By Bill Berkrot
(Reuters) – A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc’s cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said.
The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States.
NEW YORK (Reuters) – A young woman complaining of abdominal pain and nausea who had traveled to Africa arrived at a Long Island hospital fearful that she had contracted Ebola. She did not have the virus, but the pregnancy test was positive.
The woman had been to South Africa, more than 3,400 miles (5,400 km) from the three West African countries enduring the worst Ebola outbreak on record, and the trip ended six weeks prior, or twice the potential incubation period for Ebola infection.
Oct 15 (Reuters) – Heart device maker St. Jude Medical Inc
on Wednesday forecast fourth-quarter revenue below Wall
Street estimates, citing soft international sales and
unfavorable foreign exchange rates, and its shares fell nearly 4
The maker of pacemakers, implantable defibrillators,
replacement heart valves and neurological products said it
expects fourth-quarter adjusted profit of $1.02 to $1.04 per
share and revenue of $1.39 billion to $1.47 billion.
Oct 8 (Reuters) – If Actavis Plc proceeds with a
purchase of Botox maker Allergan Inc for potentially
more than $60 billion, it will represent the biggest bet yet by
one of the traditional generic drugmakers on the upside of
expanding branded medicine holdings.
Reuters reported on Tuesday that Actavis plans to approach
Allergan about a potential merger, providing an alternative to
the hostile pursuit by Valeant Pharmaceuticals International
that Allergan had repeatedly rebuffed.
NEW YORK, Oct 7 (Reuters) – Bristol-Myers Squibb Co
on Tuesday said it is no longer seeking U.S. approval for an
oral two-drug combination to treat hepatitis C because of
competition from rival drugs that require treatment for half as
long and have shown higher cure rates.
The drugmaker’s shares fell more than 2 percent.
Bristol-Myers’ combination of experimental antiviral drugs
daclatasvir and asunaprevir was intended for patients with the
genotype 1b form of the liver-destroying virus, which is far
less prevalent in the United States than the 1a form.
Oct 1 (Reuters) – A new type of experimental cholesterol
fighter being developed by Esperion Therapeutics Inc
lowered LDL levels significantly more than Merck & Co
Inc’s Zetia in a midstage clinical trial, the company
said on Wednesday.
In the 12-week study involving 348 patients with high LDL
cholesterol the Esperion drug, ETC-1002, led to an average 30
percent reduction in levels of the “bad” cholesterol for those
who received a 180 milligram dose and a 27 percent reduction
with a 120 mg dose, according to initial results.
By Bill Berkrot
(Reuters) – Being unable to smell bacon frying may be far more dire than simply missing out on one of life’s pleasures. In older adults, it could be a predictor of increased risk of death within five years.
In a study of more than 3,000 people aged 57 to 85, 39 percent of subjects who failed a simple smelling test died within five years, according to results published on Wednesday in the science journal PLOS ONE.
Sept 27 (Reuters) – Pfizer Inc’s Xalkori, which
treats lung cancer patients with a specific gene mutation,
proved effective in shrinking tumors in those with an even rarer
form of the disease, according to data presented at a medical
meeting on Saturday.
In the study of 50 non-small cell lung cancer patients with
a rearrangement of the ROS1 gene, Xalkori treatment led to
significant tumor shrinkage in 36 of them, or 72 percent, and
halted tumor growth in an additional 9 patients, researchers
Sept 25 (Reuters) – Hedge fund ValueAct Capital said on
Thursday it would return to the board of directors of Valeant
Pharmaceuticals International Inc, which is pursuing a
hostile takeover offer for Allergan Inc, and that it
planned to increase its stake in the company.
Valeant shares rose more than 3 percent.
ValueAct Chief Executive Officer Jeffrey Ubben said in a
statement that once he is on the board, he would work with
Valeant on its $53 billion acquisition of Allergan, a deal whose
certainty he has previously questioned.
Sept 23 (Reuters) – The large premium Germany’s Merck KGaA
agreed to pay in a $17 billion acquisition of
Sigma-Aldrich Corp shines a spotlight on, and
potentially raises the value of, a company Merck discarded a
VWR Corp, a supplier of laboratory chemicals and equipment
with annual sales of about $4.2 billion, is owned by private
equity firm Madison Dearborn Partners. It is gearing up for an
initial public offering after filing with U.S. regulators in