Pharmablog

UM researchers receive $23.4 million to research AIDS vaccine

2011-05-06T16:41:00.000-05:00

Scientists at the University of Maryland School of Medicine will be able to move forward nearly decades-long work on a promising HIV/AIDS vaccine after receiving their biggest research gift ever — $23.4 million from a consortium led by The Bill & Melinda Gates Foundation. The money was awarded to the university's Institute of Human Virology, headed by Dr. Robert Gallo, who helped discover the

Top 10 Pharma CEO salaries of 2010

2011-05-06T10:03:00.000-05:00

Despite a year fraught with manufacturing issues and drug recalls, Johnson & Johnson CEO Bill Weldon takes the top spot, with $28.7 million in 2010 pay. And Novartis' Daniel Vasella grabs the number two spot thanks to a lucrative golden handshake. Next year we'll have to say goodbye to a few familiar faces that are making their final appearance on this list. Pfizer's Jeff Kindler won't be

The Private Market for Tuberculosis Drugs

2011-05-06T00:06:00.000-05:00

Tuberculosis (TB) is widely considered a public health concern and its treatment a public sector responsibility. But according to a study published today in the journal PLoS ONE, the private sector for TB treatment is ignored at our peril. Across 10 high-burden countries, there is as much TB drug volume in the private sector as in the public sector—and at least a third of all private sector

SAS and Pharmaceutical Industry Focus on Optimizing Clinical Research

2011-05-05T12:19:00.000-05:00

Industry leaders at SAS Health Care & Life Sciences Executive Conference to discuss clinical trial design CARY, N.C.--(BUSINESS WIRE)--May 5, 2011 - Drug developers are challenged as never before to deliver innovative medicines through a business model that boosts the bottom line. Optimizing clinical trial design and portfolio management is paramount for managing outcomes and costs, and for

Top 200 Drugs for 2008 by Sales

2009-09-14T13:51:00.001-05:00

Rank Drug Total Retail Dollars ($000) % change from 2007 1 Lipitor 5,880,128 -4.6% 2 Nexium 4,794,450 10.1% 3 Plavix 3,796,221 23.1%

FDA Staff Asks President to Straighten Up Agency

2009-04-14T03:09:00.001-05:00

The clearance or approval of medical devices that was not made in accordance with federal laws, rules and regulations needs to be revisited, according to a recent letter sent to President Barack Obama by disgruntled FDA employees. This is the second letter FDA employees have written to the president. “The culture of wrongdoing and cover-up is nothing new, but is part of a longstanding pattern of

Update on Ipsen's botulinum toxin type A Product Regulatory Review Status in the US

2009-04-14T03:06:00.001-05:00

Ipsen (Paris:IPN) and its partner Medicis (NYSE: MRX) announced today that the companies are in active labeling and Risk Evaluation and Mitigation Strategy ("REMS") discussions with the U.S. Food and Drug Administration (“FDA”) related to the Biologics License Application (“BLA”) for Ipsen’s botulinum toxin type A product in both therapeutic and aesthetic

Pharmacyclics Initiates Phase 1 Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-cell Non-Hodgkin's Lymphoma

2009-04-14T03:02:00.001-05:00

SUNNYVALE, Calif., April 13 -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has begun treating patients in a Phase 1 dose-escalation study to evaluate the safety and tolerability of PCI-32765, an orally available, selective inhibitor of Bruton's tyrosine kinase, or Btk, as a potential treatment for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). This

Therapeutic effect of imatinib improved with addition of chloroquine

2009-04-14T02:58:00.002-05:00

(PHILADELPHIA) The therapeutic effects of the blockbuster leukemia drug imatinib may be enhanced when given along with a drug that inhibits a cell process called autophagy, researchers from the Kimmel Cancer Center at Jefferson reported in the Journal of Clinical Investigation. The cell-death effect of imatinib (Gleevec) was potentiated when chloroquine, an autophagy inhibitor, was given with

Enhancing the effects of the drug used to treat chronic myeloid leukemia

2009-04-14T02:58:00.001-05:00

Individuals with chronic myeloid leukemia (CML) are first treated with a drug known as imatinib mesylate. Although very effective, as the disease progresses it often becomes resistant to the drug. However, a team of researchers, at the University of Leicester, United Kingdom, and Thomas Jefferson University, Philadelphia, has identified a class of drugs that might enhance the therapeutic effects

Medtronic Completes Acquisition of CoreValve Inc

2009-04-13T12:36:00.001-05:00

In a move to further expand a comprehensive cardiovascular portfolio, Medtronic, Inc. announced the completion of its acquisition of CoreValve Inc. CoreValve develops percutaneous, catheter-based transfemoral aortic valve replacement products. Medtronic also recently acquired Ventor Technologies, Ltd., a developer of percutaneous, catheter-based transapical aortic valve replacement products. “

Epilepsy Pipeline Conference 2009 to Showcase Cutting-Edge Therapies in Development and Advances in the Treatment of Epilepsy

2009-04-13T12:34:00.000-05:00

MIDDLEBURG, Va.--(BUSINESS WIRE)--The Epilepsy Therapy Project today announced that more than 25 emerging companies as well as leading biotechnology and pharmaceutical investors and industry executives will gather to focus on preclinical and clinical development strategies and opportunities at the Epilepsy Pipeline Conference 2009. The one-day Epilepsy Pipeline

Will Emerging Agents Disrupt the Psoriatic Arthritis Market?

2009-04-13T12:33:00.002-05:00

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/e51325/will_emerging_agen) has announced the addition of Decision Resources, Inc.'s new report "Will Emerging Agents Disrupt the Psoriatic Arthritis Market?" to their offering. Surveyed rheumatologists are open to prescribing emerging agents for psoriatic

Major Pharmaceutical Company to Utilize Vemics iMedicor Medical Communications Portal

2009-04-13T12:33:00.001-05:00

NANUET, N.Y.--(BUSINESS WIRE)--Vemics, Inc. (OTCBB: VMCI) today announced that its iMedicor HIPAA compliant medical communications portal will be utilized by a major pharmaceutical company in a specialized marketing program to commence June 1. This company, which is traded on the New York Stock Exchange, will use iMedicor to distribute customized

For cancer cells, genetics alone is poor indicator for drug response

2009-04-13T04:38:00.000-05:00

BOSTON, Mass. (April 12, 2009) — In certain respects, cells are less like machines and more like people. True, they have lots of components, but they also have lots of personality. For example, when specific groups of people are studied in aggregate (conservatives, liberals, atheists, evangelicals), they appear to be fairly uniform and predictable. But when looked at one person at a time,

Pfizer To Make A Tender Offer To Increase Stake In Pfizer Limited

2009-04-13T04:29:00.000-05:00

MUMBAI, India - Pfizer Investments Netherlands B.V., an indirect wholly-owned subsidiary of Pfizer Inc, announced today that it will make a tender offer to acquire a 33.77% stake in Pfizer Limited from public shareholders at a price of Rs. 675.00 per share.Successful completion of this offer, assuming full acceptance, would raise the indirect stake of Pfizer Inc in Pfizer Limited to 75% from the

FDA approves Novartis' malaria drug Coartem

2009-04-11T06:50:00.000-05:00

Novartis’ malaria drug Coartem, which is already available in over 80 countries, has been given the thumbs-up by regulators in the USA.The US Food and Drug Administration has approved Coartem (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilogrammes due to plasmodium falciparum, the most dangerous form of

Sanofi to buy Brazil’s Medley for 500 million euros

2009-04-11T06:47:00.000-05:00

Sanofi-Aventis has announced its second acquisition in a week and is to buy Brazilian drugmaker Medley.The French firm is going to pay 1.5 billion reals (around 500 million euros) for Medley, which is Brazil’s third-largest pharmaceutical company and number one generics group, with annual sales of about 153 million euros, The deal will be completed during the second quarter.Family-owned Sao

the leading pharmaceutical companies in the Philippines

2009-04-11T06:03:00.001-05:00

Number one pharma company is Unilab followed by GSK, Pfizer,AstraZeneca, Sanofi-Aventiz,Novartis,Roche,Boehringer Ingelheim, MSD and BMS . This is from IMS 1st Quarter Report.

How to get started in the pharmaceutical sales industry

2009-04-11T06:01:00.000-05:00

generally the sales person is a liaison. It is best if you have the technical background (Chemistry, Pharmacy, maybe pre-med) so you can understand and discuss the chemistry and bio-chemistry of the drugs with physicians & other purchasers who might be technical minded. You then need liberal arts skills so that you can effectively communicate that technical information to non-technical people who

Amgen Cuts 100 Jobs at Washington Manufacturing Plant

2009-04-10T20:41:00.001-05:00

SEATTLE --An Amgen Inc. spokeswoman confirms that the drugmaker is cutting 100 jobs at its clinical drug manufacturing site in the Seattle suburb of Bothell, Wash. Carol Pawlak says the cutbacks are not part of any larger companywide reductions. The biotechnology company has 17,000 employees worldwide. Pawlak said Thursday the company is merging clinical drug trial work at its Bothell facility

Scar-Reducing Drug Shows Promise

2009-04-10T20:40:00.001-05:00

A drug designed to reduce scarring after surgery or injury has shown promising results in early human trials, UK researchers say.

Study links the Pill to increased lupus risk

2009-04-10T20:37:00.001-05:00

It found women taking birth control pills, especially those who have just started taking them, may be 2 1/2 times more likely to contract the autoimmune disease. The link between the two has been debated for some time. This new study in Arthritis Care and Research adds weight to earlier studies that have shown a connection. Researchers speculate that estrogen from oral contraceptives could be

Pharmaceuticals Provide a Takeover Tonic

2009-04-10T20:33:00.000-05:00

Merger and acquisition activity has slowed dramatically as the global financial crisis restricts the ability of companies to put together debt-financed deals.FT.com

FDA Rebuffs Teva’s Citizen Petition on Generic Copaxone Filings

2009-04-10T20:32:00.000-05:00

The FDA has declined to review a citizen petition submitted by Teva Neurosciences asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment until certain conditions are met. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. In addition, the FDA didn’t

Supreme Court Asked to Review Prescriber Data Case

2009-04-10T20:31:00.002-05:00

IMS Health and SDI Health have asked the U.S. Supreme Court to review lower court decisions on whether states may prohibit data mining — the collection and publication of prescribing trends, which drugmakers use to identify physicians who treat particular conditions for marketing purposes. Many doctors object to the tracking of their history of dispensing prescriptions. Drug companies use that

FDA Reverses Course, Drugmakers Allowed to Make Morphine Solution

2009-04-10T20:31:00.001-05:00

Patient and hospice groups’ concerns have prompted the FDA to reverse its decision that manufacturers of morphine sulfate 20-mg/mL oral solution must stop producing the pain drug. The FDA sent nine warning letters telling companies to halt production of unapproved versions of morphine, hydromorphone and oxycodone products. The FDA is now amending those letters to allow companies to make the 20-

Medtronic Wraps Up Buy of CoreValve

2009-04-10T20:25:00.000-05:00

US medical device company Medtronic said it has closed the acquisition of local company CoreValve, which develops products that provide an alternative to heart valve replacement surgery.

Panel Rejects Stryker OP-1 Bone Putty for PMA Approval

2009-04-10T20:18:00.004-05:00

An FDA advisory committee voted 6–1 last week against recommending premarket approval (PMA) of Stryker Biotech’s OP-1 putty for use in an expanded patient population. The Orthopedic and Rehabilitation Devices Advisory Committee cited lingering concerns of whether the device promoted bone growth and pointed to safety issues regarding immunogenicity and maternal and fetal antibody transfer.

Minimally Invasive Technologies Expected to Be Boom Market

2009-04-10T20:17:00.001-05:00

With the market for minimally invasive devices expected to boom over the next several years, industry is pushing government regulators to study the technology, and analysts recommend that devicemakers develop products for this market. “Over the next decade, it’s expected that all surgeries will be minimally invasive,” Lazard Capital Markets analyst Sean Lavin said. “Virtually all device companies

Crofelemer, First-in-Class Anti-Diarrheal Agent, Positive Clinical Results to be Discussed at 13th Annual US-Japan CMSP in Kolkata, India

2009-04-10T20:15:00.000-05:00

OUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc., (“Napo”) announces that oral presentations regarding the safety, efficacy and mechanism of action of crofelemer in clinical trials in severe acute dehydrating watery diarrhea and cholera, as well as the preclinical results for other small molecule cystic fibrosis transmembrane conductance

J&J Cutting About 900 Jobs From Pharma Unit

2009-04-10T12:30:00.000-05:00

NEW YORK-Diversified health care products company Johnson & Johnson said Thursday it will cut about 900 jobs, mainly from its Ortho-McNeil-Janssen Pharmaceuticals unit. The cuts include a mix of attrition and hiring freezes. They are part of the company's strategy to trim its U.S. sales force and refocus its approach in the market,

Pfizer's Oncology Business Unit Appoints Vice President of Medical Affairs

2009-04-10T11:18:00.000-05:00

EW YORK--(BUSINESS WIRE)--Apr 10, 2009 - <A HREF="http://ad.doubleclick.net/jump/PharmaLive/main;sz=300x250;abr=!ie4;abr=!ie5;ord=1239380321408?"> <IMG SRC="http://ad.doubleclick.net/ad/PharmaLive/main;sz=300x250;abr=!ie4;abr=!ie5;ord=1239380321408?" width="300" height="250" border=0 ALT=""></A>

the Impact of the Withdrawal of Raptiva (efalizumab) on the Psoriasis Market

2009-04-10T10:29:00.000-05:00

EXTON, Pa., April 10 On April 8th, 2009, Genentech and Roche announced the voluntary withdrawal of Raptiva (efalizumab, marketed by Genentech/Roche and Xoma) from the US market. The withdrawal comes after recent post-marketing reports of PML associated with Raptiva treatment. BioTrends will field its fourth annual TreatmentTrends(TM): Psoriasis survey on April 13th with a special section

New drug shows promise in treating drug-resistant prostate cancer

2009-04-10T09:34:00.000-05:00

A new therapy for metastatic prostate cancer has shown considerable promise in early clinical trials involving patients whose disease has become resistant to current drugs. Chemists and biologists at UCLA and colleagues at several other institutions, including Memorial Sloan-Kettering Cancer Center, have created a new drug to treat a particularly lethal form of the disease, known as

'Unapproved' morphine to stay on market, FDA rules

2009-04-10T05:58:00.000-05:00

WASHINGTON (CNN) -- A form of liquid morphine used by terminally ill patients will remain on the market even though it is an "unapproved drug," according to a decision by the Food and Drug Administration.After talking with hospital and hospice organizations, which expressed concern that taking the product off the market would result in hardship for terminally ill patients and their caregivers,

Test quickly assesses whether Alzheimer's drugs are hitting their target

2009-04-10T03:41:00.001-05:00

A test developed by physician-scientists at Washington University School of Medicine in St. Louis may help assess more quickly the ability of Alzheimer's drugs to affect one of the possible underlying causes of Alzheimer's disease in humans, accelerating the development of new treatments. Scientists used the test to show that an Alzheimer's drug given to healthy volunteers reduced production of

FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications

2009-04-09T12:13:00.001-05:00

WILMINGTON, Del., April 08, 2009 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized

Merck & Co., Inc. and Cardiome Sign License Agreement for Vernakalant, an Investigational Drug for Treatment of Atrial Fibrillation

2009-04-09T08:15:00.001-05:00

WHITEHOUSE STATION, N.J. & VANCOUVER--(BUSINESS WIRE)--Apr 8, 2009 - Merck & Co., Inc. and Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation. The agreement provides Merck with exclusive global rights to the oral

Research could lead to new non-antibiotic drugs to counter hospital infections

2009-04-09T05:46:00.001-05:00

Lack of an adequate amount of the mineral phosphate can turn a common bacterium into a killer, according to research to be published in the April 14, 2009, issue of the Proceedings of the National Academies of Science. The findings could lead to new drugs that would disarm the increasingly antibiotic-resistant pathogen rather than attempting to kill it. Pseudomonas aeruginosa is one of the most

Drug shows activity in men with advanced prostate cancer

2009-04-09T05:44:00.002-05:00

A new multi-center study shows that an experimental drug lowers prostate specific antigen (PSA) levels – a marker for tumor growth – in men with advanced prostate cancer for whom traditional treatment options have failed. The study, led by researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), is published today in Science Express, the online version of the journal Science. Most men with

Stem cell therapy makes cloudy corneas clear, according to Pitt researchers

2009-04-09T05:44:00.001-05:00

PITTSBURGH, April 9 – Stem cells collected from human corneas restore transparency and don't trigger a rejection response when injected into eyes that are scarred and hazy, according to experiments conducted in mice by researchers at the University of Pittsburgh School of Medicine. Their study will be published in the journal Stem Cells and appears online today. The findings suggest that

Rheumatoid Arthritis Therapeutics in China

2009-04-09T05:42:00.000-05:00

JAKARTA, Indonesia, April 9 - Rheumatoid arthritis (RA) is a systemic disease or an autoimmune disorder in which the body's defense system attacks the joints through the thin layer of cells called the synovium that lines and lubricates the joints. The most visible symptoms of RA are swollen joints and crippling stiffness, particularly of the hands and feet. It can cause fatigue, fever, loss of

American College of Pediatricians: Another Blow to Children's Rights

2009-04-08T16:07:00.003-05:00

GAINESVILLE, Fla., April 8 (Pharmablog)- The following was released today by the American College of Pediatricians: Children's rights have suffered a severe blow in the last week. Iowa and Vermont became the third and fourth states to redefine marriage and in so doing has jeopardized every child's right to be nurtured by a mother and a father. Of particular concern, the Iowa Supreme Court

FDA Approves Label Change for Non-Invasive Fibroid Treatment

2009-04-08T16:07:00.002-05:00

TIRAT CARMEL, Israel, April 7 (Pharmablog)- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the

Core Essence Receives FDA Approval for SECURUS(TM), an Innovative Knotless Suture Anchor System

2009-04-08T16:04:00.000-05:00

YARDLEY, Pa., April 8 (Pharmablog)- Core Essence Orthopaedics, Inc., a medical device company focused on soft tissue and skeletal repair of the extremities, today announced that it has received 510(k) regulatory approval from the Food and Drug Administration (FDA) for SECURUS(TM), a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery. SECURUS provides increased

Parkinson's Disease Medication Triggers Destructive Behaviors

2009-04-08T16:03:00.000-05:00

ROCHESTER, Minn., April 8 (Pharmablog)- A new study conducted at Mayo Clinic reports that one in six patients receiving therapeutic doses of certain drugs for Parkinson's disease develops new-onset, potentially destructive behaviors, notably compulsive gambling or hypersexuality. VIDEO ALERT: Additional audio and video resources including excerpts from an interview with Dr. J. Michael Bostwick

J. Michael Cook to Retire from Lilly Board of Directors

2009-04-08T16:01:00.002-05:00

INDIANAPOLIS, April 8 (Pharmablog) - The board of directors of Eli Lilly and Company (NYSE: LLY) today announced that J. Michael Cook will retire from the Lilly board effective April 20, 2009. Mr. Cook, the retired chairman and chief executive officer of Deloitte & Touche LLP, has been a director on the Lilly board since 2005. Mr. Cook has been a member of the board's compensation committee and

Sinobiopharma, Inc. Appoints New Director of Marketing

2009-04-08T16:01:00.001-05:00

NANTONG, China, April 8 /(Pharmablog)- Sinobiopharma Pharmaceutical Group (OTC Bulletin Board: SNBP) is pleased to announce the appointment of Ms. Yan Tan as Director of Marketing. Ms. Tan joins Sinobiopharma from Organon Pharmaceutical Co., Ltd., Netherlands. She served as a China-based Unit Marketing Director for Organon, which was recently sold to Schering-Plough. Prior to Organon, Ms. Tan

New England Journal of Medicine Opinion Column Suggests Ineffective Shortcuts to Solve Obesity Challenge

2009-04-08T16:00:00.000-05:00

WASHINGTON, April 8 (Pharmablog)- In response to an opinion column published today in the New England Journal of Medicine, Susan Neely, president and CEO for the American Beverage Association (ABA), issued the following statement: "We agree that obesity is a serious and complex problem. It defies both science and common sense, however, to think singling out one product as a unique contributor