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May 20, 2015

J&J to submit at least 10 new drugs for approval by 2019

By Bill Berkrot and Caroline Humer

(Reuters) – U.S. healthcare conglomerate Johnson & Johnson said on Wednesday it expects to submit more than 10 new medicines with annual revenue potential of at least $1 billion each to regulators by 2019, and is testing dozens of new uses for existing medicines.

J&J said it would file for approval of daratumumab for the blood cancer multiple myeloma in the United States and Europe this year based on mid-stage clinical data.

May 20, 2015

J&J to submit at least 10 medicines for approval by 2019

NEW YORK (Reuters) – U.S. healthcare conglomerate Johnson & Johnson said on Wednesday it expects to submit more than 10 new medicines with annual revenue potential of at least $1 billion each to regulators by 2019, and is testing dozens of new uses for existing medicines.

J&J said it would file for approval of the experimental drug daratumumab for the blood cancer multiple myeloma in the United States and Europe this year based on mid-stage clinical data that will be presented at a major cancer meeting this month.

May 18, 2015

Veracyte lung cancer test could help avoid some risky biopsies

By Bill Berkrot

(Reuters) – A new diagnostic test from Veracyte Inc could help many people avoid risky and costly invasive lung biopsies at a time when millions of American smokers are eligible for lung cancer screening, according to data from studies presented on Sunday.

The company’s Percepta Bronchial Genomic Classifier takes cell samples from the windpipe of smokers during a bronchoscopy procedure and analyzes 23 genes for their reaction to exposure to cigarette toxins.

May 15, 2015

U.S. FDA warns on newer class of type 2 diabetes drugs

May 15 (Reuters) – The U.S. Food and Drug Administration on
Friday warned that a widely used newer class of type 2 diabetes
drugs sold by AstraZeneca, Johnson & Johnson and
Eli Lilly in partnership with Boehringer Ingleheim may
cause dangerously high levels of blood acids that could require
hospitalization.

The oral drugs belong to a class known as SGLT2 inhibitors
that work by causing blood sugar to be secreted in the urine.
They include AstraZeneca’s Farxiga (dapagliflozin), J&J’s
Invokana (canagliflozin) and Jardiance (embagliflozin) from
Lilly and Boehringer.

May 13, 2015

Bristol, AbbVie drug extends multiple myeloma remission-study

May 13 (Reuters) – The addition of an experimental
Bristol-Myers Squibb biotech medicine to standard
therapy for patients whose multiple myeloma has relapsed led to
longer remissions and cut the risk of death over standard
treatment alone, according to data from a late stage study.

The drug, elotuzumab, which is being developed in
collaboration with AbbVie, extended the duration of
remissions by about five months on average when used with
Celgene’s Revlimid and the corticosteroid
dexamethasone. It is the first antibody to be used against this
type of blood cancer, researchers said.

May 13, 2015

Pfizer drug shows early promise in Xalkori-resistant lung cancer-study

May 13 (Reuters) – An experimental Pfizer Inc drug
that aims to help lung cancer patients with specific genetic
mutations who have stopped responding to the company’s Xalkori
was showing promise in a small, early stage study, according to
preliminary data revealed on Wednesday.

The ongoing Phase I trial of the drug, PF-3922, was designed
to determine if there is a maximum tolerable dose and which dose
or doses to test in future larger trials.

May 13, 2015

Number of Americans using $100,000 in medicines triples: Express Scripts

By Bill Berkrot

(Reuters) – More than a half-million U.S. patients had medication costs in excess of $50,000 in 2014, an increase of 63 percent from the prior year, as doctors prescribed more expensive specialty drugs for diseases such as cancer and hepatitis C, according to an Express Scripts report released on Wednesday.

Of the estimated 575,000 Americans who used at least $50,000 in prescription medicines last year, about 139,000 used at least $100,000 worth of medication, nearly triple the 47,000 who hit that mark in 2013, the report said.

May 11, 2015

U.S. says insurers must cover FDA-approved birth control methods

By Bill Berkrot

(Reuters) – The U.S. government said health insurers must
cover all FDA-approved methods of birth control without co-pays
or charges to the patient, as it issued a paper on Monday
looking to clarify coverage guidelines under the Affordable Care
Act.

Recent published reports found that some payers were
ignoring federal requirements for covering birth control, a
benefit under the healthcare reform commonly referred to as
“Obamacare.”

May 7, 2015

EU patent office revokes Celgene Revlimid patent; appeal planned

May 7 (Reuters) – Celgene Corp on Thursday said the
European Patent Office revoked a key patent on the company’s
flagship multiple myeloma drug Revlimid, a move that could shave
a year or two from the medicine’s exclusivity in Europe.

The so-called polymorph patent in question would have kept
cheaper versions of Revlimid off the European market until
September 2024.

May 5, 2015

Mylan maintains commitment to acquire Perrigo, reports profit

May 5 (Reuters) – Generic drugmaker Mylan NV, at the
center of a high-stakes, three-way takeover battle, said on
Tuesday it is fully committed to acquiring Ireland-based Perrigo
Co.

Mylan also reported slightly higher-than-expected
first-quarter profit.

“We remain steadfast in our legally binding commitment to
acquire Perrigo and have taken numerous concrete steps to lay
out a clear and certain path towards completion,” Mylan Chief
Executive Heather Bresch said in a statement.

    • 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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