1. New Compound may lead to
development of cheaper anti-cancer drugs (03/02/2015)
A new
compound developed at the University of Toronto Scarborough could play an
important role in developing cheaper anti-cancer drugs. Professor Bernie
Kraatz, chair of the Department of Physical and Environmental Sciences at U of
T Scarborough, has developed a new compound that can be used to monitor the
biochemical processes involved with a group of enzymes called protein kinases.
The prevailing form of monitoring kinase activity involves the use of
radioactive isotopes, which is costly because the isotopes are expensive to use
and have a short shelf life. They are also difficult to work with because of
the regulations associated with their handling and disposal. http://www.medicalnewstoday.com/releases/290030.php
2. Synthetic biology breakthrough
leads to cheaper statin production (03/03/2015)
University
of Manchester researchers, together with industrial partner DSM, have developed
a single-step fermentative method for the production of leading
cholesterol-lowering drug, pravastatin, which will facilitate industrial-scale
statin drug production. In a study published in Proceedings of the National
Academy of Sciences, the researchers have devised a single-step fermentative
method for the industrial production of the active drug pravastatin that
previously involved a costly dual-step fermentation and biotransformation
process. http://www.medicalnewstoday.com/releases/290116.php
3. FDA approves first biosimilar
product Zarxio(03/09/2015)
The U.S
Food and Drug Administration have approved Zarxio (filgrastim-sndz), the first
biosimilar product approved in the United States. Sandoz, Inc.’s Zarxio is
biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed
in 1991. Zarxio is approved for the same indications as Neupogen, and can be
prescribed by a health care professional for:
http://www.medicalnewstoday.com/releases290537.php
4. FDA involved in case after
approving psych meds that cause boys to grow breasts (03/10/2015)
It’s not
often the FDA gets sued for anything, but a powerful Philadelphia legal firm
that handles whistleblower and class action cases throughout the nation,
Sheller, P.C., has petitioned the Federal Court to demand the FDA follow
through with black box warnings for Johnson & Johnson’s drug Risperdal or
remove its pediatric approval. The FDA had ignored Sheller’s requests to allow
the legal firm to release documents held by drug company Johnson & Johnson
and its subsidiary Janssen that would prove the necessity of withdrawing the
FDA’s 2006 approval of Risperdal for pediatric prescriptions or at least demand
black box warnings. By November 2014, the FDA simply denied all legal actions
from Sheller and dismissed their motions to proceed toward a black box warning
or remove the drug’s pediatric prescription classification. So, Sheller has
filed a suit which would insist that a federal judge issue an injunction to the
FDA for either issuing a black box warning or removing the drugs from pediatric
use. The law under which Sheller is suing the FDA is the Administrative
Procedures Act (APA). According to Epic.org: “The APA serves to police improper
agency behavior, protect public safety, and secure proper entitlements. The APA
governs all three main agency functions: rulemakings, adjudications, and
licensing. http://www.naturalnews.com/048936_psych_meds_sexual_development_FDA.html
5. Remsima (infliximab) accepted for
restricted us in NHS Scotland by the Scottish Medicines Consortium (03/11/15)
Patients
in Scotland suffering from inflammatory conditions including rheumatoid
arthritis (RA), Crohn’s Disease (CD), ulcerative colitis (UC), and psoriasis
will now have access to a new wave of biological medicines. Remsima
(infliximab) is a new biosimilar medicine which has the potential to bring
significant savings to the NHS without compromising patient care. Patient
access follows a review of Remsima by the SMC, which has accepted Remsima for
restricted use in line with SMC and Health Improvement Scotland (HIS) advice
for the originator medicine Remicade (infliximab), in RA, UC (adults and pediatric),
CD (adults and pediatric), psoriasis and psoriatic arthritis. http://www.medicalnewstoday.com/releases/290661.php
6. New test uses human stem cells to
identify dangerous side effects of drugs (03/11/2015)
Scientists
at Imperial College London have developed a test that uses combinations of
cells from a single donor’s blood to predict whether a new drug will cause a
severe immune reaction in humans. The test could avert disasters like the 2006
trial of the drug TGN1412, which led to six healthy young men being admitted to
intensive care with multiple organ failure. The volunteers receiving TGN1412
experienced a catastrophic inflammatory reaction called a cytokine storm.
http://www.medicalnewstoday.com/releases/290646.php
7. New Rules are Issued for Testing
of Medical Devices (03/12/2015)
FDA has
released a new guideline for testing procedures of reusable medical devices. It
issued the new requirements in the wake of news that two people in a Los
Angeles hospital had died from a deadly bacteria traced to medical scopes. The
changes will apply to new devices that the FDA approves, not the ones on the
market that have led to the infections. The FDA has said it received 75 reports
from January 2013 to December 2014 of bacterial infections across the country
believed to be linked to duodenoscopes. See the new guideline: http://www.fda.gov/downloads/MedicalDevices/Devices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080268.pdf
8. #BeCrueltyFree South Korea
campaign welcomes cosmetics bill requiring mandatory use of alternatives, but
loopholes must be closed (03/12/2015)
Humane
Society International’s #BeCrueltyFree South Korean campaign joined
Congresswoman Moon Jeong-Lim and officials on 11 March at the National Assembly
to witness the launch of a Korean bill that marks an initial milestone towards
ending animal testing of cosmetics in the country. The #BeCrueltyFree campaign
has been working with the Congresswoman over the past two years, including
discussions last week regarding bill language. Most recently, the campaigners
also held a public event with TV star Sam Hammington and LUSH cosmetics to call
for the bill to be an effective ban on cosmetics cruelty http://www.medicalnewstoday.com/releases/290767.php
9. Teva to buy Auspex, an American
Drug Developer for $3.2 billion (03/30/2015)
Teva
Pharmaceutical had agreed to acquire Auspex Pharmaceuticals, a developer of
drugs that treat people with movement disorders, for about $3.2 billion in
cash. Teva will pay $101 a share for Auspex. Including debt, the deal is worth
$3.5 billion, and the boards of both companies have approved it http://www.nytimes.com/2015/03/31/business/dealbook/teva-to-buy-auspex-an-american-drug-developer-for-3-2-billion.html
10. More research needed on use of
‘smart drugs’ by healthy people (04/01/2015)
Researchers
have called for the pharmaceutical industry, governments and medical
organizations to work together to investigate the consequences of long-term use
of cognitive-enhancing drugs by healthy individuals http://www.medicalnewstoday.com/articles/291757.php
11. FDA issues final guidance on the
evaluation and labeling of abuse-deterrent opioids (04/03/2015)
The U.S
Food and Drug Administration has issued a final guidance to assist industry in
developing opioid drug products with potentially abuse-deterrent properties.
Opioid drugs provide significant benefit for patients when used properly; however,
opioids also carry a risk of misuse, abuse and death. To combat opioid misuse
and abuse, the FDA is encouraging manufacturers to develop, abuse-deterrent
drugs that work correctly when taken as prescribed, but, for example, may be
formulated in such a way that deters misuse and abuse, including making it
difficult to snort or inject the drug for a more intense high. While drugs with
abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as
an important step toward balancing appropriate access to opioids for patients
with pain with the importance of reducing opioid misuse and abuse.
http://www.medicalnewstoday.com/releases/291920.php
12. Amphetamine-like stimulant
remains in dietary supplements 2 years after FDA discovery (04/08/2015)
The 2014
study from the Food and Drug Administration (FDA), published in the Journal of
Pharmaceutical and Biomedical Analysis, revealed that nine of the tested 21
dietary supplements marketed for weight loss, improved cognitive function or
enhanced athletic performance containing a plant extract called Acacia rigidula
also contained beta-methylphenylethylamine (BMPEA). BMPEA is a synthetic
compound closely related to amphetamine. Though the safety of the substance has
not been tested in humans, studies in cats and dogs have shown it to increase
blood pressure and heart rate conditions known to raise the risk of heart
attack and stroke in humans. But despite the FDA’s findings, it seems the
organization has taken no action to enforce the removal of BMPEA from dietary
supplements or warn consumers about the potential risks http://www.ncbi.nlm.nih.gov/pubmed/24176750
J Pharm Biomed Anal. 2014 Jan; 88:457-66. doi: 10.1016/j.jpba.2013.09.12 Epub
2013 Oct 5.
13. Making food more ‘porous’ could
reduce its salt content (04/13/2015)
Scientists
from the University of Illinois have found that manipulating the porosity of
food during manufacturing can affect its health benefits. Much of the salt that
is added to food for flavoring is not released into our mouths, which means
that a lot of salt content is wasted. The Illinois researchers wanted to see if
they could release more salt during chewing. The implications of this would be
no difference in terms of taste to the consumer, but food manufacturers would
not have to add as much salt as before. They attempted to do this by targeting
a certain fat-protein emulsion structure to increase the porosity of the food.
When the porosity of the food was increased, the researchers found that the
foods broke apart differently when chewed, which exposed more surface area and
increased the saltiness.
http://www.medicalnewstoday.com/articles/292276.php
14. L’Oréal says demand slowed in
Europe for mass beauty (04/20/2015)
The market
for mass beauty products in Western Europe had slowed in the early part of the
year but was still growing moderately in North America as it posted a 14.1
percent rise in first-quarter sales according to L’Oréal. Looking forward, L’Oréal
forecast sales growth in the first quarter would be below its average for the
year due to an improvement in demand for mass market consumer beauty products
later in the year.
http://www.reuters.com/article/2015/04/20/us-l-oreal-sales-idUSKBN0NB1XD20150420
15. FDA: Medtronic Must Stop Most
Sales of Synchromed Drug Pumps (04/27/2015)
The Food
and Drug Administration says Medtronic must stop most sales of its implantable
drug pumps after years of uncorrected problems. The FDA has filed a court order
against Medtronic that says the medical device giant must halt most production
and distribution of its Synchromed II drug pumps, which are implemented devices
used to treat patients with cancer, chronic pain and severe muscle spasms.
Medtronic will be legally required to hire an outside expert to help correct
the problems. The FDA issued the company three warning letters about quality
control and manufacturing problems at its drug pump facility in Columbia
Heights, Minnesota between 2006 and 2013. FDA inspectors visited the plant five
times over that period, the agency said in a Monday statement. http://abcnews.go.com/Health/wireStory/fda-moves-halt-medtronics-production-drug-pump-30623194
16. Mylan Rejects Teva’s $40 Billion
Takeover Offer (04/27/2015)
Mylan
rejected a $40 billion takeover bid from an Israeli competitor, Teva. Mylan
firmly and sharply rejected Teva’s bid to become the industry’s biggest generic
drug company, deriding its unwanted suitor as a tangle of flawed corporate
culture and mismanaged operations. Mylan will not begin negotiating unless a
big surpasses $100 a share, while Teva is offering about $82 a share. http://www.nytimes.com/2015/04/28/business/mylan-rejects-tevas-40-billion-takeover-offer.html