regulation

Latest From Policy

India’s Stem Cell Guidelines Require Institutional Review Panels

Draft update to national guidelines would direct institutional panels to coordinate with national stem cell oversight committee. Gene editing would be an area of "restrictive" research.

Policy Review Pathway

Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

Generic Drugs Legal Issues

Brazil Makes Drug Prices Transparent To Strengthen Hand In Pricing Talks

Brazil wants to drive competition and lower drug prices by obliging health authorities to publish the prices paid for all drugs bought by the national health system. A voluntary system has already helped save $1bn and cut the price of Gilead’s Sovaldi by around 30%.

BioPharmaceutical Market Access

Clinical / R&D Explore this Topic

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Latest From Research & Development

Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns

News and highlights about novel agents from our FDA Performance Tracker.

Approvals Complete Response Letters

Keeping Track: Tremfya Clears FDA; Dextenza Amendment Is Too Late; Emicizumab, Abemaciclib Filed

The latest drug development news and highlights from our US FDA Performance Tracker.

Regulation Research & Development

Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock

Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.

Clinical Trials Personalized Medicine

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Latest From Commercial

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales

Emerging Dialysis Drugs Will Face Medicare Reimbursement Challenges

Navigating Medicare's complicated bundled payment system could be tricky for new class of anemia drugs, the HIF prolyl hydroxylase inhibitors, which may start to reach the market for dialysis patients in 2019.

Medicare Reimbursement

Trump Lauds Big Pharma Collaboration On Super Strong Glass Packaging

President announces Merck, Pfizer and Corning collaboration on new glass packaging for injectable drugs as part of "Made In America Week;" says FDA is streamlining regulations.

BioPharmaceutical Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

CMC Regulatory Updates In Brief: CSL's Haegarda Specs; CMC Data Elements; ICH Q3C Maintenance

US FDA explains why it requested CSL Behring to reinstate non-critical manufacturing process controls and tighten container specs in line with process capability. FDA also proposes CMC data elements and posts ICH Q3C updates.

Manufacturing Quality

FDA Guidance Addresses Self-Identification, Facility Payments Under GDUFA

An FDA guidance addresses which types of facilities must self-report under GDUFA and pay the facility fee and which facilities must just self-report. Guide also covers whether two separate locations of the same company have to pay a user fee.

Compliance Manufacturing

Trump Lauds Big Pharma Collaboration On Super Strong Glass Packaging

President announces Merck, Pfizer and Corning collaboration on new glass packaging for injectable drugs as part of "Made In America Week;" says FDA is streamlining regulations.

BioPharmaceutical Commercial

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Consumer Health Weekly Trademark Review July 18, 2017

Compiled from the Official Gazette of the U.S. Patent and Trademark Office] for [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) trademarks registered and published for opposition.

Consumer Trademarks

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales

International Headwinds Counter J&J's Consumer Growth Confidence

"Some much weaker markets and some macroeconomic conditions, particularly in China and India" prompt J&J to adjusts its overall and consumer business expectations, CFO Dominic Caruso says. Its consumer product revenues climbed 1.7% to $3.5bn in is latest quarter.

Consumer Advertising, Marketing & Sales
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