BioPharma Today

Coming In "The Pink Sheet" DAILY - Sunovion Buys Elevation For $100M Upfront

Sunovion Pharmaceuticals will pay $100 million upfront and up to $430 million total to buy out privately held Elevation Pharmaceuticals in a deal announced Aug. 30. Central to the deal is Elevation’s Phase IIb candidate for chronic obstructive pulmonary disease (COPD), EP-101, which combines an aerosolized formulation of glycopyrrolate with a proprietary inhaler device, the eFlow Nebulizer System.

Australian regenerative medicines company Mesoblast is working with Teva to move a stem-cell treatment for congestive heart failure into Phase III.

CMS finalizes stage 2 meaningful use standards for electronic health records and delays implementation.

Multi-state settlement with Janssen over Risperdal off label marketing has a focus on reprint concerns

Latest News From "The Pink Sheet" DAILY - Ironwood's Linzess To Launch In Q4

Ironwood/Forest Talk Ballpark Pricing For Linzess, Gear Up For Q4 Launch Locally-acting linaclotide wins FDA approval for two indications - chronic idiopathic constipation and constipation-predominant irritable bowel syndrome - with no limits on length of use, a development that could reinvigorate the GI space.

Aerpio Obtains $27M In Series A To Fund Pair Of Phase II Studies The recently spun-out company raised money to fund two Phase II trials in hopes of garnering a partner for its diabetic macular edema drug.

Janssen Boosts Multiple Myeloma R&D With Genmab Deal Janssen Biotech has signed its second deal in less than two months with antibody discovery company Genmab, this time licensing the Danish company's potential first-in-class multiple myeloma therapy daratumumab for $55 million upfront and an equity investment.

FDA Forgoes Sponsor Support In Safety Study Of Contrast Agents To Avoid Potential Bias Instead of requiring sponsors to conduct a study, the agency is providing grant to the University of Pittsburgh Medical Center to create a prospective registry that will examine the relationship between exposure to gadolinium-based contrast agents and nephrogenic systemic fibrosis.

Merck Seeks Oxytrol Switch For Women As First Overactive Bladder OTC Merck will present to FDA's Nonprescription Drugs Advisory Committee Nov. 9 in support of switching Watson's Oxytrol as a female-specific OTC.

Editor's Picks From The World Press

Business & Finance

Sunovion will buy Elevation in deal worth as much as $430M
Mass High Tech (Boston) Aug. 30, 2012, Xconomy Aug. 30, 2012

SynopiaRx is acquired by United Drug in potentially $12M deal
American City Business Journals Aug. 30, 2012

XBiotech eyes construction of $200M campus in Texas
American City Business Journals Aug. 30, 2012

Investors await data on Ziopharm's cancer drug palifosfamide
Xconomy Aug. 29, 2012

Government & Legal News

Ironwood-Forest constipation drug Linzess receives FDA OK
Bloomberg Aug. 30, 2012, Reuters Aug. 30, 2012

J&J will settle antipsychotic-marketing case with 36 states
Bloomberg Businessweek Aug. 30, 2012

FDA cautions against pediatric use of Pfizer's PAH drug Revatio
Reuters Aug. 30, 2012

Novartis submits COPD combo drug for Japanese and EU approval
PharmaTimes (U.K.) Aug. 30, 2012

Pipeline/R&D News

Spinifex drug works against postherpetic neuralgia in study
Pharmaceutical Business Review Online Aug. 29, 2012

Aeterna Zentaris' cachexia drug candidate enters midstage trial
Pharmaceutical Business Review Online Aug. 29, 2012

Phase II trial demonstrates benefit of muscle drug by Sarepta
Reuters Aug. 30, 2012

Genentech's Herceptin ups heart failure risk in breast cancer study
MedPage Today Aug. 30, 2012

Coming in Friday's "The Pink Sheet" DAILY

Akebia Therapeutics spinout Aerpio raised $27 million in a Series A financing that will help the firm pay for a Phase II trial of its diabetic macular edema drug AKB-9778, a Tie-2 activator.

Latest News From "The Pink Sheet" DAILY - Vertex Must Study Cystic Fibrosis Drug Kalydeco For Cataract Risk

Republican National Platform Embraces Medicare Transformation, FDA "Reform" The platform signals party support for converting Medicare from a "defined benefit" to a "defined contribution" program, a change supported by the biopharmaceutical industry. It also calls for greater predictability and efficiency in the FDA review process.

Editor's Picks from the World Press

Business & Finance

Zafgen gets $3M in debt financing for weight-loss drug beloranib
Mass High Tech (Boston) Aug. 28, 2012

Coming In Thursday's "The Pink Sheet" DAILY - Alnylam Lands 10-Year License Agreement With Monsanto

RNA-interference pioneer Alnylam brings in $29.2 million upfront in a 10-year exclusive strategic partnership with Monsanto under which the agricultural products firm will apply Alnylam technology and IP to create biological products for agricultural use. The Alnylam technology will be paired with Monsanto’s BioDirect technology with a goal of delivering innovative biological solutions, such as next-wave pesticides, to farmers.

Opening a CLIA (Clinical Laboratory Improvement Amendments) Certified Laboratory

CLIA (Clinical Laboratory Improvement Amendments) passed by Congress in 1988 (Federal Register, 1992), is an increasingly key requirement for clinical research laboratories that provide human-derived sample testing. These evaluations derive information on the diagnosis, treatment, and prevention of disease, impairment or assessment of human health conditions. CLIA certification is an affirmation of the laboratory testing quality standards to ascertain patient test result accuracy, reliability and timeliness.

Latest News From "The Pink Sheet" DAILY - Statisticians Negative On Humira

Abbott's Humira Gets Advisory Committee Endorsement, But Can't Convince Statisticians FDA's Gastrointestinal Drugs Advisory Committee concludes that Humira's benefits outweigh its risks for patients with moderately to severely active ulcerative colitis, but two biostatisticians on the panel argued that the effect was modest and the data problematic.

Editor's Picks From The World Press

Business & Finance

Shionogi sells severe-drooling drug Cuvposa to Merz
Drug Store News Aug. 28, 2012

Moleculin brings in $3.2M to develop compounds for skin disease
MedCityNews.com Aug. 28, 2012

Depomed licenses drug-delivery technology Acuform to Janssen
Pharmaceutical Business Review Online Aug. 28, 2012

Hepatitis C drugs might draw fresh M&A interest for Achillion
Bloomberg Businessweek Aug. 28, 2012

Government & Legal News

FDA allows Caraco to restart operation at 2 Mich. sites
Drug Store News Aug. 28, 2012

EU approves AstraZeneca's antibiotic Zinfor
Reuters Aug. 28, 2012

Novartis' blood cancer treatment Jakavi gains European OK
Reuters Aug. 28, 2012

Canada approves Lundbeck's cancer drug Treanda
Reuters Aug. 28, 2012

Pipeline/R&D News

Spironolactone aids certain heart failure patients in midstage study
MedPage Today Aug. 28, 2012

Study finds no link between flu vaccine and serious birth defects
Reuters Aug. 28, 2012

Newer cancer drugs are tied to higher toxicity in study
Medscape (free registration) Aug. 27, 2012

Morphotek's sarcoma drug candidate enters Phase II trial
Pharmaceutical Business Review Online Aug. 28, 2012