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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

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Pharmalot

STAT Pharmalot: Drug Makers Fund More Compassionate Use Programs Than You May Think

Boston, MA, August 4, 2017 — Pharmalot ‘s Ed Silverman reports on STAT News that patient advocates have long complained that drug and device makers do not make enough experimental medicines available, but a new study finds that the industry funds most trials that aim to get such products to patients.

Specifically, companies funded 61 percent of nearly 400 studies that make drugs or devices available to patients prior to regulatory approval, according to the analysis in BMS Research Notes. Continue reading

Pharmalot: FDA to Hold Two-Day Meeting on Off-Label Drug Marketing

STAT PharmalotBoston, MA, November 8, 2016 ― Pharmalot reporter-blogger Ed Silverman reports on STAT that, after years of anticipation, the U.S. Food and Drug Administration (FDA) will hold a public, two-day meeting starting on Wednesday to review the extent to which so-called off-label information about medicines may be disseminated to physicians.

Nothing will get decided, though.  The meeting is designed simply to give the public — drug makers and patient advocates alike — a long-awaited chance to convey their opinions and debate the issue.

Off-label information refers to materials that describe unapproved uses of a drug.   Continue reading

Pharmalot: Study Show More Clinical Trials Are Succeeding for First Time in Years

Clinical Trial 3Boston, MA, June 14, 2016 ― Pharmalot reporter-blogger Ed Silverman reports on STAT News that after years of declines, the pharmaceutical industry is experiencing a greater rate of success with its clinical trials in recent years, according to a new analysis from McKinsey & Co.,

Between 2012 and 2014, more than 11 percent of clinical trials succeeded, which meant compounds being tested survived the arduous journey from the laboratory to the pharmacy counter.

This reversed a downward trend seen over the past 20 years, according to executives at McKinsey & Co., the consulting firm that conducted the analysis and does consulting work for drug makers. Continue reading

Pharmalot: What Generics? Study Shows Americans Spent an Extra $73 Billion for Brand-Name Drugs

STAT PharmalotBoston, MA, May 11, 2016 ― Pharmalot reporter-blogger Ed Silverman reports on STAT News that doctors may be encouraged to prescribe lower-cost generics, but a new study found that Americans spent an extra $73 billion between 2010 and 2012 on pricier brand-name drugs because physicians failed to sufficiently recommend these copycat treatments to their patients.

And consumers paid nearly one-third of those additional costs through out-of-pocket payments.

Notably, Silverman reported, the study found that the excess spending occurred when a generic version was not available for a specific brand-name drug, but a doctor could have prescribed a lower-cost, copycat for a similar brand-name medicine. Continue reading

Pharmalot: Senate Republicans Urge Obama to Withdraw Medicare Part B Experiment

STAT PharmalotBoston, MA, May 2, 2016 ― Pharmalot reporter-blogger Ed Silverman reports on STAT News that one month after the Obama administration unveiled an experiment to revamp the Medicare Part B program, more than a dozen Republican Senators are urging that it be withdrawn.

At the same time, House Republicans and Democrats are circulating letters among themselves that express varying degrees of concern with the program.

In a letter sent on Friday to the U.S. Centers for Medicare and Medicaid Services, the Senators charged that the program would “severely disrupt care for vulnerable beneficiaries with cancer” and other serious medical conditions.

The Senators also complained that CMS failed to undertake a fully transparent process to assemble its program. Continue reading

Pharmalot: FDA Continues to Struggle with Backlog of Generic Drug Applications

STAT PharmalotBoston, MA, March 3, 2016 ― Pharmalot reporter-blogger Ed Silverman reports in STAT that, under pressure to speed approval of generic medicines, the Food and Drug Administration (FDA) last week released data to defend its progress.

And while industry watchers say the statistics indicate the agency is making headway, there are also clear signs the FDA continues to struggle with the workload.

On the bright side, the number of full and tentative drug approvals has been rising each month since last April and reached 99 this past December, which is the largest tally ever issued in a single month, according to FDA watchers. Continue reading

FDA Designated a Record Number of Orphan Drugs Last Year

STAT PharmalotBoston, MA, February 12, 2016 ― Pharmalot’s Ed Silverman reports on STAT that orphan drugs may target small patient populations, but they are racking up big numbers at the Food and Drug Administration.

Last year, the agency received a record 472 requests from companies to have their medicines designated as orphan drugs.  And the FDA agreed to award 354 designations, which was a 22 percent increase over 2014.

As for approvals, Silverman reported that the agency endorsed 41 orphan medicines, just seven fewer than the previous year, according to the FDA Office of Orphan Products Development. A designation, by the way, means the FDA has decided a drug qualifies for orphan status and takes place before a drug is approved. Continue reading

Pharmalot: FDA Wants Consumer-Friendly Drug Ads

New York, NY, February 8, 2015 ― Pharmalot reports that anyone who leafs through a newspaper or magazine and sees prescription drug ads would be hard-pressed to miss the lengthy fine print describing risks and caveats in copious detail.  Drug makers include this information to comply with the law.

But after years of complaints and concerns this amounts to information overload to consumers, the Food and Drug Administration (FDA) is proposing a new approach.

In a new draft guidance, the FDA suggests that drug makers instead offer “consumer-friendly” summaries in print ads and promotional materials.   Continue reading

Pharmalot: New Analysis Explores to Extent Drugmakers Are Having Trouble Sustaining Innovation

New York, NY, February 4, 2015 ― Is the biopharmaceutical industry undergoing a big squeeze?

Pharmalot, a Wall Street Journal blog, today reports that a new analysis argues that drug makers are experiencing a challenging combination of rising overall costs and, in many cases, pressure on pricing.

Taken together, “the forces of market competition… have essentially eroded the economic profitability of newly launched brand-name” drugs in recent years, according to a paper in Health Affairs, the policy journal. Continue reading

Pharmalot: Report Finds Prescription Medicine Prices Rose in 2014

New York, NY, January 27, 2015 ― Pharmalot reports that the prices of prescription medicines is a front-and-center issue as the cost to treat everything from some of the rarest diseases to the most common afflictions is causing increasing concern among payers, physicians and consumers.

But how much exactly did prices rise last year?

A new analysis indicates prices rose significantly across the board for all types of medicines.   Continue reading