Prescription Drug News and Research

RSS

Omeros completes enrollment in first of two OMS103HP Phase 3 meniscectomy trials

Omeros Corporation today reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery.

8 Aug 2012

Drug companies developing novel treatments for MDR-TB

With incentives to find new antibiotics signed into U.S. law last month, "multiple players are vying for the lead in the [multi-drug resistant tuberculosis (MDR-TB)] drug development niche," Nature Medicine reports.

8 Aug 2012

Viewpoints: Orszag on CAP cost-control proposals; High-tech and health costs

The Center for American Progress proposals thus wisely recognize that there is no single strategy to continue the recent progress in slowing the growth in health-care costs. In contrast, the Republican budget plan put forward by Representative Paul Ryan of Wisconsin seems based on a belief that all that's needed is to shift risks: from Medicare to beneficiaries through a premium-support program, and from the federal government to state governments by turning Medicaid into block grants.

3 Aug 2012

New FDA risk management plan aims to reduce opioid abuse in the U.S.

A new risk management plan from the U.S. Food and Drug Administration to help clinicians properly prescribe drugs with addiction potential aims to help reduce the growing epidemic of opioid abuse in the United States.

2 Aug 2012

Roundup: Most high-ranking Iowa gov't employees to pay more for health care; Federal judge strikes Fla. law on docs asking about guns

The New Jersey state Legislature endorsed a constitutional amendment Monday requiring judges to contribute more to their government benefits, sending to voters an issue that some consider a linchpin of judicial independence. In a rare midsummer voting session, lawmakers responded quickly and almost unanimously to a state Supreme Court decision last week that said judges can't be forced to pay more for pension and health benefits, as other government workers were in a historic 2011 law.

31 Jul 2012

FibroGen receives FDA Orphan Drug Designation for FG-3019 to treat IPF

FibroGen, Inc., today announced that FG-3019, the Company's human monoclonal antibody against connective tissue growth factor (CTGF), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

31 Jul 2012

Top-line results from Pfizer's tofacitinib Phase 3 study on moderate-to-severe active RA

Pfizer Inc. announced today top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

31 Jul 2012

McKesson settles Rx drug pricing case with 29 states

The nation's largest drug wholesaler by revenue will pay $151 million to settle a lawsuit that alleged the company inflated prescription drug prices for state Medicaid programs.

31 Jul 2012

FDA grants Senesco's SNS01-T orphan-drug designation to treat lymphomas

Senesco Technologies, Inc. reported today that it was informed on July 26th that the U.S. Food and Drug Administration has granted orphan-drug designation for the company's lead drug candidate SNS01-T for treatment of both mantle cell lymphoma and diffuse large B-cell lymphoma.

30 Jul 2012

Watson seeks FDA approval to market Epiduo Gel for severe acne

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Epiduo (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%.

30 Jul 2012

First Edition: June 30, 2012

Today's headlines include recent reports about both the policies and politics related to the health law's implementation.

30 Jul 2012

FDA accepts Exelixis’ cabozantinib NDA for filing

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

30 Jul 2012

Roundup: Mass. lawmakers struggle to reach agreement on cost controls; $100M grant for Calif. stem cell research; N.C. to move mentally ill from elderly homes

The House and Senate are under the gun to reach an agreement on how to lower health care costs while improving care. A conference committee aims to have a bill out on Sunday. Their deadline is Monday evening. In the meantime, several major issues are still unresolved, including what to do about hospitals that use their market clout to demand high prices that are not based on higher quality. Attorney General Martha Coakley, the state's top insurers and several consumer groups argue that price is a critical issue.

28 Jul 2012

CMS: Doughnut hole provision in health law has saved seniors $4B

According to the Obama administration, seniors have saved on average $629 on their medications during the first half of this year.

27 Jul 2012

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion.

27 Jul 2012

Humana, Matrix sign multi-year contract to offer Medicare Advantage medical assessment services

Matrix Medical Network, a national leader in prospective medical assessment services, announced today that Humana Inc., one of the nation's leading health and well-being companies, has signed a multi-year contract with Matrix to provide prospective medical assessments to Humana Medicare Advantage health plan members.

26 Jul 2012

RADARS System Poison Center data can predict methadone overdose trends in the U.S.

A new report, published today in PLoS One shows that RADARS(R) System Poison Center data can be used to predict methadone overdose trends in the U.S.

26 Jul 2012

New investment to fund Chiasma's Octreolin Phase 3 pivotal program for acromegaly

Chiasma, Inc., a privately held biopharma company, announced that it closed a $38.5 million equity financing co-led by new investor Abingworth and current investor MPM Capital that also included investments from existing shareholders 7 Med Health Ventures, ARCH Venture Partners, F3 Ventures and Fredric Price, Chiasma's Chairman & CEO.

23 Jul 2012

Herbal therapy no alternative in HCV infection

The commonly used herbal remedy, silymarin, offers no benefit to patients with treatment-resistant hepatitis C virus infection, a study shows.

23 Jul 2012

Longer looks: Physicians and assisted suicide; Avoid getting sick in July

Peggy Sutherland was ready to die. The morphine oozing from a pump in her spine was no match for the pain of lung cancer, which had evaded treatment and invaded her ribs. … Sutherland, 68, decided to use Oregon's "Death With Dignity Act," which allows terminally-ill residents to end their lives after a 15-day requisite waiting period by self-administering a lethal prescription drug. ... But not all doctors are on board with the law.

20 Jul 2012