Tuesday, April 30, 2013

J&J’s licence to make baby powder cancelled - “We have not suspended the licence, we have cancelled it"

The Maharashtra Food and Drug Administration has cancelled Johnson and Johnson's (J&J) licence for manufacturing cosmetics, following complaints of carcinogenic substances residue in its talcum powder for infants.
The complaint relates to 15 batches of talcum powder, comprising 160,000 containers, manufactured in 2007, by the company at its facility in Mulund, a Mumbai suburb. The J&J baby powder has a three-year shelf-life.
“We have not suspended the licence, we have cancelled it. The company cannot manufacture the Johnson baby powder at this stage,'' confirmed K.B. Shende, Joint Commissioner (Drug), Maharashtra FDA.
Speaking to Business Line, Shende told that “The company has been using ethylene oxide in its skin powder for infants. The sterilisation process using the chemical is completely wrong, for it remains as a residue. With usage, the talcum powder could turn carcinogenic and cause irreparable damage''.
Following complaints, the Maharashtra FDA carried out a series of investigations and laboratory tests on some containers and found “unacceptable levels of ethylene oxide, which is a main trigger for cancer. We found ethylene oxide residue, which was used to bring down the microbial load in the powder”,' said Shende.
A J&J official said the FDA raised concerns about ethylene oxide treatment, which is not part of the manufacturing process as submitted to the FDA. The shelf-life of the concerned batch ended July 2010.
J&J has up to June to plead its case before the State Government. “We have followed the due process of law. The company can now take up the matter with the State Government, if it wants to continue to manufacture the baby powder at its plant,” said Shende.

GRC News - Apr 30

Norway ordered BP Plc (BP) to review its safety procedures on Monday, saying a North Sea oil leak in September threatened the lives of workers and ...
April 29, 2013 -- FOXBusiness.com
The factory collapse in Bangladesh that killed over 300 people this week is a stark reminder of the risks in the global retail industry's search f ...
April 30, 2013 -- Reuters
The first UK court case linked to a complaint over the alleged rigging of Libor interest rates has been delayed until next year to allow Barclays ...
April 29, 2013 -- Reuters
Level Global Investors LP agreed to pay $21.5 million to settle U.S. Securities and Exchange Commission civil charges that its co-founder and an a ...
April 29, 2013 -- Reuters
Morgan Stanley and two ratings agencies have agreed to pay about $225 million to settle lawsuits claiming they concealed risks in two mortgage-rel ...
April 30, 2013 -- Reuters

Monday, April 29, 2013

Draft bill gives FDA authority over some pharmacies

The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.
The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.
The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.
"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.
The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

GRC News Digest - Apr 29

After a Twitter hoax caused the Dow to drop temporarily by 150 points, regulators are increasingly concerned about the combination of social media ...
April 28, 2013 -- NYT > Business
Carson Yeung, owner of English soccer club Birmingham City, is set to appear in court in Hong Kong today for trial on money laundering charges in ...
April 28, 2013 -- Bloomberg
Twelve days into his job as co- chief executive officer of Deutsche Bank AG (DBK), Anshu Jain stood beside Germany's finance minister and in front ...
April 29, 2013 -- Bloomberg
The European Commission began an investigation into industry claims that Chinese makers of solar glass benefit from illegal subsidies.
April 27, 2013 -- NYT > Energy & Environment
Twice this past week, the US Department of Justice filed lawsuits alleging Novartis Novartis The allegations have a familiar ring, given that the ...
April 29, 2013 -- Forbes.com

Friday, April 26, 2013

Life Science News - Apr 26

Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US ...
April 25, 2013 -- Medical Devices Business Review
Andrew Technologies has obtained 510 (k) clearance from the US Food and Drug Administration (FDA) for its Autologous Fat Transfer device. The lipo ...
April 25, 2013 -- Medical Devices Business Review
Medical device manufacturer Life Care Medical Devices (LCMD) has obtained CE mark approval for its Keyhole Cup Laparoscopic Access Device. The dev ...
April 25, 2013 -- Medical Devices Business Review
Medical device maker Boston Scientific Corp posted a first-quarter loss on Thursday as it took $578 million in charges for litigation and restruct ...
April 26, 2013 -- Reuters
Stryker Corp.'s 1st-quarter profits fall 13% on costs from the recall of its Rejuvenate and ABG II hip implants and a U.S. Justice Dept. probe int ...
April 25, 2013 -- MassDevice

GRC News - Apr 26

Aeropostale Inc. (ARO)'s former top merchandise executive was found guilty of defrauding the clothing retailer by striking illegal deals with a ve ...
April 25, 2013 -- Bloomberg
A Spokane, Washington man sued for defrauding investors used the 2012 Jumpstart Our Businesses Act to tout his plan to raise billions of dollars i ...
April 25, 2013 -- Bloomberg
A Life Technologies Corp. shareholder sued to block the $13.6 billion acquisition of the biotechnology equipment maker by Thermo Fisher Scientific ...
April 25, 2013 -- Bloomberg
U.S. regulators led by the Treasury Department have targeted an oft-criticized benchmark interest rate as a risk to financial stability, putting f ...
April 26, 2013 -- Huffington Post
Stefano Colombo, a former chief financial officer at Telekom Austria AG (TKA), is being investigated by Austrian prosecutors on suspicion of money ...
April 25, 2013 -- BusinessWeek

Wednesday, April 24, 2013


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Monday, April 1, 2013

GRC News Digest - Apr 1

China expressed 'resolute opposition' and 'strong dissatisfaction' with a new U.S. cyberespionage rule limiting imports of Chinese-made informatio ...
March 31, 2013 -- NYT > Business
More stock trades, about 40 percent on some days, are being conducted outside public exchanges.
March 31, 2013 -- NYT > Home Page
Money laundering by large international banks has reached epidemic proportions, and U.S. authorities are supposedly looking into Citigroup Inc. (C ...
March 31, 2013 -- Bloomberg
Banks including Bank of America Corp., Barclays Plc (BARC) and JPMorgan Chase & Co. (JPM) won dismissal of antitrust lawsuits by plaintiffs claimi ...
March 31, 2013 -- Bloomberg
Dell Inc. (DELL) founder Michael Dell will only consider backing a buyout by Blackstone Group LP (BX) if the private-equity firm guarantees he can ...
March 31, 2013 -- Bloomberg

Novartis loses 7 years old battle

The apex court on Monday ruled that the compound for which Novartis was seeking a patent "did not satisfy the test of novelty or inventiveness" required by Indian law.

After the landmark ruling, activists say it will protect access to cheap generic versions of drugs in developing nations.
Novartis fought a seven-year legal battle to gain patent protection for an updated version of its blockbuster cancer drug Glivec, arguing that the compound was a significant improvement because it is more easily absorbed by the body.

API Active Pharma Ingredients are the substances which goes inside the body and fights against the diseases. But to make it easily soluble in body there are various formats which is created by the pharma companies and these are typically patented in US EU and Japan, but SC in India said that unless it is advanced than its earlier form and give a substantiate benefit it can not be called as significant improvement and patent can not be done and hence its rejecting Novartis's claim.

This is a landmark ruling which will pave way the path for drug companies in developing economics to produce generic versions of lifesaving drugs and a major jolt to the big MNCs plan to reap benefit from the disease prone big population in these countries..