Health News Daily :: Elsevier Business Intelligence

Elan Tries To Transform With Three New Deals; Wall Street Still Skeptical

Stacy.Lawrence@elsevier.com — Wed, 22 May 2013 00:00:00 -0400

In its continuing effort to spend its way into becoming a diversified pharma, Elan announced a new trio of deals. Some liken its geographically diverse, specialty pharma strategy to that of highly successful Valeant, but Wall Street remains unsure that Elan can execute.

Proposed N.Y. Supplement Marketing Restrictions Worry Industry

m.spicer@elsevier.com — Wed, 22 May 2013 00:00:00 -0400

Dietary supplement stakeholder fear proposed legislation in New York to restrict sports supplement sales to consumers 18 and older and to require additional labeling could prompt additional states to consider restricting product marketing. Trade groups say DSHEA already covers the proposed legislation’s goals.

FDA Audit Slows Down Medtronic Launch Plans For Low-Glucose-Suspend Diabetes System

re.miller@elsevier.com — Wed, 22 May 2013 00:00:00 -0400

A recent FDA inspection of Medtronic’s diabetes business identified deficiencies related to insulin pump quality systems that are likely to delay the firm’s launch of its MiniMed 530g insulin pump/continuous glucose monitoring system.

GSK Uses Contests To Target Young Hopefuls And Academic Minds

s.stovall@elsevier.com — Tue, 21 May 2013 00:00:00 -0400

With a view to front-loading GlaxoSmithKline’s pipeline, the drug maker’s venture capital arm SR One is increasingly targeting early prospects – to the point of running intense entrepreneurial competitions to fan the flames of innovation in Europe and tap into early startups there.

Actavis’ Warner Chilcott Buy Brings Switch Options In Diversified Portfolio

e.crawford@elsevier.com — Tue, 21 May 2013 00:00:00 -0400

Actavis’ acquisition of Warner Chilcott creates a women’s health powerhouse with Rx-to-OTC switch potential. UBS analysts expect $400 million in cost synergies and an “even more robust than previously disclosed” pipeline and diverse product portfolio that compliments Actavis’ existing products.

Orthopaedic Devices Panel To Discuss Classification Of Two Pre-Amendments Devices

l.radick@elsevier.com — Tue, 21 May 2013 00:00:00 -0400

FDA’s Orthopaedic and Rehabilitation Devices Panel will discuss and make recommendations regarding the classification of shortwave diathermy and pedicle screw spinal systems.

Amgen, Novartis Are Investors In Atlas Venture’s Ninth Fund

p.bonanos@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

Atlas pledges to explore areas of mutual interest to the firm and its new corporate limited partners, but the drug firms won’t receive exclusive rights to anything in the new fund’s portfolio.

CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter

re.miller@elsevier.com — Mon, 20 May 2013 00:00:00 -0400

In addition to the more than 1,300 ablation procedures completed outside the U.S. with the unique visually guided ablation catheter, the venture-backed company is conducting an IDE trial in 21 U.S. centers, which it expects to complete in 2014.

Tainted Peanut Lessons Remain For Food Industry – Attorney

Mon, 20 May 2013 00:00:00 -0400

Recalls linked to 2009 distribution of PCA’s tainted products made more firms focus on supplier verification and improving supply chain security, but Sunland’s problems in 2012 illustrated more needs to be done, says lawyer Sarah Brew.

Broader Indications For Tarceva As Astellas Scales Back In The U.S.

l.lamotta@elsevier.com — Fri, 17 May 2013 00:00:00 -0400

The Japanese pharma is consolidating its U.S. operations, including the shuttering of OSI, where Tarceva initially was developed, as the cancer drug gains another indication with a companion diagnostic.

Pfizer Guards Viagra Sales With Strike Against Tainted Supplements

e.crawford@elsevier.com — Fri, 17 May 2013 00:00:00 -0400

A Pfizer study that finds 81% of sexual performance products claiming to be natural have undeclared pharmaceuticals could pressure FDA to increase enforcement and Congress to boost funding. The firm also launches online sales of Viagra to combat sales of counterfeit erectile dysfunction drugs.

Draft Guidance Addresses Company Requests For Rationale Of FDA Decisions

m.houghton@elsevier.com — Fri, 17 May 2013 00:00:00 -0400

The document offers FDA’s interpretation of the terms “substantive summary” and “significant decisions,” both of which appear in new statutory provisions related to the longstanding process for manufacturers to appeal an agency decision.

J&J Hoping To Position Simeprevir As Top Next-Gen Protease Inhibitor For HCV

j.haas@elsevier.com — Thu, 16 May 2013 00:00:00 -0400

The pharma’s Janssen Research & Development unit has filed protease inhibitor simeprevir for approval in the U.S., Europe and Japan, recently receiving notification of priority review from FDA; meanwhile, the company waits to see if its compound will be used in combination with Bristol’s daclatasvir or Gilead’s sofosbuvir.

FDA Receptive To Establishing Metrics For Clinical Trials, Says CDRH Entrepreneur

rebecca.kern@elsevier.com — Thu, 16 May 2013 00:00:00 -0400

Chip Hance, a member of CDRH’s entrepreneurs-in-residence program, discussed progress that the group has made towards improving FDA’s highly variable clinical trials processes.

Firms Sift Eye Study Data For Benefit From Lutein And Zeaxanthin

e.crawford@elsevier.com — Thu, 16 May 2013 00:00:00 -0400

After the Age-Related Eye Disease Study found lutein, zeaxanthin and omega-3s do not slow age-related macular degeneration, supplement firms revisit the data and find lutein and zeaxanthin could slow the disease in deficient populations.

Elan Makes A $1 Billion Theravance Royalty Play; What Will Investors Say?

j.merrill@elsevier.com — Wed, 15 May 2013 00:00:00 -0400

The Irish company, fighting a takeover offer from Royalty Pharma, has made the first of several planned deals: Elan will pay $1 billion to Theravance in exchange for a 21% interest in future royalty payments from four respiratory programs partnered with GlaxoSmithKline. Theravance shares soared on the news.

P&G Looks To “Transform” Categories, But Ackman Presses For Results

Wed, 15 May 2013 00:00:00 -0400

CFO Jon Moeller says product launches will make “obsolete our existing categories and transform them in ways that create competitive advantage” for the firm. Activist investor Bill Ackman, however, says P&G is “vastly under-earning relative to its intrinsic earnings power.”

Boston Scientific Subsidiaries Barred From Selling Multiple Drug-Eluting Stent Lines In Germany

d.tahir@elsevier.com — Wed, 15 May 2013 00:00:00 -0400

A German court had previously barred Boston Scientific’s German subsidiary from selling drug-eluting stents affected by OrbusNeich’s patent suit and the new injunction prevents any Boston Scientific subsidiary from selling the devices in Germany.

FDA’s Generic Regulatory Science Plan Taking Broad-brush Approach So Far

c.dombrowski@elsevier.com — Tue, 14 May 2013 00:00:00 -0400

Agency lists five topics for industry and stakeholders to focus on during a June 21 meeting on what its fiscal year 2014 priorities should be; among issues for consideration are prioritizing projects based on public health impact and identifying challenges that limit the availability of generic drugs.

Chinese Researchers Develop Diagnostic With High Specificity to New Bird Flu Virus

s.darcey@elsevier.com — Tue, 14 May 2013 00:00:00 -0400

University of Hong Kong researchers say they have developed a new test for rapid identification of the H7N9 virus, which has killed more than 30 people in China this spring and has triggered concerns about a pandemic.

NBTY Private Label Business Woes Prompt Facilities Restructuring

d.schiff@elsevier.com — Tue, 14 May 2013 00:00:00 -0400

The nutritional products firm is ceasing operations at several domestic locations, mainly involved in private label and contract manufacturing, likely pressed by owner The Carlyle Group to shrink its footprint and cut costs. NBTY expects to absorb between $34 million and $45 million pre-tax in restructuring costs.

Describing An Investigational Drug On Your Website? Don’t Be Definitive About The Data, FDA Says

c.dombrowski@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

FDA issues untitled letter to CBA Research Inc. for touting the safety and efficacy of CBT-1 as a cancer therapy on the company website although the agency has yet to complete review of an NDA for the drug.

FDA Moves To Appeals Court In Plan B Case

m.spicer@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Judge Edward Korman denied FDA’s request to stay his order requiring the agency allow universal OTC sales of nonprescription emergency contraceptives while the agency appeals. He granted a DoJ request to defer the imposition of his order while the department appeals the stay decision.

Industry Largely Supports FDA’s New Proposal On Pediatric Data Submission

rebecca.kern@elsevier.com — Mon, 13 May 2013 00:00:00 -0400

Device companies are generally happy with FDA’s rewrite of a rule requiring information on pediatric populations suffering from conditions their devices are intended to treat. The American Academy of Pediatrics is less pleased.

Forest Takes Option On Trevena’s Heart Failure Drug, And Some Equity

p.bonanos@elsevier.com — Fri, 10 May 2013 00:00:00 -0400

Already strong in both CNS and cardiovascular drugs, Forest obtained an option to license the Pennsylvania start-up’s lead program in acute heart failure. In the process, Forest took a stake in Trevena as the young company shifts its focus toward pain drugs based on Nobel Prize-winning research.

BRUISE CONTROL: ICD, Pacemaker Surgery Can Be Safe On Anticoagulantion Therapy

re.miller@elsevier.com — Fri, 10 May 2013 00:00:00 -0400

The study was stopped early after it became clear that patients on warfarin receiving a pacemaker or ICD had a reduced rate of device-pocket hematomas compared to those on heparin.

GNC Still Selling DMAA As Congress Questions Ingredient’s Safety

m.spicer@elsevier.com — Fri, 10 May 2013 00:00:00 -0400

Energy & Commerce Subcommittee on Oversight and Investigations leaders ask GNC, USPlabs and FDA about the safety and history of use of DMAA. GNC says it does not manufacture products that include DMAA, but continues to sell USPlabs’ Jack3d product containing the ingredient.

Celgene Goes Big And Early: Aims For Two New Blockbusters And A Robust, Transformative Pipeline

Stacy.Lawrence@elsevier.com — Thu, 09 May 2013 00:00:00 -0400

The biotech has a three-pronged strategy to double revenues by 2017: continue to expand core multiple myeloma product Revlimid, bring new blockbusters online, and develop its early stage pipeline through deals.

One-Third of Device Firms Expect Increased Customer Base From ACA –MassMEDIC Survey

s.darcey@elsevier.com — Thu, 09 May 2013 00:00:00 -0400

The 123-respondent survey probed the impact of the Affordable Care Act on the device industry. Of the 33% who expect an increase in patient customer base from the insurance expansion, about one-quarter said it would be enough to counter the negative impact of the device excise tax.

“Devil Is In The Details” On Prop 65 Reform Benefits – AHPA

d.schiff@elsevier.com — Thu, 09 May 2013 00:00:00 -0400

California Governor Jerry Brown plans to tweak Proposition 65 to reduce the number of frivolous lawsuits against small businesses. More than 10% of Prop 65 litigation targets since 2008 have been supplement firms, says the American Herbal Products Association.

Pfizer Cracks Down On Big Black Market For Little Blue Pill

j.haas@elsevier.com — Wed, 08 May 2013 00:00:00 -0400

To combat the broad availability of counterfeit Viagra, Pfizer will provide direct-to-consumer availability of its ED drug. CVS will fulfill the prescriptions through a portal at the product’s website.

FDA Acting Rx-to-OTC Switch Review Leader Prioritizes Personnel

d.schiff@elsevier.com — Wed, 08 May 2013 00:00:00 -0400

Shaw Chen, acting director of FDA’s Division of Nonprescription Clinical Evaluation, wants to stabilize the division’s staffing during a period of management transition. On the same CHPA conference panel, OTC monograph division chief Scott Furness shares good news on time and extent applications.

Advanced Imaging Slowdown Significant To Overall Health Care Spending Deceleration – Study

s.darcey@elsevier.com — Wed, 08 May 2013 00:00:00 -0400

Policymakers have cited the struggling economy as the primary source of the deceleration in overall health care spending, but an advanced imaging slowdown, in addition to a retraction in prescription drug spending and a few other factors may have combined to play an even more significant role, Harvard economists found.

Gilead Working 24/7 To Fix Manufacturing Problems In HIV “Complete Response” Letters

e.hayes@elsevier.com — Tue, 07 May 2013 00:00:00 -0400

In its first quarter earnings call, Gilead says it’s been working around the clock to address manufacturing issues that blocked FDA approval of two individual drugs in the approved Stribild HIV combination pill, problems that also affect other marketed drugs. But rising star HCV drug sofosbuvir won’t be affected, company says.

One A Day Marketing Claims Spark Another CSPI-Bayer Face Off

e.crawford@elsevier.com — Tue, 07 May 2013 00:00:00 -0400

The Center for Science in the Public Interest threatens to sue if Bayer HealthCare does not discontinue claims that One A Day multivitamins “support” breast, heart, eye and bone health. CSPI argues the problem is rooted in linking legitimate claims to scientific research in a way that implies disease claims.

Medtronic Claims Clinical, Cost Advantages For Newly Approved Viva CRT-D

re.miller@elsevier.com — Tue, 07 May 2013 00:00:00 -0400

Viva is the first of Medtronic’s U.S. CRT-Ds to incorporate the proprietary AdaptivCRT algorithm designed to more readily adapt to a patient’s condition and optimize therapy.

Sequestration Trims CMS’ Part D Gap Payments, But Not Drug Company Discounts

s.steinke@elsevier.com — Mon, 06 May 2013 00:00:00 -0400

CMS memo clarifies how it is applying the 2% federal budget sequestration cuts to Medicare Part D.

FDA Outlines Next Steps For Online Repository And Standard Elements For Device Labeling

Mon, 06 May 2013 00:00:00 -0400

Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.

Plan B One-Step Goes OTC, With Three-Year Exclusivity, Lower Age Limit

m.spicer@elsevier.com — Mon, 06 May 2013 00:00:00 -0400

FDA approved Plan B One-Step to be sold in some OTC venues to women 15 and older, lowering the age restriction and moving the product out from behind pharmacy counters. Teva Women’s Health gets three years of exclusivity for the product, based on studies of label comprehension among women as young as 15.

From Monkeys To Men: Panel Will Review Use Of Animal Rule For Filgrastim As Radiation Countermeasure

s.karlin@elsevier.com — Fri, 03 May 2013 00:00:00 -0400

FDA’s Medical Imaging Drugs and Oncologic Drugs Advisory Committee will discuss whether evidence supports approval of filgrastim as a medical countermeasure for radiation-induced bone marrow injury using the “animal rule.”

ForMor Challenges FDA On Own-Label Supplement GMP Stance

Fri, 03 May 2013 00:00:00 -0400

ForMor contests a warning letter from FDA stating that as an own-label distributor, the firm is subject to both packager and labeler GMP requirements. The firm says it is only a “holder” of finished products and FDA bases its warning on the GMP rule preamble, not the actual rule.

FDA Considers Reducing UDI Direct Marking Requirements For Implants

Fri, 03 May 2013 00:00:00 -0400

An agency official says FDA is reworking the UDI direct part marking requirements for implants and making other changes in the final unique device identification rule, due out in June.

Harvard Gets Down To Business With $50 Million For Biomedical Accelerator, MBA Program

Stacy.Lawrence@elsevier.com — Thu, 02 May 2013 00:00:00 -0400

The university is setting up an evergreen translational research fund and a post-grad fellowship for the Harvard Business School with a donation from the foundation of Russian-born billionaire Len Blavatnik. The idea is to provide the financing and the business acumen to help life science research bridge the oft-noted valley of death.

Novartis OTC Plant Troubled By Quality Failures A Year After Shutdown

d.schiff@elsevier.com — Thu, 02 May 2013 00:00:00 -0400

FDA recorded nine observations – many of them repeats from 2011 and 2012 – on a form 483 during its early 2013 visit to Novartis Consumer Health’s facility in Lincoln, Nebraska. The observations cited inadequate consumer complaint handling and container closure stability testing.

FDA Risk Communications Panel Critiques MedWatch, And Medwatcher App

s.darcey@elsevier.com — Thu, 02 May 2013 00:00:00 -0400

Promotion of the consumer MedWatch form and the newly released MedWatcher adverse event reporting app needs to be improved if more physicians and consumers are to use it, FDA’s Risk Communications Advisory Committee says.

Merck And Pfizer Make A Late Play For The Diabetes Market

l.lamotta@elsevier.com — Wed, 01 May 2013 00:00:00 -0400

Two of the world’s largest pharmaceutical companies are teaming up to develop a treatment for type 2 diabetes, but the drug will have plenty of competitors with a better market position by the time it faces regulatory approval.

Small Trial Shows InSightec’s Focused Ultrasound Can Stop Disabling Tremor

re.miller@elsevier.com — Wed, 01 May 2013 00:00:00 -0400

The results are an encouraging sign not only for the company but also for the novel device development model employed by the trial’s sponsor, the Focused Ultrasound Foundation.

FDA Lowers Plan B One-Step Age Restriction to 15

m.spicer@elsevier.com — Wed, 01 May 2013 00:00:00 -0400

The agency approved an amended application Teva Women’s Health submitted to market Plan B One-Step for OTC use by women 15 years of age and older, lowering the age restriction from 17 and moving the product out from behind pharmacy counters.

Actavis Generic OxyContin To Launch In 2014 Under Patent Settlement

b.sandburg@elsevier.com — Tue, 30 Apr 2013 00:00:00 -0400

Actavis can sell a generic version of Purdue’s abuse-deterrent formulation 11 years before patents on the formulation expire; the company will launch on Jan. 1 if FDA approves its ANDA, or launch an authorized generic in October if approval is delayed.

Garden Of Life, POM Wonderful Cases Help FTC Hone Decree Language

d.schiff@elsevier.com — Tue, 30 Apr 2013 00:00:00 -0400

When courts disagree with FTC counsel on health claims cases, the agency looks for takeaways it can use to sharpen consent decree language in the future, says FTC advertising practices official Richard Cleland.