New Rule on Bulk Substances for Compounding Drugs Proposed by ...

www.fdanews.com/articles/179788

9 hours ago - The FDA issued a proposed rule adding six bulk drug substances to the list of materials that can be used in compounding, while removing four substances.

Former sales director to testify against Wrentham owner of compounding pharmacy linked to meningitis deaths

Former sales director to testify against Wrentham owner of compounding pharmacy linked to meningitis deaths: WRENTHAM - A former sales official of the controversial New England Compounding Center linked to a deadly meningitis outbreak in 2012 is expected to testify against a local man, who was the owner and head pharmacist, at his upcoming trial.

One-on-one interview with Harold Bornstein, MD, President-elect Trump's personal physician. (Ike Swetlitz, STAT)

McKesson, Change Healthcare get antitrust clearance for IT deal

The U.S. Justice Department has completed its review of a proposed merger that would combine San Francisco-based drug distributor McKesson Corp.'s tech business with Nashville-based tech firm Change Healthcare.  READ MORE

FDA Annual Summary Report on Antimicrobials Sold or Distributed in 2015 for Use in Food-Producing Animals

The U.S. Food and Drug Administration today published its annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals. The report shows that sales and distribution of all antimicrobials increased 1 percent from 2014 through 2015, tying for the lowest annual increase since 2009. The percentage of those antimicrobials that are considered medically important in human medicine increased by 2 percent from 2014 through 2015.

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2015 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals

It's the same song, but a brand new verse for 2017's drug-pricing ...

FiercePharma-1 hour ago

1 in pharma this year was drug pricing. ... In late December, 19 Democratic senatorswrote Trump to offer their assistance in a drug-pricing ... The report even advances the idea of emergency imports to combat sudden, sharp increases in price.

Senators call for action on drug price 'gouging' - The Hill

64.147.104.30/policy/.../311343-senators-call-for-action-on-drug-price-gouging

2 hours ago - The most famous example is Turing Pharmaceuticals, which was run by Martin ... The report is the result of a months-long investigation by the Senate Aging ...

Report: Drug price spikes threaten patient health, economic stability

www.usatoday.com/story/money/2016/12/21/report-drug-price.../95695010/

13 mins ago - He thinks the U.S. should discuss pharmaceutical pricing as part of trade deals. Video provided by TheStreet Newslook. SENATE REPORT ON DRUG PRICE ...

Essential Reads

Collins, McCaskill Release Committee Report of Bipartisan Drug ...

https://www.collins.senate.gov/.../collins-mccaskill-release-committee-report-bipartisa...

10 hours ago - Collins, McCaskill Release Committee Report of Bipartisan Drug Pricing ... Member of the Senate Aging Committee, released a report on drug pricing ... by four pharmaceutical companies to exploit market failures, the report ...

[PDF]Executive summary - Senate Finance

www.finance.senate.gov/download/sfc-sovaldi-report-executive-summary

The following bipartisan report is the result of an 18-month investigation launched ... breakthrough Hepatitis C drugs, Sovaldi and Harvoni in order to understand the .... 29 states said Sovaldi was the most or second most costly pharmaceutical ...

Senate Aims to Stop Firms From 'Buying Up Drugs and Jacking Up ...

www.nytimes.com/2016/12/21/us/politics/prescription-drug-prices.html

11 hours ago - Pharmaceutical executives say they worry that Mr. Trump will soon assail a ... The Senate report said brand-name drug companies had abused ...

Must Read! Senate report suggests ways to blunt impact of drug prices

Senate report suggests ways to blunt impact of drug pricesSTAT · 10 hours ago

Must Read! The Senate just released a massive report on drug pricing

The Senate just released a massive report on drug pricing - here's ...

Markets Insider-1 hour ago

The report details the instances of four drug companies that made headlines in September 2015 - including former pharmaceutical executive Martin Shkreli's ...

Report: Drug price spikes threaten patient health, economic stability
USA TODAY-1 hour ago

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Prescription drug spending reaches $29.4B in Canada

CBC.ca-Dec 17, 2016

Combined with data on overall drug spending, the report "adds evidence to suggest Canada's reprieve from pharmaceutical budget pressures is over," Morgan ...

Sanders Calls for Investigation of Big Pharma Drug Pushers Over .

Sanders Calls for Investigation of Big Pharma Drug Pushers Over ...

Common Dreams (press release)-20 hours ago

Drug-pushing, multi-billion dollar pharmaceutical companies should be "investigated and prosecuted," declared Sen. Bernie Sanders (I-Vt.) in response to ..

Sen. McCaskill wants FDA to beef up supplement regulations

Sen. McCaskill wants FDA to beef up supplement regulations

ConsumerAffairs-Dec 15, 2016

Photo U.S. Senator Claire McCaskill (D-Mo.) is pushing the Food and Drug Administration to take stronger action to ensure that dietary supplements available to ...

Sen. McCaskill Asks FDA for More Guidance on NDI Enforcement

Natural Products INSIDER (blog)-Dec 16, 2016

U.S. Sen. Claire McCaskill (D-Missouri) recently urged FDA to elaborate in a guidance document how it will take enforcement action against dietary supplement ...

Are dietary supplements riskier than OTC drugs?

Roanoke Times-Dec 19, 2016

Will your vitamins or dietary supplements hurt you? Millions of Americans take multivitamins, herbs or other supplements every day. Most people don't worry ..

FDA Names Permanent Director to Oversee Dietary Supplements

Natural Products INSIDER (blog)-Dec 15, 2016

Steven Tave, a lawyer who has been temporarily leading FDA's Office of DietarySupplement Programs (ODSP) since the spring of 2016, has been named ...

Dietary Supplement Industry Argues 2016 Guidance Contrary to ...

Natural Products INSIDER (blog)-Dec 14, 2016

Draft guidance published by FDA for the dietary supplement industry could burden manufacturers, chill investment, reduce choices for consumers, and fail to ...

Synthetic Botanicals Should Be Dietary Ingredients, Industry ...
Nutritional Outlook-Dec 14, 2016

The selling of unsafe dietary supplements leads to prison sentence

CBS46 News Atlanta-Dec 19, 2016

Chensin Chan of New York involved with selling unsafe dietary supplements online, was sentenced to eleven years and three months in prison on December 16 ...

NY Man Gets Long Prison Term for Selling Ephedra

Natural Products INSIDER (blog)-35 minutes ago

The owner of a dietary supplement marketing company based in Elmhurst, New York, was sentenced to more than 11 years in federal prison for selling dietary ...

Government Pressure on Retailers Forces Compliance on Dietary ...

Natural Products INSIDER-19 minutes ago

GNC's agreement stems from its sale of USPlabs LLC's OxyElite Pro, Jack3d and VERSA-1 dietary supplement products. The products reputedly contained .

Russia 'working well' on tackling doping, but no progress overnight ...

RT-16 hours ago

Russia is cooperating with the World Anti-Doping Agency (WADA), its president Craig Reedie, told RT. He said that how long Russia takes to be reinstated in the ...

Sports scandals, from doping to abuse, creep into New Year
Daily Sabah-19 hours ago

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Mayo pharmacist cleared of professional misconduct

Irish Times-22 hours ago

A Co Mayo pharmacist has been cleared of charges of professional misconduct and poor professional performance in relation to medicines supplied to a young ...

What a great question!! Daily Mail editorial: What's the point of rules that regulators ignore?

Daily Mail editorial: What's the point of rules that regulators ignore?
Charleston Gazette-Mail (subscription)-12 hours ago

S8 standards deteriorating in pharmacy

Australian Journal of Pharmacy (registration) (blog)-11 hours ago

In its latest quarterly newsletter, the Board has warned of the “deterioration” of S8 care in community pharmacy. “Experience amongst pharmacy premises ...

Daily Mail editorial: What's the point of rules that regulators ignore?
Charleston Gazette-Mail (subscription)-12 hours ago

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Fred's to Expand Pharmacy Unit with Rite Aid Buyout, Stock Up

Nasdaq-1 hour ago

Fred's pharmacy segment will continue to employ certain field and regional team members of the acquired stores. Upon completion of the acquisition, Fred's will ...

Rite Aid/Walgreens: It Looks Like Smooth Sailing From Here
In-Depth-Seeking Alpha-19 hours ago

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Imprimis Pharmaceuticals and FocusScript Partner to Exclusively Offer ...

www.fox34.com/.../imprimis-pharmaceuticals-and-focusscript-partner-to-exclusively-off...

3 hours ago - The Correct Compound™ program combines the cost savings of the Imprimis Cares® portfolio of compounded medications with FocusScript's accredited and ...

meningitis-etc: Key NECC Defendant Enters Guilty Plea

meningitis-etc: Key NECC Defendant Enters Guilty Plea: By Walter F. Roche Jr. A key figure in the investigation of a deadly fungal meningitis outbreak has entered a guilty plea and has agreed ...

meningitis-etc: Judge Approves Payment of Legal Fees

meningitis-etc: Judge Approves Payment of Legal Fees: By Walter F. Roche Jr. A federal judge has approved the payment of legal fees and expenses totaling $6.25 million for a group of lawyers ...

meningitis-etc: Judge Sets Dates in NECC Criminal Case

meningitis-etc: Judge Sets Dates in NECC Criminal Case: By Walter F. Roche Jr. Opening arguments in the murder case against Barry Cadden, part owner of a defunct drug company, are tentatively s...

What do new FDA letters dinging 'misleading' pharma TV ads mean for the industry?

Florida reaches multimillion-dollar settlement with doctor over false ...

Legal News Line-11 hours ago

Nagda purportedly ordered large quantities of Bayer's Mirena IUDs from an online pharmacy via credit card on a monthly basis. To be eligible for Medicaid ...

Faced with unaffordable drug prices, tens of millions buy medicine ...

Foster's Daily Democrat-11 hours ago

... but found an online Canadian pharmacy that sold her a three-month supply for $60. Bobby Grant, of Los Angeles, has relied on foreign pharmacies for seven 

Court Grants Motion to Dismiss for Lack of Case or Controversy ...

Lexology (registration)-9 hours ago

Tech Pharmacy filed a patent infringement action against Defendant Alixa Rx LLC and Defendant Golden Gate National Senior Care LLC d/b/a Golden ...

Probe reveals flood of 780M painkillers in 6 deadly years in West ...

CBS News-10 hours ago

“These numbers will shake even the most cynical observer,” former Delegate Don Perdue, D-Wayne, a retired pharmacist who finished his term earlier this ...

Report: DEA records show W. Va. flooded with painkillers
In-Depth-U.S. News & World Report-Dec 19, 2016

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Arizona Agrees to Stop Using Drug Tied to Botched Executions

New York Times-1 hour ago

In Virginia, officials plan to execute a death-row inmate, Ricky Gray, using compounded midazolam on Jan. 18. State prison officials around the country have ...

DEA rules CBD hemp oil illegal

WLOS-2 hours ago

Inside the compounding pharmacy are shelves full of CBD oil. The most popular - Charlotte's Web. "Industrial hemp CBD has very low to no THC, what the DEA ...

Sales executive pleads guilty in fatal meningitis outbreak

U.S. News & World Report-1 hour ago

The compounding center used expired ingredients and failed to follow cleanliness standards, resulting in tainted steroid injections, prosecutors said. More than ...

Animal Drug Compounding Market is Expected to Gain Popularity ...

Satellite PR News (press release)-16 hours ago

Animal drug compounding is a mixing or of drugs prepared by approved pharmacist to fulfill the particular patient's requirement. These drugs are made by ...

Hospitals warn of job losses, billions in cuts if Trump repeals ACA 

The nation's hospital lobbying groups are warning that President-elect Donald Trump's promise to repeal the Affordable Care Act could lead to massive service cuts, layoffs and hospital closures if an adequate replacement is not developed.  READ MORE

Baxter bags India's Claris to further beef up sterile injectables biz by Eric Palmer | Dec 19, 2016 1:22pm

http://www.fiercepharma.com/manufacturing/baxter-bags-india-s-claris-to-further-beef-up-sterile-injectables-biz?utm_medium=nl&utm_source=internal&mrkid=765989&mkt_tok=eyJpIjoiTTJNek9XSmxaREV3WXpWayIsInQiOiJYODVWM3ZJaXQ3WjA0UDJHMno5c3NUUzNPUnNDa3BBaTVHMXQwVFR5b3hUUXd4dTRuNTZsWHloZW1TWk9QNWZTWjBkRFZBYURJNFoxT2JGMkFmOG5IM2N1TDlwVWl3VE9FZFNhR1Nlb3EzM2JKZGY3MVZhOUVBVUJKQkVJbitCUyJ9

United States: At Long Last, OIG Issues Final Rule For Beneficiary Inducement Safe Harbors

ß

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

More than two years since issuing the proposed rule, the HHS Office of the Inspector General issued the long-awaited and highly anticipated final rule that provides amendments to the Anti-Kickback Statute regulatory safe harbors ...

United States: HHS OIG Adopts New Anti-Kickback Safe Harbor And Civil Monetary Penalty Exceptions

ß

Proskauer Rose LLP

On December 7, 2016, the Department of Health and Human Services, Office of Inspector General, issued a final rule that will have a widespread impact on health care service providers, medical transport providers, . . .

United States: HHS-OIG Issues Final Rules On Anti-Kickback And Civil Monetary Penalty Statutes

ß

Dentons

Earlier today, the US Department of Health & Human Services, Office of Inspector General issued two final rules.

United States: 21st Century Cures Act - Provisions Relating To Digital Health

ß

Ropes & Gray LLP

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.

United States: 21st Century Cures Act - Provisions Relating To Reimbursement & Fraud And Abuse

ß

Ropes & Gray LLP

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.

United States: 21st Century Cures Act - Provisions To Promote Drug Development

ß

Ropes & Gray LLP

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.

United States: 21st Century Cures Act And Its Effect On Digital Health

ß

Morgan Lewis

On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it.

United States: 'Tis The Season For Giving: OIG Updates Policy On Gifts Of Nominal Value To Medicare And Medicaid Beneficiaries

ß

McDermott Will & Emery

On December 7, 2016, the OIG of the US Department of HHS issued a policy statement increasing its thresholds for gifts that are considered "nominal" for purposes of the patient inducement provisions...

Future Trends and Competitive Landscape of Sterile Injectable ...

Digital Journal-20 hours ago

Drug makers rising interest in injectable could ease shortages. ... New York, NY -- (SBWIRE) -- 12/19/2016 -- The global pharmaceutical market is highly ...

Is Trump the first crack in the drug industry's right flank?

STAT-8 minutes ago

To some, a splintering between the GOP and the drug industry has been years ... “I think the pharmaceutical industry's instinctual alignment with Republicans is ...

Generic Drug Makers Accused of Illegal Conspiracies over Drug ...

DrugWatch.com-18 hours ago

A coalition of 20 states is suing six generic drug manufacturers, alleging they ... bid rigging and other anticompetitive conduct in the generic pharmaceutical ...

Six Generic Drug Makers Caught In Price-Fixing Conspiracy

Shadowproof (blog)-19 hours ago

Last Thursday, attorneys general in 20 states sued six generic drug makers for ... Pharmaceutical executives agreed to avoid competing with one another as it ...

AG Derek Schmidt sues general drug companies, alleging price-fixing
Hiawatha World-21 hours ago

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No, Updating Federal Drug Regulations Will Not Spawn 'Dangerous ...

The Federalist-1 hour ago

First, opponents condemn the Cures Act for failing to control drug prices. Second ... After spending half the keystrokes attacking the pharmaceutical industry or ...

21st Century Cures Act Requires FDA to Expand Role of Real World ...
The National Law Review-22 hours ago

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