Prescription Drug News and Research

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First Edition: January 8, 2014

Today's headlines include news from Capitol Hill about how current events offer a window into the dynamics of the 2014 campaign season.

8 Jan 2014

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration has accepted and filed for review the company's Biologics License Application for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism.

7 Jan 2014

Medicare seeks to tighten drug program rules to fight fraud

Draft regulations issued Monday would overhaul the prescription drug program and could save up to $1.3 billion over five years.

7 Jan 2014

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Aeterna Zentaris Inc. today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

7 Jan 2014

FDA grants orphan drug designation for DiaVacs' type 1 diabetes mellitus therapy

DiaVacs, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy.

6 Jan 2014

Medicare shapes what others pay for health care

Because of Medicare's huge scale, the prices it pays for procedures often shape what others pay for similar care, economist are finding. In the meantime, the program continues to look for ways to prevent inappropriate prescribing by its doctors.

2 Jan 2014

Most clinical trials of vitamin supplements have flawed methodology

Most large, clinical trials of vitamin supplements, including some that have concluded they are of no value or even harmful, have a flawed methodology that renders them largely useless in determining the real value of these micronutrients, a new analysis suggests.

31 Dec 2013

FDA accepts Cubist Pharmaceuticals' tedizolid phosphate NDA with Priority Review

Cubist Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the Company's New Drug Application for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. The FDA has assigned a Prescription Drug User Fee Act action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections.

30 Dec 2013

Medicare drug program gets Senator's scrutiny after vulnerability report

A Senate committee chairman said he is concerned about the "serious vulnerabilities" detailed in a ProPublica report about scams that target Medicare's popular prescription drug program.

26 Dec 2013

FDA extends PDUFA Priority Review action date for UC indication of Takeda's vedolizumab

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States Food & Drug Administration has extended the Prescription Drug User Fee Act Priority Review action date for the ulcerative colitis indication of Takeda's investigational biologic, vedolizumab.

24 Dec 2013

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

Veloxis Pharmaceuticals A/S, today announced that Envarsus was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

24 Dec 2013

Researchers compare prescription drug costs between the U.S. and the U.K

The 2009 costs of antibiotics covered by private insurance companies in the U.S. for children younger than 10 years old were estimated to be more than five times higher than the costs in the United Kingdom (U.K.), which are covered by a government universal health plan.

23 Dec 2013

Researchers receive 3 Patient-Centered Outcomes Research Institute awards from PCORI

Research teams at Group Health Research Institute have been approved for funding awards by the Patient-Centered Outcomes Research Institute (PCORI) to study opioid therapy and asthma-and to help expand a health data network that will be part of PCORnet: the National Patient-Centered National Clinical Research Network.

20 Dec 2013

Nuvo Research, NovaMedica enter into agreement to market Pennsaid products in Russia

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology, and NovaMedica LLC, a Russian pharmaceutical company, today announced that they have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo's Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States.

19 Dec 2013

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted for standard review the Company's supplemental Biologics License Application for EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema.

18 Dec 2013

Prescription drug misuse and driving after using drugs on the rise among Ontario students

Alcohol consumption and smoking among Ontario students in grades 7-12 is at an all-time low; however recreational use of over-the-counter drugs is on the rise. Prescription drug misuse and driving after using drugs also remain elevated according to the 2013 Ontario Student Drug Use and Health Survey released by the Centre for Addiction and Mental Health.

16 Dec 2013

New test may help decrease risk of suicidality in patients treated with antidepressants

The new test, based on research carried out at the Max Planck Institute of Psychiatry, should help doctors to decrease the risk of suicidality in patients treated with antidepressants who show certain gene markers. Sundance is completing a new round of funding to extend the initial validation results reported by the Institute. The company plans to launch the test immediately as a laboratory developed test. In addition, clinical studies in support of a U.S. Food and Drug Administration submission for market clearance, CE marking and reimbursement will be initiated. Sundance expects to submit its application to the agencies within 18 months.

13 Dec 2013

State highlights: States scramble to change newborn screening programs; obesity rate flat; New York hospital charges vary considerably

States across the country are making significant changes to their newborn screening programs after a Milwaukee Journal Sentinel investigation found that thousands of hospitals were sending babies' blood samples late to state labs that test for rare yet deadly genetic disorders. From keeping labs open on weekends to identifying problem hospitals and providing them with regular performance reports, dozens of health officials are reviewing and retooling their state-run programs (Gabler, 12/11).

13 Dec 2013

FDA Advisory Committee recommends metreleptin for treatment of generalized lipodystrophy

AstraZeneca and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).

12 Dec 2013

GW Pharmaceuticals receives U.S. patent for treating glioma

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 12/996,124, a patent which covers the use of cannabinoids for treating glioma.

11 Dec 2013

Prescription Drug News and Research

First Edition: January 8, 2014

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

Medicare seeks to tighten drug program rules to fight fraud

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

FDA grants orphan drug designation for DiaVacs' type 1 diabetes mellitus therapy

Medicare shapes what others pay for health care

Most clinical trials of vitamin supplements have flawed methodology

FDA accepts Cubist Pharmaceuticals' tedizolid phosphate NDA with Priority Review

Medicare drug program gets Senator's scrutiny after vulnerability report

FDA extends PDUFA Priority Review action date for UC indication of Takeda's vedolizumab

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

Researchers compare prescription drug costs between the U.S. and the U.K

Researchers receive 3 Patient-Centered Outcomes Research Institute awards from PCORI

Nuvo Research, NovaMedica enter into agreement to market Pennsaid products in Russia

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Prescription drug misuse and driving after using drugs on the rise among Ontario students

New test may help decrease risk of suicidality in patients treated with antidepressants

State highlights: States scramble to change newborn screening programs; obesity rate flat; New York hospital charges vary considerably

FDA Advisory Committee recommends metreleptin for treatment of generalized lipodystrophy

GW Pharmaceuticals receives U.S. patent for treating glioma

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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