Merck - Gardasil: carry on injecting

A review of health problems reported after women and girls received Merck's Gardasil vaccine shows it remains safe and effective for protecting against a virus that causes cervical cancer, U.S. officials said on Tuesday.

More at Reuters

Schering Plough - Vytorin: the bottom line

"We just don't have evidence here for a benefit for Vytorin," Dr Steve Nissen says. "Let's stick with the statins, because we know they work."

BusinessWeek

Vytorin - all at sea

Oh dear!

Heavy SEAS - a Vytorin publicity stunt?

Some think so.

A question for the Merck Schering Plough statisticians

Do they consider comparing clinical trial endpoint data between the study groups in a manner lacking specific identifiers as 'blinded'?

Functional unblinding - a tutorial.

Dissecting ezetemibe and ENHANCE

The manufacturer "has invested far more in marketing than in science".


At present, ezetimibe’s mechanism of
action is not fully understood, and its benefit—
for now, only mild LDL-C reduction—is too
uncertain for us to be spending $5.2 billion a
year for it. Its manufacturer is fortunate that
the drug is even licensed, given the current
and seemingly appropriate regulatory changes
under which drugs introducing new therapeutic
classes are scrutinized more closely for benefit.

Gliptin wars - let battle commence

A drug candidate critical to Takeda's mainstay diabetes franchise is expected to show sufficient promise to gain approval but may not be much better than Januvia, a rival medicine from Merck.

Takeda's drug, called alogliptin or SYR-322, is under regulatory review and data will be presented at the American Diabetes Association's annual meeting, which runs from June 6-10.

More at Reuters

Vytorin's decline continues

Hat tip.

Vytorin - The Truth

....according to Condor.

Guess what Merck has called it's 1200 drug rep layoff programme?

"Plan to Win"!

The Vytorin Saga contd. - over to you Melissa

Probe

Dissection

Merck gives the field force little to cheer about

Merck said Monday that it is eliminating 1,200 U.S. sales jobs, a move that comes a week after federal regulators' surprise rejection of Cordaptive.

The cuts come on top of the elimination of about 8,100 positions under the sweeping restructuring plan announced in December 2005.

The new cuts are to be completed by the end of July and amount to nearly 15 percent of the 8,500 sales jobs Merck had at the beginning of 2007, said Amy Rose, spokeswoman for the Whitehouse Station, N.J.-based firm.

More at The Trib

Insider's view: time to blow the whistle, perhaps?

Lo(we) - The Bearded One Speaks

And we must listen:

"Stupid R&D most definitely steals money from smarter R&D, and here's some of it that's made off with the swag."

Derek Lowe

Mike Huckman interviews the one and only Roy Vagelos

Well worth a read.

Here's a quote:

In Wednesday's speech Dr. Vagelos said, "Most drugs are a terrific bargain." And he believes that high prices are justified if the drug offers high value. But value, of course, can be subjective. Dr. Vagelos was diplomatic enough not to identify the company from behind the lectern--you can probably figure which well-known biotech he's referring to--but he went on to say that he has a problem with the $50,000 price tag for a drug that adds four months of life.

"There is a shocking disparity between value and price and it's not sustainable," he said. "The industry will bring about government price controls which will be devastating for the industry," Dr. Vagelos added. And if the feds don't step in, he believes market forces will.

Dick Clark - on the other hand

Quote 1 Quote 2

Surrogate endpoints - is the party over?

"The party for all these 'me-too' drugs has been over for at least two years. It's just that these pharmaceutical companies are only now beginning to realize it."

Story

Merck - Cordaptive: trial shock exclusive

Story

Merck - Cordaptive: so that's a "no" then?!

Merck’s bid to revitalise its cholesterol portfolio has been dealt a blow as US regulators rejected the firm’s new combination treatment MK-0524A.

The US Food and Drug Administration has issued a not approvable letter for MK-0524A (extended-release niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia. The move has taken the firm and analysts by surprise, seeing as how European regulators recommended approval just days before for the drug, which lowers ‘bad’ low-density lipoprotein cholesterol and triglyceride levels, and also increases cardioprotective ‘good’ high-density lipoprotein cholesterol levels .
More
By Kevin Grogan

Source: PharmaTimes

Merck and Schering Plough - allergic to each other?

Typical Friday afternoon news release.

Schering-Plough and Merck announced that the U.S. Food and Drug Administration rejected a proposed asthma-allergy drug that would have combined two best-selling drugs, Claritin and Singulair, into one tablet.

The two companies said they received a "not-approvable" letter from the FDA for the combination product. They did not say whether the drug was rejected for safety, efficacy or other reasons.

Schering spokeswoman Lisa Ellen declined to elaborate on why the FDA rejected the product or say if the two companies planned to resubmit the drug for approval at a later date.

"We're still looking at it, and still evaluating the future of the joint venture as well," Ellen said.

Forbes

Looks like Dick Clark might be learning from recent history

"I think everyone has a lesson to be learned from this," Clark said. Drug companies may have to become more transparent about their external spending, as well as their relationships with physicians, he said.

"There is," he said, "a trust deficit we have to fix."

Source