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Generic Industry Hit With Avalanche Of Price Fixing Suits

As state attorneys general and Department of Justice move against generic manufacturers, plaintiffs’ firms have filed more than 90 antitrust suits on behalf of third party payers.

BioPharmaceutical Policy Pricing Debate

US FDA's Authority Over CRISPR Is Adequate, NASEM Finds, But Off-Label Challenge May Emerge

National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.

FDA Policy Regenerative Medicine

Patient-Centered Promotion? Marathon's Non-Launch Of Emflaza Illustrates Challenge Of New Era

Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?

Advertising, Marketing & Sales Legal Issues Regulation

Is Takeda's Consumer Unit 'Agile' Enough To Stretch Outside Japan?

Takeda says spinning off its consumer product portfolio into a wholly owned and independent subsidiary will boost its profile in the sector, but all signs continue to point to the firm's Rx operations as its predominant revenue drivers.

Consumer Japan Deals
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Policy & Regulation Explore this Topic

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Pediatric Drug Development A Priority For US FDA’s New Oncology Center Of Excellence

Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers.

Regulation Pediatrics FDA

Latest From Regulation

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll, secretary general of biotech industry body EuropaBio, is to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation, EFPIA’s new leader will have a lot of weighty dossiers to deal with.

Leadership Regulation

How EMA’s Adaptive Pathways Fits Into The Complex Drug Pricing Puzzle

The European Medicines Agency’s adaptive pathways concept may have a role to play in reducing the prices of medicines. But early market access initiatives such as these are just one piece in the complex drug reimbursement puzzle.

Regulation Reimbursement

‘Non-Medical Switching’ Claim Riles Europe’s Biosimilars Industry

Two patient advocacy groups have said that a number of issues surrounding biosimilar switching, patient consent and traceability remain to be addressed in Europe, despite growing support for biosimilar use from physician bodies and clinical studies. But the European biosimilars industry has dismissed these concerns, saying that biosimilar medicines will significantly improve access to biologics patients while contributing to the sustainability of pharmaceutical budgets.

Biosimilars Drug Safety

Latest From Policy

Rx Spending Stands Out In CMS Projections – As Slowing Down

Pharmaceutical industry’s message on overall drug spending trends is getting some timely support from the Center for Medicare and Medicaid Services’ annual national health expenditure projections.

Pricing Debate Policy

A Drag On Drugs? Trump’s Tariffs Could Raise Costs, Particularly For Generics

Drug makers remain mum on Trump tariffs despite worries that older generics could get squeezed. Landmark WHO study is adamant that tariffs should never be imposed on medicines.

Manufacturing Policy

How US Tax Plan Could Affect Global Pharma Manufacturing Networks

Allergan, Pfizer, Bristol-Myers Squibb, AbbVie, GSK, Sanofi and Roche showed glimpses in recent earnings calls of potential impacts on their global manufacturing networks from a US plan to legislate border-adjusted tax cuts. But there was not a word about President Trump’s threat of tariffs.

Manufacturing Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

Catabasis Refutes MRI T2 Biomarker In Duchenne Study

Catabasis says biomarker MRI T2 doesn't work after all in boys with Duchenne's, plans to stick with four-step climb test or 10-meter walk/run test from now on.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

Cost Versus Value: Earnings Calls Spotlight US Pricing Reforms

Pink Sheet has scoured big pharma annual results presentations to gauge the industry's reactions and concerns around the increasingly tough US drug pricing environment and proposed changes to the Affordable Care Act under the new Trump administration.

Pricing Debate Pricing Strategies

J&J Outlines Pricing Transparency Plan, Will Others Follow?

CEO Gorsky describes J&J’s approach to drug pricing and pledges to provide more detail in an annual transparency report. Investor pressure regarding the pricing debate continued during the Novartis earnings call. Value arguments expected to dominate pharma’s message.

Pricing Debate Sales & Earnings

New Policy Fund Reflects Korea’s Commitment To Health Biotech

South Korea's plan to create a policy fund to support new growth engine industries seems to reaffirm the government's unwavering commitment to nurture the biotech and health care sectors despite the ongoing political chaos in the country.

South Korea Financing

Manufacturing Explore this Topic

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Latest From Manufacturing

Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA

ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.

Quality Manufacturing

A Drag On Drugs? Trump’s Tariffs Could Raise Costs, Particularly For Generics

Drug makers remain mum on Trump tariffs despite worries that older generics could get squeezed. Landmark WHO study is adamant that tariffs should never be imposed on medicines.

Manufacturing Policy

How US Tax Plan Could Affect Global Pharma Manufacturing Networks

Allergan, Pfizer, Bristol-Myers Squibb, AbbVie, GSK, Sanofi and Roche showed glimpses in recent earnings calls of potential impacts on their global manufacturing networks from a US plan to legislate border-adjusted tax cuts. But there was not a word about President Trump’s threat of tariffs.

Manufacturing Policy

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Consumer Health Weekly Trademark Review Feb. 14, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Consumer Trademarks

Ipsen's Latest Consumer Health Play: Growth Or Attracting Suitors?

Less than a month after investing in Italian nutritional supplement maker Akkadeas Pharma, Ipsen acquires five Sanofi OTC drug brands marketed in Europe, including Prontalgine analgesics available in France.

Consumer M & A

Reckitt Expands 'OTC' Business, China Presence With Mead Johnson

Marketing Enfamil and other Mead Johnson formula and nutritional brands, says RB CEO Rakesh Kapoor, is "very much in the core of what consumer health stands for," and also immediately doubles the size of the firm's consumer business.

Consumer China
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