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The Pink Sheet

The Pink Sheet


Expert, in-depth analysis of biopharma regulatory, legislative, legal and business developments.


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Today's News

For Novartis, 2012 Is Set To Be A Bumpy Ride / With the loss of exclusivity for its blockbuster heart drug, Diovan, coming in September, management focused on the company’s long-term prospects during a fourth quarter financial update. / “The Pink Sheet”

Current Issue:  Jan. 23, 2012

Year In Review And The Year Ahead

FDA Approving More Novel Drugs Without Advisory Committee Review / The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand. / “The Pink Sheet” Jan. 23, 2012

2011 FDA Advisory Committee Recommendations / Full-year listing of drug review recommendations from FDA advisory panels, including regulatory actions. / “The Pink Sheet” Jan. 23, 2012

Generic Opportunities In 2012 Diluted By Shared Exclusivities / Despite the patent cliff, 2012 is one of the final years of blockbusters going generic, leaving the large generic companies to establish their place in the morphing market. / “The Pink Sheet” Jan. 23, 2012

Austerity Holds Back VC Investing in European Biotech Companies in 2011 / Funding for private biotech companies in Europe declines 17% during 2011, while funding for public biotech companies falls 50%, although 2012 starts strongly. / “The Pink Sheet” Jan. 23, 2012

Regulatory Update

Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations / The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates. / “The Pink Sheet” Jan. 23, 2012

Accelerated Approval Could Expand As Alternative To Progressive Approval / CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway. / “The Pink Sheet” Jan. 23, 2012

European Regulatory Round-Up: New Faces; Revised Guidances; More Cost Controls / A new chairman will take the helm of Germany's G-BA panel at a pivotal time for AMNOG implementation; the European Medicines Agency issues guidances in oncology drug development and genotoxicity; more regulatory updates. / “The Pink Sheet” Jan. 23, 2012

Business & Finance

Deals Of The Week: Genentech/Constellation, Bayer/Ventana, Genzyme/Veracyte / Epigenetics took the spotlight this week, with Genentech being the latest pharma to move into the field in partnership with Constellation Pharmaceuticals. In other deals, Bayer signed Ventana to develop a companion diagnostic, and Pfizer walked away from Medivation and Alzheimer’s drug Dimebon. / “The Pink Sheet” Jan. 23, 2012

Optimer’s Dificid Could Pave A Path To Higher Prices For Antibiotics / The drug developer appears to be making the case for premium pricing by differentiating fidaxomicin for its ability to sustain clinical response and cut costs associated with recurrence. / “The Pink Sheet” Jan. 23, 2012

Revelations And Resolutions, In Brief / News about Inhibitex, Gilenya, Genzyme manufacturing, Forest's linaclotide, and Paula Deen / “The Pink Sheet” Jan. 23, 2012

Drug Safety

Mini Sentinel Data Covers 126 Million Patients; FDA Weighing Potential Uses For Drug Industry / With the recent addition of claims data from two major insurance companies, the FDA postmarketing drug safety surveillance pilot project known as Mini Sentinel has already exceeded its statutory goal of gaining access to electronic health care data for 100 million individuals by July 12, 2012. / “The Pink Sheet” Jan. 23, 2012

FDA’s Temple Sees Sentinel As Important Tool For Confirming And Analyzing Drug Adverse Events / FDA clinical science expert Robert Temple discusses how the Sentinel project – a drug data monitoring initiative – can support the agency’s postmarket drug safety investigations. / “The Pink Sheet” Jan. 23, 2012

Comparative Effectiveness Research

PCORI Draft Research Agenda Offers Broad Areas Of Study With Intention Of Getting Specifics From Public Comments / The Patient-Centered Outcomes Research Institute’s issues its draft national priorities and research agenda for comment Jan. 23. Rather than identify specific research items, the list contains five broad areas designed to elicit the greatest amount of input from stakeholders on what projects should be funded for investigation. / “The Pink Sheet” Jan. 23, 2012

On Capitol Hill

ADHD Drug Shortages Draw Attention In Congress, Court / Lawmakers seek information from Shire, Novartis and the Drug Enforcement Administration as to the reason behind short supplies of some attention deficit/hyperactivity disorder drugs. A legal dispute over supply of an Adderall XR authorized generic is slated for trial in April. / “The Pink Sheet” Jan. 23, 2012

Burgess Not Changing Conflict Of Interest Thinking Despite Flap Over Oral Contraceptive AC / Sponsor of bill that would adjust conflict of interest rules says requiring public release of financial disclosure documents, as one group suggested, may not require a legislative fix. / “The Pink Sheet” Jan. 23, 2012

Advisory Committees

Recent And Upcoming FDA Advisory Committee Meetings / Recent and upcoming FDA advisory committee meetings and a summary of topics covered. / “The Pink Sheet” Jan. 23, 2012

Generic Drugs

FDA’s ANDA Approvals / Generic drug approvals and tentative approvals for mid-January. / “The Pink Sheet” Jan. 23, 2012

Publisher's Spotlight

9th Annual Pharmaceutical Strategic Outlook (PSO) Conference, April 11-13, 2012 / Join us at PSO 2012 where we will delve into the top issues affecting the pharma industry. Experience a dynamic three days of networking and discussion - with a personal and interactive setting, in-depth on-stage interviews, thought-provoking panels, one-on-one partnering meetings and innovative company presentations by carefully selected biotech companies. / “The Pink Sheet” Jan. 23, 2012