(Reuters) – U.S. regulators have approved a new dose of AstraZeneca’s blood thinner Brilinta for longer-term use in patients with a history of heart attacks, boosting prospects for a drug the company thinks will eventually sell $3.5 billion a year.
The green light from the U.S. Food and Drug Administration (FDA), announced late on Thursday, could theoretically more than double the number of people eligible for the medicine.
Sept 3 (Reuters) – AstraZeneca Plc on Thursday said
the U.S. Food and Drug Administration approved a new dose of its
blood thinner Brilinta intended for longer-term use in patients
with a history of heart attack or a condition known as acute
The FDA approved Brilinta tablets at a new 60 milligram dose
that would be taken along with aspirin beyond a year after a
heart attack. The drug, which is used to prevent blood clots
that can cause heart attacks, strokes and deaths, had previously
been approved at a higher dose for use during the first year
after a heart attack.
By Andrew Chung and Bill Berkrot
(Reuters) – In another setback for prominent hedge fund
manager Kyle Bass and his campaign to eliminate some drug
patents, the U.S. Patent and Trademark Office on Wednesday
declined to hold a trial on the validity of a patent on Biogen
Inc’s multiple sclerosis drug Tecfidera.
Last month the patent office also declined reviews requested
by Bass and his Coalition for Affordable Drugs on two Acorda
Therapeutics Inc patents. The Biogen
patent covered a dosing regimen for Tecfidera, which had $2.9
billion in sales last year.
NEW YORK (Reuters) – Ten weeks after closing its $8.4 billion purchase of Synageva BioPharma Corp, Alexion Pharmaceuticals Inc on Tuesday announced European approval for two drugs acquired through the deal, both enzyme-replacement therapies for ultra-rare, life threatening diseases.
European health regulators approved Kanuma for patients with lysosomal acid lipase deficiency (LAL-D), and Strensiq for patients with pediatric-onset hypophosphatasia (HPP). The treatments are awaiting U.S. approval decisions after receiving breakthrough therapy designations from the Food and Drug Administration.
NEW YORK (Reuters) – Perrigo Co Plc’s (PRGO.N: Quote, Profile, Research, Stock Buzz) chief executive expressed confidence on Tuesday that his company’s shareholders will reject rival generic drugmaker Mylan NV’s hostile takeover attempt, and said the offer is not close to what it would take to get a deal done.
Mylan (MYL.O: Quote, Profile, Research, Stock Buzz) shareholders are set to vote on Friday on whether the company should move forward with the Perrigo bid, whose value has declined with the recent market sell-off. If more than half vote “yes,” Mylan plans to take its cash and stock offer directly to Perrigo shareholders.
NEW YORK, Aug 7 (Reuters) – Some of the most heralded new
cancer drugs fight the disease by removing brakes on the immune
system. Now a few leading drugmakers are paying attention to a
second, opposing force: medicines that accelerate the immune
Pfizer Inc, which is lagging rivals in the lucrative
field of cancer immunotherapies, has been the first to report
early data of an “accelerator” treatment that targets a protein
called 4-1BB. It has at least five other Phase I studies
underway or in planning stages in solid tumor cancers and
lymphomas, which are blood cancers.
NEW YORK, Aug 6 (Reuters) – Generic drugmaker Mylan Inc’s
chief executive said on Thursday that acquiring Perrigo
Co was not a must and that it had other options should
Perrigo successfully fend off Mylan’s $34 billion hostile
“There are alternatives to Perrigo. We believe Perrigo is
the right first step. We like Perrigo, but we don’t have to have
Perrigo,” CEO Heather Bresch said during a conference call with
Wall Street analysts to discuss quarterly results
Aug 5 (Reuters) – CVS Health Corp, which operates
the nation’s second-biggest pharmacy benefit manager, said that
next year it will exclude an additional 31 prescription
medicines from insurance coverage, including Viagra and widely
used treatments for diabetes and multiple sclerosis.
The 2016 excluded drugs, disclosed on Wednesday, also
include Vivus Inc’s weight loss treatment Qsymia, which
last week was excluded from the 2016 formulary of rival PBM
Express Scripts Holding Co. Vivus officials could not
immediately be reached for comment.
By Bill Berkrot
(Reuters) – Perrigo Co Plc (PRGO.N: Quote, Profile, Research, Stock Buzz) on Wednesday made a fresh case for rejecting a $34 billion offer from generic drugmaker Mylan NV (MYL.O: Quote, Profile, Research, Stock Buzz) and said Mylan’s recent share price plunge reinforces Perrigo’s intention to remain independent.
Perrigo Chief Executive Joseph Papa, in his first comments on the unsolicited acquisition attempt since Israel’s Teva Pharmaceutical Industries (TEVA.TA: Quote, Profile, Research, Stock Buzz) dropped its pursuit of Mylan in favor of another deal, reiterated that the $205 per share offer substantially undervalues Perrigo.
July 30 (Reuters) – Amgen Inc on Thursday reported
higher-than-expected second-quarter profit and revenue, helped
by strong sales of its Enbrel rheumatoid arthritis drug and cost
cutting, and the company raised its full-year forecasts.
Excluding special items, Amgen earned $2.57 per share,
topping analysts’ average expectations by 14 cents, according to
Thomson Reuters I/B/E/S.