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Amgen Data on T-Vec to Be Published This Week

Bloomberg Brief — Mon, 13 May 2013 17:53:38 +0000

Data for Amgen’s talimogene laherparepvec (T-VEC) in advanced melanoma is among many abstracts that will be published ahead of the American Society of Clinical Oncology (ASCO) annual meeting. Abstracts will be available on May 15 at 6 p.m. ET.

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Specialty Pharmaceutical Revenue Growth Driven by Niche Demand

ekrutoholow — Mon, 06 May 2013 15:00:21 +0000

by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries

Increasing demand in niche therapeutic areas has driven 11 percent revenue growth among specialty pharmaceutical companies during the last five years. The sector has benefited from new product launches, fresh income streams from label expansions and entry into diversified geographical markets. Mergers and acquisitions has also bolstered pipelines and continued sales growth.

Biotech Company Owns Clinical Trial Property Held by CRO

ekrutoholow — Mon, 29 Apr 2013 15:01:43 +0000

By Jason M. Brocks, Legal Analyst,Bloomberg Law

A recent U.S. District Court decision emphasizes the importance to research sponsors and contract research organizations(CROs) of understanding the terms set out in their agreements, particularly those terms relating to the responsibilities of each party upon termination of the arrangement.

Pharmaceutical, medical device and biotechnology companies that sponsor clinical research regularly rely on CROs to administer and monitor clinical trials because sponsors themselves are insufficiently equipped to perform these tasks.

Avanir May Gain Second Regulatory Backing for Nuedexta

ekrutoholow — Mon, 22 Apr 2013 15:01:48 +0000

by Andrew Berens, MD, Senior Healthcare Analyst and Grace Guo, Bloomberg Industries

Avanir’s Nuedexta may receive a decision from the Committee for Medicinal Products for Human Use (CHMP) this week as a treatment for pseudobulbar affect (PBA). Approval in the EU would be the second regulatory nod for the drug.

PBA is also called emotional lability (incontinence) and is characterized by involuntary, sudden, and frequent episodes of laughing or crying. It occurs in patients with certain underlying neurologic diseases or injuries like multiple sclerosis (MS), Lou Gehrig’s disease (ALS ), Parkinson’s disease or Alzheimer’s.

Diabetes Market Growing in China

ekrutoholow — Mon, 15 Apr 2013 15:37:53 +0000

by Sam Fazeli, Director Bloomberg Industries, Europe

The diabetes market is rapidly growing in China, leading to a significant opportunity for companies with complete diabetes portfolios like Novo Nordisk and Sanofi. In addition to urbanization and obesity rates, diabetes prevalence has been fueled by the region’s aging population. The prevalence of the disease increased at a compounded annual growth rate of 12 percent in China over the past 12 years. This compares to an 8 percent CAGR globally.

Litigation Restricts Cash-Poor on U.S. Biosimilar Path

ekrutoholow — Mon, 25 Mar 2013 15:31:03 +0000

By Asthika Goonewardene, Pharmaceuticals Equity Research Analyst, Bloomberg Industries

The cost of allegations that process patents may have been infringed under a biosimilar application may deter small generic developers from pursuing approval through the 351(k) pathway, which was specifically set up for copies of cheaper biologic drugs.

The FDA created an abbreviated pathway for generic companies to demonstrate that a proposed biological product is biosimilar to an FDA-approved biological product or “reference product” under section 351(k) of the Public Health Service Act (PHS Act).

Additional Data May Clarify Boston’s Watchman Mixed Results, Chances for Approval

ekrutoholow — Mon, 18 Mar 2013 15:06:48 +0000

Compiled by Michael Manns, Senior Equity Analyst, Jason McGorman, Equity Analyst, Bloomberg Industries and Elizabeth Krutoholow

Additional data on Boston Scientific’s Watchman device may provide clarity on mixed results from the Prevail trial. A preliminary analysis of how effective the device was after 18 months yielded varied results as the study met one of two efficacy endpoints. A limited number of patients have had follow-up thus far, so results from the complete patient population may be different.

Biogen’s Recombinant Factors for Hemophilia May Provide Breakthrough for Patients

ekrutoholow — Mon, 11 Mar 2013 16:04:54 +0000

by Elizabeth Krutoholow

Biogen’s hemophilia drugs may provide a breakthrough for patients by offering protection against bleeding with fewer infusions than standard agents, Dr. Jerry Powell, a hematologist with the UC Davis Comprehensive Cancer Center said in an interview.

These drugs will compete against currently marketed recombinant factors like Baxter’s Advate and Pfizer’s BeneFIX.

Price Premium May Pose Hurdles for Arena, Eisai’s Belviq Similar to Vivus’ Qsymia

ekrutoholow — Mon, 04 Mar 2013 16:20:14 +0000

Compiled by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries and Elizabeth Krutoholow

Arena and Eisai’s decision to price obesity drug Belviq at a premium to competitor Vivus may create a hurdle for the companies without broad coverage from insurers.

Eisai disclosed that the wholesale acquisition cost of Belviq has been set at $199.50 for a bottle of 60 10mg tablets, or a one-month supply. This compares to Vivus’s Qsymia, which retails for $160 for a month of medium-dose therapy and $220 a month for high-dose therapy.

Court Deals a Blow to Pharma by Excluding Off-Label Drugs From Part D Reimbursement

ekrutoholow — Mon, 25 Feb 2013 16:30:13 +0000

by Jason M. Brocks , Legal Analyst, Bloomberg Law

Pharmaceutical companies may begin to rethink their pipeline and marketing strategies in light of the U.S. District Court’s highly technical analysis of the language of the Medicare law. The court’s opinion resulted in a denial of reimbursement to a Medicare Part D beneficiary for a drug that had been prescribed to him by his doctor.