BIOPHARMACEUTICAL.INFO
PHARMACEUTICAL
AND BIOTECH NEWS
A
daily compilation of industry news from
Today's
Top News Stories
Mon, 12 Jul 2010 08:00:00 GMT
The New York Times:
Drugmaker Merck announced it is closing eight research centers and
eight manufacturing plants and laying off 15,000 people from its
worldwide operations during the next two years because of its merger
with Schering-Plough. "The restructuring is expected to save $2.7
billion to $3.1 billion in 2012, the company said...
Commenting on the EU General
Court’s ruling that AstraZeneca had acted anti-competitively to...
AstraZeneca announced today
that Judge Joseph Farnan, Jr., US District Court, District of Delaware,
has found that the substance patent protecting CRESTOR (RE37,314 – the
‘314 patent) is valid and enforceable...
The pharmaceutical industry
has faced well documented challenges over the last 12 months, such as
the Pfizer...
Mon, 12 Jul 2010 21:35:00 GMT
Mon, 12 Jul 2010 21:12:49 GMT|FierceBiotech
With the backing of Novo A/S, Irving, TX-based Reata Pharmaceuticals
has raised a whopping $78 million round to finance a pivotal study of a
new therapy for chronic kidney disease and Type 2 diabetes. The new
money brings Reata's total venture funding to $180 million. Reata's
eggs have been...
Mon, 12 Jul 2010 18:36:23 GMT|PharmaGossip
A former U.S. Food and Drug Administration official said
GlaxoSmithKline Plc withheld from regulators a study showing its
Avandia diabetes drug may cause heart attacks, according to two people
familiar with her deposition in a lawsuit against the drugmaker. Dr.
Rosemary Johann-Liang , a...
Mon, 12 Jul 2010 18:36:13 GMT|Jim Edwards
The first of three new diet
drugs — Vivus (VVUS)’s Qnexa — comes up for a vote at the FDA on July
15, and its fate will send...
Mon, 12 Jul 2010 18:25:32 GMT
Mon, 12 Jul 2010 18:00:43 GMT
Bristol-Myers Squibb Co.
said Monday it is recalling eight production lots of its anti-clotting
drug Coumadin because the amount of the active ingredient in the drug
could change.
Johnson & Johnson is
buying medical device maker Micrus Endovascular for about $480 million,
adding to the health care company's range of treatments for stroke and
brain aneurysms.
Sun, 11 Jul 2010 22:00:00 GMT
GlaxoSmithKline (GSK)
confirmed that on behalf of the European Medicines Agency (EMA), the
Committee for Medicinal Products for Human Use (CHMP) is to review the
benefit/risk profile of Avandia (rosiglitazone). This follows the
recent publication of an observational study and a meta-analysis
regarding Avandia since the CHMP last reviewed the product in early
2010. All data generated by the Company has previously been submitted
to the EMA.
The
The Rest of
Today's News
AstraZeneca and MRC
Technology, announced a new strategic collaboration to share access
to...
Ingen Biosciences, today
announced that the company has appointed Dr. Karine Mignon-Godefroy as
director of research & development...
Phagenesis Limited, a leader
in technology for the treatment of stroke patients, has appointed Henry
Hyde-Thomson as Chairman and Daniel Green as CEO...
HiTEL Laboratory at the
University of York is a service facility offering bespoke protein
expression, using a Freedom EVO 200 workstation...
The Leibniz-Institut für
Molekulare Pharmakologie in Berlin, is using Tecan’s Freedom EVO®
workstations for systematic high throughput screening of bioactive
small molecule libraries...
Mon, 12 Jul 2010 22:20:00 GMT
HERCULES, CA (MARKET WIRE)
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a
multinational manufacturer and distributor of life science research and
clinical diagnostic products, will report financial results for the
second quarter 2010 on Tuesday, August 3, 2010, after the close of the
market. The company will discuss these results in a conference call
scheduled for 2 PM Pacific Time (5 PM Eastern Time) that day.
Mon, 12 Jul 2010 22:14:21 GMT
Piramal may sell diagnostics
business to Super ReligarePiramal may sell diagnostics business to
Super Religare
Mon, 12 Jul 2010 22:12:16 GMT
Abri Health Plan in West
Allis, a provider of Medicaid managed care services to BadgerCare Plus
and SSI Managed Care enrollees in Wisconsin, has agreed to be purchased
by California managed care provider Molina Healthcare Inc. for $16
million.
Mon, 12 Jul 2010 22:10:20 GMT
MEMPHIS, Tenn. a ' The Merck
& Co. manufacturing site in Memphis has survived a round of
plant closings.
Mon, 12 Jul 2010 21:16:49 GMT
NEW YORK (Reuters Health) -
Older adults who get plenty of vitamin E in their diets may have a
somewhat lower risk of developing dementia than those who consume less
of the nutrient, a study published Monday suggests.
Mon, 12 Jul 2010 20:39:25 GMT
BioMimetic Therapeutics Inc.
plans to sell another 5 million shares of its common stock to fund
development and commercialization of its product pipeline, including
its Augment Bone Graft that is expected to gain U.S. Food and Drug
Administration clearance within the next year. (BMTI)
Mon, 12 Jul 2010 20:30:00 GMT
SAN DIEGO, July 12, 2010
(GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that
is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the
Hercules Market of the Osaka Securities Exchange (Code Number: 4875),
today announced that it expects to make an initial payment from the
escrow account to the former stockholders of Avigen, Inc. by July 29,
2010.
Mon, 12 Jul 2010 20:30:00 GMT
CORALVILLE, Iowa, July 12,
2010 (GLOBE NEWSWIRE) -- Vivakor, Inc. (OTCBB:VIVK) announced that it
has expanded United States distribution of its VivaThermic vials. A
listing of Authorized Distributors of VivaThermic vials is available at
www.vivathermic.com/distributors. Speaking of its growing network
authorized distributors, Dr. Tannin Fuja, Vivakor's CEO and Chief
Scientific Officer, said, "We are proud of the strong group of premier
distributors we work with to accelerate the delivery of Vivakor
technologies to markets throughout the world to our customers who have
come to expect the high quality of Vivakor's superior products."
Mon, 12 Jul 2010 20:26:08 GMT
WASHINGTON (Reuters) - The
U.S. Veterans Affairs department published new rules on Monday meant to
make it easier for veterans seeking treatment and financial support for
post-traumatic stress disorder or PTSD.
Mon, 12 Jul 2010 20:25:16 GMT
HONOLULU (Reuters) - A new
online service designed to match Alzheimer's patients with clinical
trials may help address a big bottleneck in developing new drugs -- a
lack of people to test them on, U.S. researchers said on Monday.
Mon, 12 Jul 2010 20:24:22 GMT
WASHINGTON (Reuters) - The
American Society of Clinical Oncology issued new guidelines on Monday
for the use of hormone-based breast cancer drugs called aromatase
inhibitors.
Mon, 12 Jul 2010 20:23:36 GMT
LONDON (Reuters) - Older
people with low levels of vitamin D appear more likely to have problems
with memory, learning and thinking, suggesting low vitamin D could give
an early warning for dementia risk, scientists said on Monday.
Mon, 12 Jul 2010 20:23:00 GMT
Wildlife Trust Scientist
Employs Advanced Genetic Sequencing to Uncover New Pathogen
NEW YORK, July 12 /PRNewswire-USNewswire/ -- Wildlife
Trust, the global
conservation health organization, announced the discovery of a
previously unknown pathogen that may offer insight into the origins of
the ...
Mon, 12 Jul 2010 20:02:00 GMT
OKLAHOMA CITY, July 12
/PRNewswire/ -- For the second consecutive year, Orthocare Innovations
has been selected by R&D Magazine to receive its prestigious
R&D 100 Award. Orthocare Innovations received this
award for its Galileo™ system, a novel approach for measuring,
analyzing a
Mon, 12 Jul 2010 20:00:00 GMT
REDWOOD CITY, Calif., July
12, 2010 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc.
(Nasdaq:THLD), today announced two preclinical presentations on its
clinical stage hypoxia-activated prodrug, TH-302, at the American
Association for Cancer Research (AACR) Translational Cancer Medicine
Meeting, being held July 11 to 14, 2010, in San Francisco, CA. The
preclinical presentations describe new findings regarding the efficacy
of TH-302 when combined with multi-kinase inhibitors that inhibit VEGF
signaling, as well as the efficacy of TH-302 in combination with
gemcitabine in models of pancreatic cancer.
Mon, 12 Jul 2010 20:00:00 GMT
MORRISTOWN, N.J., July 12
/PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI)
today confirmed that its subsidiary, Watson Laboratories, Inc., filed
an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug
Administration (FDA) seeking approval to market sevelamer carbonate./..
Mon, 12 Jul 2010 19:57:33 GMT|Jim Edwards
The federal appeals courts
haven’t explicitly legalized “channel-stuffing,” an accounting trick
that artificially inflates...
Mon, 12 Jul 2010 19:50:00 GMT
BEDFORD, Mass.----Anika
Therapeutics, Inc. , a leader in products for tissue protection,
healing and repair, based on hyaluronic acid technology, announced
today that they had been served with a complaint alleging patent
infringement with respect to the MONOVISC product by Genzyme
Corporation.
Mon, 12 Jul 2010 19:45:00 GMT
PITTSBURGH, July 12
/PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) announced today that
it will host a conference call and live webcast on Thursday, July 29,
2010, at 10 a.m. ET, to review the company's financial results for the
second quarter 2010, which ended June 30, 2010. Mylan will release
Mon, 12 Jul 2010 19:34:01 GMT
Angeion Corp. has
"terminated" Chief Financial Officer William Kullback's employment, the
med-tech company reported in a regulatory filing on Monday.
Mon, 12 Jul 2010 19:00:00 GMT
What to expect from Cubist,
Amylin, Cephalon, and Shire Pharmaceuticals.
Mon, 12 Jul 2010 18:30:00 GMT
LYNBROOK, N.Y., July 12
/PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq:
BSTC), a biopharmaceutical company developing first in class
collagenase-based products, today announced that its strategic partner
Auxilium Pharmaceuticals, Inc. has provided an update on XIAFLEX, its
injectable...
Mon, 12 Jul 2010 18:25:00 GMT
PALO ALTO, Calif., July 12
/PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK) today announced
the publication of a review in the journal, Cell Death and
Differentiation: Glutathione transferases as mediators of signaling
pathways involved in cell proliferation and cell death;
http://www.nature.com
Mon, 12 Jul 2010 16:27:36 GMT
Xcelience LLC will expand
its pharmaceutical manufacturing to Europe as part of a joint venture
agreement with Penn Pharma. (PFE)
Mon, 12 Jul 2010 16:26:21 GMT
Christian Homes Inc. plans
to move its corporate headquarters to Creve Coeur, Mo., from Lincoln,
Ill.
Mon, 12 Jul 2010 16:25:53 GMT
Mon, 12 Jul 2010 16:23:51 GMT
Novelos Therapeutics, Inc.,
the biotechnology company that suffered a heavy blow when its promising
lung cancer drug target failed in a late stage trial, is advancing the
same candidate as a potential breast cancer therapy.
Mon, 12 Jul 2010 16:19:37 GMT
WASHINGTON (Reuters) -
Lawyers for patients who say they have been harmed by GlaxoSmithKline
Plc's Avandia say critical data is still under wraps even as a U.S.
advisory panel prepares to weigh the fate of the controversial diabetes
drug.
Mon, 12 Jul 2010 16:09:47 GMT
Kodak and MedCo Data LLC
teamed up on a product to help physician practices create electronic
medical records. (EK)
Mon, 12 Jul 2010 16:07:09 GMT
WASHINGTON (Reuters) -
Contaminated salsa and guacamole dips are common causes of food
poisoning in restaurants, and food workers need to take greater care,
researchers told a Centers for Disease Control and Prevention meeting
on Monday.
Mon, 12 Jul 2010 16:04:05 GMT
From Associated Press (July
12, 2010)
MALVERN, Pa. -- Auxilium Pharmaceuticals Inc. said Monday
it
received $3.1 million in revenue from its drug Xiaflex in the
second quarter, the first full quarter the drug was on the
market.
The company said...
Mon, 12 Jul 2010 16:00:00 GMT
PRINCETON, N.J., July 12
/PRNewswire/ -- Novo Nordisk Inc., a global healthcare company and
leader in diabetes care, today announced the second issue of the Novo
Nordisk BlueSheet, a resource for information on diabetes and chronic
disease, highlighting key issues in diabetes prevention, detection,
Mon, 12 Jul 2010 15:46:00 GMT
BALTIMORE, July 12, 2010
(GLOBE NEWSWIRE) -- Goldman Small Cap Research, a stock market research
firm focused on the small cap and micro cap sectors, has released a
research update on Catalyst Pharmaceutical Partners, Inc.
(Nasdaq:CPRX), a biopharmaceutical company focused on the
commercialization of drugs targeting diseases of the central nervous
system with a focus on the treatment of drug addiction and epilepsy.
Mon, 12 Jul 2010 15:39:56 GMT
Birmingham-based Proventix
Systems Inc. Monday announced a partnership with Synapse Wireless, a
Huntsville technology firm, to produce a hand wash monitoring system
for the health care industry.
Mon, 12 Jul 2010 15:20:00 GMT
SOUTH EASTON, Mass., July
12, 2010 (GLOBE NEWSWIRE) -- Pressure BioSciences, Inc. (Nasdaq:PBIO)
("PBI" and the "Company") today announced that Mr. Alan I. Goldberg has
been unanimously elected to fill the open, Class III seat on the
Company's Board of Directors, effective Monday, July 12, 2010. This
seat has been vacant since shareholders voted to amend the Company's
Articles of Incorporation and to divide the Board of Directors into
three classes.
Mon, 12 Jul 2010 15:02:10 GMT
Mon, 12 Jul 2010 15:00:24 GMT
Immunotope Inc. and Midatech
Group Ltd. said Monday that they formed a joint venture to develop
antigen-based immune therapies to treat chronic viral infections and
cancers.
Mon, 12 Jul 2010 14:58:39 GMT
Cancer Drug Olaparib Shows
Early Promise
From Philadelphia Inquirer (PA) (July 12, 2010)
July 12--A novel therapy designed to exploit the renegade power of
malignant cells showed remarkable effectiveness against...
Mon, 12 Jul 2010 14:55:17 GMT
Auxilium Pharmaceuticals
Inc. Monday reported its first full-quarter of revenues for Xiaflex,
the company’s new treatment for a condition that causes the fingers to
contract and impairs hand function. (AUXL) (PFE)
Mon, 12 Jul 2010 14:32:24 GMT
26 - 27 October 2010,
Vienna, Austria.
Leading Pharmaceutical players understand, how to complete trials with
greater levels of cost-efficiency, timelines and success. Reveal, how
to tailor clinical trials to the needs of the patients.
Mon, 12 Jul 2010 14:32:00 GMT
Shares of U.K.
pharmaceutical giant GlaxoSmithKline PLC increase marginally in early
trading, the day before U.S. regulators are scheduled to meet to
discuss the safety of one of the company's biggest selling products,
the diabetes drug Avandia.
Mon, 12 Jul 2010 14:30:00 GMT
NASHVILLE, Tenn., July 12
/PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq:
CPIX) today announced that data supporting the efficacy of Caldolor in
treating fever associated with falciparum malaria was published in the
July edition of the peer-reviewed American Journal of Tropical Me
Mon, 12 Jul 2010 14:29:04 GMT
Theragenics Corp. has
renewed a distribution relationship with Oncura Inc. for TheraSeed
palladium-103 brachytherapy seeds. (TGX)
Mon, 12 Jul 2010 14:06:52 GMT
Combination of Neurovascular
Businesses to Advance the
Treatment of Stroke
NEW BRUNSWICK, N.J. and SAN JOSE, Calif., July 12
/PRNewswire-FirstCall/ -- Johnson & Johnson (NYSE:JNJ) and
Micrus Endovascular Corporation
(NASDAQ: MEND) , a global...
Mon, 12 Jul 2010 14:00:00 GMT
ROCHESTER, N.Y., July 12
/PRNewswire/ -- Bio-Optronics and Clinical Research Associates (CRA)
have developed a strategic relationship to provide a turn-key solution
for a clinical research site's patient recruitment needs, which couples
Bio-Optronics' Clinical Conductor™ Clinical Trial Managem
Mon, 12 Jul 2010 14:00:00 GMT
PRINCETON, N.J., July 12
/PRNewswire/ -- Signum Biosciences announced that its partner, Rohto
Pharmaceutical Co., Ltd., has launched AFC Medirepair® with Signum's
compound Arazine™ (n-acetyl-s-farnsylcysteine or AFC) in Japan.
Arazine™ is the first compound from Signum's novel
Mon, 12 Jul 2010 13:55:08 GMT|Jim Edwards
An FDA advisory committee
meets July 13 and 14 to decide the fate of GlaxoSmithKline’s Avandia,
and the protagonists’ slideshows...
Mon, 12 Jul 2010 13:53:00 GMT
BEDFORD, Ohio,
July 12 /PRNewswire/ -- Bedford Laboratories™, a division of
Ben Venue Laboratories, Inc., is pleased to announce the addition of
Dactinomycin for Injection USP 500 mcg (0.5 mg) to its
comprehensive line of generic oncology products. Dactinomycin
was approved e
Mon, 12 Jul 2010 13:50:24 GMT|Jim Edwards
If there’s one thing that
Roche (ROG) can’t see coming, it’s a conman. On three occasions the
pharmaceutical company has been...
Mon, 12 Jul 2010 13:38:55 GMT
About 300 Ethicon-Endo
Surgery staff members are now employed by Devicor Medical Products
Inc., now that the company has completed its purchase of Ethicon’s
breast care portfolio.
Mon, 12 Jul 2010 13:33:00 GMT
Findings Could Lead to Lower
Doses of Medication for Lupus Patients, Reducing Serious Side Effects
DALLAS, July 12 /PRNewswire-USNewswire/ -- Two immune
system proteins
could be the culprit behind many lupus patients' resistance to widely
used steroid treatments, scientists with the Baylor Research
Mon, 12 Jul 2010 13:28:00 GMT
CAMBRIDGE, Mass.----Vertex
Pharmaceuticals Incorporated will announce its second quarter 2010
financial results on Wednesday, July 28, 2010 after the financial
markets close. The Company will host a conference call at 5:00 p.m.
Mon, 12 Jul 2010 13:01:33 GMT
Mon, 12 Jul 2010 13:00:00 GMT
SANTA ANA, Calif., July 12,
2010 (GLOBE NEWSWIRE) -- BioCentric Energy Holdings, Inc.'s (Pink
Sheets:BEHL) Founder and Chairman of the Board, Dennis Fisher, today
announced several qualified candidates were interviewed for the
position of CEO and management has identified a seasoned Harvard
Graduate Business Professional with a proven track record of success to
assume the position with the company.
Mon, 12 Jul 2010 12:51:21 GMT
NEWTOWN, Pa., July 12, 2010
–– Canon Data Products
Group and PharmaLive.com announce the release of a new
Special
Report in their therapeutic category series, “Oncology Review
and Outlook 2010.” This report provides...
Mon, 12 Jul 2010 12:39:06 GMT
Mon, 12 Jul 2010 12:30:00 GMT
LAVAL, Quebec, July 12, 2010
(GLOBE NEWSWIRE) -- Neptune Technologies & Bioressources Inc.
("Neptune") (Nasdaq:NEPT) (TSX-V:NTB) and Acasti Pharma Inc. ("Acasti")
are pleased to announce the outcome of the recent Acasti's Scientific
Advisory Board ("SAB") general meeting held on June 15, 2010.
Mon, 12 Jul 2010 12:30:00 GMT
SAN DIEGO, PARSIPPANY, N.J.
and INDIANAPOLIS, July 12 /PRNewswire/ -- Accumetrics, Inc., Daiichi
Sankyo, Inc, and Eli Lilly and Company announced today that the
companies have entered into a strategic collaboration in the United
States to raise awareness about antiplatelet therapy and the role of pl
Mon, 12 Jul 2010 12:30:00 GMT
CHADDS FORD, Pa., July 12
/PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today
announced the expiration of the subsequent offering period of the
tender offer by its wholly owned subsidiary, HT Acquisition Corp., for
all of the outstanding shares of common stock of HealthTronics, Inc.
Mon, 12 Jul 2010 12:00:00 GMT
MOUNTAIN VIEW, Calif., July
12 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:
ALXA) announced today that it has selected AZ-007 (Staccato zaleplon)
for the treatment of insomnia as the next product candidate to move
forward into active development. This decision follows an Ale
Mon, 12 Jul 2010 12:00:00 GMT
MIAMI, July 12 /PRNewswire/
-- Fuisz Pharma today announced that it has acquired a key issued
patent (US 7,214,385 "Pharmaceutical Formulation Containing Dye"
(invented by Dr. Thomas Gruber)). This patent covers the use
of dyes and staining agents in pharmaceutical dosage forms as a method
to
Mon, 12 Jul 2010 12:00:00 GMT
STAMFORD, Conn., July 12
/PRNewswire/ -- Recognizing the importance education and awareness play
in preventing crime, Purdue Pharma L.P. is providing a free security
ceiling mobile and the RxPATROL Pharmacy Safety and Security video to
the nationwide network of approximately 3,600 Good Neighbor Phar
Mon, 12 Jul 2010 12:00:00 GMT
NANTONG CITY, China, July
12, 2010 (GLOBE NEWSWIRE) -- Sinobiopharma, Inc. ("Sinobiopharma" or
the "Company"), (OTCBB:SNBP), an innovative biopharmaceutical products
company with primary operations in China, today announced that it
launched a new corporate and investor relations website at
http://www.sinobp.com.
Mon, 12 Jul 2010 12:00:00 GMT
WALTHAM, Mass., July 12
/PRNewswire/ -- Decision Resources, one of the world's leading research
and advisory firms for pharmaceutical and healthcare issues, finds that
the launch of several high-priced novel disease-modifying
therapies—including the first oral agents approved for the indicatio
Mon, 12 Jul 2010 11:50:00 GMT
NASHVILLE, Tenn., July 12
/PRNewswire/ -- Oncologists working with DiaTech Oncology have
published the results of a comprehensive study to determine the
effectiveness of the Microculture Kinetic (MiCK) assay for apoptosis in
predicting the best chemotherapy response for Endometrial Cancer
patients.
Mon, 12 Jul 2010 11:06:49 GMT
Biogen Idec Inc. and Swedish
Orphan Biovitrum said Monday a potential hemophilia B treatment met key
safety goals in an early-stage study.
Mon, 12 Jul 2010 11:00:00 GMT
MOUNTAIN VIEW, Calif., July
12 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced
that data on Qnexa®, an investigational drug candidate, will be
presented at the 11th International Congress on Obesity (ICO) in
Stockholm, Sweden. Kishore Gadde, MD, director of obesity clinical
Mon, 12 Jul 2010 10:45:00 GMT
REYKJAVIK, Iceland, July
12, 2010 /PRNewswire-FirstCall/ -- Points to
Novel Pathway for Drug Discovery, Will be Incorporated
Into Tests to
Improve
Screening and Early Detection of Abdominal Aortic Aneurysm, Heart
Attack and
PAD
Scientists at deCODE genetics and academic colleagues from the
Mon, 12 Jul 2010 10:00:00 GMT
ALISO VIEJO, Calif., July 12
/PRNewswire-FirstCall/ -- Clarient, Inc. (Nasdaq: CLRT), a premier
technology and services resource for pathologists, oncologists and the
pharmaceutical industry, today announced that a manuscript based on a
study of Clarient Insight®Dx Mammostrat®, a test used
Mon, 12 Jul 2010 10:00:00 GMT
SEATTLE----ZymoGenetics,
Inc. announced today that it will report second quarter financial
results on Tuesday, August 3, 2010 after market close. Following the
announcement, members of the company’s senior management will discuss
the results and provide a corporate update.
Mon, 12 Jul 2010 09:41:32 GMT
|10NewsFederal health scientists
have panned a GlaxoSmithKline study that the company used to defend the
safety of its embattled diabetes drug Avandia, a once
blockbuster-seller that has fallen out of favor because of potential
ties to heart attacks.
Mon, 12 Jul 2010 09:00:00 GMT
A Johns Hopkins review of
nearly 150 randomized controlled trials on children - all published in
well-regarded medical journals - reveals that 40 to 60 percent of the
studies either failed to take steps to minimize risk for bias or to at
least properly describe those measures...
Mon, 12 Jul 2010 08:36:57 GMT
Mon, 12 Jul 2010 07:00:59 GMT|Pharma Manufacturing
Mon, 12 Jul 2010 07:00:00 GMT
Bristol-Myers Squibb (BMS)
and Otsuka Pharmaceutical's supplemental new drug application (sNDA)
for Sprycel (dasatinib), for the treatment of adult patients with newly
diagnosed chronic myeloid leukemia (CML) in chronic phase, has been
accepted by the FDA for filing and review.
Mon, 12 Jul 2010 07:00:00 GMT
Daiichi Sankyo's
investigational once-daily oral, direct factor Xa inhibitor, Edoxaban,
is said to have been demonstrated superiority over Enoxaparin in
preventing venous thromboembolic (VTE) events in patients following
total knee replacement (TKR), in Phase III STARS E-3 (Studying
Thrombosis After Replacement Surgery) study.
Mon, 12 Jul 2010 07:00:00 GMT
FDA has accepted to review
Protalix BioTherapeutics' new drug application (NDA) for Taliglucerase
alfa.
Mon, 12 Jul 2010 07:00:00 GMT
Merck KGaA said that the
Russian Federal Service on Surveillance in Healthcare and Social
Development has granted marketing approval to Cladribine Tablets for
the treatment of relapsing-remitting multiple sclerosis (MS).
Mon, 12 Jul 2010 07:00:00 GMT
Biogen Idec and Swedish
Orphan Biovitrum's fully-recombinant factor, IX Fc fusion protein
(rFIXFc), in hemophilia B patients, was well tolerated and demonstrated
an approximately three-fold increase in half-life compared to
historical data for existing therapies, in a Phase 1/2a open-label,
dose-escalation, safety and pharmacokinetic study.
Dieters, doctors and
investors get their first extensive look at the first of a trio of new
weight loss drugs this week.
Mon, 12 Jul 2010 06:30:00 GMT
WESTON, Mass. &
STOCKHOLM----Biogen Idec and Swedish Orphan Biovitrum AB today
announced results from a Phase 1/2a open-label, dose-escalation, safety
and pharmacokinetic study of the companies’ long-lasting,
fully-recombinant factor IX Fc fusion protein in hemophilia B patients.
Mon, 12 Jul 2010 06:20:00 GMT
MELBOURNE, Australia, July
12 /PRNewswire/ -- Australian regenerative medicine company, Mesoblast
Limited (ASX: MSB; ADR: MBLTY), today announced that based on positive
results from its bone marrow transplant clinical trial conducted at the
University of Texas MD Anderson Cancer Center, a formal mee
Mon, 12 Jul 2010 04:00:00 GMT
Keeping track of patients’
health can be a time-consuming and costly endeavor.
Mon, 12 Jul 2010 04:00:00 GMT
A metro Atlanta
biopharmaceutical firm is developing a drug that could slow the
progression of renal disease in some patients and delay the need for
expensive dialysis treatments.
Mon, 12 Jul 2010 04:00:00 GMT
DURHAM – A Chicago company’s
play to strengthen its hold on the market for testing products used to
speed drug development is causing some pain at Durham-based
CellzDirect, which makes similar products for its pharmaceutical
clients.
Mon, 12 Jul 2010 04:00:00 GMT
CureDM’s goal of developing
a drug to not only treat, but possibly cure, diabetes was practically
on life support last summer.
Mon, 12 Jul 2010 04:00:00 GMT
Dr. Paul Chew said he can’t
speak for other pharmaceutical companies, but his company —
Sanofi-Aventis — is willing to make deals on experimental drugs not yet
tested in humans when the science behind the technology is sound.
Mon, 12 Jul 2010 04:00:00 GMT
Medivation Inc. is packaging
its future — and the hopes of Alzheimer’s and Huntington’s disease
patients — in a small, light green tablet.
Mon, 12 Jul 2010 04:00:00 GMT
Cardiac Concepts Inc., a
med-tech firm that’s remained largely quiet since raising $21 million
in venture capital in 2008, has launched a clinical trial in Europe.
Mon, 12 Jul 2010 04:00:00 GMT
While a state fund for life
sciences research shrinks, the federal health care reform enacted in
March has set off a scramble among local biotechnology companies to
take advantage of one of the law’s major carrots: a $1 billion
“therapeutic discovery tax credit” program.
Mon, 12 Jul 2010 04:00:00 GMT
Vaccine developer Integrated
BioTherapeutics Inc. is preparing to decamp from Germantown to more
spacious headquarters in Gaithersburg, becoming the second tenant in a
Firstfield Road building the owners had struggled to fill during the
recession.
Mon, 12 Jul 2010 00:00:00 GMT
The U.S. Food and Drug
Administration (FDA) posted a comprehensive review conducted by
GlaxoSmithKline (GSK) of the cardiovascular safety data on Avandia®
(rosiglitazone maleate).
The ongoing study by
associate professor Moul Dey in SDSU's Department of Health and
Nutritional Sciences -- funded by the National Institutes of Health --
moves on now to examine the potential use of the plant extract against
colon cancer.
NEW YORK A big-ticket
acquisition could be in the works for French drug maker Sanofi-Aventis,
according to a report by British market research firm Datamonitor.
Sun, 11 Jul 2010 08:16:08 GMT
Sun, 11 Jul 2010 07:00:00 GMT
A new letter report from the
Institute of Medicine recommends a conceptual framework to help the
U.S. Food and Drug Administration evaluate the ethical issues involved
in determining whether companies should start or continue clinical
trials on approved drugs and in ensuring that these studies are
ethically conducted...
Sangamo BioSciences, Inc.
announced the publication of data demonstrating the preclinical
efficacy of a human stem cell therapy for human immunodeficiency virus
based on its proprietary zinc finger DNA-binding protein nuclease
technology.
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