All are saying "KNOWLEDGE IS POWER" but i am saying that having brain power is the greatest power among all, whether you have or have not knowledge....
Sunday, May 10, 2015
Tuesday, July 2, 2013
Mylan introduces eight new women's care products in India
Mylan introduces eight new women's care products in India
Generic and specialty pharmaceutical company Mylan Pharmaceuticals has introduced a portfolio of women's healthcare products in India, expanding its product base in the country.
Consisting of eight products initially, the portfolio is focused on hormones, pre- and post-natal nutrition and management of premenstrual syndrome (PMS).
Mylan CEO Heather Bresch said women's care being a high-growth therapeutic category in India provides the company with an opportunity to help satisfy unmet medical needs.
"More than 85% of women of childbearing age in India suffer from PMS, approximately one in five pregnancies in Indian women end in miscarriage, and it is estimated that the number of infertile couples in India is around 12 million.
"In addition to launching our innovative, high quality product portfolio, Mylan will help to strengthen the capabilities of health care providers in this area through training programs and workshops, working together with the medical community to address areas of concern in women's health and improve timely access to appropriate high quality treatment."
The company has launched a complete portfolio of antiretroviral products in India earlier and expects to continue to expand into new therapeutic categories along with field force expansion.
Friday, June 28, 2013
FDA’s move to cancel Johnson & Johnson licence upheld by Maharashtra Government
After finding residues of carcinogenic substances in 15 batches of Johnson & Johnson baby powder, Maharashtra Food and Drug Administration (FDA), the apex body for food and drug products in the State, had, in March, cancelled the licence of Johnson & Johnson, the multinational healthcare and consumer products major, to manufacture cosmetic products at their Mulund plant. On Monday, The Maharashtra Government also upheld the Food & Drug Administration (FDA) Commissioner’s decision to cancel the same.
The FDA had cancelled the company’s licence after finding that the carcinogenic residue was found because the batches were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.
“The State Government has given no relief and upheld the FDA move to cancel the Johnson & Johnson India”s licence to manufacture cosmetics,” FDA Commissioner Mahesh Zagade said.
J&J’s appeal was heard by the Maharashtra Minister of Food and Drugs Administration, Manohar Naik, on June 20.
The State Government in its order ruled that “J&J has violated section 18 of the Drugs & Cosmetic Act, 1940 and rule 142 (c) of 1945 rules. The appeal stands rejected. FDA directives issued in this regard on March 30 are upheld. The licence stands cancelled from June 24.”
The State FDA alleged that Johnson & Johnson did not register the process with the local FDA and failed to conduct tests to check for traces of ethylene oxide in the batches of talcum powder.
In its appeal, Johnson & Johnson explained the circumstances under which it had to use ethylene oxide to sterilise the 15 batches – which comes to about 1,50,000 bottles of baby powder.
A J&J India spokesman was quoted in Business Standard saying that, “We appreciate that the Maharashtra State FDA has given us a hearing on the matter of our Mulund plant. However, we are deeply disappointed with the outcome. Nothing is more important to us than the safety of our products and the health of the consumers who use them.”
He further added, “We would like to reaffirm that we have been manufacturing Johnson’s Baby Powder at the Mulund plant for more than four decades with a strong record of safety, quality and regulatory compliance, and that product safety was not compromised at any point.”
He further added, “We would like to reaffirm that we have been manufacturing Johnson’s Baby Powder at the Mulund plant for more than four decades with a strong record of safety, quality and regulatory compliance, and that product safety was not compromised at any point.”
What all consumers should learn from this is that blindly following a brand is not wise. The contents of the products should be carefully checked by them to prevent themselves from such things.
Monday, February 25, 2013
FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer
FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer
Roche announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Roche to receive FDA approval for people with advanced cancers within the past two years.
An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease.
"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, M.D., Roche's Chief Medical Officer and Head, Global Product Development. "We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future."
Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Roche ADC approved by the FDA. Roche has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer.
Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA), for Kadcyla for the treatment of people with HER2-positive mBC. This application is currently under review by the EMA.
About Kadcyla
Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer.
Like Herceptin, Kadcyla binds to HER2-positive cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once Kadcyla is taken up by those cells, it is designed to destroy them by releasing the DM1 inside the cells.
Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
About breast cancer
Breast cancer is the most common cancer among women worldwide.2 Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually.In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as "HER2 positivity" and affects approximately 15-20 percent of women with breast cancer HER2-positive cancer is a particularly aggressive form of breast cancer.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.2 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
Friday, February 22, 2013
Abbott to collaborate with Janssen and Pharmacyclics
Abbott to collaborate with Janssen and Pharmacyclics
Under the agreement, Abbott will develop a FISH-based test to identify high-risk CLL patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib, an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK). Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma. Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options. Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need.
"Like Abbott's other collaborations in the area of companion diagnostics, our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person," said John Coulter, vice president, Molecular Diagnostics, Abbott. "Cancer is a complex disease where, historically, therapies have demonstrated only a 25 percent efficacy rate. Companion diagnostic tests can help improve these outcomes by selecting patients that are more likely to respond to specific therapies, reducing time to the most effective treatment and increasing the number of positive outcomes."
In 2011, Abbott received U.S. Food and Drug Administration clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes, including TP53 (tumor protein p53 gene, located on chromosome 17p) within the del17p region, and is used as an aid for determining prognosis for patients with CLL. Abbott's Vysis CLL FISH Probe Kit will be used for investigational use only to determine genetic marker status as part of the co-development efforts between Janssen, Pharmacyclics and Abbott.
About FISH
FISH (fluorescence in-situ hybridization) technology has a variety of uses. It can identify whether too many, or too few, copies of a particular gene are present in the body's cells or whether certain genes have rearrangements that play an active role in disease progression. Since the technology works especially well for identifying genetic markers in solid tumors, cancer diagnostics are one of the fastest growing applications.
About Abbott Molecular
Abbott Molecular is a leader in molecular diagnostics - the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential to aid with early detection or diagnosis, can influence the selection of appropriate therapies, and may assist with monitoring of disease progression.
About Abbott
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000.
Saturday, February 16, 2013
Thursday, February 14, 2013
5 Lessons from Coca Cola’s New Content Marketing Strategy
5 Lessons from Coca Cola’s New Content Marketing Strategy
Coca Cola has been part of popular culture for over 100 years and has been called a “Vision Brand“.
Its marketing and communication is purposeful and connects with its audience in a way that makes it stand out from its competitors.
Its mission is not about selling products but to create significant positive change in the world that makes the world a better place.
Coca Cola’s mission statement
- To refresh the world
- To inspire moments of optimism and happiness
- To create value and make a difference
Recently they have realised that their marketing strategy that has worked well for them for decades needed to evolve and as such they are moving from “Creative Excellence” to “Content Excellence”
Creative excellence has always been at the heart of Coca Cola’s advertising and they have decided that content is now the key to marketing in the 21st century on a social web.
Content for Coca Cola is is now the “Matter” and “Substance” of “Brand Engagement”
So what can we learn from Coca Cola’s new marketing strategy?
Lesson 1: Create Liquid Content
The purpose of content excellence is to create “Ideas” so contagious that they cannot be controlled this is what is called “liquid content”.
On a social web people can easily share ideas, videos and photos on social networks such Facebook.
So create content that begs to be shared whether that be an image, a video or an article.
Lesson 2: Ensure your Content is Linked
The next part of the equation is to ensure that these ideas create content that is innately relevant to
- The business objectives of your company
- The brand
- Your customer interests
This is “Linked” content…. Content that is relevant and connected to the companies goals and brand.
Ensure that the content communicates your message that is congruent with your mission and values.
Lesson 3: Create Conversations
Coca Cola has realised that the consumer creates more stories and ideas than they do so the goal is provoke conversations and then “Act” and “React” to those conversations 365 days of the year.
The new “Distribution Technologies” of Twitter, YouTube and Facebook provide greater connectivity and consumer empowerment than ever before.
Don’t just publish but interact with your audience and tribe.
Lesson 4. Move onto Dynamic Story Telling
On traditional media in the past, story telling was static and a one way street. Television and newspapers shouted at you with no means of interaction.
Coca Cola has come the realisation that to grow their business on the social web they need to move on from “One Way Story Telling” to “Dynamic Story Telling”
This means you need to allow the story to evolve as you interact and converse with your customers. You need to converse with your customers in many media formats and social networks.
Storytelling has moved on from static and synchronous to multifaceted, engaged and spreadable.
Lesson 5: Be Brave and Creative with Your Content Creation
Part of the new Coca Cola content strategy is applying a 70/20/10 Investment principle to creating “Liquid content“.
- 70% of your content should be low risk. It pays the rent and is your bread and butter marketing (should be easy to do and only consumes 50% of your time)
- 20% of your content creation should innovate off what works.
- 10% of your content marketing is high risk ideas that will be tomorrows 70% or 20%…. be prepared to fail
This provides a blueprint regarding moving on from just developing white papers, to trying some content that is more visual, courageous and engaging in web world that has embraced multimedia and interactive content.
The 30 Second TV Ad is no Longer King
Coca Cola has come to the conclusion that the world has moved on from the 30 second TV ad. So has the the Old Spice brand and many other businesses who are embracing social media as part of their marketing strategy.
We need to move towards a genuine consumer collaboration model that builds buzz and adopts a more iterative approach to content creation.
Learning how to fuel the conversations, act and interact has never been more important.
Consumers ideas, creativity and conversations have been set free with the evolution of social networks, learning to leverage and wrangle those conversations to increase your brand visibility is now a vital part of your marketing.
Wednesday, February 13, 2013
Bristol-Myers Squibb enters a collaboration agreement with Reckitt Benckiser Group plc
Bristol-Myers
Squibb enters a collaboration agreement with Reckitt Benckiser Group plc
(13-02-2013)
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a
three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL)
for several of its over-the-counter medicines currently sold across Latin
America, primarily in Mexico and Brazil.
Under
the terms of the collaboration agreement, Reckitt Benckiser will pay
Bristol-Myers Squibb an upfront payment in the amount of $438 million for the
exclusive rights to sell, distribute and market the following medicines for a
three-year period: Picot, an antacid, Tempra, a pain reliever and fever
reducer, Micostatin, an antifungal, and Graneodin, a cough and cold medicine,
sold primarily in Mexico; and Dermodex, an anti-rash cream, Luftal, an anti-gas
medicine, and Naldecon, a cold and flu symptoms treatment, sold primarily in
Brazil.
"As
part of our BioPharma strategy, Bristol-Myers Squibb has worked to focus its
businesses around the world on innovative medicines in areas of high unmet
medical need," said Charles Bancroft, executive vice president,
Intercontinental Region and Japan, and chief financial officer. "This
agreement allows us to increase our focus on the launch and commercialization
of our innovative portfolio in these important markets in Latin America."
During
the collaboration term, Bristol-Myers Squibb will retain responsibility for
manufacturing all of the products covered by the collaboration (either by
itself or through third party manufacturers), and Reckitt Benckiser will
purchase products from Bristol-Myers Squibb and pay royalties on product sales
during the term of the collaboration.
Reckitt
Benckiser will also pay to Bristol-Myers Squibb an option fee in the amount of
$44 million for the right to purchase these products outright at the end of the
three-year term, acquiring the sales, marketing, and distribution rights, along
with assets related to the products, including the trademarks, remaining
inventories, and certain other assets. Subject to certain rights it has to
extend the term of the supply agreement with Bristol-Myers Squibb, Reckitt
Benckiser would then assume all responsibility for the products. The purchase
price will be based on average net sales during the two year period preceding
the closing of the sale. No manufacturing facilities will be transferred from
Bristol-Myers Squibb to Reckitt Benckiser Group plc as part of this
transaction.
The
transaction is subject to the satisfaction or waiver of customary closing
conditions, including competition law authorizations in Brazil and Mexico.
Jefferies
Group, Inc. acted as exclusive financial advisor to Bristol-Myers Squibb, and
Kirkland & Ellis LLP acted as its legal adviser.
Bristol-Myers
Squibb enters a collaboration agreement with Reckitt Benckiser Group plc
(13-02-2013)
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a
three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL)
for several of its over-the-counter medicines currently sold across Latin
America, primarily in Mexico and Brazil.
Under
the terms of the collaboration agreement, Reckitt Benckiser will pay
Bristol-Myers Squibb an upfront payment in the amount of $438 million for the
exclusive rights to sell, distribute and market the following medicines for a
three-year period: Picot, an antacid, Tempra, a pain reliever and fever
reducer, Micostatin, an antifungal, and Graneodin, a cough and cold medicine,
sold primarily in Mexico; and Dermodex, an anti-rash cream, Luftal, an anti-gas
medicine, and Naldecon, a cold and flu symptoms treatment, sold primarily in
Brazil.
"As
part of our BioPharma strategy, Bristol-Myers Squibb has worked to focus its
businesses around the world on innovative medicines in areas of high unmet
medical need," said Charles Bancroft, executive vice president,
Intercontinental Region and Japan, and chief financial officer. "This
agreement allows us to increase our focus on the launch and commercialization
of our innovative portfolio in these important markets in Latin America."
During
the collaboration term, Bristol-Myers Squibb will retain responsibility for
manufacturing all of the products covered by the collaboration (either by
itself or through third party manufacturers), and Reckitt Benckiser will
purchase products from Bristol-Myers Squibb and pay royalties on product sales
during the term of the collaboration.
Reckitt
Benckiser will also pay to Bristol-Myers Squibb an option fee in the amount of
$44 million for the right to purchase these products outright at the end of the
three-year term, acquiring the sales, marketing, and distribution rights, along
with assets related to the products, including the trademarks, remaining
inventories, and certain other assets. Subject to certain rights it has to
extend the term of the supply agreement with Bristol-Myers Squibb, Reckitt
Benckiser would then assume all responsibility for the products. The purchase
price will be based on average net sales during the two year period preceding
the closing of the sale. No manufacturing facilities will be transferred from
Bristol-Myers Squibb to Reckitt Benckiser Group plc as part of this
transaction.
The
transaction is subject to the satisfaction or waiver of customary closing
conditions, including competition law authorizations in Brazil and Mexico.
Jefferies
Group, Inc. acted as exclusive financial advisor to Bristol-Myers Squibb, and
Kirkland & Ellis LLP acted as its legal adviser.
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL) for several of its over-the-counter medicines currently sold across Latin America, primarily in Mexico and Brazil.
Tuesday, February 12, 2013
All Products of Pfizer(part-2)
All Products of Pfizer(part-2)
Brand Name
(oprelvekin)
(gabapentin)
(nicotine nasal spray)
(nicotine inhalation
system)
(nitroglycerin
tablets, USP)
(norgestrel and
ethinyl estradiol tablets)
(disopyramide
phosphate capsules)
(amlodipine besylate)
(estropipate tablets,
USP)
(ondansetron for
injection, USP)
(oxaliplatin injection,
USP)
(oxycodone HCl
tablets, immediate-release)
(injection)
(pamidronate disodium)
(paclitaxel injection)
(delayed-release
tablets)
(neomycin and
polymyxin B sulfates and hydrocortisone otic suspension, USP)
(penicillin G procaine
injectable suspension)
(penicillin G
potassium)
(echothiophate iodide
for ophthalmic solution)
(piperacillin sodium)
(conjugated estrogens)
(conjugated estrogens
plus medroxyprogesterone acetate tablets)
(conjugated
estrogens/medroxyprogesterone acetate tablets)
(dinoprostone cervical
gel)
(Pneumococcal
13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])
(desvenlafaxine)
extended-release tablets
(nifedipine)
(propranolol
hydrochloride extended-release capsules)
(dinoprostone vaginal
suppository)
(alprostadil
injection, USP)
(pantoprazole sodium)
(medroxyprogesterone
acetate tablets, USP)
(methylphenidate
hydrochloride)
(sirolimus)
(interferon beta-1a)
sc injection
(Antihemophilic Factor
[Recombinant])
(methylnaltrexone
bromide) subcutaneous injection
(eletriptan HBr)
(sildenafil) tablets
(10% arginine
hydrochloride injection, USP)
(for injection, USP)
(trimethoprim and
sulfamethoxazole)
(silver sulfadiazine)
(metaxalone)
(hydrocortisone sodium
succinate for injection, USP)
(methylprednisolone
sodium succinate for injection, USP)
(zaleplon)
(pegvisomant for
injection)
(tiotropium bromide
inhalation powder)
(sunitinib malate)
(nafarelin acetate
nasal solution)
(quinupristin /
dalfopristin for injection)
(methimazole tablets)
(100mg perles and
200mg capsules benzonatate, USP)
(chlorthalidone
tablets)
(thrombin / gelatin
foam hemostat)
(thrombin, topical,
bovine origin)
(3x3 hemostatic pad)
(trimethobenzamide
hydrochloride)
(dofetilide)
(nedocromil sodium
inhalation aerosol)
(etoposide injection,
USP)
(topotecan
hydrochloride for injection, USP)
(temsirolimus)
injection
(fesoterodine fumarate
extended release tablets)
(ethionamide tablets)
(triptorelin pamoate
for injectable suspension)
(spectinomycin for
injectable suspension, USP)
(hydrocodone
bitartrate and homatropine methylbromide)
(tigecycline)
(ampicillin
sodium/sulbactam sodium)
(sterile vancomycin
hydrochloride)
(vecuronium bromide
for injection)
(extended-release
capsules)
(voriconazole)
(sildenafil citrate)
tablets
(doxycycline calcium,
doxycycline hyclate, doxycycline monohydrate)
(vinorelbine
injection)
(nelfinavir mesylate)
(trifluridine
ophthalmic solution)
(hydroxyzine pamoate)
(latanoprost
ophthalmic solution)
(crizotinib)
(tofacitnib)
(alprazolam tablets)
(antihemophilic factor
(recombinant), plasma/albumin-free)
(capsules)
(ethosuximide
capsules, USP and ethosuximide)
(dexrazoxane for
injection)
(azithromycin)
(azithromycin extended
release) for oral suspension
(sertraline HCI)
(piperacillin and
tazobactam for injection)
(linezolid)
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