Today's Top Stories | By Tracy Staton |  Comment |  Forward | < a href="http://links.mkt1985.com/ctt?kn=17&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_2jvI6CNyjsOW8y1qOUMovw" > Twitter |  Facebook |  LinkedIn | Merck is expanding its tent in China with another partnership, this time with Simcere Pharmaceutical Group. It's a drug follow-up to the company's vaccines partnership with Sinopharm, which began with a deal to sell Merck's human papillomavirus vaccine. That link-up was intended to spread to other shots and, possibly, prescription meds. The Simcere joint venture, still subject to final conditions, will focus at first on branded drugs for cardiovascular and metabolic diseases, with each company contributing existing products for manufacturing and marketing. On the CV side, think Zocor and Cozaar from Merck, and Simcere's Shufutan (Crestor), which it markets under license. In the metabolic area, the partnership will start with the diabetes drug Januvia, aiming to "maximize access" in a country that's facing a growing problem with that disease. The partnership will also work on the development side of things, but the details on that are sketchy at this point. "This partnership is another step forward in Merck's strategy to grow our business in China and is fully aligned with the Chinese government's goal to increase access to quality products," Adam Schechter, Merck's president of global human health, said in a statement. China, of course, is one of the world's most promising markets for drugmakers. Pharmaceutical sales there are enjoying double-digit growth, and the market is expected to reach $73 billion by 2013. Merck is aiming to boost its sales in the country by more than 20% per year, but for that, it will have to contend with virtually every Big Pharma competitor. - get the release from Merck
- read the RTT News story Related Articles:
Merck aims for growth in China with Sinopharm
Merck CFO: Don't overestimate emerging market gains
Chinese pharma's a challenge on all sides Read more about: Merck, Pharma deals, Simcere Pharmaceutical, cardiovascular market
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 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
| By Tracy Staton | Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=27&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_edN9MSDzwSdsxCKKjM9nw" >Twitter | Facebook |  LinkedIn | Johnson & Johnson's quality control problems were caused by mismanagement at McNeil Consumer Healthcare, a board committee investigation found. The report places the blame for a rash of recalls--not only the massive withdrawals of McNeil products, but also substandard prescription drugs, devices and contact lenses--squarely on lower-level execs, letting senior executives off the hook, Bloomberg reports. McNeil quality-control staff and production folks didn't play well together, and the division suffered from "an emphasis on production volume" rather than on compliance, the panel's report states. J&J's consumer division leadership should have watched McNeil more closely, especially as it worked to integrate Pfizer's consumer health division, the committee said. "[S]ome McNeil employees may have lost focus and commitment to maintain quality standards," Bloomberg quotes. True, integrating the Pfizer operation was a big job, with thousands of new products to handle. New manufacturing lines were put in at Fort Washington, PA, and Las Piedras, Puerto Rico--both factories that would end up on the FDA's hit list for quality lapses. And McNeil's management suite had a revolving door at the time, the report notes, so company leaders didn't know what was happening at the plant level. The board committee praised J&J execs for acting quickly once they discovered the manufacturing issues. It also denied any red flags or "systemic failure" overlooked by top management--two allegations raised by shareholder lawsuits attempting to hold executives and board members accountable. But the report also fingers restructuring at J&J for making the problem worse: Quality and compliance staff were cut by 35%, and the corporate types lost the authority to show up unexpectedly to audit subsidiaries' operations. Plus, a "virtual hiring freeze" hampered McNeil's ability to hire quality-review staff. Someone in J&J's senior management obviously signed off on those decisions. And while top management may not have known the depth of McNeil's problems, one might argue that they should have known. Absolving J&J's leadership of responsibility for the widespread problems may help dispose of shareholder claims, but it won't force them to do the tough soul-searching required to make a company better. - read the Bloomberg coverage
- get more from Pharmalot Related Articles:
J&J boosts sales, profits, but analysts wary
Musty smell touches off yet another J&J recall
Finding the source of J&J's river of woe
J&J splits off troubled consumer-drug unit Read more about: Johnson & Johnson, quality, McNeil
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| By Tracy Staton | Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=87&ms=MzU1ODYyMwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEyMDc4MDQ1S0&mt=1&rt=0" name="api_addthis_com_oexchange_UdVqkL6Mp0QmDATnsphNA" >Twitter | Facebook | LinkedIn | FDA has joined the Multaq review effort. The agency said that it is analyzing data from the recently halted trial of Multaq in patients with permanent atrial fibrillation. Sanofi stopped that 3,000-patient study two weeks ago when "a significant increase in cardiovascular events" cropped up in a data analysis. The FDA, however, revealed some actual, preliminary numbers from that study, known as PALLAS. According to the agency, 16 patients in the Multaq arm died, compared with 7 in the placebo group. The number of patients who died from cardiovascular causes, or had a heart attack, stroke or embolism, was 32 in the Multaq group, versus 14 with placebo. Thirty-four Multaq patients were hospitalized with heart failure, compared with 15 placebo patients. European regulators are already reviewing the drug; they say they'll release their results in September. In announcing its review, FDA said that a critical question is whether the "unfavorable results of the PALLAS study" apply not only to patients with permanent atrial fibrillation, but also to patients with temporary versions of fibrillation. Multaq is FDA-approved for use in patients with paroxysmal atrial fibrillation and atrial flutter. Sanofi says "the benefit-risk profile remains positive" for the approved use, the New York Times reports, but advised doctors never to prescribe it for permanent atrial fibrillation. As for FDA's advisory experts, one who voted for Multaq's approval called the PALLAS data "concerning," while Public Citizen's Sidney Wolfe, who voted against, said the drug was "really too dangerous," the Times reports. - check out the FDA statement
- read the news from Reuters
- get the NYT piece
- see the MedPage story Related Articles:
EMA broadens safety review on Sanofi's Multaq
Sanofi expects EMA to require Multaq alert
Sanofi's Multaq takes hit from trial failure Read more about: FDA, Sanofi-Aventis, Multaq
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Regulators on both sides of the Atlantic issued a slew of decrees about drug safety, weighing in on everything from flu vaccine to bone drugs to Pfizer's smoking cessation med Chantix. The biggest decision came from the Europeans, which decided to leave the Takeda diabetes drug Actos on the market, but added strong warnings about possible links to bladder cancer. France and Germany have both halted sales of Actos, which belongs to the same class of diabetes remedies as the GlaxoSmithKline drug Avandia. While the European Medicines Agency decided to withdraw Avandia on its cardiovascular risks, it won't restrict use of Actos, which has been tagged with increasing the risk of bladder cancer. The risk could be minimized by proper patient selection, the EMA said. FDA recently added new cautionary language to the drug's label about the possible cancer link. FDA, for its part, reported on an ongoing review of bone drugs known as bisphosphonates; the agency has been looking at some conflicting studies of the drugs' potential links to esophageal cancer. For now, the agency said, the benefits appear to outweigh the risks, but an FDA advisory panel will be discussing their safety at a meeting in September. The class includes such popular meds as Merck's Fosamax and Roche's Boniva. Meanwhile, an EMA committee said it had determined that Chantix's benefits outweigh its risks. New questions about the drug were raised by a meta-analysis that found an increase in cardiovascular problems, such as heart attack and stroke, in patients using the drug. The EMA's Committee for Medicinal Products for Human Use found some weaknesses in that analysis, including the exclusion of studies in which no patient experienced a cardiovascular event, Pharmalot reports. Finally, the EMA wants GlaxoSmithKline to update its label on the pandemic flu shot Pandemrix, after finding a link between its use in young people and the rare sleeping disorder narcolepsy. The agency said the CHMP has recommended that people under 20 should avoid Pandemrix unless they have no access to seasonal flu vaccines and they're at high risk of complications from H1N1. - read the Reuters news
- see the Bloomberg piece
- get more from Pharmalot
- check out the Dow Jones story Related Articles:
Docs revisit strategies for bone-drug use
French officials force Takeda to pull Actos off market
Study: Pfizer's Chantix raises heart risks 72%
EMA puts off Actos ruling until July
WHO broadens probe of narcolepsy-flu vax link Read more about: GlaxoSmithKline, Pfizer, Actos, Chantix
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Might Eli Lilly ($LLY) emerge as a buyer for Pfizer's animal health business? CFO Derica Rice told Lilly investors that the company is keeping an eye on Pfizer's plans for the unit, which may be sold or spun off. If Lilly likes any of the available assets, it would pursue them, Rice said. When asked about that pledge, Pfizer said that it doesn't envision selling off the animal health business in pieces. The whole unit would be sold or spun off, spokeswoman Joan Campion told Bloomberg. "While we are evaluating a variety of options including a sale, spin-off or other transaction, we believe we will favor one overall option rather than dividing assets and business operations," Campion told the news service. Pfizer has tagged its animal health and nutrition units for disposal, so it can return cash to shareholders and focus on pharma development. The units could bring in more than $20 billion; the animal health unit alone had 2010 sales of $3.48 billion, Bloomberg notes. A deal of that size could be beyond Lilly's ken; CEO John Lechleiter has repeatedly said he's not in the market for a big buyout. Pfizer will be weighing its options for the animal health unit for at least a year, Campion said. - read the Bloomberg story Related Articles:
Lilly animal health unit offers to buy Janssen outfit
Note to Pfizer: Bayer shopping for vet buys
With Sanofi-Merck deal off, look for animal health M&A Read more about: Pfizer Animal Health, Animal health, Pfizer, Eli Lilly
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@FiercePharma: Now that Brilinta's approved, AZ has to sell it. 
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