Prescription Drug News and Research

RSS

New drug approval pathway to encourage development of critically needed, lifesaving antibiotics

Congress will consider a new drug approval pathway to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance. The Infectious Diseases Society of America (IDSA) proposed the new pathway, the "Special Population Limited Medical Use (SPLMU)" mechanism, to provide an important new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.

10 Mar 2012

Get ready for Be Medicinewise Week 2012

Building on the success of last year’s inaugural event, the week will urge all Australians to stop, think and learn more about the medicines they are using and encourage them to seek information to make better decisions about their health.

8 Mar 2012

Australian TGA approves Bayer's EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has received approval from the Australian Therapeutic Goods Administration (TGA) for EYLEA (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg) via intravitreal injection per month for three consecutive months, followed by 2 milligrams via intravitreal injection every two months.

8 Mar 2012

FDA accepts Eisai's resubmission of perampanel NDA for review

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's resubmission of the New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy.

5 Mar 2012

Meda announces positive results from three MP29-02 studies on allergic rhinitis

Meda announced today positive results of three studies of MP29-02 (tentatively called Dymista), a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate.

5 Mar 2012

GOP presidential candidates look to health policies to highlight differences

Mr. Romney and Mr. Santorum both support the repeal of President Obama's national health care law. Mr. Santorum has criticized Mr. Romney for creating the Massachusetts plan that served as the federal model.

2 Mar 2012

The health law and the states

Stateline reports that some GOP governors are moving very slowly on health insurance exchanges. Also in the news, a bill in the Georgia House would restore child-only plans.

2 Mar 2012

First Edition: March 1, 2012

Today's headlines set the stage for the Senate's scheduled vote on a measure sponsored by Sen. Roy Blunt, R-Mo., that would allow employers and insurers to opt out of provisions in Obama's health care law to which they object on religious or moral grounds.

1 Mar 2012

FDA extends action date for Bristol-Myers Squibb, Pfizer's Eliquis NDA

Bristol-Myers Squibb Company and Pfizer announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

1 Mar 2012

Mass. Senate race: Brown-Kennedy dust-up continues

Sen. Scott Brown, R-Mass., has refused a request from former Rep. Patrick Kennedy, D-R.I., to pull a campaign advertisement rejecting the federal birth control mandate that features Kennedy's father, the late Sen. Edward Kennedy, D-Mass.

29 Feb 2012

Abortion legislation making noise at state capitols

A host of abortion legislation proposals in state capitols around America -; ranging from requiring Colorado doctors with religious objections give patients notice to mandated insurance coverage of abortion in Washington -; are making news.

28 Feb 2012

Report identifies patterns in misuse of illicit and prescription drugs among young adults

A new report from researchers at the Drexel University School of Public Health identifies patterns in the misuse of illicit drugs among young adults who also misuse prescription drugs.

28 Feb 2012

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

EMA acceptance of peginesatide MAA triggers $5M milestone payment to Affymax

Affymax, Inc. today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide.

27 Feb 2012

Cost of NHS prescriptions set to rise

Mr. Burns outlined a number of changes in the amounts charged for NHS services in a written statement to MPs. He added that patients purchasing a three-month or annual prescription payment certificate (PPC) will not face any increase, with the costs remaining at £29.10 and £104, respectively. The health minister pointed out that PPCs “offer savings for those needing four or more items in three months or 14 or more items in one year”.

26 Feb 2012

Impax announces FDA acceptance of NDA filing for IPX066

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson's disease (PD) submitted to the Agency on December 21, 2011.

23 Feb 2012

GOP presidential hopefuls face off in two battleground states

Issues ranging from plans to cap or cut Medicaid spending to voting positions on the Medicare prescription drug program are among the policies being tossed about as candidates jockey for Tea Party votes and conservative credentials.

23 Feb 2012

Enrollment complete in Onyx Phase 3 ASPIRE trial for relapsed multiple myeloma

Onyx Pharmaceuticals, Inc. today announced that it has reached the target enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low dose dexamethasone in patients with relapsed multiple myeloma.

23 Feb 2012

Onyx reports total operating revenue of $237.0M for fourth quarter 2011

Onyx Pharmaceuticals, Inc. today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010.

23 Feb 2012

FDA EMDAC recommends approval of VIVUS' Qnexa for obesity

VIVUS, Inc. today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.

23 Feb 2012