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BioCentury, the Bernstein Report on BioBusiness

As published for the week of Monday, May 14, 2012

Cover Story: Regulation: Lorcaserin's niche

Despite potential REMS hurdles, Arena's lorcaserin could fill niche in obesity
By Erin McCallister
Senior Writer
If FDA follows the advice of its advisory committee and approves Arena Pharmaceuticals Inc.'s lorcaserin, the biotech may be able to carve out a niche for the obesity compound despite modest efficacy and potential hurdles to use, including advice that recurring echocardiograms be used to rule out a cardiovascular risk.
Last week, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 18-4 with one abstention that the benefit-risk profile for lorcaserin supports approval for obesity.
Full Article

STRATEGY

Teva: No more silos

How new R&D head Hayden plans to remake Teva's discovery, global partnering

Michael Hayden, Teva's new president of global R&D, plans to integrate generics and branded development, beef up efforts in discovery and personalized medicines, and partner with academics, charities and biotechs.
Outcomes trumping volume

How payers, pharmas are experimenting with outcomes based reimbursement

A handful of health plans and pharma companies are experimenting with new contracting models that tie reimbursement to health outcomes instead of drug volumes.
EMERGING COMPANY PROFILE

Galecto: Two-pronged attack

Galecto developing galectin-3 inhibitors for idiopathic pulmonary fibrosis

Galecto is developing galectin-3 inhibitors targeting both macrophages and fibroblasts, which it expects to provide potent inhibition of fibrosis in IPF by itself and in combination with other compounds.
- Sidebar: Corporate Profile
Visionary: Sights on drug design

Visionary using structure-based design to discover small molecules

Visionary believes a large library and computational technology that accounts for conformational changes will allow it to design more drug-like small molecules than those discovered by conventional HTS.
- Sidebar: Corporate Profile
REGULATION

Radiographic conundrum in RA

Pfizer radiographic data show challenge in proving effect on progression of RA

Companies may need to enlarge and enrich placebo groups in RA trials to show significance on radiographic endpoints, given ethical concerns that limit how long patients can be on placebo.
Risky business

Next issue for Gilead's Truvada to prevent HIV: What REMS will FDA require

Now that an FDA panel voted to recommend Truvada to prevent HIV, the next step is for FDA and Gilead to address calls for a strict REMS, including potential mandates for HIV testing.

BCIQ Profiles in the News

Companies

Products

Targets

EBB & FLOW

Vertex the odds-on favorite

Wall Street more than doubles Vertex valuation on odds of bigger CF franchise
More details, please

Actelion to focus on specialty indications; investors wanted more details
Life sciences leverage

Life sciences debt provider Oxford Finance raises $271M in bond offering
Royalties don't dilute

BB Biotech boosts Intercell with EUR25M in equity and debt with royalty twist
The lure of research

Tel Aviv exchange with bids for U.S. listed life science plays analyst research
Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

BCIQ Database

Money Raised in 2012

Last week, the biotech industry raised $310 million, bringing to $11.6 billion the total raised year-to-date. In 2011, a total of $49.5 billion was raised, including $37.2 billion in debt and other fundraising, $4.2 billion in follow-ons, $1.8 billion in PIPEs, $1 billion in IPOs, and $5.4 billion in venture capital. Totals include overallotments and warrants, and are rounded to the nearest millions.

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Week in Review

Deals GlycoMimetics, Glycosensors and Diagnostics LLC, International AIDS Vaccine Initiative (IAVI) deal Affymetrix, eBioscience deal Valeant Pharmaceuticals, University Medical Pharmaceuticals Corp. deal Human Genome Sciences, GlaxoSmithKline deal Nuevolution, Boehringer Ingelheim deal more >>	Sales & Marketing Bial-Portela, MediGene sales and marketing update AssureRx sales and marketing update Teva sales and marketing update Mitsubishi Tanabe Pharma sales and marketing update Pathway Genomics sales and marketing update more >>	Other News Helicos, Pacific Biosciences genomics news Abbott neurology news China Nuokang hematology, cardiovascular news Repligen diagnostic news Biolex infectious news more >>	Management Updates Synthon management update RXi Pharmaceuticals management update F-star management update Affitech board of directors update Celgene management update more >>
FDA, EMA & Other Regulatory Androxal enclomiphene regulatory update LuViva Advanced Cervical Scan regulatory update Seven-day contraceptive patch regulatory update Giazo balsalazide tablet regulatory update Trobalt retigabine regulatory update more >>	Clinical Results Hemopurifier: Additional data 4-factor prothrombin complex concentrate: Phase IIIb data SUN11031: Development discontinued ATX-101: Additional Phase III data Fluzone Quadrivalent: Phase III data more >>	Preclinical Results Senesco preclinical data Immunocore preclinical data Mirna preclinical data Eleven Biotherapeutics preclinical data Genocea preclinical data more >>	Clinical Status PF-05280586: Phase I/II started Digital PCR assays update Travoprost-loaded punctum plug update ALD403: Phase I started 212Pb-TCMC-Trastuzumab: Phase I started more >>

Cover Story: Regulation: Lorcaserin's niche

Despite potential REMS hurdles, Arena's lorcaserin could fill niche in obesity

Teva: No more silos

How new R&D head Hayden plans to remake Teva's discovery, global partnering

Outcomes trumping volume

How payers, pharmas are experimenting with outcomes based reimbursement

Galecto: Two-pronged attack

Galecto developing galectin-3 inhibitors for idiopathic pulmonary fibrosis

Visionary: Sights on drug design

Visionary using structure-based design to discover small molecules

Radiographic conundrum in RA

Pfizer radiographic data show challenge in proving effect on progression of RA

Risky business

Next issue for Gilead's Truvada to prevent HIV: What REMS will FDA require

Companies

Products

Targets

Vertex the odds-on favorite

More details, please

Life sciences leverage

Royalties don't dilute

The lure of research

Highlights of weekly biotech stock moves

Money Raised in 2012

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Deals

Sales & Marketing

Other News

Management Updates

FDA, EMA & Other Regulatory

Clinical Results

Preclinical Results

Clinical Status

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