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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 Legislation

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 Generic Drugs

EMA Review Of Non-EU Drugs To Be Made More Useful For African Regulators

The European Medicines Agency is looking into how it can better promote the Article 58 procedure under which it evaluates the quality, safety and efficacy of medicines or vaccines intended for use outside the EU. The procedure has been underutilized by industry to date and the EMA wants to encourage its use, especially for drugs to be used in Sub-Saharan Africa.

Regulation Middle East and Africa Europe

Amphastar's Naloxone Nasal Spray Delayed; User Human Factors Study Among FDA Concerns

FDA 'complete response' letter follows advisory committee's conclusion that the current naloxone approval standard is inadequate.

FDA Complete Response Letters United States
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Gilead Buys Its Third Priority Review Voucher, But Is The Mania Over?

Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.

Financing Rare Diseases Regulation

Latest From Regulation

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

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

‘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

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

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

Medicaid Drug Rebates Will Get Closer Scrutiny From CMS, Verma Pledges

CMS Administrator-nominee Seema Verma promises stronger agency oversight of Medicaid drug rebate program in response to question from Sen. Grassley during Senate confirmation hearing.

Policy Medicaid

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

Set Alert for Manufacturing

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

US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

FDA Life Cycle Management

Biotech Firms Struggle To Replicate Analytical Methods For Commercial Use

The process of transferring analytical methods from research labs to commercial labs is fraught with challenges and biotech manufacturers must pay careful attention to everything in the transfer process, especially for overseas transfers. A diverse toolkit is needed to test these complex molecules. An increasing number of product launches is putting pressure on biotech manufacturers to complete these tech transfers quickly, and industry is receiving little guidance from FDA.

Biologics Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

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
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