The hot news at the FDA this
week is the news that the announcement that every bottle of
ephedra will soon bear stern warnings that the popular herb can
cause heart attacks or strokes, even kill. The warning labels
are part of a series of steps aimed at building the case for
more restrictions on the controversial dietary supplement. "This
is not the end of the story," said Health and Human Services
Secretary Tommy Thompson. The FDA is "building the case for
further regulatory action under the law." The move, however,
didn't satisfy consumer advocates who had pushed for an
immediate ban of the amphetamine-like stimulant. Thompson "needs
to show the courage to ban this product and be willing to stand
up to protect American families," said Sen. Richard Durbin,
D-Ill., who listed, by name, several ephedra users who have died
since he began urging Thompson to stop sales six months ago.
Companies included in this issue: IVAX, GSK, Xechem, Aventis,
Unigene, Merck, CV Therapeutics, Bayer, Akzo Nobel, Organon,
Sanofi-Synthelabo, Gensia Sicor, Given Imaging, CuraGen, Shire,
Matritech and Amersham.
7 -- IVAX Corporation submitted an ANDA to the FDA for
approval to market fluticasone propionate aqueous nasal
spray, 50 mcg. Fluticasone propionate is a synthetic
corticosteroid anti-inflammatory drug used in the
treatment of the nasal symptoms of seasonal and perennial
allergic and nonallergic rhinitis in adults and pediatric
patients 4 years of age and older. It is the generic
equivalent of GSK's Flonase.
Mar 7 -- Xechem International, Inc. filed its Orphan
Drug Application with the FDA seeking Orphan Drug status
for its Phyto-Pharmaceutical product, HEMOXIN, which is a
strong candidate as a treatment for patients suffering
with Sickle Cell Disease.
Mar 6 -- The safety risks of Aventis SA's drug Arava
are acceptable when weighed against its benefits for
treating rheumatoid arthritis, a FDA advisory panel ruled
unanimously. A consumer group had petitioned the FDA to
ban the drug, charging that it posed too great a risk of
Mar 6 -- Unigene Laboratories, Inc. has filed a NDA
with the FDA for FORTICAL, its patented formulation of
Mar 5 -- Merck and Co. Inc.'s experimental drug to
prevent vomiting caused by chemotherapy was better than
standard therapy in clinical trials, according to a memo
from the FDA. The FDA agreed the drug, Emend, achieved its
primary objectives of significantly reducing vomiting
among cancer patients who had received chemotherapy and of
sparing them the need to take additional medicines to
Mar 5 -- CV Therapeutics, Inc. announced that the FDA
has accepted the company's NDA for Ranexa (ranolazine),
for the treatment of chronic angina, for filing.
Mar 4 --The FDA has approved Bayer's supplemental NDA
for Avelox (moxifloxacin HCl) Tablets/I.V. as a treatment
for community-acquired pneumonia (CAP) due to
penicillin-resistant Streptococcus pneumoniae (PRSP).
Mar 4 --Akzo Nobel's human pharmaceutical business unit
Organon and Sanofi-Synthelabo announced that the FDA
granted a six-month priority review for a supplemental NDA
for Arixtra (fondaparinux sodium) for ``Prophylaxis of
deep venous thrombosis, which may lead to pulmonary
embolism, in patients undergoing hip fracture surgery,
including extended prophylaxis.''
4 --SICOR Inc. announced that its wholly owned subsidiary,
Gensia Sicor Pharmaceuticals, Inc., has received approval
of an ANDA from the FDA for Norepinephrine Bitartrate
Injection. Norepinephrine bitartrate is used to restore
blood pressure and control acute hypotensive states and as
an adjunct in the treatment of cardiac arrest and profound
Mar 4 --Given Imaging Ltd. announced the
FDA has cleared the Suspected Blood Indicator (SBI), a new
feature of the Given Diagnostic Platform that
automatically marks images that correlate with the
existence of suspected blood or red areas. The SBI feature
should give physicians more confidence in making a
diagnosis and allow them to identify bleeding sites with
greater precision during the review process.
Mar 4 -- Delivering on a promise made one month ago,
CuraGen Corp. said that the FDA has approved a phase I
protocol to begin testing its therapeutic protein CG53135
as a treatment for oral mucositis in cancer patients.
Mar 3 -- GlaxoSmithKline announced that the FDA
approved Avandia (rosiglitazone maleate) for use in
combination with insulin for the treatment of type 2
Mar 3 -- Shire Pharmaceuticals Group plc received an
approvable letter from the FDA for FOSRENOL (lanthanum
carbonate). The approvable letter asks for additional data
and analysis to address a number of remaining questions.
Shire is initiating a dialogue with the FDA to agree the
balance between pre and post approval commitments which
will resolve the questions. FOSRENOL is a treatment for
high phosphate levels in the blood, which occur in
patients undergoing dialysis as a result of chronic kidney
Mar 3 -- The FDA notified Matritech that the NMP22
BladderChek, which detects bladder cancer proteins in
patients' urine, is approvable as an aid in diagnosing
bladder cancer patients. This is the first urine screening
test that physicians can use in their offices to help
diagnose patients with bladder cancer.
Mar 3 -- Britain's biggest health care firm, Amersham
Plc received FDA approval for a new use of Myoview, a
special radioactive tracer that helps doctors get a better
view of the heart.
Introgen, EntreMed, Hybridon, Oncolytics Biotech,
Medinox, Ligand, ConjuChem, AVI BioPharma, Microscience,
NicOx, AstraZeneca, Emisphere Technologies, Novartis,
DOR BioPharma, VaxGen, Chiron Corp., Acusphere,
Refractec, Amarin, Galen Holdings, Able Laboratories,
Hi-Tech Pharmacal, Watson, Guildford, King, Monarch,
Wyeth and Amgen.
Therapeutics, Inc. published preclinical data
which showed that its non-viral delivery system
may be a more effective method of delivering
therapeutic genes to tumors than other non-viral
In a preclinical study conducted by EntreMed,
Inc. to investigate Panzem's potential use in
preventing and treating osteoporosis, Panzem
compared favorably with other accepted bone-loss
treatment approaches, but without any observable
secondary side effects.
Hybridon, Inc. demonstrated activity of their
MDM2 antisense compound in preclinical prostate
cancer models. The study was undertaken to
investigate the functions of the MDM2 oncogene
in prostate cancer growth and the importance of
MDM2 as a drug target for prostate cancer
therapy by antisense inhibition of MDM2
Oncolytics Biotech Inc. announced the successful
completion of its animal toxicology program
examining the systemic delivery of their cancer
Medinox, Inc. announced the
completion their Phase 1 trial in Europe of
MX-1094, a NSAI prodrug in development for the
treatment of arthritis. Nearly 40% of patients
with chronic severe hand dermatitis who were
Ligand Pharmaceutical'sTargretin (bexarotene)
gel 1%, experienced clinical improvement of 90%
or more, and almost 80% of patients improved by
at least 50%, according to final results of a
Phase I/II dose escalation study.
ConjuChem Inc. resolved the formulation issues
which interrupted the their DAC:GLP-1 clinical
program enabling the Company to resumed their
single-dose Phase I/II trial.
AVI BioPharma, Inc. released data from two
recently completed Phase I studies that showed
that a proprietary
NEUGENE antisense drug (AVI-4557) had a dramatic
effect on down-regulating a targeted liver
announced results from a multi-centre clinical
trial which shows that their new generation
single dose oral typhoid vaccine is safe,
well-tolerated and highly immunogenic.
French-based NicOx took a hit on the Nouveau
Marché with shares plummeting by more than 83
percent last week after AstraZeneca plc issued a
statement in the names of both companies
announcing that the recently completed Phase II
trial of a drug candidate they are developing
did not attain its primary therapeutic
Emisphere Technologies, Inc. announced favorable
results of a Phase IIa study with Novartis
Pharma AG evaluating the performance in
post-menopausal women of an oral tablet
formulation of the peptide, salmon calcitonin ("calcitonin"),
which is currently available only as nasal spray
or as an injectable therapy.
DOR BioPharma Inc. completed
enrollment of more than half of the patients in
its pivotal phase III clinical trial of orBec
for the treatment of Intestinal Graft-Vs.Host
Disease (IGVHD). VaxGen share price tumbled last
week, extending a massive sell-off that began
when the company announced disappointing initial
results of an AIDS vaccine trial.
In response to media inquires, VaxGen, Inc.
issued the following statement: "VaxGen's
analysis of data from its Phase III clinical
trial of AIDSVAX B/B followed a statistical
analysis plan that was agreed on in advance with
the U.S. Food and Drug Administration (FDA). The
statistical analysis plan included analyses of
various subgroups, including racial backgrounds.
The results VaxGen reported on Monday remain
accurate as stated, and the analysis continues."
Chiron Corp. plan to launch a phase III trial in
the US of Menjugate, its conjugated vaccine for
the prevention of meningococcal C disease, by
Acusphere, Inc. initiated its Phase III study of
AI-700, an ultrasound contrast agent designed
for detecting coronary artery disease in
patients with ischemic heart disease. Refractec,
Inc. completed patient enrollment for its Phase
III trial of CK(SM) (Conductive Keratoplasty(SM))
for the treatment of presbyopia, a condition
commonly referred to as "aging eyes."
The FDA issued Approval
Letters to Amarin Corp. plc for Zelapar, a novel
and proprietary formulation of selegiline, that
addresses the dopamine deficiency, which
characterizes Parkinson's disease, and to Galen
Holdings PLC for Ovcon, an oral contraceptive.
APPROVALS AND MARKETING CLEARANCE
Able Laboratories Inc.
received FDA approval for its ANDA 50 mg
promethazine hydrochloride suppositories, used
to treat allergies, anaphylactic reaction, pre-
and post-operative sedation, nausea and
vomiting. The product is a generic equivalent to
Wyeth's 50 mg Phenergan suppositories.
Hi-Tech Pharmacal Co., Inc. received approval to
market its Prednisolone Syrup USP, 15 mg per 5
mL. Hi-Tech's Prednisolone Syrup is the generic
equivalent of Muro Pharmaceutical's Prelone
Syrup, 15mg per 5 mL indicated for the treatment
of endocrine, rheumatic and dermatological
disorders and allergic states.
Watson Pharmaceuticals, Inc. received approval
for OXYTROL (oxybutynin transdermal system), the
first and only transdermal therapy to treat
Guilford Pharmaceuticals Inc. marketed product,
GLIADEL Wafer (polifeprosan 20 with carmustine
implant), received FDA approval for use in newly
diagnosed patients with high-grade malignant
glioma as an adjunct to surgery and radiation.
King Pharmaceuticals, Inc.
announced that newly published data from the
landmark Heart Outcomes Prevention Evaluation
("HOPE") Study relating to the prevention of
heart failure and use of Altace (ramipril), an
angiotensin converting enzyme ("ACE") inhibitor
is featured in the February 25, 2003 issue of
Circulation, a journal published by the American
Heart Association. Altace is marketed by Monarch
Pharmaceuticals, Inc., a wholly owned subsidiary
of King, and Wyeth Pharmaceuticals, in the
United States and Puerto Rico pursuant to a
co-promotion agreement. Amgen submitted data to
the FDA demonstrating that ENBREL (etanercept)
inhibits radiographic progression of structural
damage without increased side effects in many
people with rheumatoid arthritis (RA) over a
INVESTORS wiped nearly £3.3bn
from the value of GlaxoSmithKline after the drugs giant
confirmed it had lost a US court case governing patent
protection for its top-selling drug.
GlaxoSmithKline (GSK) said it may have to
reassess its profit forecasts for this year, depending on the
launch of a rival to its Paxil anti-depressant. The case in
Chicago, pitching GSK against Canadian generic firm Apotex, is
one of two over Paxil patents due to be heard in the US this
year. A date for the second case in Philadelphia has yet to be
set. GSK said it would appeal the Chicago ruling. Paxil's sales
topped £2bn last year, representing nearly 10% of group sales.
Two-thirds of sales were made in the US. GSK has forecast high
single-digit percentage growth in earnings this year - as long
as there is no generic competition to Paxil in the US. A
spokesman said it would stick with that guidance, but would have
to reassess its forecasts if the launch of a generic version of
Paxil became imminent. Apotex could launch its version of the
drug as early as September. Martin Hall, pharmaceuticals analyst
at HSBC, who rates GSK a 'sell', said the arrival of cheap Paxil
generics in the US would slow earnings growth sharply. 'If
everything translated through, you're looking at 7% underlying
earnings growth over the next five years dropping to 3%,' he
said. 'What they would do is cut their cost base to probably get
it back up to 7%.
your kids beg to stay on the computer for just one more hour
before bedtime, you can now say forget it. And researchers will
back you up.
|An Israeli study of fourth- and
sixth-grade children has found that up to one extra hour of
sleep markedly improved their performance on tests assessing
attention span and memory, both of which are necessary for
optimum school performance.
"If fourth-graders get an extra hour of sleep, they can function
on tests as if they were two or more years older," says Avi
Sadeh, a professor of psychology at Tel Aviv University. Sadeh
is lead author of the study, which appears in the March/April
issue of Child Development.
Most sleep studies focus on extreme sleep deprivation among
adults, Sadeh says. However, as a parent who struggles daily
with bedtimes for his own children, he was interested in finding
out whether lesser amounts of sleep would really have an effect
on school performance. The answer, he and his colleagues were
somewhat surprised to learn, was "yes."
"As parents, we intuitively knew there must be an effect, but as
scientists with all the familiarity with previous studies, we
weren't really sure we were going to find these results," he
"One of the effects of sleep deprivation is that if there is a
sleep reduction, the sleep quality actually increases, with
decreasing night awakenings and an increased percentage of
sleep," he says. "So, the question was that if sleep quality
improves as a compensation mechanism for sleep deprivation, will
we find any important change in performance?" "So it was very
striking to find a significant effect on cognitive functioning,"
Despite objections from several
World Health Organization (WHO) has adopted the final text
of the Framework Convention on Tobacco Control, the
New York Times reported March 1.
|The United States and Germany are
among the countries opposed to the treaty, which is aimed at
reducing tobacco-related illnesses and deaths worldwide. The two
nations said they would not adopt the treaty in its current
As it now stands, the treaty would ban tobacco advertising and
promotion in countries where the constitution allows; set high
taxes on tobacco products; require companies to disclose all the
ingredients in cigarettes; prohibit the use of such terms as
"ultra light" or "light;" and require warning labels on at least
30 percent of tobacco packages.
The countries against the treaty said the strong wording of the
text is unacceptable and, in some instances, unconstitutional.
"While the U.S. does not object to forwarding the draft
convention to the World Health Assembly, these and other issues
will have to be addressed," said David Hohman, the American
The treaty, which took four years of negotiations to complete,
will be presented in May during the WHO's annual conference. If
approved at the conference, the treaty goes before WHO's 192
member nations for ratification. Forty nations need to approve
it before it can officially take effect in the countries where
it has been approved.
SOURCE: New York Times
DATE POSTED: 03/2/2003
Frances Polack has taken an extraordinary measure to ensure
doctors do not try to prolong her life against her wishes.
|Ms Polack, 85, from
Lyndhurst in Hampshire, is so concerned about unwanted medical
care that she has invested in a £25 tattoo across the front of
her chest. It reads "Do Not Resuscitate" in capital
letters and is set around a red heart with a line through it.
|SOURCE: http://news.bbc.co.uk/1/hi/health/2819149.stm DATE POSTED: 03/5/2003