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Jun 29, 2015

Celgene to invest $1 billion in Juno to partner in cancer therapies

By Rosmi Shaji and Bill Berkrot

(Reuters) – Celgene Corp on Monday launched a 10-year partnership with Juno Therapeutics, announcing a $1 billion investment aimed at bringing to market Juno technologies that harness the immune system to treat cancer and autoimmune diseases.

The biotech companies, in a conference call to discuss the multi-faceted deal, said they anticipate potential product approvals in 2020.

Jun 25, 2015

Obamacare ruling ends threat to U.S. hospitals, insurers

NEW YORK (Reuters) – The U.S. hospital and health insurance
industries breathed a collective sigh of relief on Thursday
after the U.S. Supreme Court upheld subsidies for individuals
under President Barack Obama’s signature healthcare law.

Shares in hospitals surged, with several hitting all-time
highs, on the expectation that patients would be able to
continue paying for services. Health insurer stocks also gained.
Wall Street analysts called the ruling positive for an industry
on the edge of consolidation.

Jun 25, 2015

Obamacare ruling ends threat to U.S. hospitals, shares rally

NEW YORK, June 25 (Reuters) – The U.S. hospital industry
breathed a collective sigh of relief on Thursday after the U.S.
Supreme Court upheld subsidies for individuals under President
Barack Obama’s signature healthcare law.

Shares in hospitals surged, with several hitting all-time
highs, as investors cheered that the growing number of paying
customers created by Obamacare would not disappear.

Jun 17, 2015

Edwards gets U.S. approval for third generation heart valve

By Bill Berkrot

(Reuters) – The U.S. Food and Drug Administration on Wednesday said it approved Edwards Lifesciences Corp’s Sapien 3 heart valve, the third-generation version of the company’s system for replacing diseased aortic valves.

Edwards shares rose nearly 3 percent following the announcement.

The FDA approved use of the Sapien 3 transcatheter aortic valve replacement (TAVR) system for patients not likely to survive traditional open heart surgery and those deemed to be at high risk for death or complications with surgery.

Jun 15, 2015

Avalanche eye therapy meets safety goal; vision improvement modest

By Ransdell Pierson and Bill Berkrot

(Reuters) – Avalanche Biotechnologies Inc’s experimental gene therapy for a leading cause of blindness met its primary safety goal in a small mid-stage trial, while staving off vision loss.

The product, called AVA-101, was well tolerated and was not associated with any serious adverse events in the 12-month study involving patients with the age-related “wet” form of macular degeneration, the company said.

Jun 12, 2015

Agios leukemia drug demonstrates impressive response rate: study

By Bill Berkrot

(Reuters) – Forty percent of patients, most with a particularly aggressive form of leukemia, responded to an experimental Agios Pharmaceuticals Inc drug, including several who experienced complete remission, according to data presented at a medical meeting on Friday.

New data from the ongoing Phase I clinical trial appears to confirm the early promise seen with the Agios drug, AG-221.

Jun 9, 2015

FDA undercuts Amarin lawsuit on fish oil drug information

By Bill Berkrot

(Reuters) – The U.S. Food and Drug Administration,
responding to a lawsuit filed by Amarin Corp over
information the company wants to disseminate for its fish oil
drug, said it had no objection to Amarin sharing the data with
healthcare providers.

The FDA’s letter to Amarin, dated June 8 and filed with a
U.S. District Court judge in New York, appears to undercut the
lawsuit, saying the small drugmaker should have come to the
agency with its concerns “as other pharmaceutical companies
sometimes do” before filing a complaint against it in court.

Jun 8, 2015

No heart safety issues seen with Merck Januvia diabetes drug -study

June 8 (Reuters) – Details of a large heart safety study
presented on Monday appear to give Merck and Co’s
diabetes drug Januvia a clean bill of health, possibly setting
the stage for a return to sales growth for the drugmaker’s
biggest product.

Merck in April said the study, called Tecos, of 14,724
patients with type 2 diabetes and a history of heart disease
demonstrated that adding Januvia to usual care did not increase
major heart problems any more than adding a placebo, removing a
cloud that has been holding back sales of the medicine and the
company’s share price.

Jun 8, 2015

No heart, other safety risks seen with Sanofi diabetes drug- study

June 8 (Reuters) – A large study demonstrated the heart
safety of Sanofi’s injectable type 2 diabetes
drug lixisenatide and appears to rule out other potential health
hazards as well, according to data presented at a medical
meeting on Monday,

The results pave the way for the French drugmaker to file
for U.S. approval of the medicine, which it said it plans to do
in the third quarter of this year.

Jun 7, 2015

Novo Nordisk type 2 diabetes combo drug tops Sanofi’s Lantus -study

June 7 (Reuters) – Novo Nordisk’s IDegLira
combination drug for type 2 diabetes led to significant
reductions in blood sugar, weight and rate of hypoglycemia
compared with Sanofi’s top-selling Lantus insulin
product, according to data from a late-stage trial presented at
a medical meeting on Sunday.

The Novo drug, given by once-daily injection, combines its
experimental long-acting insulin degludec with liraglutide, a
type 2 diabetes treatment sold under the brand name Victoza that
was recently approved under another name for weight loss.

    • 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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