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Jan 8, 2014

FDA approves AstraZeneca type 2 diabetes drug

Jan 8 (Reuters) – U.S. health regulators on Wednesday
approved an AstraZeneca drug from a new class of
medicines to treat type 2 diabetes after previously rejecting it
over safety concerns.

The Food and Drug Administration’s approval had been
expected after an outside advisory panel of medical experts
voted by a wide margin in December to recommend its approval,
saying the benefits of the drug, dapagliflozin, outweighed its
safety risks. It will be sold in the United States under the
brand name Farxiga.

Jan 7, 2014

J&J, Pharmacyclics leukemia drug improves survival in study

By Bill Berkrot

(Reuters) – An independent committee recommended a late stage trial of a cancer drug developed by Pharmacyclics Inc and Johnson & Johnson be stopped early as it became clear it helped patients with chronic lymphocytic leukemia (CLL) live longer, paving the way for additional approval of the medicine.

The announcement of the study’s early success by Pharmacyclics on Tuesday sent its shares soaring 20 percent higher and took J&J shares up by nearly 2 percent.

Dec 19, 2013

Vertex cystic fibrosis drug misses trial goal, helps some

By Bill Berkrot

(Reuters) – Vertex Pharmaceuticals Inc’s Kalydeco cystic fibrosis drug failed to meet the main goal of a late-stage study aimed at expanding its use into patients with a specific gene mutation associated with the rare, life-threatening lung disease, the company said on Thursday.

Overall, Kalydeco (ivacaftor) did not significantly improve lung function in CF patients ages 6 and older with the R117H gene mutation. However, among those aged 18 and older in the 69-patient study with more advanced lung disease, Kalydeco led to a statistically significant improvement in lung function and other secondary measures, the company said.

Dec 18, 2013

Stellar hepatitis C data puts Gilead farther ahead of pack

By Ransdell Pierson and Bill Berkrot

(Reuters) – Gilead Sciences Inc released impressive late-stage data for its once-daily combination pill to treat hepatitis C, advancing its lead in the race to develop new, all-oral treatments for the liver disease, and pushed up its timeline for seeking U.S. approval.

Gilead on Wednesday unveiled initial results from three Phase III studies that demonstrated cure rates well in excess of 90 percent with as little as 8 weeks of treatment for some patients.

Dec 13, 2013

AbbVie drug shows promise against difficult type of breast cancer

By Bill Berkrot

(Reuters) – Women with an especially deadly type of breast cancer who received a treatment regimen containing an experimental AbbVie Inc drug prior to surgery are likely to have a significantly better response than those who get a standard chemotherapy regimen, according to data from a clinical trial.

Patients with so-called triple negative breast cancer, who tend to be younger and have a very poor prognosis, appeared to have double the response rate to the regimen containing AbbVie’s veliparib in a new type of study that exploits advances in molecular understanding of the disease, researchers found.

Dec 10, 2013

CVS, Cardinal Health form U.S. generic drug venture

By Bill Berkrot

(Reuters) – Pharmacy chain CVS Caremark Corp and pharmaceutical distributor Cardinal Health Inc on Tuesday announced a 10-year agreement to form the largest generic drug sourcing operation in the United States, the world’s biggest generic drug market.

The 50-50 joint venture, which combines the generic drug purchasing power of two of the largest companies in the market for the cheaper medicines, will be operational as soon as July 1, 2014. Under the agreement, Cardinal will pay CVS $25 million on a quarterly basis for the duration of the contract, with an estimated after-tax value to CVS of $435 million.

Dec 10, 2013

AbbVie oral hep C drugs cure 96 pct in late stage trial

Dec 10 (Reuters) – AbbVie Inc’s all-oral hepatitis
C therapy cured 96 percent of difficult-to-treat patients in a
late-stage clinical trial after 12 weeks, keeping the company
well placed in a highly competitive race to deliver new
treatments for the serious liver disease.

The study of 394 patients with the most common Genotype 1
version of the virus tested the AbbVie regimen in people who had
failed to be cured by the older standard treatments of
pegylated interferon and ribavirin.

Dec 9, 2013

U.S. FDA advisory panel backs Takeda bowel disease drug

Dec 9 (Reuters) – An advisory panel of medical experts on
Monday voted to recommend that U.S. health regulators approve an
experimental drug for ulcerative colitis and Crohn’s disease
developed by Takeda Pharmaceutical Co.

The panel voted by wide margins that the benefits outweigh
the risks of the biotech drug, vedolizumab, and advised the Food
and Drug Administration to approve it for both ulcerative
colitis and Crohn’s disease in patients who have not been helped
by prior therapies.

Dec 9, 2013

High response rates seen with oral Takeda myeloma drug -study

Dec 9 (Reuters) – Most newly diagnosed patients with the
blood cancer multiple myeloma had a very strong response to an
experimental oral drug being developed by Takeda Pharmaceutical
Co when given in combination with standard treatments,
according to data from a study presented on Monday.

Overall, 94 percent of the 62 patients in the Phase I/II
trial had their cancer respond to Takeda’s MLN9708 taken twice a
week in combination with Celgene Corp’s Revlimid and
the corticosteroid dexamethasone.

Dec 8, 2013

J&J, Pharmacyclics leukemia drug effective long term: study

By Bill Berkrot

(Reuters) – A closely watched leukemia drug developed by Johnson & Johnson and Pharmacyclics Inc maintained its effectiveness in keeping the disease at bay for most patients, according to long-term follow-up data from a midstage study being presented at a major medical meeting.

The oral drug, ibrutinib, last month won U.S. approval to treat a rare and aggressive form of non-Hodgkin lymphoma known as mantle cell lymphoma. It is awaiting a Food and Drug Administration decision on treating chronic lymphocytic leukemia (CLL), a slowly progressing form of blood cancer that primarily affects people aged 65 and older.

    • 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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