Feeds:
Posts
Comments

Archive for the ‘News’ Category

TODAY’S NEWS

So, have we been pursuing the wrong course for GERD all this time? Is it actually caused by immune system cells, not stomach acid?

Maybe cheap/old/tried-and-true really is better. Diuretics for HPB, for instance. Or just plain generic simvastatin for cholesterol.

Pfizer gets good news on Revatio (which is the same as Viagra, by the way) for the treatment of PAH; Spiriva for COPD; and the Prevnar 13 vaccine.

Genzyme: Train wreck?. But wait – there’s more.

Getting excited about sex: not so easy to be excited about B-I‘s experimental treatment for female desire; Vivus‘ competitor to current ED drugs still on track, however.

RECOMMENDED

Marketing/Sales – tele-detailing. Is your company looking to augment its promotional voice with telesales, virtual detailing, and other “surround sound” solutions? Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

PLUS

Blind Spots and Broken Limbs. I’ve got them, too…

JUST FOR FUN

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

Connect with Steve Woodruff

Advertisements

Read Full Post »

Roche‘s MabThera can help extend CLL patients’ lives. Meanwhile, surprisingly good results for AZ‘s lung cancer drug Iressa. But, disappointment for an experimental lung cancer drug being developed by Amgen and Takeda. And, Novartis‘ promising kidney cancer drug Afinitor gets the FDA delay treatment (fuller Novartis pipeline update here).

Glaxo gets U.S. approval for platelet drug Promacta.

Biotech bankruptcies looming?

AstraZenecacutting, selling, stopping.

More positive info for Takeda‘s experimental gout drug.

Can Pharma learn from the Detroit automaker situation? Some good thoughts here.

Generic coming? Let’s hike the price! – Cephalon has already taken heat for off-label promotion of its narcolepsy drug Provigil. Now, facing the prospect of generic competition to Provigil in 2012, the company is dramatically hiking Provigil’s price…more

Javelin tosses 15% – Javelin Pharmaceuticals, Inc., a leading developer of novel products for pain management, today announced that it will reduce its workforce by approximately 15 percent. The reduction is intended to reduce Javelins cost structure…more

Cancer drugs for diabetes? The mice say maybe… – Two popular leukemia drugs, Gleevec and Sutent, kept lab mice from developing type 1 diabetes and put 80 percent of diabetic mice in remission, an international team said on Monday…more

J&J patch leads to costly settlement.

Merck’s Gardasil promising in boys – Scientists are reporting at a scientific meeting in Nice, France, today that 90% fewer men ages 16 to 26 years developed genital warts and other lesions after receiving Gardasil…more

Pfizer: big bucks toward stem cells – Over the next five years, the drugmaker will create dual facilities in the UK and Massachusetts to use stem cells to treat heart disease, diabetes, cancer and vision loss common among the elderly. In doing so, Pfizer is touting that it becomes the first big pharma to have such a dedicated effort, which will include hiring 70 scientists to staff the labs…more

Beauty fillers, ugly side effects? – An ugly side of the beauty business emerged today, as an FDA briefing listed 930 reports of side effects for injectable wrinkle fillers such as Restylane and Juvederm…more

King’s new pain pill might make the grade – An FDA advisory committee determined that Remoxy is less susceptible to abuse than the notorious OxyContin, suggesting the pill will win FDA approval, Bloomberg News reports, although the committee did not take a formal vote…more

FDA to require meta-analyses of diabetes drugs.

More questions about Effient? – Researchers have overestimated the ability to the experimental drug without causing dangerous bleeding, according to a prominent cardiologist, Reuters writes. Prasugrel, you may recall, has twice been delayed by the FDA, which is reportedly set to hold an advisory meeting early next year…more

Major Amylin layoffs – The 25 percent staff reduction, which follows sluggish sales of its flagship Byetta diabetes med, is designed to save more than $100 million next year. After the dust clears, Amylin will have 1,800 employees…more

All right, what’s the big deal with the Crestor/Jupiter/cholesterol study? Some questions answered.

Did you know that the FDA gives drug review vouchers? Neither did I – Two months ago, a new program got under way in the US to promote the development of drugs for so-called neglected diseases that continue to plague the poorest nations. Here is the outline: a drugmaker that seeks approval of a drug to treat one of these infectious diseases gets a voucher, which awards an expedited FDA review of a new drug application for any other med…more

Amgen doing an “Obama” to market new drug? – Taking a leaf out of the marketing playbook of President-elect Barack Obama, biotechnology company Amgen Inc plans to make use of the Internet and social networking sites to market its drugs to consumers…more, plus another take here.

Merck: we still have heart – Merck wants the world to know that when it comes to developing new drugs for cardiovascular disease, the company is in the fight for the long haul…more

The cost of rep sales calls. Have a calculator handy. From John Mack’s Pharma Marketing blog.

I have some real problems with this. Brand-name drug manufacturers liable for generic injuries – A ruling on Friday by a California appeals court is likely to spark a good many lawsuits against big pharma. The upshot – brand-name drugmakers were put on notice that they can be held liable not only for harm caused by their own meds, but also for injuries caused by a generic drugmaker selling a copycat version…more

More doctors quitting.

This is really funny. From the Colbert Report, via PharmaGossip.

Reblog this post [with Zemanta]

Read Full Post »

Is Eli Lilly the “mystery suitor” for ImClone? – Eli Lilly & Co. is in advanced talks to buy cancer-drug developer ImClone Systems for $70 a share, or $6.1 billion, The Wall Street Journal reported on Thursday, citing people familiar with the matter…more And why the big interest in ImClone? Business Week says “it’s the pipeline.”

Prasugrel delayed…again – Once again, the FDA has delayed its approval of prasugrel, a blood thinner that Lilly and its partner, Daiichi Sankyo, have been hoping will one day compete against Plavix, which is marketed by Bristol-Myers Squibb and Sanofi-Aventis…more

Judge: Amgen yes, Roche no – A federal judge in Boston ruled the drugmaker infringed on Amgen’s patents with its Mircera anemia med, essentially upholding a preliminary decision issued in February. The order by US District Court Judge William Young deals a big setback to Roche, which already cut costs after its plans to market Mircera flopped…more

Credit crunch? Roche says, nah…we still want Genentech – The market isn’t so sure Roche can raise the money to buy Genentech, but Roche seems pretty confident…more

Encouraging data for Pfizer’s HIV drug – The Pfizer Inc. AIDS drug maraviroc helps thwart the HIV virus in nearly half of people who have developed resistance to other treatments, according to two related studies published on Wednesday…more

Pfizer bailing out of some therapeutic areas for drug development – Pfizer Inc  will drop efforts to develop medicines for heart disease, as part of a reshuffling of its research activities that the pharmaceutical giant plans to announce on Tuesday, according to a Wall Street Journal report. Pfizer also is expected to announce it will abandon therapies for obesity and bone health to focus on more lucrative areas such as cancer and Alzheimer’s disease, WSJ said on its online site…more More here from Forbes

The Pfizer pipeline: current status – Even as Pfizer is bailing out of drug research for heart disease, the company’s late-stage pipeline has increased to 25 projects from 16 in the past six months…more

A potential Viagra competitor derived from a plant with…well, a pretty bizarre name!

Merck drops experimental weight-loss pill – The drugmaker made the decision after spending months reviewing trials showing the taranabant obesity pill caused psychiatric side effects. You may recall that a late-stage trial showed the drug didn’t yield the hoped-for weight loss of 5 percent at the 2 mg dose the drugmaker hoped to sell…more

Daiichi Sankyo cleared to buy Indian drugmaker Ranbaxy.

From PharmExecspecialty drug prices spiking.

Big settlement by Cephalon on out-of-bounds marketing practices. Whistleblower vindicated.

What’s $1.2 billion between competitors? Ask Boston Scientific

Reblog this post [with Zemanta]

Read Full Post »

The Sales Force Shuffle, from Pharmaceutical Executive – The last week the pharma atmosphere was abuzz with news about sales force cuts, outsourcing, and overhauls. First, Schering-Plough announced that it had eliminated the 1,000 sales positions it said it would trim in April. This is being done as part of a new sales model called—internally—a productivity transformation program (PTP). The new model, to go into effect next month, will streamline the sales force to take a more customer-centric approach, including targeted and relevant physician calls and a relationship management–oriented business model…more

Alpharma to King: No. – In a filing with the Securities and Exchange Commission, Alpharma calls the $37-a-share offer was inadequate and continues to explore all strategic alternatives, including a possible sale to King or another party for a higher price…more

Lilly CEO to Boston: you’re scaring us away – The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports…more

B-I goes to the shrink – The drugmaker has ended a contract with InVentiv, one of the players in the Rent-A-Rep business, which was promoting its troubled Micardis, an angiotensin receptor blocker, otherwise known as a blood pressure med…more

The needle or the drug? – Acupuncture works as well as Wyeth’s antidepressant to fight hot flashes and other menopausal symptoms caused by breast cancer treatment, and its benefits last longer without causing unwanted side effects, according to new research…more

Pfizer’s Pfuture – The big drugmaker is dramatically stepping up sales efforts in emerging markets, overhauling US business operations and slashing more costs ahead of the 2011 patent loss for cholesterol blockbuster Lipitor, the Associated Press informs us…more Plus, going after emerging markets for growth

Paxil damages sperm? – A group of 35 healthy men who were given Paxil over a five-week period had higher levels of sperm with damaged DNA, according to a report..more

Medicis to re-state numbers; stock plunges.

Tarceva linked to liver damage – Genentech Inc and OSI Pharmaceuticals have alerted doctors about cases of liver damage among patients who took the cancer drug Tarceva in a post-approval study, U.S. regulators said on Tuesday…more

Takeda goes for diabetes combo – Takeda Pharmaceutical Co said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes…more

An interesting analysis on adverse event reporting, and social media.

Is the war on cancer really winnable? A realistic and pessimistic analysis from Newsweek.

Reblog this post [with Zemanta]

Read Full Post »

King begins hostile takeover proceedings with Alpharma – Brain Markison, King’s ceo, is disappointed that Dean Mitchell, Alpharma’s ceo, hasn’t responded to his initial offer $1.4 billion offer, which amounted to $33 a share. So Markison raised the bid to $37, or $1.6 billion, and is going directly to shareholders…more

J&J’s Christine Poon to retire.

ImClone to BMS: maybe we’re already dating – The drugmaker calls the $60-a-share bid by Bristol-Myers Squibb ‘inadequate,’ and goes on to say in a statement this morning that famed corporate raider Carl Icahn, who chairs ImClone’s board, has had ’several conversations with the ceo of a large pharmaceutical company,’ which was not named…more And more BMS-to-ImClone here, and on the response here.

Meanwhile, BMS grounding its fleet – Bristol-Myers Squibb is preparing to shut down its aviation operation at Trenton-Mercer Airport, sell four aircraft and dismiss about 32 employees as the drugmaker and leading Mercer County employer seeks to cut costs, according to sources familiar with the company’s plans…more

Amgen violating patents?

Can Botox relieve migraines?

FDA reports rare brain infection/death with Rituxan – The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec…more

Sanofi fills top job with Viehbacher from Glaxo – Chris Viehbacher, GlaxoSmithKline Plc’s head of North American operations, is to take a top job with French drugmaker Sanofi-Aventis, a person familiar with the situation said on Tuesday…more

Januvia, 2 years in: thumbs up – Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed…more

Experimental diabetes drug (BMS/AZ) promising – Bristol-Myers Squibb and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday…more

Fast track for cancer drug Afinitor – An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer. Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given the medicine’s potential to help patients who fail to respond to standard therapy…more

Tysabri for cancer? – Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies said on Friday…more

Celgene gets a fast track for lung cancer drugCelgene Corporation (NASDAQ: CELG) today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy…more

Is Pfizer interested in Bayer?

Sample trouble: drives up costs? – Free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run, according to a new retrospective study in the Southern Medical Journalmore

The Allergan-Medicis “death match” – Allergan and Medicis have been locked in a highly profitable death-match for several years, with both companies bringing out me-too versions of the others’ products, just like Coke and Pepsi…more

But will it be posted in the Post Office? The FDA 20The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed…more

Zimmer growing some spine.

GSK and Valeant on epilepsy drug tie-up.

Pfizer and Medivation to work together on Alzheimer’s/Huntington’s treatment.

Genentech and Roche acting merged: facilities closing – The fallout from Roche’s looming acquisition of Genentech has started. Roche will close a research facility in Palo Alto, Calif., where a 1,000 people work, the San Jose Mercury News reports. Back in July Roche said it would pull the plug on the lab in Stanford Research Park, but the company hedged, saying the closure would happen if the bid for Genentech were successful. Genentech has demurred so far, but most people think it’s just a matter of time before the deal happens. And now, Roche told the Mercury News it’s closing the plant, no matter what…more

No vigil for Provigil at TakedaCephalon Inc. will end its co- promotion agreement with Takeda Pharmaceutical Co. in North America for the sleep-disorder drug Provigil, because net sales dropped to less than $850 million this year…more

UCB: Yep, we’re specialty now. Translation: downsizing – If you can’t buy a biopharmaceutical company, you might as well become one. UCB Pharma last week announced that it will trim 17 percent of its work force—about 2,000 employees—in order to reestablish the company as specialty drug firm….more

Every once in a while you want to visit here – Forbes’ New Drugs to Watch page.

This is way cool – A little-used cancer drug called bryostatin can repair brain tissue if it’s administered within 24 hours after a stroke, according to U.S. researchers. Current stroke treatments must be administered within three hours and aren’t able to repair damaged brain tissue, the scientists said…more

Shire and Vyvanse for ADHD – One of the recent unheralded successes of the drug world was Shire Pharmaceuticals‘ launch of Vyvanse, a new, long-acting treatment for attention deficit and hyperactivity disorder. The fact that so little attention has been paid to Vyvanse is a shame because the take-up of this drug has been impressive — it appears to be well on its way to supplanting Adderall XR as the king of the ADHD drugs…more

I kinda think this one’s a no-win for Genentech – Negative public opinion just keeps piling on to Genentech regarding its pricing policy on Lucentis and Avastin. This weekend saw a big Associated Press story describe how the company is refusing to ask the FDA to approve Avastin for use in treating “wet age-related macular degeneration,” an eye condition that leads to blindness. Genentech is doing this, most people believe, because Avastin would be a much cheaper treatment for wet AMD than Lucentis, another Genentech drug. It costs about $60 per dose to use Avastin on the disease, and $2,000 to use Lucentis…more

Speaking of no-win – releasing Vytorin data…more

Reblog this post [with Zemanta]

Read Full Post »

Who needs exercise? Maybe we can get the benefits in a pill! – That dream, cherished by millions of sedentary couch potatoes, just got a little bit closer. Today, researchers are reporting that an experimental drug can mimic the results of an exercise regimen — with no exercise required. After four weeks of taking the pill, mice who hadn’t worked out displayed a 44 percent increase in their running endurance…more

Schering gets a surprise FDA thumbs down.

BMS looking to buy up the rest of ImClone.

BMS: more jobs on the chopping block. Will BMS be an acquisition target?

OK, you don’t hear about this every day – A contractor for Novartis was charged with running a prostitution ring from his desk at the drugmaker in suburban New Jersey…more

Sales rep access limits identified – Pharma sales reps that want to see a doctor might want to take a less-is-more approach—and by less, we mean fewer doctors. It turns out that the more physicians a practice has on staff, the more likely a rep will get denied access…more (from Pharma Exec)

Viagra for tumors, depressed women? – Viagra, a popular anti-impotence pill, may help some women on antidepressants have better sex, U.S. researchers said on Tuesday…more Impotence drugs may help carry cancer-fighting drugs through the brain to treat malignant tumors, U.S. researchers reported on Monday…more

Encouraging liver cancer results for Nexavar – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that The New England Journal of Medicine published landmark results of a Nexavar study in liver cancer. The data of the Phase III trial showed that Nexavar® (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo. This represents a 44 percent improvement in median overall survival for patients treated with Nexavar…more

Zyprexa and freedom of non-speech.

Elan, Wyeth, and others – not the greatest progress on Alzheimer’s treatments.

Tysabri: the return of brain infections. More here.

Congress wants Vytorin/cancer data – The House Energy and Commerce Committee wants the FDA to turn over the results of an analysis looking into the potential links between Vytorin and cancer…more

Tax money for counter-detailing? – In an effort to dilute the impact of sales reps, several Senators and Congressmen today are introducing a bill that would create funding for a program to send trained pharmacists, nurses, and other health care professionals into a doctor’s office with independent data about benefits, risks, costs, and comparative effectiveness of prescription drugs, including generics…more

Big Pharma stocks – safe haven no more.

The price of malpractice. This is kinda scary.

Zemanta Pixie

Read Full Post »

Breaking news from the ACC:

Vytorin/Zetia gets panned – shows no benefit on the primary endpoint, though effective in reducing some markers. Doctors now wary and skeptical. Merck and Schering-Plough comment. Good summary with more links from Ed Silverman (Pharmlot blog – one of the best btw!) here.
Prasugrel gets a boost – The investigational antiplatelet drug prasugrel plus aspirin produced a marked and highly statistically significant reduction in the risk of coronary stent thrombosis (ST) – a major concern for physicians and patients with potentially fatal consequences – in patients who received a stent as compared to standard therapy with clopidogrel (Plavix®) plus aspirin (1.13 percent vs. 2.35 percent, p<0.0001), according to a stent analysis from the head-to-head TRITON-TIMI 38 trial…more. And, more here from Pharmalot.

Angiomax: pretty much equivalent to heparin – A study released on Saturday found the two drugs worked about the same in low- to moderate-risk patients in preventing death, heart attack and the need to repeat medical intervention on a diseased blood vessel…more

Positive results for AstraZeneca’s cholesterol-reducer CrestorAstraZeneca Plc is stopping a clinical trial of its blockbuster cholesterol fighter Crestor early because of the clear benefits of the medicine compared to placebo, the company said on Monday…more

——OK, now on to other news:

Free drug samples – higher prescription costs? – Following free drug sample receipt, patients who receive these samples have significantly higher out-of-pocket prescription costs than those who don’t, according to the first study to look at the out-of-pocket cost associated with free-sample use…more

Wyeth cutting 1,200 sales reps – The positions are being eliminated as of Monday as part of a major companywide program announced two months ago to save money in the face of regulatory setbacks and generic competition. At the time, the drugmaker acknowledged plans to cut about 10 percent of its global workforce of 50,000 or so, and that sales reps were high on the list. Wyeth employs roughly 25,000 people in the US…more

Sanofi-Aventis to give daily Cialis a boostSanofi-Aventis of France is partnering with Eli Lilly of America’s heartland to give Lilly’s impotence pill Cialis a boost over here…more

Speaking of Sanofi and Lilly: Lantus shows better efficacy than Humalog – A once-daily injection of Sanofi-Aventis‘s insulin drug Lantus controls blood sugar as effectively as Eli Lilly‘s Humalog, which needs to be taken three times daily, researchers said on Friday…more

Singulair trouble – suicide link? – The Food and Drug Administration said Thursday it is investigating a possible link between Merck‘s best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug…more

Takeda drops cholesterol drug candidate lapaquistatTakeda Pharmaceutical Co Ltd, Japan’s biggest drug maker, on Friday dropped development of a cholesterol-lowering drug candidate that had once been seen as one of its most promising medicines…more

Otsuka pays for fraudulent Abilify marketing Otsuka American Pharmaceutical, the US unit of the Japanese drugmaker, agreed to pay more than $4 million to resolve allegations that it marketed the Abilify antipsychotic for off-label uses…more

Disease-mongering brought to a whole new level (are these people serious)? – Anyone familiar with involuntary emotional expression disorder? This is another way of saying uncontrollable laughing or crying, and a little drugmaker called Avanir Pharmaceuticals hopes to market a pill for this “distinct neurological disorder.” Also known as pseudobulbar affect, the affliction has gotten talked up in recent years and investors are buying into the concept…more

The Vytorin studies – what will be revealed at the ACC meeting? Good news from the Enhance study? And why is the Improve-It study being expanded/delayed? Is it for sound data gathering reasons, or is it a conspiracy?

Physician gifting crackdown? – The latest legislative maneuver to control pharmaceutical marketing: Last week, congressman Pete Defazio (D-OR) introduced the Physician Payment Sunshine Act, a bill that will create a public registry of gifts and payments to physicians in excess of $25 by pharmaceutical companies…more

Lunesta moth flying away.

Did you know there are now 30 job openings listed in the Impactiviti Job Board?

Read Full Post »

Older Posts »