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Jun 22, 2013

Lilly once-weekly diabetes drug proves superior in late-stage trials

By Bill Berkrot

(Reuters) – A once-weekly drug for type 2 diabetes developed by Eli Lilly and Co worked better at controlling blood sugar than three other widely used medicines, according to data from late- stage clinical trials.

The data, presented on Saturday at the American Diabetes Association (ADA) meeting in Chicago, also showed that the Lilly shot helped patients lose twice as much weight as those taking Merck & Co’s $4 billion-a-year drug, Januvia.

Jun 12, 2013

Drugmakers to cooperate in safety review of diabetes drugs

NEW YORK (Reuters) – Global drugmakers said on Wednesday they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer and other safety problems.

The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co’s $4 billion a year Januvia franchise, Novo Nordisk’s Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others.

Jun 11, 2013

Celgene arthritis drug maintains efficacy at 52 weeks-study

June 11 (Reuters) – Celgene Corp’s experimental
drug for psoriatic arthritis maintained its ability to
significantly reduce painful symptoms through 52 weeks of
treatment, according to data from a late stage study being
presented this week at a medical meeting.

The U.S. biotechnology company had previously released
positive data from the 500-patient Phase III trial called
Palace-1 that compared its drug, apremilast, to a placebo
through 16 weeks of treatment.

Jun 11, 2013

J&J’s Stelara effective in psoriatic arthritis trial

June 11 (Reuters) – Johnson & Johnson’s Stelara
produced significant improvement in signs and symptoms of
psoriatic arthritis through 52 weeks of treatment in a late
stage study, according to data being presented at a medical
meeting in Europe.

The Phase III trial tested Stelara at two doses against a
placebo in 312 patients with active psoriatic arthritis, and
included both subjects who had previously been treated with
widely used biotech drugs from a class known as anti-TNF
medicines and those who had not.

Jun 7, 2013

Exclusive: Forest braces for third bout with Icahn

By Bill Berkrot and Nadia Damouni

(Reuters) – Forest Laboratories Inc is trying to avert yet another bitter proxy battle with billionaire investor Carl Icahn ahead of its annual investor meeting this summer, according to two sources familiar with the situation.

Icahn, Forest’s second-largest shareholder, and the company have been in discussions over the course of the year and talks are ongoing to avoid a third proxy fight in as many years, the sources said.

Jun 2, 2013

Roche’s Avastin fails to prolong survival in brain cancer study

June 2 (Reuters) – The widely used Roche Holding AG
cancer drug Avastin failed to prolong survival when added to
chemo-radiation therapy for glioblastoma – a fast-growing type
of brain tumor – according to data presented on Sunday.

Those who received Avastin in the late-stage study of 637
previously untreated patients also experienced more side
effects, such as low platelet counts, blood clots and elevated
blood pressure. Researchers said the toxicity was not severe
enough to preclude use of Avastin, or bevacizumab, had it helped
patients live longer.

Jun 2, 2013

Roche’s Avastin extends life in advanced cervical cancer

June 2 (Reuters) – Roche Holding AG’s drug Avastin
helped prolong the lives of women with advanced cervical cancer
when added to chemotherapy in a late-stage clinical trial,
likely paving the way to another major use for the
multibillion-dollar medicine.

This marked the first study to demonstrate that a drug which
blocks blood vessel formation in the tumor can prolong the lives
of women with gynecologic cancers, researchers said.

May 30, 2013

GSK melanoma drugs add to tally of U.S. drug approvals

LONDON/NEW YORK (Reuters) – U.S. health regulators have approved two new GlaxoSmithKline drugs for treating advanced melanoma, in the latest sign that companies are having more success getting novel medicines to market.

The Food and Drug Administration (FDA) gave the green light to Tafinlar and Mekinist late on Wednesday, bringing the tally of new drugs approved by the U.S. agency so far this year to 13, compared with 11 at the same stage in 2012.

May 27, 2013

Heart device approval delays leave US doctors frustrated

NEW YORK, May 27 (Reuters) – Americans accustomed to
immediate access to the newest technology may be shocked to find
that is not the case when it comes to devices that treat ailing
hearts.

U.S. approval requirements for cardiac devices are much more
stringent than in Europe, where there is no centralized
decision-making body. But a growing number of U.S. heart doctors
feel the regulations are so demanding that patients are being
denied access to beneficial therapies.

May 23, 2013

Denner added as nominee to Vivus board by activist investor

By Bill Berkrot

(Reuters) – First Manhattan Company (FMC) added some heavyweight muscle on Thursday to its bid to shake up the board of drugmaker Vivus Inc (VVUS.O: Quote, Profile, Research, Stock Buzz) by naming former Carl Icahn top lieutenant Alex Denner and two others to its slate of proposed nominees.

Vivus shares rose as much as 11 percent after First Manhattan, which has nearly a 10 percent stake in Vivus, expanded its slate of proposed directors from six to nine, including Denner.

    • About Bill

      "Based in New York, I primarily cover the pharmaceutical and biotechnology sectors as well as other publicly traded companies involved in health care. Previously covered a wide range of sports for Reuters."
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