amphastar pharmaceuticals is a publicly traded american pharmaceutical company .

its products include enoxaparin sodium injection , cortrosyn , amphadase , emergency syringes in luer-jet , lidocaine , naloxone , and phytonadione injection .

amphastar pharmaceuticals

amphastar announces final judgment in the patent litigation against momenta pharmaceuticals , inc . and sandoz inc .
amphastar pharmaceuticals , inc . ( amph ) announced business expansion plans for its subsidiary , amphastar nanjing pharmaceuticals inc . ( “anp” ) . to date , anp has provided active pharmaceutical ingredients ( “apis” ) and starting materials specifically to amphastar . after the expansion is completed , anp intends to begin selling apis both to amphastar and externally around the world to expand its overall markets .
amphastar pharmaceuticals inc ( nasdaq : amph ) , a pharmaceuticals company based in united states , received a lot of attention from a substantial price movement on the nasdaqgs in the over the last fewread more . . .
moving average crossover alert : amphastar pharmaceuticals , inc . ( amph ) 6 / 5 / 2018 5 : 21 : 00 am - urltoken
rancho cucamonga , calif . , july 09 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced business expansion plans for its subsidiary , amphastar nanjing pharmaceuticals inc . ( “anp” ) . to date , anp has provided active pharmaceutical ingredients ( “apis” ) and starting
commit to purchase amphastar pharmaceuticals at $ 15 , earn 6 . 9 % annualized using options 2 / 22 / 2018 12 : 42 : 58 pm - bnk invest
amphastar pharmaceuticals inc said on tuesday that the u . s . food and drug administration had rejected its application to market an intranasal version of the emergency opioid - overdose treatment , naloxone .
the fda sent warning letters to two chinese suppliers of amphastar in april this year .
amphastar pharmaceuticals , inc . ( amph ) announced today that bill peters , cfo , will be presenting at the jefferies healthcare conference on tuesday , june 5 , 2018 at 3 : 00 p . m . eastern time in new york , ny . this presentation will be made available with a live webcast and may be accessed by visiting amphastar’s pharmaceuticals website at http : / / ir . amphastar . com . this webcast will be available for 90 days following the presentation .
the investigation was commenced after an ethics complaint was filed by amphastar pharmaceuticals inc . which charges that dr . woodcock has a conflict of interest favoring its competitor , momenta pharmaceuticals inc . both companies seek approval for the generic version of the drug , lovenox , a blood thinner with multi - billion - dollar sales .
measuring amphastar pharmaceuticals inc’s ( nasdaq : amph ) track record of past performance is a valuable exercise for investors . it allows us to understand whether or not the company has met or exceedread more . . .
if you are a shareholder in amphastar pharmaceuticals inc’s ( nasdaq : amph ) , or are thinking about investing in the company , knowing how it contributes to the risk and reward profile of yourread more . . .
on nov . 2 , 2007 , the fda rejected amphastar’s application , although the agency acknowledged that amphastar had passed a key hurdle in demonstrating its drug’s chemical equivalence to lovenox . the fda told amphastar that it needed more data to show that the product wouldn’t cause dangerous immune reactions .
rancho cucamonga , calif . , march 21 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced that on march 20 , 2018 , the united states court for the district of massachusetts ( the “district court” ) entered final judgment in favor of amphastar in a lawsuit brought by
amphastar already sells naloxone in pre - filled syringes , as does privately held kaleo pharmaceuticals , which came under fire earlier this month for raising the price of its naloxone device evzio by 550 percent to $ 4 , 500 .
3 stocks to watch on tuesday : amphastar pharmaceuticals inc ( amph ) , coupa software inc ( coup ) and kronos worldwide , inc . ( kro ) 3 / 13 / 2018 7 : 00 : 14 am - investorplace media
amphastar pharmaceuticals , inc . is a progressive , forward - looking company that will recognize your talents , challenge you , and reward your efforts competitively . we invite you to explore employment opportunities with amphastar and its subsidiaries . we are over 1200 employees strong ; developing , manufacturing and marketing quality pharmaceutical products at six ( 6 ) locations :
reports net revenues of $ 58 . 4 million for the three months ended march 31 , 2018 rancho cucamonga , calif . , may 09 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) ( “amphastar” or the “company” ) today reported results for the three months ended march 31 , 2018 .
in its complaint , amphastar alleges that its competitor had special access to dr . woodcock at critical times in the prolonged approval process , which is ongoing . amphastar points out that dr . woodcock co - authored a scientific paper with scientists at momenta pharmaceuticals inc . while both companies were battling to win fda approval of their generic blood thinners .
amphastar pharmaceuticals , inc . ( amph ) announced that the u . s . food and drug administration ( “fda” ) granted approval of the company’s abbreviated new drug application ( “anda” ) supplement for the manufacture of semi - purified heparin at the company’s subsidiary , amphastar nanjing pharmaceuticals ( “anp” ) and the manufacture of heparin sodium usp at the company’s subsidiary , international medication systems , limited . this market information is based on iqvia data for the 12 months ended march 31 , 2018 .
amphastar pharmaceuticals , inc . ( amph ) announced today that jason shandell , president , and bill peters , cfo , will be presenting at the bank of america merrill lynch health care conference on tuesday , may 15 , 2018 at 1 : 00 p . m . pacific time in las vegas , nv . this presentation will be made available with a live webcast and may be accessed by visiting amphastar’s pharmaceuticals website at urltoken . amphastar is a specialty pharmaceutical company that focuses primarily on developing , manufacturing , marketing , and selling technically - challenging generic and proprietary injectable , inhalation , and intranasal products .
amphastar pharmaceuticals inc ( nasdaq : amph ) is currently trading at a trailing p / e of 188 . 9x , which is higher than the industry average of 22 . 9x . while this makes amph appear like a stockread more . . .
reports net revenues of $ 58 . 4 million for the three months ended march 31 , 2018 . rancho cucamonga , calif . , may 09 , 2018 - - amphastar pharmaceuticals , inc . today reported results for the three months ended . . .
amphastar’s subsidiary , international medication system , ltd . ( ims ) , utilizes the proprietary prefilled disposable emergency syringes for
amphastar pharmaceuticals , inc . , headquartered in rancho cucamonga , california , established in 1996 , is a recognized specialty pharmaceutical company that uses state - of - the - art , cgmp compliant facilities to develop , manufacture , and market injectable and inhalation products .
investors are always looking for growth in small - cap stocks like amphastar pharmaceuticals inc ( nasdaq : amph ) , with a market cap of us $ 895 . 24m . however , an important fact which most ignore is : how financiallyread more . . .
both amphastar and momenta , which is based in cambridge , mass . , submitted applications seeking fda approval of their generic versions of lovenox heparin sold by sanofi - aventis sa . amphastar applied in 2003 , two years before momenta .
a novartis spokeswoman said the company was unaware of the ethics complaint filed by amphastar . - jake sherman contributed to this article
amphastar pharmaceuticals , inc . is a specialty pharmaceutical company that is engaged in the development , manufacture and marketing of generic and proprietary injectable and inhalation products . amphastar and its subsidiaries are all recognized names in the pharmaceutical industry whose capabilities have evolved over the years . although each unit has its own distinct focus , each compliments the others . together they strive to meet the varied needs of the pharmaceutical industry .
amphastar and its subsidiaries each have their own distinct focus that they skillfully bring together to meet the varied needs of the pharmaceutical industry .
amphastar pharmaceuticals , inc . , ( amph ) announced that the u . s . food and drug administration ( “fda” ) has granted approval of its abbreviated new drug application ( “anda” ) for isoproterenol hydrochloride injection , usp 0 . 2mg / ml , 1ml and 0 . 2mg / ml , 5ml single dose vial . isoproterenol hydrochloride is indicated for multiple uses including for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy . amphastar’s newly approved product was determined by the fda to be therapeutically equivalent to isuprel® ( isoproterenol hydrochloride injection ) sold in the united states by valeant pharmaceuticals .
this conference call may contain forward - looking statements including statements relating to amphastar pharmaceuticals . these statements are not historical facts , but rather based on amphastar pharmaceutical ' s current expectations , estimates and projections regarding amphastar pharmaceutical ' s business , operations and other similar or related factors . words such as may , will , could , would , should , anticipate , predict , potential , continue , expects , intends , plans , projects , believes , estimates and other similar or related expressions are used to identify these forward - looking statements . these statements are only predictions and are such are not guarantees of future performance . and they involve risks , uncertainties and assumptions that are difficult or impossible to predict . actual results may differ materially from those in the forward - looking statements . as a result of a number of factors including these described from time to time and amphastar pharmaceuticals ' filings with the sec . *
rancho cucamonga , calif . , june 04 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced that the u . s . food and drug administration ( “fda” ) granted approval of the company’s abbreviated new drug application ( “anda” ) supplement for the manufacture of semi - purified heparin
rancho cucamonga , calif . , may 03 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced that the company will release results for its first quarter of 2018 ended march 31 , 2018 , after the market closes on wednesday , may 9 , 2018 , and will hold a conference call to
the investigation of janet woodcock , the director of the fda’s center for drug evaluation and research , stems from an ethics complaint filed by amphastar pharmaceuticals inc . , a california company that says it has been delayed in its six - year effort to win approval for a generic version of lovenox , a multi - billion - dollar blood thinner .
rancho cucamonga , calif . , june 19 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . , ( nasdaq : amph ) announced that the u . s . food and drug administration ( “fda” ) has granted approval of its abbreviated new drug application ( “anda” ) for isoproterenol hydrochloride injection , usp 0 . 2mg / ml ,
rancho cucamonga , calif . , june 04 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced today that bill peters , cfo , will be presenting at the jefferies healthcare conference on tuesday , june 5 , 2018 at 3 : 00 p . m . eastern time in new york , ny .
rancho cucamonga , calif . , may 14 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced that the u . s . food and drug administration ( “fda” ) granted approval of the company’s abbreviated new drug application ( “anda” ) for calcium chloride injection 10 % in the 10 ml luer - jet
rancho cucamonga , calif . , march 26 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced today that bill peters , cfo will be presenting at the needham‘s 17 th annual healthcare conference on wednesday , march 28 , 2018 at 9 : 30 a . m . eastern time in new york , ny .
rancho cucamonga , calif . , may 10 , 2018 ( globe newswire ) - - amphastar pharmaceuticals , inc . ( nasdaq : amph ) announced today that jason shandell , president , and bill peters , cfo , will be presenting at the bank of america merrill lynch health care conference on tuesday , may 15 , 2018 at 1 : 00 p . m .
amphastar offers a competitive benefits package that includes medical , dental , life insurance plans , education assistance , 401 ( k ) retirement savings plans , paid holidays and vacation days . amphastar is committed to providing its employees with an environment that empowers them to realize their full potential and to achieve both personal and professional goals .
amphastar ( amph ) has witnessed a significant price decline in the past four weeks , and has seen negative earnings estimate revisions for the current quarter and year .
enoxaparin is available in prefilled syringes with ultrasafe® needle guard making it fully compliant with the needlestick safety and prevention act . amphastar ' s enoxaparin is available in seven dosage forms .
the fda ' s complete response letter identifies issues with user human factors study - which is designed to evaluate the user interface of a product - among others , amphastar said .
while the tainted - heparin crisis offered rival momenta a chance to shine , it added to the delays for amphastar . at the height of the chinese heparin crisis in 2008 , amphastar learned that one of its chinese suppliers for the main ingredient used in its experimental heparin had misled the company about where the raw material had been produced , although the fda didn’t find contamination .
in addition to the corporate headquarters , amphastar has five manufacturing facilities located in the united states , china and europe along with a state - of - the - art new drug research center .
he noted that the fda’s demand for more information about immune reactions affected momenta as well as amphastar , and caused momenta’s share price to fall nearly 60 % on nov . 6 , 2007 .
amphastar pharmaceuticals , inc . ( amph ) announced that the company will release results for its first quarter of 2018 ended march 31 , 2018 , after the market closes on wednesday , may 9 , 2018 , and will hold a conference call to discuss its financial results at 2 : 00 p . m . pacific time . to access the conference call , dial toll free ( 877 ) 881 - 2595 , or ( 315 ) 625 - 3083 for international callers , five minutes before the conference . the passcode for the conference call is 5298899 .
mainly , however , amphastar points to dr . sasisekharan’s appointment to lead an fda task force in early 2008 , which put him and momenta in regular contact with the agency . that task force was investigating tainted chinese - made heparin , a crisis that led to nearly 100 deaths .
earlier this week , sen . bernie sanders ( i - vt ) and rep . elijah cummings ( d - md ) blasted amphaster pharmaceuticals , the maker of the drug naloxone , in a letter in which the duo questioned the rationale of increasing the price of the drug during a time when heroin overdose deaths have more than tripled within a three - year period .
amphastar , in letters sent to the fda in april and june , cited some public contacts and email between dr . woodcock and one of momenta’s founders , massachusetts institute of technology biological engineering professor ram sasisekharan , beginning in february 2007 . among those contacts were their attendance at an international medical conference in thailand in november 2007 .
amphastar contends that dr . woodcock’s collaboration with momenta is a conflict of interest and has asked that she recuse herself from the entire matter at the fda .
the fda is aware of the situation , takes it seriously , and is looking into the matter ,
an agency spokesman said . he said dr . woodcock isn’t recusing herself .
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we are a specialty pharmaceutical company that focuses primarily on developing , manufacturing , marketing and selling technically challenging generic and proprietary injectable , inhalation , and intranasal products , as well as insulin active pharmaceutical ingredient , or insulin api , products . we currently manufacture and sell over 20 products . additionally , we are currently developing a portfolio of 15 generic abbreviated new drug applications , or andas , three generic biosimilar product candidates and six proprietary product candidates . for the years ended december 31 , 2017 , 2016 , and 2015 , we recorded net revenues of $ 240 . 2 million , $ 255 . 2 million , and $ 251 . 5 million , respectively . we recorded net income of $ 4 . 5 million and $ 10 . 5 million for the years ended december 31 , 2017 and 2016 , respectively , and recorded a net loss of $ 2 . 8 million for the year ended december 31 , 2015 . . . . more . . .
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the ongoing fight over big pharma’s pricing policies continues as congressional leaders shift their focus to a drug that police departments use to treat heroin overdoses . while law enforcement agencies have become more accepting of this approach to combat drug abuse , recent price spikes put the future of city and state distribution programs in jeopardy .
“over the past several months , police departments , law enforcement agencies , and public health officials across the country have warned about the increasing price of naloxone , which they use to combat the scourge of heroin abuse , ” sanders and cummings wrote in their letter .
naloxone , a generic drug that’s also known as narcan , reverses the effects of potentially fatal opioid overdoses by relieving the depression of the nervous and respiratory systems and quelling symptoms of hypertension . nearly half of u . s . states have passed laws granting wider access to naloxone , which can be administered in the bloodstream and through the nostrils . doctors in those states can prescribe naloxone to friends and family members of opioid abusers . these measures also remove liability from people who dole out the drug , including police officers .
in april 2014 , the food and drug administration approved evzio , a user - friendly naloxone injector to the satisfaction of public health officials and advocates . however , a sticker price of more than $ 400 keeps the tool out of the hands of many people who would prefer having the drug on hand in case a friend or family member overdoses . the price of the formula that can be injected nasally also doubled to the chagrin of law enforcement officials and heads of nonprofits , many of whom have turned to amphaster — its sole producer — for answers .
“you’re being held at the whim of companies that can do what they want because they have a monopoly on a drug , ” eliza wheeler , project manager for the harm reduction coalition’s dope program , told medpage today in november 2014 . “the balance of our program rests on whether we can afford a product . that they can wantonly raise the price is terrifying . ”
when it comes to naloxone , this type of price manipulation is nothing new . pharmaceutical companies have adjusted prices of the drug according to its demand since it appeared on the market in the early 1970s . after the centers for disease control and prevention declared an opioid epidemic in 2008 , for example , the price of the drug — which cost less than $ 3 per dose at the time — increased by more than $ 1 , 100 since then .
today , law enforcement officers are reeling from naloxone price spikes of up toward 50 percent that threaten the potential to curb heroin addiction . health officials in maryland said they’re worried that the rising prices will stall their efforts to train police officers in doling out the drug to those experiencing an overdose . long before sanders and cummings railed against amphaster , massachusetts attorney general maura healey inquired about the increase in the price of naloxone amid a public health emergency in the state .
ed schneiderman , new york’s attorney general , took a similar approach and secured an agreement for $ 6 rebate per dose to agencies in the state for a year . lawmakers , however , aren’t satisfied . in their letter , sanders and cummings called on amphaster to make across - the - board price changes and subsidies similar to what was done for new york consumers , citing its potential to save lives .
“although we are encouraged by your stated willingness to work with other states , it remains unclear why your company has not already lowered its prices in states other than new york . the rapid increase in the cost of this life - saving medication in such a short time frame is a significant public health concern , ” the duo wrote .
data from the centers for disease control and prevention supports their point : if made more readily , naloxone could prevent more than 20 , 000 deaths in the united states annually . a 2013 study found that distributing the drug could save one life for every 227 kits that are distributed . empirical evidence has also played a part in authorities’ change of heart . for example , more than 100 , 000 overdose reversals were reported from 188 naloxone distribution programs in the united states . in these programs , more than 53 , 000 people had been trained to administer the drug .
that’s why more people want to see community groups get access to the drug during a critical juncture in the fight against heroin abuse . one criticism has been that of the monopoly that pharmaceutical companies have on these products . years before naloxone’s price exploded , advocates suggested taking the new approach a step further by distributing naloxone over the counter , predicting that failing to do so would further marginalize heroin addicts .
even though widespread distribution in this manner doesn’t seem likely to happen , discussions about taking the life - saving medicine out of big pharma’s hands still occur . the editorial board of the herald news , for example , suggested that pharmaceutical companies in massachusetts develop a drug - delivery device that could compete with naloxone toward the end of last year .
in a twist of irony , john santilli of access market intelligence , an organization that works with big pharma , had similar thoughts about the drawbacks that amphaster’s stranglehold on naloxone could have for heroin addicts and their families .
“the increase in price of nasal naloxone from the lone manufacturer is having a large negative impact on the ability of community groups to pay for the drug , ” santilli told the modern medicine network last year . “the price of a new auto - injector naloxone is projected to also be expensive . to keep naloxone affordable , it should not be burdened with regulatory obstacles and made available at a price similar to what it costs to produce , ” santilli added .
we currently produce approximately 15 injectable products while we continue to develop a portfolio of generic and branded products that target large markets with high technical barriers to entry . amphastarâ€™s long - standing relationship with the major group purchasing organizations and drug wholesalers in the u . s . enables it to establish significant market share upon the introduction of its new products .
we are a specialty pharmaceutical company that focuses primarily on developing , manufacturing , marketing , and selling technically - challenging generic and branded injectable and inhalation products . we currently manufacture and sell 15 products in the u . s . and are developing a portfolio of 13 generic and 7 branded injectable and inhalation products that primarily target markets with high technical barriers to entry .
is a diagnostic agent used in the screening of patients presumed to have adrenocortocal insufficiency . with cortrosyn ' s rapid effect on the adrenal cortex , it may be utilized to perform a 30 - minute test of adrenal function ( plasma cortisol response ) as an office or outpatient procedure requiring only two venipunctures ( see cortrosyn® professional prescribing information ) .
is an enzyme that breaks down hyaluronic acid in connective tissue , increasing tissue permeability . hyaluronidase is typically used as an adjunctive agent to facilitate the dispersion and absorption of other drugs . it is used in local anesthesia to increase the area affected and speed the onset of action , especially in nerve - block anesthesia and anesthesia prior to ophthalmic surgery ( see
a nonsteroidal anti - inflammatory drug ( nsaid ) , is indicated for the short - term ( up to 5 days in adults ) management of moderately severe acute pain that requires analgesia at the opioid level , usually in a postoperative setting .
a completely needleless , luer lock syringe . luer - jet™ complies with osha ' s needlestick safety and prevention act , and is compatible with most luer activated systems ( including icu medical clave® valve ) .
is a preservative - free topical local anesthetic agent and is provided in the uniquely designed uro - jet prefilled syringe , which is specially designed to reduce discomfort during the product application .
is indicated for the topical anesthesia of the respiratory tract . it is provided in the laryng - o - jet prefilled syringe , which is designed to reduce discomfort during product application .
naloxone hcl injection is indicated for the complete or partial reversal of narcotic depression and diagnosis of suspected acute opioid overdose .
needleless luer jet prefilled syringe : completely needleless syringe , provided in luer lock syringe , complies with osha ' s needlestick safety and prevention act . compatible with most
( vitamin k1 ) for newborns has been on the market for many years . recently , however , with the trend moving towards safe needle technology , ims has combined its product’s configuration with the saf - t - jet™ prefilled syringe , which complies with the needlestick and safety prevention act .
is indicated for the treatment of documented ventricular arrhythmias , such as sustained ventricular tachycardia , that , in the judgement of the physician , are life - threatening . because of the proarrhythmic effects of procainamide , its use with lesser arrhythmias is generally not recommended . treatment of patients with asymptomatic ventricular premature contractions should be avoided .
new york , june 05 , 2018 - - in new independent research reports released early this morning , fundamental markets released its latest key findings for all current investors , traders , and shareholders of summit . . .
here ' s a roundup of top developments in the biotech space over the last 24 hours . scaling the peaks ( stocks hitting 52 - week highs on may 14 ) abiomed , inc . ( nasdaq : abmd ) bio - rad laboratories , inc . ( nyse : . . .
the rancho cucamonga , california - based company said it had a loss of 16 cents per share . losses , adjusted for non - recurring costs , were 5 cents per share . the results missed wall street expectations . the . . .
new york , april 12 , 2018 - - in new independent research reports released early this morning , fundamental markets released its latest key findings for all current investors , traders , and shareholders of . . .
the ipo profiles may contain historical records . please visit the latest ipos for the most recent information .
we are a specialty pharmaceutical company that focuses primarily on developing , manufacturing , marketing and selling technically - challenging generic and proprietary injectable and inhalation products . we currently manufacture and sell 15 products in the u . s . and are developing a portfolio of 13
edgar® online , a division of donnelley financial solutions . edgar® is a federally registered trademark of the u . s . securities and exchange commission . edgar online is not affiliated with or approved by the u . s . securities and exchange commission .
mallinckrodt plc ( mnk ) jumps : stock rises 15 . 3 % 2 / 28 / 2018 9 : 56 : 00 am - urltoken
dr . daniel schultz , who has been fda’s chief medical device official , is the first high ranking fda official whose controversial device approvals have resulted in his leaving the agency
by mutual consent .
earlier this year , nine scientists spoke up to incoming president obama that they had concerns about how medical devices were approved without adequate checks for effectiveness and safety . read more : the approvals had been issued by dr . schultz , over the objections of fda scientists .
dr . janet woodcock , director of the fda’s all - powerful , center for drug evaluation and research ( cder ) , is under investigation by the inspector general .
the wall street journal reports ( below ) that dr . woodcock’ close contacts with momenta in the middle of a drug - approval process were ( to say the least ) ethically questionable . morgan stanley characterized the woodcock / momenta connection as a
game changer
whereupon momenta’s stock jumped 17 % in a day .
it is further reported that dr . woodcock co - authored journal articles with momenta scientists , then co - authored two medical journal articles last year that won scientific — as well as wall street — kudos for momenta .
the wsj notes :
it is unusual for fda officials to co - author journal articles with industry researchers , though the fda said it encourages publication in journals in collaboration with noted scientists . dr . woodcock , who joined the fda about 20 years ago , has done so only a handful of times in recent years . in addition , this instance occurred in the middle of a drug - approval process .
another high ranking fda official , dr . thomas laughren , fda’s director of psychiatry products , overruled fda’s team of safety officers , much as dr . schultz did : on april 29 , 2007 , dr . laughren issued an approvable letter to eli lilly for pediatric use of zyprexa ( olanzapine ) – despite serious concerns about the integrity of the data obtained in russia .
dr . thomas laughren has been in a pivotal high ranking position at fda’s powerful cder center that has authority over the review and drug approval process since 1983 . throughout his tenure at the fda dr . laughren has maintained close ongoing collaborative ties with pharmaceutical industry officials and industry financed psychiatrists in academia and professional associations . dr . laughren has participated in influential industry sponsored consensus panels convened by the american academy of child and adolescent psychiatry ( aacap ) that recommended expanded use of psychotropic drugs - primarily ssri antidepressants and the so - called ‘atypical’ antipsychotics - for unapproved , off - label uses in children . the alliance for human research protection has compiled a list of influential journal articles , a book chapter , and industry sponsored consensus statements that list dr . laughren as co - author–thereby greatly enhancing their influence .
dr . laughren participated in consensus forums whose purpose was to influence regulatory policy and / or expanded use of psychotropic drugs and to influence practice guidelines . his name and position are penned to articles whose authors include eli lilly’s chief medical officer , and unabashed industry - subsidized drug promoters - even a convicted felon .
for more than a decade dr . laughren endorsed industry’s denials that ssri antidepressants increased the suicide risk for consumers . he dismissed safety concerns raised by fda medical reviewers : instead , he penned his name to articles and consensus statements that recommended broadening the criteria for diagnosing psychiatric illness and expanded use of ssri antidepressants , antipsychotics , and combinations .
for example , dr . laughren’s name is penned to consensus statements recommending broadening the criteria for pediatric bipolar disorder . such an endorsement by dr . laughren provides an authoritative green light to physicians to prescribe antipsychotics–the most hazardous drugs in pharmacopoeia for children–even as the drugs had not been approved for children .
dr . laughren not only co - authored major articles promoting industry’s marketing goals but his name is penned to an apparently ghostwritten article :
mood disorders in the medically ill : scientific review and recommendations ,
published by the journal of the society of biological psychiatry , 2005 .
the article promotes the notion that depression accompanies practically all patients with medical illnesses - e . g . , cardiovascular disease , cancer , aids , alzheimer’s , parkinson’s , diabetes , osteoporosis , obesity , and pain . dr . laughren , a co - author , recommends the use of antidepressants for presumed underlying depression , even claiming that
ssris may be cardioprotective .
dr . laughren’s name has lent the appearance of legitimacy of what is clearly industry propaganda that has no basis in science or evidence - based medicine .
see , ahrp letter of complaint addressed to the former fda commissioner , dr . andrew voneschenbach ( june 2007 )
dr . schultz , dr . woodcock , and dr . laughren are among top echelon fda officials who have held sway for years , serving the interest of the industry they are supposed to regulate . these pivotal fda officials–and several others–have approved unsafe–indeed , dangerous–prescription drugs and medical devices disregarding the recommendations of the agency’s safety scientists .
the beneficiaries of ill - considered fda marketing approvals have been drug and device manufacturers , while the american public has been badly served : millions have suffered serious harm , hundreds of thousands have died as a result of poorly reviewed fda - licensed drugs and devices .
during the third quarter of 2008 the fda received 24 , 872 serious adverse drug event reports identifying 854 different drugs . for the third quarter of 2008 reported serious , disabling adverse drug events were 30 . 5 % higher than the same quarter one year ago .
there were 2 , 778 patient deaths , 1 , 162 cases of disability and 20 , 932 cases of other kinds of serious injury . reported patient deaths in the third quarter were 41 % higher than the same quarter in the previous year . see , synopsis of this qw report at : urltoken
the wall street journal august 12 , 2009 , 5 : 06 a . m . et fda medical - device regulator resigns by alicia mundy
washington — the food and drug administration’s top medical - device regulator said tuesday he is resigning .
the departure follows internal dissent over device - approval decisions that the regulator’s critics said were too friendly to industry .
daniel schultz said his move comes
by mutual agreement
with fda commissioner margaret hamburg , who took office in may .
an fda spokesman said dr . schultz’s decision came as the result of talks with dr . hamburg , and had nothing to do with any specific issue related to a device’s approval process .
dr . schultz has worked at the fda’s center for devices and radiological health for 15 years and led it for the past five years .
sen . chuck grassley ( r . , iowa ) held hearings two years ago on dr . schultz’s approval of a nerve stimulation device to treat depression , approval that came over the objections of several fda doctors . mr . grassley complained at the time that science was being ignored in favor of industry . dr . schultz said his decision was based on sound medical data .
in march , sen . grassley opened an investigation into a knee - surgery device made by regen biologics inc . , after the wall street journal reported that dr . schultz approved it over the objections of numerous fda scientists and reviewers .
fda deputy commissioner joshua sharfstein said in may that the agency would re - examine the approval process for the regen knee device to see if proper procedures were followed .
a group of nine device division employees wrote to the house energy and commerce committee last october to complain that the division’s leaders had approved devices despite formal safety and efficacy concerns raised by fda . they also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division . the fda at the time declined to comment .
the advanced medical technology association , a medical - device industry group , praised dr . schultz , saying he ensured stable funding for the fda via industry user fees .
dr . hamburg said in a statement that dr . schultz left a strong legacy and helped the division enhance understanding of medical - device use in children .
write to alicia mundy at alicia . mundy @ urltoken printed in the wall street journal , page b2 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
washington — the inspector general of the department of health and human services is investigating a conflict - of - interest allegation involving the official in charge of drug approvals at the food and drug administration , the fda said .
the fda , responding to repeated queries over a week , declined to make dr . woodcock available for comment . an hhs official said the department cannot confirm or deny ongoing investigations .
in separate fda news , the agency on tuesday said its top medical - device regulator , daniel schultz , is resigning , following internal dissent over decisions that his critics said were too friendly to industry .
lovenox , a low - molecular - weight heparin , is a blockbuster biologic drug that brought in $ 3 . 5 billion in world - wide sales last year .
momenta was also asked to submit such data . both companies said they have complied and are awaiting the fda’s response .
drs . woodcock and sasisekharan , along with other momenta scientists , then co - authored two medical journal articles last year identifying the cause of the contaminated chinese heparin imports , a finding that won scientific — as well as wall street — kudos for momenta .
it is unusual for fda officials to co - author journal articles with industry researchers , though the fda said it encourages publication in journals in collaboration with noted scientists . dr . woodcock , who joined the fda about 20 years ago , has done so only a handful of times in recent years . in addition , this instance occurred in the middle of a drug - approval process .
dr . woodcock has held her post since 1994 , except for two years as deputy commissioner under george w . bush .
in april 2008 , after the tainted - heparin article was published , an investment report from morgan stanley cited momenta’s fda connection as a
game - changer ,
and momenta’s stock jumped 17 % in a day .
momenta’s chief executive , craig wheeler , said contacts between representatives of his company and dr . woodcock were appropriate . he said they were part of an effort to persuade the fda that it should use a higher standard of equivalence in approving generic versions of lovenox — a standard that he believes momenta’s technology enables it to meet .
i’m not sure why having lower [ generic ] standards would be in the public interest ,
said mr . wheeler .
without addressing the specific case , an fda spokesman cited
evolving science
as having raised agency concerns about immune - system issues with complex drugs such as lovenox .
momenta has teamed up with a unit of swiss drug giant novartis ag to bring its product to market .
write to alicia mundy at alicia . mundy @ urltoken printed in the wall street journal , page b1
| tagged academia , fda , bi - polar , senator grassley , zyprexa , novartis , psychiatry , ssri , the wall street journal , eli lilly , diabetes , psychotropic drugs bookmark the permalink .
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the bitter truth was that aids did not just happen to america – it was allowed to happen by an array of institutions , all of which failed to perform their appropriate tasks to safeguard the public health … there was no excuse , in this country and in this time , for the spread of a deadly new epidemic .
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president donald trump described them as america’s “forgotten people , ” the less - educated white , middle - aged americans . this group of individuals , together with the baby boomers and the so - called generation x , are among the most vulnerable to heroin and prescription drug abuse . several studies indicate that the number of drug overdose deaths among baby boomers , generation x and less - educated white americans has jumped in recent years .
data released by the centers for disease control and prevention ( cdc ) in late february showed that the age - adjusted rate of drug overdose deaths in the u . s . in 2015 was more than 2 . 5 times the rate in 1999 . the cdc claimed that the spike in the number of drug overdose deaths was tied in to the drop in the price of heroin along with easier access to prescription drugs .
in 1999 , the rate of drug overdose was estimated at 6 . 1 per 100 , 000 . it jumped to 16 . 3 per 100 , 000 in 2015 or an increase of 5 . 5 % annually . from 1999 to 2006 , the number increased by 10 % and then another 3 % from 2006 to 2013 before jumping again by 9 % per year from 2013 to 2015 as shown in government data .
warning ! gurufocus has detected 7 warning signs with bicx . click here to check it out .
“the pattern of drugs involved in drug overdose deaths also has changed in recent years , ” according to an official in the cdc report . “in 2010 , 29 % of drug overdose deaths involved natural and semisynthetic opioids and 12 % involved methadone . in 2015 , the percentage of drug overdose deaths involving these drugs decreased to 24 % and 6 % . in contrast , drug overdose deaths involving heroin increased from 8 % in 2010 to 25 % in 2015 . increases were also seen in drug overdose deaths involving synthetic opioids other than methadone , from 8 % in 2010 to 18 % in 2015 . ”
brady granier , president , ceo and director of biocorrx inc . ( bicx ) expressed concern over the growing drug abuse problem in the u . s . he agrees with the government’s opinion that drug overdose deaths is a major public health burden . the cdc reported that the total number of drug overdose deaths totaled 47 , 055 in 2014 .
granier commented , “the best way to combat this problem is through prevention , but this will take a collaborative effort between parents , educators , governments , not for profits , law enforcement agencies and more . then on the other side , there’s treatment and recovery . treatment options are evolving to address that side of the problem especially in the field of medication - assisted treatment . we are seeing some potentially very effective new tools on the horizon that can help people more efficiently in the areas detox and relapse prevention . ”
the drop in the price of pain medications is one of the leading causes why many americans are misusing the drug and becoming drug addicts , according to the cdc report .
“since 1999 , the amount of prescription opioids sold in the u . s . nearly quadrupled yet there has not been an overall change in the amount of pain that americans report , ” according to the cdc . they also said that statistically , the number of deaths from prescription opioids has risen more than 400 % over the last 15 years . this includes abuse of medications like oxycodone , hydrocodone and methadone .
a similar study by researchers at the princeton university has confirmed that the so - called forgotten people of america are more susceptible to drug overdose deaths due to drug and alcohol poisonings , suicide and chronic liver diseases and cirrhosis .
the princeton study concluded , “those with less education saw the most marked increases . rising midlife mortality rates of white non - hispanics were paralleled by increases in midlife morbidity . ”
the year 2016 was a banner year for the u . s . coast guard’s fight against drug trafficking with a record illegal drug haul .
the coast guard seized more than 416 , 000 pounds of cocaine with a street value estimated at $ 5 . 6 billion by the end of october 2016 . the catch was the largest made by the coast guard in a single year of its history , covering 263 operations spanning the caribbean , the gulf of mexico and the eastern pacific ocean .
that year , the coast guard also arrested 585 suspected drug smugglers , 465 of whom were repatriated to the u . s . mainland to face charges .
however , america’s “war on drugs” netted an estimated 1 . 25 million individuals arrested in the u . s . in 2015 for possession of illegal drugs . the war on drugs also resulted in unparalleled hostility and instability in drug - producing nations including mexico , colombia , etc . sadly , illegal drugs still proliferate the streets despite the billions of dollars spent by the federal government in the fight against illegal drugs .
the stigma associated with drug addiction is preventing most from seeking treatment . a study by the national survey on drug use and health has found that only 14 % of drug dependents will seek treatment . a majority of drug addicts find it difficult to accept that they are addicted to an illegal substance which is typically the first step in the treatment process .
researchers said that the stigma attached to being labeled a drug addict has a profound impact in the fight against addiction as it prevents treatment resources from reaching many people who need them , and it discourages drug dependent individuals from seeking treatment at all .
however , granier said there are several programs available to rehabilitate those suffering from addiction while preventing them from relapsing . biocorrx offers its biocorrx® recovery program , a non - addictive , medication - assisted treatment ( mat ) program used to treat both alcohol and opioid addictions to independent treatment providers across the u . s . .
the program uses naltrexone in an implantable form that can block cravings and prevent relapse for several months while the patient goes through the proprietary counseling program that was written by addiction experts specifically for those receiving long term naltrexone treatment . naltrexone is an opioid antagonist that blocks some of the effects of alcohol and opioids and has been fda approved in the oral and injectable form for many years . the program also includes 12 months of peer recovery support to add another layer of support for the patient and family while also tracking results using an algorithmic software program .
one of the first - line treatments for opioid abuse includes reckitt benckiser group ’s ( mex : rb n ) buprenorphine , which is being marketed under the suboxone brand name . but suboxone is facing controversies over alleged illegal trade practice and the drug itself is suspected of causing addiction amongst its patients .
another first - line treatment is naloxone , sold under the brand name narcan . narcan is said to be an effective treatment to reverse opioid overdose if treatment is administered in time . however , the price of narcan has spiked tremendously over the past month making the drug very expensive .
a third option is naltrexone , a nonaddictive medication that is found to be an effective medication in the fight against opioid abuse , as well as alcoholism . alkermes , a $ 8 . 39 billion pharmaceutical company , is currently selling naltrexone under its vivitrol brand .
granier added that biocorrx is in the preclinical stage of developing its own injectable naltrexone . he said , “bicx101 is being developed to provide another option to patients and doctors in the fight against addiction . our goal is to deliver a product in a much smaller volume , with a smaller needle , and therefore presumably , less discomfort . ” he added that the product should not require refrigeration and may also be able to be given subcutaneously instead of in the buttocks .
while the statistics on the drug overdose deaths is a cause for alarm , health authorities and researchers are predicting that the volume of drug overdoses will decline soon . they cited better law enforcement practices and more effective monitoring of prescription drugs should help reduce the drug overdose cases and eventually the number of deaths associated with it .
scientists at columbia university’s mailman school of public health estimated that the number of deaths from drug overdose will peak at 50 , 000 this year declining to “a nonepidemic state” of 6 , 000 deaths by 2035 .