Dr. Kuldeepak Sharma PhD

GLG News by Dr. Kuldeepak Sharma PhD, President/Pharmaceutical Consultant

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Good and Bad From Astellas Joint Venture With Maxygen

July 5, 2009

Analysis of:Astellas Announces Joint Venture with Maxygen to Develop Protein Pharmaceuticals | www.pipelinereview.com

I read this news with great interest. This joint venture called (MPC) will advance Maxy 4 development program for rheumatoid arthritis and transplant rejection. Maxygen & Astellas  are committing $ 10 million each for this joint venture. Since I have worked with Astellas (Yamanouchi) and based on my experience, I think this joint venture (JV) is good for shareholders of Maxygen and Astellas but bad for Maxygen employees. I think Maxygen will shift programs and assets to other companies and it's R&D operations and personnel will go to this new JV with Astellas. This will leads to layoff form financial, administrative, corporate and support departments. This press release did not said when and how many pink slips will be handed out. .I think This strategy is already working based on Maxygen stock closed on July 1 at $7.17 up $0.45 (6.7%).  

Efalizumab Withdrawn Due to Serious Side Effect

April 16, 2009

Analysis of:Efalizumab withdrawn from US Market | www.medscape.com

I read with great interest that Genentech, the maker of Raptiva (Efalizumab) to treat psoriasis, has begun a voluntary, phased withdrawal of the drug from the U.S. market. The drug is not being withdrawn immediately to give physicians and patients taking Raptiva time to safely and appropriately discontinue treatment. Because it's possible that abruptly discontinuing Raptiva may cause a severe flare of psoriasis, As a pharmaceutical consultant and pharmacist, I think phase withdrawal is a good approach. Overall I do not think this withdrawal will have long term impact on other biologic products in US and world.Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.

Various Generic Topiramate Tablets Approved by FDA

March 31, 2009

Analysis of:Ranbaxy, Aurobindo get US FDA nod for epilepsy drug | economictimes.indiatimes.com

As a Pharmaceutical consultant and pharmacist I read this article with great interest since prices Topiramate will further reduced due to additional generic company. Topamax® is very useful drug for the treatment of adult and pediatric Epilepsy. On September 2006, Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets, 25mg, 100mg and 200mg On March 28, 2009, Various companies (Teva, Sun, Ranbaxy) will market its version of the Topiramate tablets, the medicine in Topamax, in dosages of 25, 50, 100, and 200 mg. Annual sales of Topamax(R) were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.

No Bidding War For CV Therapeutics From Astellas

March 17, 2009

Analysis of:Astellas to Terminate Offer for CV Therapeutics | www.pipelinereview.com

I read this news with great interest since I have worked with Astellas (Yamanouchi). Based on my experience with Astellas I am not surprise that Astellas did not increase prices (although Astellas had so much to gain from a merger with CV) due the these reasons: * Astellas (as a Japanese company) is a disciplined acquirer * $20 per share offer from Gilead, which values the company at around $1.4 billion is too expensive for Astellas * Astellas now needs to look elsewhere in order to find a company or products * Astellas will follow other Japanese drug companies like Takeda and Eisai

Multivitamin Supplements can not prevent Cancer or Heart Disease.

March 12, 2009

Analysis of:Multivitamins: Fact or Fiction | www.usatoday.com

As a pharmaceutical consultant, I read this article with great interest. Overall this article support my thinking that multivitamin supplements can not prevent Cancer or Heart Disease due to these reasons: Our Daily requirements of Multivitamins supplements are very low and food is the best source of vitamins and minerals is from our body Multivitamins should be used as part of an overall healthy lifestyle Despite many health warnings, the quest for the right multivitamin still uncontrollable.

Indian pharmaceutical Companies Are Attractive For Multinational Companies

February 24, 2009

Analysis of:Pharma cos on lookout for Indian drug firms | economictimes.indiatimes.com

As a pharmaceutical consultant, working with various clients in India and here, I think Indian pharmaceutical companies are attractive for acquisitions by Multinational Companies due to these reasons: * Their relatively low valuation compared to firms elsewhere * India's massive internal market * Multinational Companies has few patented drugs in the market and       generic market is growing in USA.

How Should NIH Spend $10B ?

February 12, 2009

Analysis of:Senate Passes Recovery Bill with $10B for NIH | www.genomeweb.com

I read this news with great interest. I think NIH should spend this money in these direction:   Take the opportunity to revamp the system including labs, buildings, equipments and researchers. I think either altering or completely retooling the peer review process to allow for a greater dispersal of NIH funds among American scientists. We might want to update our aging and decaying instruments, so save a little money for that and improve our lab productivity and will attract more researchers

Great News For NIH

February 5, 2009

Analysis of:Economic Recovery Act Now Holds $10B for NIH | www.genomeweb.com

I read this article with great interest and hope that this additional funding will be god send for NIH specifically  in the area of biomedical research Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill. I think that the US still has the best opportunities for scientists, Providing money will certainly provide the stimulus!

Lower safer dose of Soma approved by FDA

September 24, 2007

Analysis of:FDA approves SOMA 250 mg | www.pipelinereview.com

As a pharmaceutical consultant working in pain management area, I think lower dose will offer similar efficacy as Soma 350 mg but with a more favorable tolerability profile. Last week, Last week, The Food and Drug Administration (FDA) have approved 250 mg (lower dose) of Soma (carisoprodol) for treatment of painful musculoskeletal conditions such as backache. As a pharmaceutical consultant working in pain management area, I think lower dose will offer similar efficacy as Soma 350 mg but with a more favorable tolerability profile. FDA approved lower dose based on two randomized, double-blind, placebo-controlled, multi-site parallel group studies which have been ongoing for several years and included more than 1,300 patients. I think Soma is a well-established brand and generates around 10 million prescriptions per year. Soma 250mg is granted a minimum 3 year exclusivity period in the US.

Good News: First Generic Versions of Coreg is Approved

September 10, 2007

Analysis of:Ranbaxy Gains Approval To Manufacture And Market Carvedilol Tablets In The U.S. Market | www.medicalnewstoday.com

 Food and Drug Administration (FDA) has approved the first generic versions of Coreg (carvedilol).  It is good news for patients. Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack. Generic Coreg contains same active ingredients (Carvedilol) as brand-name drugs and work the same way.  Carvedilol tablets in four strengths (3.125 milligrams, 6.25 mg, 12.5 mg and 25 mg) are manufactured by about 15 generic drug companies. All 15 pharmaceutical companies got approval on September 5, 2007. The labeling of the generic products may differ from that of Coreg because parts of the Coreg labeling are protected by patents and/or exclusivity. Total annual market sales for Carvedilol Tablets were $1.6 billion . Overall I think it is a cost effective and safe alternative to expensive brand name drug product for patients.

Sharpe Rise of Opioid Drugs Abuse in United State

August 30, 2007

Analysis of:Painkiller Widely Abused in South | www.washingtonpost.com

This article is sad but consistent with overall increase use / abuse of opioids pain killers such as morphine, oxycodone, and hydrocodone. As a pharmacist & pharmaceutical consultant I think these are main reasons for alarming increase of opioids drugs use in America: The population is getting older. As age increases, so does the need for pain medications such as opiodsPharmaceutical companies have embarked on unprecedented marketing campaigns.A major change in pain management philosophy is now in its third decade. this leads to liberal use of opiodsMore people are abusing prescription painkillers because the medications are more available.I think that it is impossible to reliably measure painkiller abuse. Therefore we have to educate patients, physicians, medical community about the opiods us and abuse potential. We must help drug abuser such as Steve Dotson with medical treatment and other supports. Also we should improve DEA enforcement of law related opiods.

Major Step for Personalized Medicine: Warfarin Sensitivity DNA Test Required By FDA

August 20, 2007

Analysis of:PERSONAL DOSE | online.wsj.com

The FDA has announced changes in the Warfarin label, recommending that a lower initial Warfarin dose should be considered for patients with certain genetic variations. Warfarin (Coumadin) is a commonly prescribed blood thinner with an exceptionally narrow safe-dosage range that varies dramatically from patient to patient. I think this label modification is one step closer to personalized medicine. Based on modern science and pharmacogenomics (the science that predicts a response to drugs based upon a person's genetic makeup) we can give the right drug in the right dose for the right patient. Overall as a pharmacist & pharmaceutical consultant I think, this labeling change highlights the opportunity to use genetic tests to improve initial estimate of a reasonable Warfarin dose for individual patients.

Johnson & Johnson follows industry's job-slashing trend

August 9, 2007

Analysis of:Johnson & Johnson Plans to Improve Overall Cost Structure, While Continuing to Invest in Opportunities for Sustained Profitable Growth | www.pipelinereview.com

Recently Johnson & Johnson announced the cutbacks to improve overall cost structure. Being a Pharmaceutical consultant, I follows industry trend. I think J&J is following the trend since Pfizer, AstraZeneca and Bristol-Meyers Squibb also announced that they would be trimming back staff this year. I think most cost saving will come from pharmaceutical division, HR, IT, and finance. Also I think they should better integrate its Cordis subsidiary. Overall I think J&J is being proactive for the future and adjusting to current drug development issues. I hope these actions will enable J&J to continue investing for future growth and profitability.

Novel Oral Tablet Option For the treatment of Bone Diseases

August 7, 2007

Analysis of:Genta and Emisphere Technologies File IND with FDA for Oral Drug to Treat Bone Disease | www.pipelinereview.com

As a pharmaceutical consultant, I think this IND will be novel groundbreaking treatment option for the treatment of bone diseases because it is one of first oral tablet formulation that enables oral absorption of gallium nitrate injection for treatment of cancer-related hypocalcaemia. Also this is unique collaboration of two different type drug discovery (Genta) & drug delivery companies (Emisphere). Both companies are similar size and active partner for this product. Phase 1 clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects. I am hopeful that this oral tablet will be safe and effective since the active ingredient in G4544 has already demonstrated proof-of-concept activity in patients with multiple indications, including non-Hodgkin’s lymphoma, bone metastases, Paget’s disease, and osteoporosis.

New Oral Opioid Treatment for Chronic Pain

June 17, 2007

Analysis of:Penwest Begins Dosing Phase IIa Clinical Study of Nalbuphine ER | www.pipelinereview.com

Recently, Penwest Pharmaceuticals initiated Phase IIa study for oral Nalbuphine. Based on my extensive clinical experience in pain management, I think Oral Nalbuphine ER will be great addition oral treatment option for chronic pain patients. Currently this Nalbuphine is available in injection form and not suitable for chronic pain. Control release oral dosage form of this drug should be effective for chronic pain. Nalbuphine ER will be twice daily tablet, better option for chronic pain patent. This product will also improve compliance due to better deliver and pain management. Penwest Pharmaceutical is developing this product based on TIMERX technology. Penwest used same technology for Opana(R) ER (oxymorphone hydrochloride extended-release tablets). Overall based on Phase I study and Phase IIa study on Nalbuphine ER, I am very optimistic about this product. Please feel free to contact for additional information.

Novel treatment for “breakthrough” cancer pain

May 10, 2007

Analysis of:BDSI Announces Positive Phase III Clinical Trial Results for BEMA(TM) Fentanyl | www.pipelinereview.com

I think BEMA Fentanyl product will be very useful and novel method of delivering Fentanyl for the treatment of "breakthrough" cancer pain.

This clinical trial showed that the BEMA Fentanyl dosage form was convenient and comfortable to use for all patients and has dose linearity relationship with plasma level in patents.


Overall, based on my extensive experience with Fentanyl and related drugs, I think BEMA(TM) Fentanyl will play an important role in the future treatment of breakthrough cancer pain assuming FDA will approve this product

Aventis: One More Treatment Option for Neovasculer

June 22, 2006

Analysis of:Pinnacle Covers Avastin with Restrictions | www.aao.org

The advanced or “wet” form of age-related macular degeneration is characterized by the growth of abnormal blood vessels.

AVASTIN (bevacizumab) is being explored as a therapy for wet AMD. Early study results of Avastin, which is injected directly in the eye, have been encouraging.

Recently (May 10,2006), Pinnacle Medicare Services announced that it will cover bevacizumab (brand name Avastin) for the treatment of neovasculer (wet) age-related macular degeneration with restrictions. I think this treatment will be safe & cost effective for patents.

New and Better Treatment for Mucositis

June 20, 2006

Analysis of:Saforis NDA Accepted by U.S. FDA for Priority Review; PDUFA Date of October 12, 2006 Established | pharmalive.com

Oral mucositis, also called stomatitis, is a common, debilitating complication of cancer chemotherapy and radiotherapy, occurring in about 40% of patients.
Many different treatments are used to prevent or treat mucositis with limited success.

Saforis (glutamine in Powder for Oral Suspension) for the prevention and treatment of oral mucositis that occurs as a result of mucotoxic cancer therapy.

Saforis has successfully completed phase 3 clinical trial in patients with breast cancer who were receiving anthracycline-based chemotherapy regimens.

I think this drug will be valuable addition in the treatment of oral mucositis assuming competitive pricing. Also I strongly believed that cost of this drug will be reimbursed because it is novel cost effective treatment for Oral mucositis

New and Better Treatment for Migraines

June 16, 2006

Analysis of:Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraines | pharmalive.com

Trexima is a novel & better combination therapy consisting of sumatriptan and naproxen sodium in a single tablet for the treatment of acute migraine.

Trexima contains sumatriptan 85 mg, as the succinate salt, formulated with RT Technology(TM) and naproxen sodium 500 mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

Current Treatment for Migraine Treatment, advantages and disadvantages of Trexima and this drug place in with existing therapies is discussed in my commentary.

primary study used to defend Ketek's safety is wrought with fraud, error, and other inconsistencies

June 16, 2006

Analysis of:Sanofi Suspends Ketek Clinical Trial Enrollment | www.medscape.com

Wall Street Journal published a report raising serious safety concerns over Sanofi-Aventis' antibiotic Ketek. The report also indicates that the primary study used to defend Ketek's safety is wrought with fraud, error, and other inconsistencies.

Reports of Ketek and liver failure have begun to surface recently. The FDA has received at least 10 reports of serious liver failure in patients taking Ketek. According to the agency, this is just a preliminary estimate.

It is no longer clear to many that Ketek is safe and effective.

 

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