June 30 (Reuters) – Allergan Inc said on Monday that
the U.S. Food and Drug Administration would not approve its
acute migraine aerosol treatment until certain concerns are
addressed, but the agency approved a new use for its implantable
eye drug, Ozurdex.
The Botox maker, which is fighting a hostile takeover bid by
Valeant Pharmaceuticals International Inc, said
Semprana, formerly known as Levadex, had received a second
“complete response letter” from the FDA delaying its approval.
Allergan now expects the agency’s next action in the second
quarter of 2015.
June 24 (Reuters) – A combination of Vertex Pharmaceuticals
Inc’s cystic fibrosis drug Kalydeco and its
experimental lumacaftor succeeded in improving lung function in
a pair of closely watched late stage clinical trials of patients
with the most common genetic mutation associated with the rare
In the two, 24-week studies of patients 12 years and older
with two copies of F508del genetic mutation, the combination
therapy led to mean absolute improvements in lung function of
between 2.6 and 4 percentage points, which was deemed to be
statistically significant, the company said on Tuesday.
NEW YORK (Reuters) – In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc’s blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.
Bristol-Myers disclosed plans for the exploratory 30-patient trial testing its three-drug combination with Sovaldi in an interview with Reuters. Eric Hughes, the leader of Bristol’s global hepatitis program, said the details were due to be posted on the clinicaltrials.gov website next week.
By Susan Kelly and Bill Berkrot
(Reuters) – Medtronic Inc’s (MDT.N: Quote, Profile, Research, Stock Buzz) $43 billion deal for Dublin-based Covidien Plc (COV.N: Quote, Profile, Research, Stock Buzz) should accelerate already intense efforts by medical device rivals to seek merger partners, industry analysts and bankers said on Monday.
Medtronic announced the transaction on Sunday, saying it would re-base the combined company in Ireland, where it can take advantage of lower corporate tax rates and easier access to cash generated overseas.
June 14 (Reuters) – Novo Nordisk’s big-selling
diabetes drug Victoza appears to be an effective weight loss
therapy, data from a late-stage clinical trial presented on
In the 56-week study of 846 overweight or obese adults with
type 2 diabetes, a daily injection of 3 milligrams of Victoza
led to significantly greater weight loss than did a placebo.
June 14 (Reuters) – A Novo Nordisk drug combining
its long-acting insulin degludec with its type 2 diabetes
treatment Victoza maintained superior blood sugar reduction
after one year than either medicine separately, according to
data from a late stage trial presented on Saturday.
The combination therapy also helped more patients achieve
recommended blood sugar levels and appeared to reduce side
effects of each of the drugs when taken alone.
June 11 (Reuters) – A drug being developed by Amgen Inc
for psoriatic arthritis demonstrated sustained
effectiveness after a year of treatment with no new safety
concerns, according to data from a midstage trial.
Amgen and partner AstraZeneca Plc had previously
presented 12-week data from the 168-patient trial of the biotech
drug, brodalumab, showing it to be significantly more effective
than a placebo.
June 2 (Reuters) – New data on Bristol-Myers Squibb Co’s
melanoma drug Yervoy, including fresh results from an
effort to combine it with another promising cancer
immunotherapy, suggest it can improve treatment for patients
with both advanced and slightly earlier stage disease, according
to findings released on Monday.
Yervoy, which takes natural brakes off the immune system to
help it more effectively attack cancer, is approved to treat
metastatic, or stage 4, melanoma – the deadliest form of skin
cancer. Cowen and Co expects the drug to capture annual sales of
$1.95 billion by 2020, as it is approved in new indications and
combinations with other treatments.
May 31 (Reuters) – Eli Lilly and Co’s cancer drug
ramucirumab modestly extended survival in a large, late-stage
study of patients with advanced, nonsmall cell lung cancer who
had relapsed following initial treatment, according to data
presented on Saturday.
In the 1,253-patient trial, those who received ramucirumab
and the common chemotherapy drug docetaxel on average lived for
10.5 months compared with 9.1 months for those who got only the
LONDON/NEW YORK (Reuters) – Pfizer abandoned its attempt to buy AstraZeneca for nearly 70 billion pounds ($118 billion) on Monday as a deadline approached without a last-minute change of heart by the British drugmaker.
The decision ends a month-long public fight between two of the world’s biggest pharmaceutical companies that sparked political concerns on both sides of Atlantic over jobs and corporate tax maneuvers.