The incubator’s microchannels, fabricated in soft silicone polymer material, allow researchers to easily insert and guide cells and nutrients during experiments, while the computer-controlled electronics keep the cells at the precise temperature that enables them to multiply and thrive. The tiny incubator’s transparent design makes it easy to view the cells through a microscope or camera equipment without disrupting the conditions that help the cells to flourish.

A gas-permeable membrane on the incubator allows the microsystem to exchange carbon dioxide and oxygen but keeps out bacteria that could contaminate the cell culture. If a cell colony grows too large, an enzyme can be injected into one of the microfluidic ports to detach and flush away surplus cells without destroying the primary cell culture.

The incubator’s small size provides several advantages, the researchers say. The unit can easily be moved to different microscopes, imaging devices or other experimental tools without jeopardizing the health of the cell culture. Its size and relatively low cost should allow biologists to run numerous experiments simultaneously in a small space. Because it can be powered by batteries, the micro-incubator could be used outside a traditional lab for field tests

the thumb-size system developed by the Johns Hopkins engineers is self-contained and requires no external heating source. A drop of liquid containing living cells is injected into a port and flows through one of the microfluidic channels. A nutrient solution — the cells’ food — is also added in this manner.

The cells gravitate toward and stick to the surface of the microchip. The chip contains a simple heating unit — a miniature version of the type found in a common toaster — and is equipped with a sensor that continually checks to make sure the proper temperature is maintained. For human cells, this is usually 37 degrees Celsius or 98.6 degrees Fahrenheit. The chip is connected to a computer that controls the sensing and heating process. The prototype is connected to a computer via a hard wire, but the inventors say a wireless version would be the next step.

“The product lines and the geographic presence of these two companies are highly complementary,” said Bill Hawkins, president and chief executive officer of Medtronic. “We expect this acquisition to help accelerate the growth of Medtronic’s existing spinal business by extending our product offerings into some of the fastest growing product segments and enabling us to provide physicians with a broader range of therapies for use at all stages of the care continuum.”

Richard Mott, president and chief executive officer of Kyphon, said, “We are pleased that we were able to deliver outstanding value to our shareholders that fully reflects Kyphon’s innovation and growth potential. Combining our business with Medtronic’s Spinal business is also advantageous for our customers, their patients and our employees. As a part of the Medtronic organization, we will increase our ability to meet the needs of our clinician customers and the patients they serve with our technologies, and our employees will have the opportunity to become part of a larger organization with a shared vision as well as additional career and advancement opportunities.”

Medtronic also announced that Kyphon has completed its acquisition of the non-vertebroplasty assets of Disc-O-Tech Medical Technologies, Ltd., and has entered into a definitive agreement to divest substantially all of the assets relating to the Disc-O-Tech Confidence product line. The purchaser of the Confidence assets has agreed to assume substantially all of Kyphon’s payment obligations under Kyphon’s agreements to acquire those assets. The divestiture agreement remains subject to regulatory clearances and other customary conditions.

About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease. Its Internet address is www.medtronic.com.

The comments received from various firms and associations were examined and the following requirements were finalized for submission of applications for Global Clinical Trials. The applicants are advised to make applications as per the requirements adherent to the serial numbers given below.   As agreed earlier at the meeting at IDMA office on 17^thOctober, 2006 in Mumbai, applications would be scrutinized as mentioned above from 1^st December, 2006. The applications, if non-compliant with the requirements mentioned below, shall be rejected.
 

 Requirements For Filing Applications for Global Clinical Trial (for submission of data to countries other than India also)                                                                                                               

1.      Name of the Applicant

2.      Authorization letter from the Sponsor

3.      Name of the Drug

4.      Regulatory status of the drug in other countries (Names of countries where the drug is approved along with international package insert or where IND application is filed)

5.      Objective of the Study

6.      Phase of Study

7.      Names of  theParticipating Countries /Investigator sites

8.      Total no. of  patients to be enrolled globally

9.      No. of investigator sites to be enrolled in India

10.  No. of patients to be included in India

11.  Regulatory/ IRB approvals from participating countries

(these approvals should be submitted along with their English translation and reason in case the company is submitting an expired IRB/ IEC approval)

12.  Status of the study in other countries

(this should include no. of patients enrolled, no. patients completed the study and no. of  patients discontinued)

13.  Suspected Unexpected  Serious Adverse Reaction (SUSAR) from other participating countries if any reported

14.  Affidavit from the sponsor that the study has not been discontinued in any country and in case of discontinuation the reasons for such a discontinuation and that the applicant  would further communicate to DCG (I) about future discontinuation

15.  Data Submitted

a)             Chemical and Pharmaceutical data

i) Generic name and chemical name

ii) Dosage form

iii)Composition

b)              Animal Pharmacology Data

c) Animal Toxicology data

d)                                Clinical data

i) Phase I

ii) Phase II

iii) Phase III

iv) Phase IVe) Rationale for selecting the proposed dose(s) and indication(s)

15.            Documents Submitted

a) Form 44 and Treasury chalan

b) Form 12 and Treasury chalan

c) Details of Biological specimens to be exported

d) Protocol e) Informed Consent Documents (ICD)

e) Case Report form

f) Investigator’s Brochure duly supported by an affidavit that the summarized information submitted is based on facts

g) Undertakings by the Investigators

h) Ethics committee approvals (if already available)

 PROTOCOL AMENDMENTS a. Those amendments which do not require notification to or permission of the   Licensing Authority  i)            Administrative and Logistic changesii)         Minor protocol amendments and additional safety assessments in case the institutional ethics committee has already approved these changes    b. Those amendments which require notification to the Licensing Authoritybut need not wait for permission i)                    Additional Investigator sitesii)                   Change in investigator with the consent to withdraw from the earlier investigatoriii)        Amended Investigators Brochure, amended informed consent  c. Those amendments which require prior permission of the Licensing Authority  i)            Additional Patients to be recruitedii)         Major changes in protocol with respect to study design, dose and treatment optionsiii)         Any change in inclusion or exclusion criteria  Note: All amendments must be approved by the concerned Institutional Ethics Committee before their implementation

FDA’s approval of Tasigna includes a black box warning for possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death.

CML accounts for 15 percent of all leukemias in adults. Approximately 4,500 new cases of CML will be diagnosed in 2007. An abnormal chromosome, called the Philadelphia chromosome, is located in the leukemic cells and is present in the majority of CML patients.

“This represents another treatment option for CML patients who are resistant to or can no longer tolerate imatinib,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research. “Patients should consult with their physicians, however, because of possible life-threatening heart problems associated with this drug.”

The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Responses are associated with normalization of blood counts and bone marrow examinations. Further follow-up of patients is needed to determine how long these responses will last.

Patients may lower their chances for the heart problems by taking Tasigna without food, and by avoiding grapefruit products. Patients should also consult with their physician or other health care professional about avoiding other medications that can cause heart problems when taking Tasigna.

Patients with low blood potassium or magnesium should not use Tasigna.

The most common side effects include low blood counts, rash, headache, nausea and itching. Other possible serious side effects include liver damage, fluid accumulation and pancreas inflammation.

Women are advised to avoid becoming pregnant while taking Tasigna. Women who become pregnant are advised that Tasigna can harm their unborn child. Nursing mothers are advised not to breastfeed their child while taking the drug.

Tasigna is manufactured by Novartis Pharmaceuticals Corporation, East Hanover, N.J.

The announcement, which is expected within weeks and could come as early as Monday at the annual meeting of his scientific institute in San Diego, California, will herald a giant leap forward in the development of designer genomes. It is certain to provoke heated debate about the ethics of creating new species and could unlock the door to new energy sources and techniques to combat global warming.

Mr Venter told the Guardian he thought this landmark would be “a very important philosophical step in the history of our species. We are going from reading our genetic code to the ability to write it. That gives us the hypothetical ability to do things never contemplated before”.

The Guardian can reveal that a team of 20 top scientists assembled by Mr Venter, led by the Nobel laureate Hamilton Smith, has already constructed a synthetic chromosome, a feat of virtuoso bio-engineering never previously achieved. Using lab-made chemicals, they have painstakingly stitched together a chromosome that is 381 genes long and contains 580,000 base pairs of genetic code.

The DNA sequence is based on the bacterium Mycoplasma genitalium which the team pared down to the bare essentials needed to support life, removing a fifth of its genetic make-up. The wholly synthetically reconstructed chromosome, which the team have christened Mycoplasma laboratorium, has been watermarked with inks for easy recognition.

It is then transplanted into a living bacterial cell and in the final stage of the process it is expected to take control of the cell and in effect become a new life form. The team of scientists has already successfully transplanted the genome of one type of bacterium into the cell of another, effectively changing the cell’s species. Mr Venter said he was “100% confident” the same technique would work for the artificially created chromosome.

The new life form will depend for its ability to replicate itself and metabolise on the molecular machinery of the cell into which it has been injected, and in that sense it will not be a wholly synthetic life form. However, its DNA will be artificial, and it is the DNA that controls the cell and is credited with being the building block of life.

Mr Venter said he had carried out an ethical review before completing the experiment. “We feel that this is good science,” he said. He has further heightened the controversy surrounding his potential breakthrough by applying for a patent for the synthetic bacterium.

Pat Mooney, director of a Canadian bioethics organisation, ETC group, said the move was an enormous challenge to society to debate the risks involved. “Governments, and society in general, is way behind the ball. This is a wake-up call – what does it mean to create new life forms in a test-tube?”

He said Mr Venter was creating a “chassis on which you could build almost anything. It could be a contribution to humanity such as new drugs or a huge threat to humanity such as bio-weapons”.

Mr Venter believes designer genomes have enormous positive potential if properly regulated. In the long-term, he hopes they could lead to alternative energy sources previously unthinkable. Bacteria could be created, he speculates, that could help mop up excessive carbon dioxide, thus contributing to the solution to global warming, or produce fuels such as butane or propane made entirely from sugar.

“We are not afraid to take on things that are important just because they stimulate thinking,” he said. “We are dealing in big ideas. We are trying to create a new value system for life. When dealing at this scale, you can’t expect everybody to be happy.”(The Guardian Saturday October 6 2007)