NEW YORK (Reuters) – Shire PLC’s (SHP.L: Quote, Profile, Research, Stock Buzz) chief executive said he sees no urgency to spend the windfall the Dublin-based drugmaker received when AbbVie (ABBV.N: Quote, Profile, Research, Stock Buzz) walked away from a $55 billion takeover bid earlier this year.
AbbVie scuttled the so-called inversion deal in October after changes in U.S. tax rules aimed at preventing U.S. companies from redomiciling abroad to take advantage of lower corporate taxes.
NEW YORK (Reuters) – U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of Edwards Lifesciences said.
Such a change could help get the third generation of its Sapien transcatheter aortic heart valve replacement (TAVR) to U.S. clinicians faster than previously expected, Edwards CEO Michael Mussallem told Reuters on Monday following the company’s business update for analysts and investors in New York.
By Bill Berkrot
(Reuters) – Eighty-seven percent of Hodgkin lymphoma patients responded to a Bristol-Myers Squibb drug that helps the immune system fight the blood cancer, according to data from a small, early stage trial released on Saturday.
The study of Bristol-Myers’ immunotherapy drug nivolumab involved 23 patients whose lymphoma had progressed after numerous prior treatments, including chemotherapy, stem cell transplants and the Seattle Genetics drug Adcetris.
Dec 6 (Reuters) – Merck & Co Inc’s drug that
harnesses the immune system to fight cancer showed promise in
Hodgkin lymphoma patients whose disease had progressed following
prior therapies, according to data from a small, early stage
trial being presented at a medical meeting.
In the ongoing study of 29 patients, 66 percent had a
meaningful response to the drug, Keytruda, after 24 weeks of
treatment, including six patients (21 percent) who achieved
Dec 6 (Reuters) – Significantly more patients with relapsed
multiple myeloma responded to a three-drug regimen including
Amgen Inc’s Kyprolis than those who got the standard
two-drug treatment, according to results from a late-stage
Patients with the blood cancer who received the Kyprolis
regimen for 18 months also had a longer duration of response and
reported better health-related quality of life, data presented
on Saturday showed.
By Bill Berkrot
(Reuters) – U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date.
The drug, blinatumomab, which will be sold under the brand name Blincyto, was approved to treat a form of acute lymphoblastic leukemia (ALL) for which there are few treatment options once a patient has relapsed.
Nov 24 (Reuters) – Genentech, U.S. biotech unit of Roche
Holding, faces growing pressure over a decision to
allow only a handful of distributors to supply three of the
world’s most widely used cancer drugs, a move that prominent
hospitals say will create delays and raise costs.
Genentech in October began distributing Avastin, Herceptin
and Rituxan to hospitals and clinics through six specialty drug
distributors, rather than through drug wholesalers, which
distribute a wide range of medicines, devices and equipment on
an enormous scale. Specialty distributors supply biologic
infusion medicines that often require special storage and
CHICAGO, Nov 21 (Reuters) – Controversial heart disease
prevention guidelines that abandoned specific targets for
reducing “bad” LDL cholesterol are under fresh assault after a
major study highlighted the benefits of taking LDL to very low
Guidelines issued last year by the American Heart
Association and the American College of Cardiology asked doctors
to assess individual patients’ risk for heart disease over 10
years based on a complex calculation of risks posed by
lifestyle, family history and other health conditions. Those
deemed at sufficient risk would be prescribed
CHICAGO, Nov 19 (Reuters) – Boston Scientific Corp’s
next generation Synergy heart stent succeeded in a pivotal study
that will be used to seek U.S. and Japanese approval of the
device, according to data presented at the American Heart
Association meeting in Chicago on Wednesday.
The ultra thin Synergy drug eluting stent, featuring a
bioabsorbable polymer coating that dissolves once the drug has
been fully delivered after about three months, proved comparable
to the company’s widely used Promus Element Plus stent in key
measures, achieving the main goal of the non-inferiority trial.
CHICAGO (Reuters) – An experimental heart failure medicine from Novartis that previously showed it reduced death and hospitalizations also curtailed worsening of symptoms, need for additional therapy and emergency room visits, adding to evidence that it will become the drug of choice once approved.
A lengthy list of additional benefits including significantly fewer intensive care unit stays from treatment with the drug, LCZ696, in the Paradigm-HF study of 8,442 patients called were presented at the American Heart Association meeting in Chicago on Monday.