The Pink Sheet

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In March 2012, FDA's Office of Prescription Drug Promotion (OPDP) issued a Draft Guidance outlining the contours of the agency's new DTC Television Advertising Pre-Dissemination Review Program established under the Food and Drug Administration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.

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.

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.

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.

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.

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.

FDA’s ANDA Approvals

Generic drug approvals for late April and early May.

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.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

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.

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.

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.

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.

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.

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.

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.

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?

Boehringer Ingelheim Shrugs Off Patent Cliff, Returns To Sales Growth

Germany's Boehringer Ingelheim returns to sales growth and looks to Phase III hepatitis C and oncology products to provide long-term growth.

ASCO Seeks More Aggressive Approach On Limiting Safety Data Collection

The American Society of Clinical Oncology says FDA’s draft guidance on targeted safety data collection is too conservative and inconsistent with the agency’s recommendations from a 2001 guidance on cancer drug clinical trials. ASCO requests the two guidances be harmonized to eliminate the potential for confusion among sponsors and clinical trial investigators.

People In The News: Tracking The Latest Industry Personnel Moves

New top leadership at Kolltan Pharmaceuticals, Array BioPharma and Quintiles; Ipsen names its North American leadership team. More personnel announcements in this month’s column