Today's News

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends / Following the breakup in March of its insulin biosimilars deal with Biocon, Pfizer confirms plans to develop monoclonal antibody biosimilars on its own, and has put its first candidate, rituximab, into Phase 1 testing. / “The Pink Sheet”

Business & Finance

ESRD Market Snapshot: The Price Has To Be Right / The market for kidney disease drugs is under pressure from Medicare cost containment policies. However, there is still room for new drugs – if they can demonstrate a cost-savings benefit. / “The Pink Sheet” May 14, 2012

Asia Spotlight: SciClone China CEO Mark Lotter On The Changing Commercial Landscape / Considered one of the top commercial minds in China, the former AstraZeneca exec and founder of NovaMed discusses how to build a sustainable commercial model in a rapidly changing China, touching on everything from retaining talent to surviving China’s latest round of price cuts. / “The Pink Sheet” May 14, 2012

Deals Of The Week: GSK/HGSI, Daiichi Sankyo/Coherus / GSK/Human Genome story takes a sharp turn, but does the big pharma’s hostile bid expose greater interest in cardiovascular drug darapladib than it is admitting? / “The Pink Sheet” May 14, 2012

R & D

Dalcetrapib Failure Raises Yet More Questions On Value Of Tinkering With HDL Cholesterol / Termination of the development program for dalcetrapib creates more doubt about the class of CETP inhibitors, long viewed with ambivalence. But important differences in how the drug works compared to rivals leaves room for some to hold out hope for CETP inhibition and the HDL hypothesis in general. / “The Pink Sheet” May 14, 2012

On Capitol Hill

PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean / Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard. / “The Pink Sheet” May 14, 2012

Regulatory Update

Weighty Issues: GW Obesity Outcomes Project Tests Model For Patient Input In Drug Development / A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. / “The Pink Sheet” May 14, 2012

Advisory Committees

Truvada PrEP REMS Needs More Work, FDA Panel Says / In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug. / “The Pink Sheet” May 14, 2012

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns / Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early. / “The Pink Sheet” May 14, 2012

Another Arcalyst Trial May Be Regeneron’s Best Path To Approval In Gout / Recommending against approval, FDA’s Arthritis Advisory Committee says there is not enough data for Regeneron’s gout therapy and suggests that chronic and refractory populations should be studied. / “The Pink Sheet” May 14, 2012

Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients / The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals. / “The Pink Sheet” May 14, 2012

Will Pharmacovigilance Be Enough To Address Questions About Pfizer’s Tofacitinib? / Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use. / “The Pink Sheet” May 14, 2012

Recent And Upcoming FDA Advisory Committee Meetings / Recent and upcoming FDA advisory committee meetings and a summary of topics covered. / “The Pink Sheet” May 14, 2012

Pipeline Update

Janssen Builds A Pulmonary Pipeline: An Interview With Sue Dillon / Citing high unmet medical need and significant commercial opportunity, Janssen Research & Development has dived into pulmonary therapeutics. TA head of immunology Sue Dillon discusses the rationale, the indications and the therapeutic approaches the company is taking. / “The Pink Sheet” May 14, 2012

Companion Diagnostics

Couples Therapy: Challenges In Companion Dx-Biopharma Relationships Noted By VC / Companion diagnostic firms facing skeptical partners in big pharma need to focus on ways of establishing the value of their test to payers and patients, Third Rock Ventures’ Mark Levin advised the Personalized Medicine Coalition. / “The Pink Sheet” May 14, 2012

Electronic Health

Linking EHRs To Cancer Registries Good In Theory, But Difficult In Practice, ASCO Says / The American Society of Clinical Oncology offers support for the notion of using electronic health records to help provide information to cancer registries, but is critical of CMS’ approach as outlined in the stage 2 meaningful use proposed rule. / “The Pink Sheet” May 14, 2012

Generic Drugs

FDA’s ANDA Approvals / Generic drug approvals for late April and early May. / “The Pink Sheet” May 14, 2012

Publisher's Spotlight

Webinar: Perspectives on FDA's New DTC TV Pre-Review Program and Other Hot DTC Topics / In March 2012, FDA's Office of Prescription Drug Promotion (OPDP) issued a Draft Guidance outlining the contours of the agency's new DTC Television Advertising Pre-Dissemination Review Program established under the Food and Drug Administration Amendments Act of 2007. During this webinar, Former FDA Associate Chief Counsel, and Principal at Arnold I. / “The Pink Sheet” May 14, 2012