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Mar 25, 2014

India generic drugmakers’ woes put new focus on quality over price

By Bill Berkrot

(Reuters) – A spate of regulatory warnings for India’s generic drug manufacturers will add a new emphasis on the quality of such medicines in an industry long dominated by the ability to deliver treatments as cheaply as possible, analysts say.

In the short term, that is expected to benefit larger global competitors, such as Teva Pharmaceutical Industries Ltd, Actavis Plc and Mylan Inc, which will be called upon to supply drugs no longer available from some of their rivals in India, they said.

Mar 22, 2014

Experimental J&J psoriasis drug shows promise in study

By Bill Berkrot

(Reuters) – An experimental Johnson & Johnson drug for moderate to severe psoriasis proved significantly better at clearing the scaly, uncomfortable skin patches associated with the disease than a placebo, according to data from a midstage study presented on Saturday.

The J&J biologic medicine, guselkumab, achieved the main goal of the Phase II study at all five dosing regimens tested by clearing or reducing the psoriasis to a minimal measure after 16 weeks of treatment in a far greater percentage of patients than in the group that received a placebo. It also appeared to be as good as or more effective than AbbVie’s big selling Humira at four of the tested doses.

Mar 21, 2014

U.S. FDA approves Celgene drug for psoriatic arthritis

March 21 (Reuters) – U.S. health regulators on Friday
approved a Celgene Corp drug to treat psoriatic
arthritis, a type of arthritis associated with the skin disease
psoriasis that causes joint pain, stiffness and swelling.

The drug, known chemically as apremilast, will be sold under
the brand name Otezla. It is also being studied by the U.S.
biotechnology company as a treatment for psoriasis and
ankylosing spondylitis.

Mar 21, 2014

U.S. lawmakers ask Gilead about Sovaldi pricing

By Bill Berkrot

(Reuters) – U.S. lawmakers have asked Gilead Sciences Inc for a briefing on the price of its new hepatitis C drug Sovaldi, which some fear is too expensive at about $84,000 per patient.

A letter to Gilead from Democrats in the House Energy & Commerce Committee asks for information on Sovaldi discounts on the recently approved medicine to payors and patients.

Mar 18, 2014

Insight – Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK (Reuters) – Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.

Mar 18, 2014

Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK, March 18 (Reuters) – Some U.S. doctors
are becoming concerned about the quality of generic drugs
supplied by Indian manufacturers following a flurry of recalls
and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and
over-the-counter drugs used in the United States, making it the
second-biggest supplier after Canada.

Mar 14, 2014

Amgen vaccine triggers immune response in advanced melanoma -study

By Bill Berkrot

(Reuters) – An experimental Amgen Inc cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented on Friday.

The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.

Mar 4, 2014

Merck says dust mite allergy drug reduces symptoms in midstage study

March 4 (Reuters) – An immunotherapy pill to treat an
allergy to house dust mites being tested by Merck & Co
significantly reduced common nasal symptoms, such as sneezing
and stuffy nose, according to data from a midstage clinical
trial, the company said on Tuesday.

The drug, MK-8237, reduced nasal symptoms by 49 percent at
the higher tested dose and 27 percent at the lower dose compared
with a placebo after 24 weeks of treatment. The results, which
were deemed to be statistically significant, were presented on
Tuesday at the American Academy of Allergy, Asthma and
Immunology (AAAAI) meeting in San Diego.

Mar 4, 2014

Roche drug cuts asthma attacks, improves lung function -study

March 4 (Reuters) – An experimental drug reduced asthma
attacks in patients with severe uncontrolled asthma by 60
percent and helped improve lung function in certain patients,
indicating that the drug could offer the first personalized
approach to treatment, according to data from a clinical trial
released on Tuesday.

The biotech drug lebrikizumab, which was developed by Roche
Holding’s Genentech unit, was tested at three doses in
patients whose asthma was not sufficiently controlled even with
high-dose, inhaled corticosteroids and a second
asthma-controlling therapy.

Feb 27, 2014

Drugmaker Mylan’s shares jump 10 percent on deal talk, rosy outlook

By Bill Berkrot

(Reuters) – Shares of Mylan Inc (MYL.O: Quote, Profile, Research, Stock Buzz) jumped more than 10 percent on Thursday after the U.S. generic drugmaker provided a 2014 forecast above analysts’ estimates and said it planned a major transaction this year that would add to future earnings.

Mylan’s plan for a big transaction comes amid a wave of recent acquisitions in the generic and specialty drug sectors.

    • 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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