WASHINGTON/NEW YORK, March 18 (Reuters) – Some U.S. doctors
are becoming concerned about the quality of generic drugs
supplied by Indian manufacturers following a flurry of recalls
and import bans by the Food and Drug Administration.
India supplies about 40 percent of generic and
over-the-counter drugs used in the United States, making it the
second-biggest supplier after Canada.
By Bill Berkrot
(Reuters) – An experimental Amgen Inc cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented on Friday.
The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.
March 4 (Reuters) – An immunotherapy pill to treat an
allergy to house dust mites being tested by Merck & Co
significantly reduced common nasal symptoms, such as sneezing
and stuffy nose, according to data from a midstage clinical
trial, the company said on Tuesday.
The drug, MK-8237, reduced nasal symptoms by 49 percent at
the higher tested dose and 27 percent at the lower dose compared
with a placebo after 24 weeks of treatment. The results, which
were deemed to be statistically significant, were presented on
Tuesday at the American Academy of Allergy, Asthma and
Immunology (AAAAI) meeting in San Diego.
March 4 (Reuters) – An experimental drug reduced asthma
attacks in patients with severe uncontrolled asthma by 60
percent and helped improve lung function in certain patients,
indicating that the drug could offer the first personalized
approach to treatment, according to data from a clinical trial
released on Tuesday.
The biotech drug lebrikizumab, which was developed by Roche
Holding’s Genentech unit, was tested at three doses in
patients whose asthma was not sufficiently controlled even with
high-dose, inhaled corticosteroids and a second
By Bill Berkrot
(Reuters) – Shares of Mylan Inc (MYL.O: Quote, Profile, Research, Stock Buzz) jumped more than 10 percent on Thursday after the U.S. generic drugmaker provided a 2014 forecast above analysts’ estimates and said it planned a major transaction this year that would add to future earnings.
Mylan’s plan for a big transaction comes amid a wave of recent acquisitions in the generic and specialty drug sectors.
Feb 25 (Reuters) – An experimental once-weekly medicine for
type 2 diabetes developed by Eli Lilly and Co proved as
effective in lowering blood sugar as Victoza from Danish
drugmaker Novo Nordisk in an eagerly anticipated late
The Lilly drug, dulaglutide, achieved the primary goal of
the 599-patient study by demonstrating so-called non-inferiority
to the highest approved dose of Victoza after 26 weeks,
according to initial results released by the company on Tuesday.
Lilly shares rose more than 1 percent before retreating.
By Bill Berkrot
(Reuters) – An experimental once-weekly medicine for type 2 diabetes developed by Eli Lilly and Co proved as effective in lowering blood sugar as Victoza from Danish drugmaker Novo Nordisk in an eagerly anticipated late stage study.
The Lilly drug, dulaglutide, achieved the primary goal of the 599-patient study by demonstrating so-called non-inferiority to the highest approved dose of Victoza after 26 weeks, according to initial results released by the company on Tuesday.
WASHINGTON/NEW YORK (Reuters) – The U.S. Food and Drug Administration is proposing sweeping changes to how it regulates over-the-counter drugs from aspirin to allergy medications to make it easier to react to new information on a product’s safety or recommended use.
The agency’s current rules for nonprescription medicines are more than 40 years old, and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medications. They do not allow the agency to respond quickly when new data emerges about a drug’s potential side effects, the agency said in documents filed on Friday .
NEW YORK, Feb 11 (Reuters) – When Gilead Sciences Inc
declined to project 2014 revenue for its high-profile
new hepatitis C drug last week, its shares fell nearly 7 percent
over the next two days.
Wall Street analysts say investors were likely spooked by
the omission, concerned it could signal that sales of the new
drug, Sovaldi, might not approach sky-high forecasts.
By Bill Berkrot
(Reuters) – The U.S. Chamber of Commerce on Friday called on the government to ratchet up pressure on India over intellectual property rights, in a move that could help prevent Indian companies from producing cheap generic versions of medicines still under patent protection.
In a submission to the Office of U.S. Trade Representative (USTR), the Chamber of Commerce requested that India be classified as a Priority Foreign Country, a tag given to the worst offenders when it comes to protecting intellectual property and one that could trigger trade sanctions.