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Posts Tagged ‘Sutent’

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TODAY’S NEWS

New experimental RA/Lupus drug suspended after patient deaths - Swiss drugmaker Roche Holding AG and U.S. biotechnology company Biogen Idec are suspending rheumatoid arthritis and lupus treatment ocrelizumab after it caused deaths, casting doubt over the drug’s futuremore

So, what about Amylin‘s Byetta? The pundits are dueling as potential once-a-week version approval draws near…

An interesting background story on Pfizer‘s expensive oncology “miracle” drug Sutent.

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A “trifecta” social media approach – Novartis sponsors a community, Twitter account, and Facebook Fan Page for Cystic Fibrosis patients. How are they doing? An Impactiviti review.

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Top 10 Most Stupid Inventions. No disagreement here!

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TODAY’S NEWS

Pfizer‘s oncology drug Sutent slows down pancreatic cancer spread – Pfizer Inc.  said Sutent, its drug for kidney cancer, also helps stop the progression of a kind of pancreatic cancer, according to a late-stage trial. Sutent is in several late-stage studies to investigate expanding its use beyond kidney and gastrointestinal treatment, exploring its efficacy in treating breast and lung cancer, among others. In the most recent study of patients with advanced tumors originating in the hormone-production area of the pancreas, disease progression was halted for more than twice as long with Sutent versus a placebo..more

Quintiles re-brands: Navigating the New Health.

In pharma-world, people often joke about how we should just put statins in the drinking water. Here’s some insight as to why (don’t shoot the messenger – I know there are plenty of detractors!)

Doc gives up hospital post over conflict-of-interest rules.

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Prilosec making a big venture into social media: a good move? – Procter & Gamble has launched a new online social media site for Prilosec OTC focused on winning new customers by talking up the lifestyle difficulties of heartburn sufferers. In an increasingly crowded market for over-the-counter heartburn medicines, is it worth spending millions more on an advertising campaign for a mature product with declining sales volumes?more

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Advertising on a bus – how to be way too creepy!

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Strangest Indication of the Year Award: first drug I’ve seen with a directional indication – Cephalon, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL® (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travelmore

Sutent for colon cancer – no dice.

New anemia drug approved – AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Feraheme™ (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease...more

Cost/benefit ratio of cancer drugs – this is going to be a hot topic in coming years.

Pain drugs under scrutiny.

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Sepracor‘s experimental epilepsy drug (Stedesa) proceeds to FDA review. STEDESA, a new chemical entity, is a novel voltage-gated sodium channel blocker. STEDESA has been studied in three Phase III, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries. Patients involved in the trials had a history of at least four partial-onset seizures per month despite treatment with one to three concomitant antiepileptic drugsmore

Glaxo makes a deal for deuterium drug technology – Patrick Vallance, Glaxo’s head of drug discovery, said Concert’s approach to deuterium modification of medicines had broad potential to enhance certain drug properties. Deuterium is a heavy isotope of hydrogen and therefore forms a stronger chemical bond to a carbon atom of a molecule. Researchers believe this may substantially improve the metabolic properties of medicines, making them more effectivemore Also, GSK announced encouraging results for a new (experimental) oncology drug for kidney cancer: Today, GlaxoSmithKline announced the results of a Phase III study demonstrating that pazopanib reduced the risk of tumor progression or death by 54 percent compared to placebomore

Pfizer halts Sutent trial in advanced breast cancer – Pfizer Inc today announced the discontinuation of the SUN 1094 Phase 3 study that evaluated SUTENT® (sunitinib malate) plus paclitaxel versus bevacizumab plus paclitaxel for the first line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee (DMC) found that treatment with sunitinib in combination with paclitaxel would be unable to meet the primary endpoint of superior progression-free survival (PFS) compared to the combination of bevacizumab and paclitaxelmore

Plus – encouraging Gardasil results in older women; and encouraging melanoma results (finally!) with a new experimental drug (from Roche/Plexxikon)

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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.

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The Xa factor: not looking so promising for Pfizer and Bristol – Bristol-Myers Squibb and Pfizer’s apixaban blood clot preventer raised rates of bleeding in a 6-month study but showed some encouraging signs of protecting at-risk heart patients, researchers said on Tuesday. Apixaban, which works through a new mechanism of action by blocking a protein called Factor Xa, suffered a setback last week when it failed its primary goal in a late-stage trial for preventing clots after orthopaedic surgery…more A little more promising for Daiichi Sankyo, however. 9/2

This potential advance on a drug to treat Hepatitis-C is quite interesting…especially if you really like medical-technical terms! 9/1

Sciele bought by Japanese pharma company: Shionogi & Co plans to buy U.S.-based Sciele Pharma Inc for $1.1 billion, the fourth big overseas deals in nine months by Japanese drug makers eager to expand overseas…more 9/1

Prasugrel (investigational anti-clotting drug) shows strong results in diabetic patients – Patients who were diabetic and diagnosed with acute coronary syndromes (ACS) were 40 percent less likely to suffer a heart attack if they were treated with prasugrel vs. clopidogrel…more 8/31

Crestor a no-go on heart failure – AstraZeneca Plc’s cholesterol drug Crestor has failed in a second clinical trial for heart failure, suggesting such statin medicines don’t improve survival in patients with the chronic condition…more 8/31

Glaxo does not score with preemption ruling in suicide case. I’m sure the lawyers are loving this. 8/30

A little fun – The Top 10 Weirdest Pharma Stories of the Month. 8/30

Anti-psychotics may double stroke risk – People taking antipsychotic drugs are nearly twice as likely to have a stroke compared to those not on the treatment, British researchers reported on Friday…more 8/29

A swipe at glitazones for diabetes treatment (from PharmaGossip) 8/29

Good news from Teva on Parkinson’s treatment: Teva Pharmaceutical Industries Ltd. said its Azilect pill is the first to slow the progression of Parkinson’s disease in new findings that may increase sales of the medicine to more than $1 billion…more 8/28

A few baby steps into social media by pharma companies. 8/28

Stroke prevention with drug combos: maybe not so much – Two studies released on Wednesday call into question the advantage of using a blood pressure medicine and a well-known blood thinner for preventing the recurrence of a stroke…more 8/28

UCB brings out a heavy axe – The Belgian drugmaker that bought Schwarz Pharma is cutting 2,000 jobs, or 17 percent of its staff, to spur profits and lower administrative costs. The move is part of an effort to redirect $444 million into research on meds for immunology and the central nervous system…more 8/28

Amgen getting rid of “bundling sales” practice (it’s about time) – the company is getting rid of “bundling” — giving docs discounts on other Amgen drugs based on how much of their anemia-drug business consisted of Amgen’s Aranesp…more 8/28

Cell Genesys plunges after troubling trial results…butRecent news of high fatalies during one its drug trials has weighed on Cell Genesys‘ stock price, but the company may be able to overcome the blow

if data from a different study helps it gain FDA approval…more 8/28

Replidyne plunging downhill fast – Drug developer Replidyne Inc said it will restructure its operations, reduce its headcount by about 80 percent to 5 employees and take a charge of $3.1 million…more 8/28

From Forbes: Vytorin - efficacy questions still nipping at the heels. And, the cancer scare. 8/28

More bad pancreatitis news with Byetta. 8/27

An interesting analysis of Abbott’s strengths and weaknesses moving forward. 8/27

Lilly’s Cymbalta: a Swiss army knife drug with too many indications? 8/27

BMS/Pfizer new blood clotting drug not flowing smoothly – Bristol-Myers Squibb Co and Pfizer Inc said on Tuesday their apixaban blood clot preventer failed its primary goal in a late-stage trial, and that they no longer plan to seek marketing approval next year for the pill…more 8/27

Scrips and tripspharmas paying out big for “medical education” junkets 8/25

So now we have the Ambien rooster?? 8/25

Amgen gets drug approval from FDAAmgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales…more 8/25

King making bid for Alpharma – The unsolicited cash bid is a move to create a bigger specialty drugmaker and expand a nascent effor to develop meds for treating pain. The offer is $33 per share amounts to a 37 percent premium over the $24.04 closing price of Alpharma’s common stock yesterday. King actually first made the offer to Alpharma in a letter on Aug. 4 and said the offering represents a 49 percent premium, based on the share price that day…more 8/22

After all that battering in the press, a positive spin on HRT – Hormone replacement therapy can improve the quality of a woman’s life, easing the distress of hot flashes, sleep disturbances and restoring lost sexual functioning, researchers reported on Thursday…more 8/22

A promising experimental cystic fibrosis drug (PTC Therapeutics) 8/22

Abbott Diagnostics planning big cuts – Abbott Laboratories Inc  said on Thursday it would eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business…more 8/22

Genentech employees getting restless about potential Roche takeover: recruiters circling, retention bonuses adding up -Aside from announcing that Genentech is not settling for Roche’s $44 billion offer because it “substantially undervalues the company,” the San Francisco-based biotech made it known that if would be implementing an employee-retention program to help its people make sense of the Roche deal… more 8/22

Gilead Sciences – growing! 8/22

J&J’s Doribax for pneumonia: more info, please. 8/21

Buying out biotechs – A buyout bull’s-eye will likely remain on biotechnology companies over the next few years as major pharmaceutical companies continue taking advantage of a weak dollar and a surplus of cash to buy pipeline additions….more 8/21

Wyeth, Elan, and Alzheimer’s: is this experimental drug worth the pursuit? – In what is becoming a sadly common ritual, Wyeth and Elan are pressing forward with an expensive, large-scale “phase III” trial of a risky drug based on wishful thinking and shoddy statistical analysis…more 8/21

Expensive cost cutting at Sepracor. 8/21

Gardasil – not worth the cost? – That’s the conclusion of a new study that is going to make life much harder for Merck to wring needed sales out of its controversial HPV vaccine. The study, which appears in the New England Journal of Medicine, comes as the drugmaker is already struggling to convince college-age and older women to get the vaccine, which costs about $360 for a three-dose regimen….more 8/21

Might daily Cialis help with symptoms of enlarged prostate? 8/20

Just came across this BNET Industries site which consolidates Pharma news. Looks pretty good! 8/20

Feel like debating a single-payer (government-run) healthcare system? Here’s a lively debate, from the WSJ Health blog (see the comments). 8/20

Roche, Accutane, and IBD – is there any link? 8/20

Clinical trials: cancer gets the lion’s share – Most registered trials were in oncology, followed by central nervous system disorders, cardiology, infectious diseases, endocrinology, and respiratory diseases. These six therapeutic areas accounted for 68 percent of 3,515l protocols…more 8/20

BMS and PDL go after MMLBristol-Myers Squibb Company and PDL BioPharma, Inc.  today announced an agreement for the global development and commercialization of PDL BioPharmas anti-CS1 antibody, elotuzumab, previously known as HuLuc63, currently in Phase I development for multiple myeloma…more 8/19

Vytorin prescriptions: hitting bottom? 8/19

My pipeline’s bigger than your pipeline – who’s got the goods to be able to claim it? You might be surprised… 8/18

Warning on deaths associated with Byetta – The FDA is working on a stronger label for the widely used diabetes drug, which is marketed by Lilly and Amylin Pharmaceuticals after deaths continue to be reported despite earlier government warnings. Six new new reports were received of patients developing a dangerous form of pancreatitis while taking Byetta… more 8/18 But, fair balance 8/20

Jersey jobs walking out - Layoffs and restructurings are taking a toll on drug and device makers in New Jersey, which for decades has prided itself on being home to many of the world’s biggest such companies…more 8/18

Was a key Vioxx study less than scientifically stellar? – A 1999 Merck study of Vioxx, which was touted to participating doctors and patients as easier to stomach than another drug, was primarily a stealth marketing strategy, according to a report to be published this week in The Annals of Internal Medicine…more 8/18

Do “charming” sales reps earn more? (from John Mack’s Pharma Marketing blog). And, in a similar vein: D’uh! 8/18

What’s Next? Ban Free Drug Samples? (from John Mack’s Pharma Marketing blog). 8/18

Which presidential candidate has received more donations from pharma execs? By a factor of three? 8/18

Abbott to co-promote Crestor – Seeking to increase its share of voice without beefing up its sales force, AstraZeneca is partnering with Abbott on a co-promotion of Crestor in the US…more 8/14

New antibody drug helps nail blood cancer – A new kind of antibody drug that makes the body’s own “killer” cells fight tumors has produced promising early-stage results in patients with a deadly form of blood cancer, researchers said on Thursday…more 8/14

Genentech to Roche: No thanks, but maybe. 8/13

MS drug may work against viral infection – A drug that Novartis AG is testing in people with multiple sclerosis also has the potential to treat certain viral infections, perhaps including the AIDS virus, U.S. researchers said on Wednesday….more 8/13

FDA extends review of Centocor drug – Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) hasextended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis…more 8/8

It’s a slow year so far for FDA drug approvals 8/8

Go ahead, Massachusetts…make my day – This morning, five trade groups representing drugmakers and biotechs took out a full-page ad in The Boston Globe arguing the bill will “significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts….more 8/7

Kidney cancer drugs too costly? Yes, says UK – Is extending life by a few months worth $50,000? No, says the UK’s National Institute for Health and Clinical Excellence. In a report out today, the group concluded that several new drugs for advanced kidney cancer aren’t cost-effective…more 8/7

King Pharma income takes a plunge. And some other question marks about an upcoming pain treatment here. 8/7

Rituxan may help a kidney disease - The cancer drug rituximab can help heal the kidneys of patients with a common condition known as membranous nephropathy, Italian researchers reported on Wednesday…more 8/6

Eat your broccoli! 8/6

Artificial blood producing genuine problems. A recent meta-analysis of trials on several substitutes — including Hemopure — contains some gory results. Turns out, the fake bloods scavenge nitric oxide, causing vasoconstriction; patients who get them are 2.7 times more likely to have a heart attack and 30 percent more likely to die… 8/6

Abbott dips into podcasting (for Chrohn’s patients). 8/6

Live long and prosper, with Byetta? – Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer? Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference…more 8/6

Which pharma company will be biggest in 2014? The projections might surprise you… 8/6

FDA to advertise fake blood pressure pill – OK, that’s weird… 8/5

Maybe sleep meds not so great – In its latest bid to track prescription drug use, Consumer Reports conducted a survey last spring of 1,466 Americans who took sleeping pills and found that nearly half have difficulties. Consquently, many are turning to prescription meds with what CR calls “frightening results.” Here they are…more 8/5

Rutgers unveils mini-MBA program for pharma professionals. 8/5

Feel-good story about Sinemet helping a young boy who has Parkinson’s. 8/5

SGP entangled with a whistleblower mess (inherited from Organon) – Last month, Schering-Plough’s lawyers filed a motion in federal court in New Jersey arguing that a former medical director at Organon, which the drugmaker recently paid $14.3 billion to acquire, wasn’t qualified to bring a whistleblower lawsuit alleging Organon covered-up serious side effects prior to launching two drugs several years ago…more 8/5

The Medicines Company gets approval for cleviprex – The Medicines Company announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable…more 8/4

Careful about giving cold meds to babies – Yet another study raises questions about the dangers of giving cough and cold meds to babies. A “surprising” number of small children taken to emergency rooms after they stop breathing or lose consciousness have OTC meds in their systems, USA Today writes, citing the study in Pediatricsmore 8/4

Beware of Mass. reps bearing gifts – When Massachusetts’ House of Representatives approved a big healthcare bill last month, drug and device makers and data firms thought they’d ducked several bullets, but the final bill, passed by both houses last night, includes a few nasty surprises for industry – including a code of conduct for drug marketers, an academic detailing program and stringent reporting requirements for payments to physicians…more 8/4

GSK cutting down oncology personnel – The ax is falling again at GlaxoSmithKline (GSK). This time it’s the oncology group… more 8/4

Who might be next in the pharma takeover phrenzy? 8/4

A doctor’s balanced perspective on the recent Vytorin kerfuffle. 8/4

Schering announces encouraging results for experimental Hep-C drug - Schering-Plough Corp  said on Monday that interim results from a mid-stage study of its experimental hepatitis C drug showed promising results, sending shares of rival Vertex Pharmaceuticals Inc down more than 10 percent in early trading…more 8/4

Novartis get two big approvals for HPB combo pills – The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT® (valsartan and hydrochlorothiazide) and Exforge® (amlodipine and valsartan), as initial or ‘first-line’ therapies in patients likely to need multiple drugs to achieve their blood pressure goals…more 8/4

Good news on statins and memory loss – People at high risk for dementia who took cholesterol-lowering statins are half as likely to develop dementia as those who do not take statins, a new study shows…more 8/4

New/old cancer treatment: methadone effective against leukemia! – “Methadone kills sensitive leukemia cells and also breaks treatment resistance, but without any toxic effects on non-leukemic blood cells…”more 8/4

Backing away from CME – Trying to steer clear of potential conflicts of interest, two medical industry giants are distancing themselves from a little-known breed of marketing specialists. The recent steps by the drugmaker Pfizer (PFE) and Zimmer Holdings (ZMH), a medical device manufacturer, illuminate subtle promotional tactics other companies continue to aim at doctors, despite mounting concern on the part of some physicians and ethicists…more 8/4

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Novartis Pharma US CEO Alex Gorsky resigns.

Genentech‘s Avastin and breast cancer – meets study goals, gets approved.

Heparin investigation gets ugly for Baxter. If you click on the link in the 2nd paragraph to look at the pictures of manufacturing in China, do so well before your next meal…uggh.

New treatment for Hemophilia A – Wyeth‘s Xyntha approved.

Prasugrel (Lilly/Daiichi-Sankyo), new anti-clotting treatment, gets priority review.

Stem cells and diabetes – an encouraging new study result.

Can statins ease irregular heartbeat?

Cancer drug Rituxan may be useful in treating MS.

Pfizer‘s Sutent linked to heart failure in some patients.

How a promising new potential treatment was unveiled through a very big mouse!

More Americans are taking more drugs. I would love to see some context around stats like this – such as, what are the possible healthcare savings that may be a result??

In defense of drug rep/doctor schmoozing.

Amgen probed for unethical marketing practices – another whistleblower case.

Stop leaking calcium!

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