GlaxoSmithKline faces more Avandia fallout

GlaxoSmithKline is in Congressional crosshairs over its marketing of Avandia, and investors arent happy either.

AMA hooks up online with Sermo

The American Medical Association announced it is partnering with Sermo, the online community for physicians.

LLNS rebrands as LyonHeart

Lyons Lavey Nickel Swift is rebranding as “LyonHeart” under its proprietary creative-strategic process dubbed “Disruption.”

Nexavar also seen as liver cancer breakthrough

Onyx and Bayers kidney cancer drug Nexavar (sorafenib) was also found to extend the lives of liver cancer patients in a clinical trial by almost three months, or 44%, doctors said.

InVentiv buys brand ID shop Addison Whitney

InVentiv Health has acquired brand identity shop Addison Whitney.

Panel to review Sanofi-Aventis’ Ketek

The FDA will convene a joint panel of outside experts to examine the risks and benefits of Sanofi-Aventis’ antibiotic Ketek (telithromycin).

Panel to review Sanofi-Aventis’ Ketek

The FDA will convene a joint panel of outside experts to examine the risks and benefits of Sanofi-Aventis’ antibiotic Ketek (telithromycin).

AHA forbids Pfizer from presenting torcetrapib results

Pfizer won’t be allowed to present new data on its closely watched developmental drug torcetrapib at the annual American Heart Association (AHA) meeting this week.

Novartis asks FDA for Galvus review extension

Novartis has asked the FDA to extend the review period for its highly anticipated developmental diabetes drug Galvus by three months to allow the agency to examine new clinical trials data.

Genentech acquires Xolair partner Tanox

Genentech has agreed to acquire its Xolair co-marketer, the Houston-based biotech firm Tanox, in a deal worth $919 million.

3M sheds pharma unit for $2.1 billion

3M has agreed to sell-off its global pharmaceuticals business, which makes dermatology, women’s health, cardiology and respiratory treatments, for $2.1 billion.

Abbott to buy Kos for $3.7 billion

Abbott has agreed to buy specialty firm Kos for $3.7 billion, a move that complements its cardiovascular franchise and boosts its pipeline.

Schering-Plough CEO calls takeover prices 'breath-taking'

The prices being paid in the recent rash of pharmaceutical acquisition deals are “breath-taking,” Schering-Plough CEO Fred Hassan said in an interview with Marketwatch.com.

Lilly, BMS part of California investigation of anti-psychotics

The California attorney general’s office expanded its probe into the marketing of anti-psychotic drugs, serving subpoenas to Eli Lilly and Bristol-Myers Squibb, the companies have said.

Trial results cloud future of Pfizer's torcetrapib

Pfizer confirmed that its leading pipeline candidate torcetrapib raised blood pressure in clinical trial patients more than previously reported.

Lilly, BMS part of California investigation of anti-psychotics

The California attorney general’s office expanded its probe into the marketing of anti-psychotic drugs, serving subpoenas to Eli Lilly and Bristol-Myers Squibb, the companies have said.

HealthMedia acquires MySelfHelp.com

Behavioral change-focused relationship marketing firm HealthMedia announced today that it has acquired the consumer Web site MySelfHelp.com.

NIH scientists seeking new work in wake of tougher disclosure rules

Nearly 40% of scientists researching diseases and cures at the National Institutes of Health (NIH) are considering new jobs to escape strict ethics rules, a recent survey said.

FDA OKs new Nexium formulation

AstraZeneca said Tuesday a new formulation of its blockbuster heartburn treatment Nexium has won FDA approval.

Sales fuel earnings growth at Pfizer, Lilly, Wyeth, Novartis, Schering-Plough

Rises in prescription drug sales contributed to robust third-quarter earnings growth posted by Pfizer, Lilly, Wyeth, Novartis and Schering-Plough.

‘No sacred cows’ in Pfizer cost-cutting efforts: Kindler

Pfizer CEO Jeffrey Kindler said all aspects Pfizer’s business would be open to reductions under an ongoing company wide cost-cutting initiative.

Senate eyes even small CME payments, Grassley aide says

Even small payments given by pharmaceutical companies to CME providers are not escaping the eye of federal investigators poring over their grant records as part of an ongoing inquiry.

FDA will offer speedy generic drug review times

Generic drugs considered important to the public health will now get quicker review times, FDA officials said.

NIH scientists accuse Lilly of manipulating Xigris treatment guidelines

Federal scientists have accused Eli Lilly of attempting to influence treatment guidelines for its blood infection treatment Xigris to boost slumping product sales.

McClellan joins DC think tanks

As promised, Mark McClellan, former administrator of the centers for Medicare and Medicaid Services has joined the think tank world.

Journal articles quickly influence doctor prescribing habits: study

Negative articles in medical journals have a major influence over doctors’ prescribing habits, according to an article in the Journal of the American Medical Association (JAMA).

South Beach Diet online publisher to compete with WebMD, About Health

Online publisher Waterfront Media plans on going to the mat with consumer healthcare heavyweights WebMD and About Health by launching EverydayHealth.com.

Company news from the 10/24/06 News Brief

Dermatology focused pharmaceutical company Stiefel Laboratories announced it has purchased prescription dermatolgical foam manufacturer Connetics Corporation for $640 million.

NIH scientists accuse Lilly of manipulating Xigris treatment guidelines

Federal scientists this week accused Eli Lilly of attempting to influence treatment guidelines for its blood infection treatment Xigris to boost slumping product sales.

FDA will offer speedy generic drug review times

Generic drugs considered important to the public health will now get quicker review times, FDA officials said yesterday.

Bayer suspends two in drug safety investigation

Bayer pinned its failure to tell the FDA about a study regarding heart surgery drug Trasylol on an error by two unnamed individuals, as it hired outside counsel to investigate the matter.

Supreme Court dismisses Zoloft patent case

The US Supreme Court dismissed an appeal from generic drugmaker Apotex over a patent challenge to Pfizer’s blockbuster antidepressant Zoloft.

Genentech’s Avastin wins lung cancer approval

The FDA yesterday approved Genentech’s Avastin for use in treating non-small cell lung cancer.

DTC ad spending up in first half of ‘06

DTC advertising spending by pharmaceutical companies was up 9% during the first half of 2006, according to data released this week by marketing information firm TNS Media Intelligence.

Easing of importation rules draws fire from PhRMA

A move by US Customs to relax enforcement on the importation of Rx drugs from Canada has drawn fire from the industry trade group PhRMA.

Dem leader would push price controls as Speaker

Democrats wouldn’t be in power more than four days before legislating price controls on pharmaceuticals, according to House Democratic leader Nancy Pelosi, the presumptive Speaker of the House should the Democrats win a majority of seats next month.

Altana to dismantle sales, marketing team

Altana Pharma said it would lay off about 400 workers as part of a dismantling of its US sales & marketing and research operations.

Shire, New River receive approvable letter for ADHD compound

Shire Friday received tentative FDA approval to market its new attention-deficit hyperactivity disorder (ADHD) drug, lisdexamfetamine dimesylate (LDX).

FDA approves new labeling saying Vytorin outperformed Crestor in study

Merck and Schering Plough last week won FDA approval to include new product labeling saying Vytorin is better at lowering bad cholesterol than competitor, AstraZeneca’s Crestor.

Days of DTC could be numbered in New Zealand

DTC advertising of prescription drugs in New Zealand could soon be a thing of the past.

Merck delays filing for cardio combo pill

Merck said it has pushed back regulatory plans for an experimental cardiovascular pill that has been hailed by some as a possible follow-on to blockbuster cholesterol drug Zocor.

NIH to compare 2 drugs for eye disease

The National Institutes of Health (NIH) said it will fund a clinical trial to compare two drugs used to treat advanced age-related macular degeneration (AMD): Genentech’s Lucentis and Avastin.

Company news from the 10/10/06 News Brief

Pfizer entered into an agreement to acquire PowderMed, a privately held UK company specializing in the emerging science of DNA-based vaccines.

IOM report urges two-year moratorium on DTC for new Rx drugs

The FDA should be empowered to enforce a two-year ad ban for new drugs, according to a report by the nonprofit Institute of Medicine (IOM).

New DDMAC group added to review DTC

The Division of Drug Marketing, Advertising & Communication (DDMAC) has added a second DTC review group to meet soaring demand for advertising approvals, said DTC group leader Melissa Moncavage.

CRM guru shifts to Ogilvy

Lita Sands, who once headed CRM at Pfizer, has been hired by Ogilvy Healthworld as client services strategy lead in its Healthcare unit.

GSK will not renew sales force deal with PDI

GlaxoSmithKline will not renew its 2007 sales engagement with contract sales firm PDI, TheStreet.com reported today.

Thomson buys Solucient

Thomson is buying the balance of Solucient from media giant VNU, private equity firm Veronis Suhler Stevenson and healthcare provider alliance VHA.

Von Eschenbach nomination still on hold despite Senate committee approval

Andrew von Eschenbach still faces hurdles in becoming permanent FDA commissioner, despite winning approval of his nomination from a Senate committee.

Company news from the 09/26/06 News Brief

Germany’s Merck KGaA is buying a majority stake in Swiss rival Serono in a deal worth approximately $13.3 billion, according to published reports.

Congressional Republicans agree to ease Rx drug import ban

Republicans in the US House of Representatives agreed Thursday to prohibit customs agents from seizing limited amounts of prescription drugs that Americans buy in Canada and bring back into the US, The Wall Street Journal reported.

Medicare benefit boosts big pharma profits by $8 billion, Congressional Dems say

Congressional Democrats claim pharma industry profits have soared by as much as $8 billion in the first six months after the Medicare drug benefit went into effect.

Germany’s Merck KGaA to buy Serono

Germany’s Merck KGaA is buying a majority stake in Swiss rival Serono in a deal worth approximately $13.3 billion, according to published reports.

Waxman and Hatch working on biotech generics legislation

US Rep. Henry Waxman plans to introduce Congressional legislation as early as this fall to create a framework to approve “biosimilar” or generic biologic drugs, according to published reports.

AstraZeneca to keep searching for deals to boost pipeline

AstraZeneca will continue looking for deals to pump up its pipeline despite company expectations that most of its products, by 2010, will come from discoveries within its own labs.

Sharer named PhRMA chairman

Amgen CEO Kevin Sharer has been named the new chairman of PhRMA following the resignation of Peter Dolan, ousted CEO of Bristol-Myers Squibb.

Stanford joins growing list of hospitals to ban gifts, samples and reps

Stanford University Medical Center has joined the growing cadre of academic medical centers limiting the access of sales reps to its halls and forbidding its doctors from accepting industry gifts and drug samples.

Schering-Plough considering Bristol-Myers Squibb buyout

Schering-Plough is seriously considering approaching Bristol-Myers Squibb about a possible merger, the New Jersey newspaper, The Star–Ledger, reported on its Web site.

Investigation delayed on 2 scientists flagged for outside consulting

Two out of the 44 federal scientists found by the National Institutes of Health to have violated rules on outside consulting warrant further investigation for possible criminal acts, yet they remain employed by the agency.

FDA removes panelist amid conflict questions

The FDA has taken the unusual step of removing an advisory committee panel member due to a potential conflict of interest, The Wall Street Journal reported.

Nature experiments with online peer review

Authors of papers submitted to the journal Nature can agree to a new form of peer review -- having the journal post their articles online for other scientists to critique.

Company news from the 09/19/06 News Brief

Pfizer and TransTech Pharma have entered into a license agreement for the development and commercialization of small and large molecule compounds under development by TransTech.

BMS ousts Dolan, retains former Lilly exec. as interim CEO

The board of Bristol-Myers Squibb named one of its directors and a former CFO for Eli Lilly as interim CEO of the company today, following a federal monitor’s recommendation to fire Peter Dolan.

CME body revamps accreditation, outlines 2-year transition

The Accreditation Council for Continuing Medical Education (ACCME) has revamped its accreditation model, setting a two-year deadline for providers to change the way they plan and deliver activities.

McClellan resigns from Medicare post

Mark McClellan is resigning his post as head of the Centers for Medicare and Medicaid Services.

Judge denies motion to halt Boniva promotion

A federal judge issued a ruling Thursday allowing GlaxoSmithKline and Roche to continue marketing the osteoporosis drug Boniva, shooting down an injunction filed by market rivals to halt the drug’s promotion.

GlaxoSmithKline to pay $3.4 billion in largest-ever IRS tax settlement

GlaxoSmithKline will pay the US government $3.4 billion—the largest tax settlement ever paid to the IRS—to end a decades-long dispute over financial dealings that ultimately allowed the British drugmaker to lower its US tax bills for nearly two decades.

AstraZeneca names AARP PR to head US corporate communications

AstraZeneca named Lisa Davis to head all internal and external corporate communications in the US.

Sales pitch pointing to study helps grow Lipitor sales

Prescriptions for higher doses of Lipitor jumped 12% for the week ending Aug. 18, The Boston Globe reported.

GCI’s DeSalva to lead H&K Healthcare

Hill & Knowlton named GCI Group’s AnnaMaria DeSalva to head its worldwide healthcare practice.

Pfizer whistleblower lawsuit dismissed

Pfizer won the dismissal of a whistleblower lawsuit filed against the company by former marketing exec Peter Rost, accusing the firm of promoting its growth hormone Genotropin for unapproved uses.

Company news from the 09/12/06 News Brief

MedImmune broke ground on a $250 million, multi-phase expansion project at its Frederick, MD, manufacturing site.

Insurer to stop paying for Nexium

Health insurer UnitedHealth Group said it has decided to stop paying for AstraZeneca’s Nexium because equally effective proton pump inhibitor (PPI) treatments are available to patients.

Merck report absolves Vioxx managers: AP

Merck said the results of a 20-month company-funded investigation found that senior management acted responsibly in the development and marketing of withdrawn painkiller Vioxx, the Associated Press reported.

Novartis hires marketing chief ahead of big drug launches

Nancy Lurker has been appointed senior vice president and chief marketing officer at Novartis, a new position at the drug company.

Wyeth gives $500k for CME block-grant pilot

Wyeth’s $500,000 independent CME grant will enable the Medical Association of Georgia (MAG) to assess a system that delegates control over the firm’s med-ed purse strings.

Schering-Plough settles off-label marketing, price fraud charges

Schering-Plough agreed to pay $435 million to settle charges that it lied to the government about drug prices and improperly marketed cancer drugs for uses not approved by the FDA.

Bristol-Myers Squibb, Sanofi-Aventis win injunction in Plavix trial

Apotex must stop selling cheaper copies of the anticoagulant Plavix but doesn't have to pull product already sold, said a federal judge who granted a preliminary injunction to Plavix co-marketers Bristol-Myers Squibb (BMS) and Sanofi-Aventis.

Norwegian court rules against Pfizer in Lipitor patent disputes

A Norwegian court has ruled in favor of Ranbaxy Laboratories in two patent disputes involving Pfizer’s blockbuster Lipitor (atorvastatin), the world’s top selling Rx drug.

Judge overturns $50m Vioxx verdict

A federal judge in New Orleans ruled that a recent $51 million verdict against Merck was excessive and ordered that the damages portion of the Vioxx case be tried again.

Most Americans support legalization of Rx drug imports: WSJ poll

Two-thirds of Americans strongly believe a law prohibiting the importation of prescription drugs from Canada and other countries is intended to protect pharma company profits and only 9% feel strongly that it helps protect Americans from potentially harmful drugs, according to a report on The Wall Street Journal’s Web site.

California Governor set to sign mandatory drug discount bill

California Governor Arnold Schwarzenegger is poised to sign a bill sent to him Thursday that would impose mandatory prescription drug discounts for consumers in that state, The San Francisco Chronicle reported.

US and Japan need a free-trade agreement: Taurel

A free-trade agreement between the US and Japan could open up a lucrative market to overseas firms while conferring broad economic benefits, said Eli Lilly chief executive Sidney Taurel in a speech last Thursday in Japan.

Frist likely to face fine over CME requirements

Bill Frist, the Senate majority leader, is likely to face a fine for not meeting Tennessee’s mandatory CME requirement, the AP reported.

PhRMA paid for part of Medicare ad campaign: AP

PhRMA quietly paid for parts of a recent multimillion-dollar ad campaign that praises lawmakers supporting the new Medicare prescription drug benefit, the Associated Press (AP) reported.

GSK's Garnier says several pharma companies to fold in next few years

GlaxoSmithKline CEO Jean-Pierre Garnier foresees several pharmaceutical companies folding in the next few years because of increasing investments in research, he recently told German business publication Manager Magazin.

Journal editor with ties to device maker steps down

The editor of the journal Neuropsychopharmacology, Charles Nemeroff, has resigned after failing to disclose financial ties to makers of a device he wrote a favorable review of.

Biovail files suit against FDA over Wellbutrin XL

Biovail announced Friday that it has filed a federal lawsuit against the FDA to prevent the agency from approving a generic form of antidepressant Wellbutrin XL before ruling on a citizen petition the firm filed with the agency in December 2005.

GlaxoSmithKline in $1.5 billion collaboration deal

GlaxoSmithKline announced a deal on Thursday with the privately held drug research firm ChemoCentryx to discover, develop and market novel medicines for a variety of inflammatory disorders.

Merck Cox-2 drug posts mixed results

Merck released results from a huge clinical trial of a possible successor to Vioxx, saying they support its bid to gain US approval for the drug. But the company also noted some cautions, including increased hypertension.

FDA proposes electronic overhaul of drug registration and listing

The FDA proposed a rule on Thursday to automate the process by which drug firms register themselves and list their products with the agency.

Company news from the 08/29/06 News Brief

Mylan Laboratories said yesterday it plans to buy a majority stake in Indian drug ingredient company Matrix Laboratories. Mylan hopes to purchase up to 71.5% of Matrix for $736 million.

Judge weighing claims of Plavix price erosion

The second and final day of a federal hearing in Manhattan saw Bristol-Myers Squibb and Sanofi-Aventis back up their request for a preliminary injunction to stop generic sales of blockbuster anticoagulant Plavix.

Online pharma ad spending to rise 25% in 2006: report

Pharmaceutical companies’ Internet spending will increase by 25% this year to $780 million, according to a new report from market research firm eMarketer.

Pfizer wins Norvasc patent lawsuit

A federal court jury in the Eastern District of Virginia ruled unanimously that Pfizer did not infringe Synthon IP’s US patent covering a process for making amlodipine, the active ingredient in the blockbuster blood pressure drug Norvasc.

Barr resubmits Plan B application

Barr Pharmaceuticals Friday resubmitted an application seeking FDA approval to sell its emergency contraceptive Plan B without a prescription.

Twin snags hamper Merck in Vioxx litigation

Merck lawyers encountered two snags in Vioxx litigation last week as jurors in a federal Vioxx trial awarded the plaintiff $51 million in damages and a New Jersey state judge threw out an earlier favorable verdict for the company.

New warning information for ADHD drugs

Two attention deficit hyperactivity disorder (ADHD) drugs must include new information about heart risks and psychotic behavior, the FDA said yesterday.

Katen out at Pfizer, Kelly's role unclear

Karen Katen will leave Pfizer, the company said.

Company news from the 08/22/06 News Brief

Barr Pharmaceuticals has formally published its tender offer for the purchase of 100% of the shares of Pliva, based in Zagreb, Croatia.


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