"The Pink Sheet" :: Elsevier Business Intelligence

FDA’s ANDA Approvals

Mon, 17 Jun 2013 00:00:00 -0400

Generic drug approvals and tentative approvals for early June.

Amgen Further Narrows Patient Population For Its EGFR Inhibitor In Colon Cancer

e.hayes@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

In new analyses of previous studies, Amgen finds that metastatic colon cancer with any RAS mutations – not just KRAS – doesn’t respond well to EGFR inhibition. The company is discussing the data with regulators.

Avandia Committee Member Votes Through The Years

c.dombrowski@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Eight individuals have participated in all three advisory committees that reviewed Avandia cardiovascular safety during the past six years; most have favored the least restrictive approach at each of the meetings.

New Opportunity For CER As Placebo Trials Show Shrinking Drug Efficacy Margins – Health Affairs

g.twachtman@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Authors of a Health Affairs article find the effect of active drugs versus placebo has declined in controlled trials over time, suggesting to them that more attention should be focused on understanding the clinical value of existing treatments, including establishing equivalence of efficacy and focusing on differences in safety, cost and tolerability.

Amgen Plays Diversity Card In Approach To Cancer; Immunotherapy Could Be Its Ace

e.hayes@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Amgen explains why it has what it takes in immunotherapy, as part of a broader oncology development plan.

ANDA Pre-Submission Meetings Being Considered By FDA

d.gingery@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Designed to boost application quality, creating such meetings would be another sign of the evolution of the Office of Generic Drugs.

AstraZeneca Oncology Focused On Combinations, But Differentiation Will Be Key

m.laffler@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

AstraZeneca is in the midst of a concerted push in oncology, but many of its top contenders are in crowded classes. The firm sees its future in the possibilities of combinations with immunotherapies.

FDA Stands Firm On ANDA Stability Guidance’s 2014 Enforcement Deadline

s.karlin@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

The generic industry is frustrated that the final version of the stability testing guidance has yet to be released, but FDA says the document is coming; the agency offered guidance clarification at a recent meeting and said it will enforce the guidance in January whether manufacturers are ready or not.

Deals Of The Week Looks At How Amgen’s Global Expansion Affects Partnering

Mon, 17 Jun 2013 00:00:00 -0400

Plus perspectives on AstraZeneca/Pearl Therapeutics, Xenon/Isis, Questcor/Novartis, BMS/Simcere and more.

Avandia Panel Wants Another Trial: Pipe Dream Or Post-market Benchmark?

c.dombrowski@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Designed with complex, multi-variate statistics, an observational trial could determine the CV risk of rosiglitazone compared to other diabetes drugs, an advisory committee member suggests during the latest assessment of Avandia.

Investors Expect Biopharma Run-Up To Cool In Summer, Heat Up In Fall

Stacy.Lawrence@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Biotech and pharma stocks have continued their hot streak unabated this year, but if the summer brings little news and a broader market pull-back the sector is likely to cool. Wall Street is hopeful that any chill will be gone by the fall, with more clinical and regulatory milestones.

Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety

c.dombrowski@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.

Market Snapshot: Diabetic Macular Edema, Another Blockbuster Opportunity For Retinal Drugs?

j.davis@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Having relatively rapidly built a multi-billion dollar market in wet age-related macular degeneration, biotech and pharma companies may be about to repeat the exercise with diabetic macular edema, a complication of diabetes that’s growing in importance as the population ages and the disease spreads.

Biotech Industry Fears Fallout From Supreme Court’s Myriad Ruling; PTO Offers Guidance

b.sandburg@elsevier.com — Mon, 17 Jun 2013 00:00:00 -0400

Supreme Court unanimously holds that DNA isolated from the human body cannot be patented but cDNA, which is created in a laboratory, can; Patent and Trademark Office tells examiners to reject product claims drawn solely to naturally occurring nucleic acids or their fragments.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 17 Jun 2013 00:00:00 -0400

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

Pfizer’s CTI Shows Tangible Signs Of Progress In Its Junior Year

j.merrill@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Pfizer’s Centers for Therapeutic Innovation program has grown in less than three years to include 24 academic partners. First drug candidate to emerge from the research model is expected to enter the clinic this year, and Pfizer’s investment in CTI has grown.

GDUFA Facility Fees Likely To Increase Due To Fewer Self-IDs

d.gingery@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Fewer API and finished dosage form facilities appear on the FY 2014 generic drug user fee self-identification list, meaning FDA may be forced to adjust next year’s GDUFA fees for more than just inflation.

Roche’s House Advantage: Does Having It All Under One Roof Make A Difference?

Mon, 10 Jun 2013 00:00:00 -0400

The size of Roche’s pipeline and in-house diagnostics business are key advantages in oncology, top execs told the firm’s analyst meeting at ASCO. Roche’s oncology strategy includes replicating its HER2 success in hematology, targeting new pathways, entering immunotherapy and going all-in on antibody-drug conjugates.

Roche Experimenting With New Pricing Models In Oncology

m.laffler@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Cancer drug prices are unsustainable and creative approaches are needed, Roche’s O’Day says. The firm’s moves into emerging markets are a lab for new methods, he said, though the real test will come as the more expensive drugs are used in combination.

Can Roche Make A Case For Avastin In Brain Cancer Based On Quality Of Life?

m.laffler@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

With two trials failing to show a survival advantage in first-line glioblastoma, the company must go to FDA with a progression-free survival benefit and quality-of-life data from one trial to support its accelerated approval in the advanced setting.

Melanoma Success Paves Way For Path Of Gold In Cancer Immunotherapy

e.hayes@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Phase I data for immune checkpoint molecules in melanoma from Bristol, Roche and Merck were a major highlight of the ASCO 2013 annual meeting. Considering potential application in many cancers regardless of genetic mutations, some analysts are predicting billions in future sales.

Asia Spotlight: AstraZeneca Shakeup Of China Business Unit Steers Focus Away From Generics To Innovative Drugs

j.dai@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

AstraZeneca will dissolve its Broad Market business unit in China by merging it with primary care and move away from attracting business for branded generics in tier-3 rural markets, putting flesh on new CEO Pascal Soriot’s plan to focus on innovation.

Big Pharma Casts Immune Checkpoint Net Wide Across Tumor Types

e.hayes@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Encouraged by data for a number of immune checkpoint molecules, Bristol, Merck and Roche are moving forward fast with development in many cancers, including melanoma, kidney cancer, lung cancer and hematologic malignancies. Trials in diseases with high unmet need could allow a faster route to approval for drugs in the anti-PD1 family.

Bayer Oncology Keystone Nexavar Looks Good For Thyroid Indication

s.haley@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Adding indications for Nexavar is critical to Bayer HealthCare’s plan to become a major global player in cancer therapeutics, Bayer oncology leader says at ASCO.

“Breakthrough” Therapies: Pharmacyclics Gains More Access, Certainty For Ibrutinib

d.gingery@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Company Chief Medical Officer Kunkel says FDA has talked about manufacturing and trial design for its breakthrough designee much earlier than would be expected with a typical application.

Deals Of The Week Ponders The ACA

Mon, 10 Jun 2013 00:00:00 -0400

In a slow week for pharma deals, standouts included GSK’s wrap up with MorphoSys for a mid-stage rheumatoid arthritis drug, Pfizer’s deal to gain access to novel kinds of antibody drug-conjugates through platform company CytomX, and the first microbiome deal between a big pharma (Janssen) and a start-up, Second Genome.

Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner

c.dombrowski@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.

FDA’s ANDA Approvals

Mon, 10 Jun 2013 00:00:00 -0400

Generic drug approvals and tentative approvals for late May and early June.

Free e-book offers valuable information management tips

Mon, 10 Jun 2013 00:00:00 -0400

Publisher’s Spotlight: This e-book offers valuable videos, articles, white papers and case studies to explore how using information management can move health care and life sciences organizations forward. More specifically, you'll discover how to transform your company’s data into useful intelligence that your organization needs to succeed.

Health IT, In Brief

g.twachtman@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

HHS offices are developing a plan to identify HIT infrastructure gaps to improve patient-centered outcomes research; ASCO announces completion of coding standards in breast cancer for its CancerLinQ information network; more work needed to collect, structure data for industry-wide consumption and use, AstraZeneca scientist says.

ISPOR Finds Its Place In Patient-Centric World

g.twachtman@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Founding executive director of the International Society of Pharmacoeconomics and Outcomes Research Marilyn Dix Smith talks to “The Pink Sheet” on the drug industry becoming more “patient-centric” and the role that ISPOR is playing to keep that patient focus going.

Public Citizen’s Health Group Changes Leadership, But Wolfe Remains On Prowl

b.sandburg@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

Wolfe steps down to become senior advisor but remains a vocal critic of the pharmaceutical industry and FDA, as his appearance at the Avandia advisory committee meeting demonstrated.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 10 Jun 2013 00:00:00 -0400

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

Rheumatoid Arthritis Drug Development Guidelines Reflect New Standards Of Care

s.sutter@elsevier.com — Mon, 10 Jun 2013 00:00:00 -0400

FDA’s new draft guidance seems to offer more flexibility on study duration, but it makes clear that trials lasting longer than 12 weeks should use an active comparator, not placebo.

With Personalized Medicine, Payers Want A Role In Early Development

g.twachtman@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

With the development of targeted therapies and companion diagnostics increasing, AmerisourceBergen Consulting’s president advises pharma industry to bring payers in around Phase II to ensure trials give them data they need to cover drugs and diagnostics.

Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives “Resounding Yes”

g.twachtman@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Work needs to be done to allow for the use of social media to support content validity of patient-reported outcomes, but one FDA endpoints reviewer says there is a place for social media to work alongside traditional methods of validating PROs.

“Complete Response” Letters Might Include Benefit-Risk Framework Discussion

d.gingery@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

FDA official says idea could be helpful; meanwhile, sponsors and others remain concerned about the framework’s undefined decision-making methods.

Deals Of The Week Watches Crowdfunders Multiply Like Rabbits

Mon, 03 Jun 2013 00:00:00 -0400

VentureHealth combines the best in venture and crowdfunding, and has two exits to show for it. Plus Valeant buys Bausch & Lomb, GSK buys Okairos, AZ buys Omthera, while ThromboGenics/Array, Pfizer/UCSF, and Amgen/Astellas do deals.

Drug Reimbursement, Biologics Exclusivity Should Be Part Of EU Trade Talks, PhRMA And BIO Say

c.kelly@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Branded drug industry representatives presented a number of recommendations for U.S. negotiating priorities in upcoming trade talks with the European Union at a May 30 public hearing.

FDA, Merck Clash Over Value Of Subjective Insomnia Endpoints

s.karlin@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Merck favors the subjective study endpoints, perhaps with an eye toward potential marketing challenges, and the Rozerem experience could haunt Merck’s dreams.

FDA’s ANDA Approvals

Mon, 03 Jun 2013 00:00:00 -0400

Generic drug approvals and tentative approvals for late May.

FDA’s Benefit-Risk Framework Should Be Used Earlier In Development, Firms Say

c.dombrowski@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Early discussions based on the framework could engender more efficient drug reviews and aid industry in decisions on clinical programs, BIO and PhRMA note in comments to the agency.

Free e-book offers valuable information management tips

Mon, 03 Jun 2013 00:00:00 -0400

GSK Prices Tafinlar At $7,600/month, Undercutting Roche’s Zelboraf

e.hayes@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

At a time when $10,000-per-month pricing is the norm in oncology, GSK has priced its just-approved BRAF inhibitor Tafinlar at $7,600, on the lower end by today’s standards. Company says it is planning to file the combination of Tafinlar with Mekinist – also just approved by FDA – in a matter of weeks in the U.S.

J&J Highlights Late-Stage R&D Prospects Across Pharma Division

l.lamotta@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

J&J says its success at integrating external and internal innovation, focus on understanding causes of disease and commercial excellence have helped its pharma subsidiary weather a $9 billion patent cliff and recoup growth prospects. One observation from its May 23 analyst meeting: seemingly more than most companies, Janssen systemically incorporates biomarkers and companion diagnostics beyond oncology into all of its core development programs.

People In The News – Tracking The Latest Industry Personnel Moves

g.twachtman@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

New top leadership at BioInvent, Injex Pharma; Hallebo leaves CEO post at Clavis Pharma; former Sen. Sununu joins Rib-X board; more personnel announcements in this month’s column.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 03 Jun 2013 00:00:00 -0400

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

Reimbursement News, In Brief

s.steinke@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

Colorado will establish immunization task force under new law; Medicare Part B will cover oral aprepitant as part of a three-drug anti-nausea regimen when used with moderately emetogenic chemotherapy; Medicare Trustees release 2013 annual report.

REMS Education Paradox: How Can Sponsors Create Independent CME?

c.dombrowski@elsevier.com — Mon, 03 Jun 2013 00:00:00 -0400

CME content must be developed without influence from drug companies, but FDA says it does not have the resources to write a blueprint for every risk management education program as it did for the opioid REMS.

Tax Benefits, Branded Portfolio, Synergies Drive Actavis’ Acquisition of Warner Chilcott

j.haas@elsevier.com — Mon, 27 May 2013 00:00:00 -0400

Actavis’ purchase of Warner Chilcott will lower the former’s overall tax rate significantly, expand its specialty pharma business to 25% of total revenues, and provide global critical mass – all necessary responses to a future that includes fewer opportunities for small molecule generics and greater pricing pressures.