Novo Nordisk Probed By Danish Police Over Tresiba Disclosure
Last February 10, Novo Nordisk issued a statement saying the FDA had rejected its Tresiba insulin and wanted a cardiovascular outcomes trial before a new review can be completed, a move that was a difficult setback for the drugmaker because such a trial would likely delay regulatory approval of an important new product for at least two years (back story). That Sunday disclosure, however, did not sit well with the Danish Financial Supervisory Authority, which has reported Novo Nordisk to the police for violating reporting obligations under the Danish Securities Trading Act to disclose inside information as soon as possible,...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Merck Proposes Paying $28M To Settle Fosamax Jaw Bone Suits
Three months ago, a federal judge ordered hundreds of lawsuits charging a Merck drug called Fosamax caused osteonecrosis, which is a painful death of jawbone tissue, to be dispersed to courts around the country for trial (back story). The move seems to have had the desired effect. Yesterday, Merck proposed paying nearly $28 million to settle 1,140 pending lawsuits. “We hope to bring this to a successful conclusion," PaulStrain, a lawyer for Merck, said at a hearing in federal court in Manhattan before Judge John Keenan, who has presided over mushrooming litigation and would have to approve the settlement. The drugmaker n...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We have returned from a brief moment of mourning, which took us away from our usual routine yesterday, and have awoken to an impressive amount of snow blanketing the Pharmalot corporate campus. This makes for some pretty scenery while we organize the day ahead. Meanwhile, we are brewing that trusty cup of stimulation and invite you to join us, as always, as we dig in - and get ready to dig out. And so, here are some tidbits. Have a grand day and do stay in touch... United Therapeutics Receives A Subpoena For Marketing Practices (Reuters) Shanghai Official Suspended In Connecti...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Biogen Plant That Makes Older MS Drugs Fails An FDA Inspection
Biogen Idec may impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex. A recent inspection report issued by the FDA, which examined a facility last summer, noted that the drugmaker did not always challenge the validity of all testing results provided in certificates of analysis as part of qualification procedures. In other words, Biogen (BIIB) did not always ensure that active pharmaceutical ingredients were sterile, as suppliers claimed. In addition, Biogen...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

University Faculty Votes To Probe A Seroquel Study Suicide
In response to a call from dozens of leading academics in different countries, the University of Minnesota faculty senate late last week voted to conduct an inquiry into how the institution runs clinical trials involving human subjects. The 67-to-23 vote was described as a “rare victory” by one academic who has pushed for the university to investigate one controversial case that prompted sustained scrutiny of university practices and negative publicity. That case involved the 2004 death of Dan Markinson, a troubled 26-year old who committed suicide while participating in a clinical trial that was run by university rese...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Glaxo Outrages Suppliers With Demand For Retroactive Rebates
Nearly one year after being admitted to the small business ‘Hall of Shame’ in the UK, GlaxoSmithKline has once again outraged many of its suppliers with payment tactics (back story). This time, the drugmaker is being chastised for seeking retroactive rebates from marketing agencies for work already performed and a so-called ‘sign on’ bonus in order to be readmitted to its roster of preferred suppliers. “If your agency has performed work for GSK in 2013, please provide a (percentage) rebate for the 2013 global annual spend by GSK,” according to letters sent suppliers. “For all future GSK annual spend levels, p...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Glaxo Paper At Center Of Fabricated Data Scandal Is Retracted
As a postscript to a scandal that enmeshed GlaxoSmithKline over fabricated data, Nature Medicine has now formally retracted a controversial 2010 paper that led five employees, including the senior vp and head of R&D in Shanghai, China, to leave the drugmaker. The paper, which appeared three years ago, examined the role of a protein called Interleukin-7 receptor in treating autoimmune disease (back story). The disclosure greatly embarrassed Glaxo, which months earlier vowed to change its practices after agreeing to plead guilty and pay $3 billion in the US to resolve criminal and civil charges in connection with off-lab...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to another working week. We hope the weekend break was relaxing. Now, though, the rourine of meetings and deadlines has resumed, a task made still more difficult by the soggy climate in the part of the world where the Pharmalot corporate campus is located. Nonetheless, we will all persevere. However, we will, unfortunately, have to break early today to say farewell to a special Pharmalot ancestor who passed away yesterday. But we will return tomorrow. Meanwhile, here is the usual menu of tidbits. Hope your day goes well and be in touch... New Leukemia Drugs Offer Potential For Chemo-Free...
Source: Pharmalot - December 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

China Finally Allows FDA To Add Inspectors To Bolster Oversight
After a year of frustration and delay, the White House has finally reached agreement with the Chinese government to allow the FDA to boost its inspection team as part of a plan to bolster oversight the pharmaceutical supply chain. As a result, the agency will add another 10 drug inspectors to its existing staff of one, an FDA spokeswoman tells us. The delay had been a setback to FDA efforts to improve oversight and assert its authority, an issue that has haunted the agency ever since contaminated heparin made in China was linked to 81 deaths in the US in 2007 and 2008 (back story). The episode sparked a firestorm of critic...
Source: Pharmalot - December 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

What Customer? Importer Sues FDA For Blocking Ingredient Shipment
In an unusual development, an importer has filed a lawsuit against the FDA for detaining a shipment of bulk acetaminophen that was destined for a customer – a contract manufacturer, specifically. And the refusal by the agency to clear the shipment is raising questions about how an ‘end user’ is defined. The lawsuit, which was first reported by the FDA Law Blog, was filed by H&M USA, and hoped to sell the active pharmaceutical ingredient to Gemini Pharmaceuticals, which provided a so-called ‘end-use letter’ that stated the acetaminophen would later be made into over-the-counter drugs and identified one  brand...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Reckitt Benckiser Pharma Unit In The US Is Raided By The Feds
Several weeks after Reckitt Benckiser signaled its intent to sell its pharmaceutical business, the company has received an intense level of interest – but not from investors. Instead, agents from the US HHS Office of Inspector General, the US Internal Revenue Service and local police raised its offices in Virginia and were seen leaving with numerous boxes of documents, according to television reports. A Reckitt spokesman, meanwhile, sends us this: “We can confirm that federal officers from the US government presented a search warrant at the offices of Reckitt Benckiser Pharmaceuticals in Richmond, Virginia, on Tuesday ...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Will This Bill Relieve 'Hardship' Caused By Generic User Fees?
Nearly two years ago, the FDA was granted authority to charge user fees to generic drugmakers in hopes of accomplishing two pressing goals – bolstering oversight of the pharmaceutical supply chain by underwriting the cost of additional plant inspections and tackling a growing backlog of applications for approvals. But the effort has generated considerable grumbling. As expected, there was a recent a rise in user fees, since there is a projected decline in the number of abbreviated new drug applications to be filed and there are fewer facilities that will carry the overall burden. And fees for the recently ended fiscal ye...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

More Drugmakers To Join Glaxo Effort To Disclose Trial Data
In yet another bid to respond to calls for greater disclosure of clinical trial data, several other drugmakers next month are expected to join to a web site that was recently launched by GlaxoSmithKline in order to satisfy the clamor for wider access to detailed study data. “Our aim is to progress to becoming an independent (portal) that accommodates multiple partners,” said Perry Nisen, who is a senior vp for science and innovation at Glaxo. “This is a start – a step in what we hope will be widespread movement to provide research data for clinical trials as well as other sources of clinical and health-related data...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

FDA Asks Drugmakers: Where Are Those Pediatric Studies?
A decade ago, the Pediatric Research Equity Act was enacted and gave the FDA the authority to require drugmakers to complete studies in children for the same adult indications when existing medicines are expected to be used in a substantial number of youngsters (read more here). And last year, the agency was given the right to shame drugmakers that fail to comply. And so, the FDA has now posted on its web site a batch of letters that were recently sent to drugmakers that have not sought or obtained a deferral extension; submitted a deferred pediatric study by a final due date or requested approval for a required pediatric ...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Up And Down The Ladder... Job Changes
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Tolera Therapeutics hired Ashleigh Palmer as ceo and president. Palmer, ...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs