Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Rx Drugs

September 21, 2018 | Daily News

Former CMS officials, a Democrat and a Republican, discussed the intense political pressure CMS staff would be subject to if Medicare were to negotiate drug prices, and they said the current system is preferable.

September 21, 2018 |

Brand drug makers have inched closer to getting Congress to lower their share of seniors’ drug costs by adding to opioid legislation an unrelated package that combines the brand-backed Part D measure with watered-down pro-generic legislation and a provision that averts steep drug cost increases for seniors in 2020.

September 20, 2018 | Daily News

HHS’ Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with Opiant Pharmaceuticals, a company that develops nasal sprays for substance use and eating disorders, to develop a fast-acting, long-lasting intranasal form of nalmefene to reverse overdose, HHS announced Thursday (Sept. 20).

September 20, 2018 | Daily News

Brand drug makers have inched closer to getting Congress to lower their share of seniors’ drug costs by adding to opioid legislation an unrelated package that combines the brand-backed Part D measure with watered-down pro-generic legislation and a provision that averts steep drug cost increases for seniors in 2020.

September 20, 2018 | Daily News

FDA awarded nearly $3 million worth of grants to five universities to study and recommend improvements in the use of continuous manufacturing of biologics, an emerging manufacturing technique the agency says will reduce manufacturing costs and drive down drug prices.

September 20, 2018 | Daily News

FDA is wholeheartedly embracing continuous manufacturing as a move that will lower drug costs and reduce product shortages, but the Association for Accessible Medicines recently told Inside Health Policy it is concerned the move could have unintended negative consequences for generic drug makers.

September 19, 2018 | Daily News

FDA issued three guidances -- two final and a new draft guide -- intended to help drug manufacturers and repackagers prepare to comply with the upcoming deadline for including product identifiers on product packages or cases, and to help them understand when product packages are exempted from the requirements, known as a grandfathering exemption.

September 19, 2018 | Daily News

Several congressional Medicaid advisers said Thursday (Sept. 13) they’re enthusiastic about the idea of giving states a grace period before covering newly approved drugs and lifting the Medicaid rebate cap.

September 19, 2018 | Daily News

FDA is facing pressure to eliminate the requirement that biosimilar sponsors conduct confirmatory powered clinical studies.

September 19, 2018 | Daily News

CMS faces growing pressure to scrap its controversial plan to allow step therapy for Medicare Part B drugs: Dozens of specialty physician groups and state medical societies are seeking congressional leaders' help in getting the Trump administration to reverse course.

September 18, 2018 | Daily News

The American Hospital Association on Tuesday (Sept. 18) touted a new voluntary 340B reporting program as an alternative to legislation to help achieve transparency in the 340B program, but key lawmakers and the pharmaceutical industry disagreed.

September 18, 2018 | Daily News

FDA for the first time has applied its opioid safety protocols to immediate-release (IR) opioids intended for use in an outpatient setting and is requiring that training be made available to nurses and pharmacists -- not just prescribers -- who are involved managing patients with pain, the agency announced Tuesday (Sept. 18).

September 18, 2018 | Daily News

Sources say brand and generic drug trade groups have agreed in principle on a deal that couples a tweaked version of the generic-backed bill to stop brands from using drug safety requirements to delay competition with brand-backed Part D bills to reduce brands’ contribution to beneficiaries’ donut hole costs and avert the so-called coverage gap “cliff.”

September 18, 2018 | Daily News

California is suing AbbVie for allegedly offering providers kickbacks to prescribe Humira, an expensive arthritis drug that has also come under fire on Capitol Hill due to steep price increases.

September 18, 2018 | Daily News

HHS Secretary Alex Azar will chair a new cabinet-level interagency biodefense steering committee launched by the White House as part of a new National Biodefense Strategy unveiled Tuesday (Sept. 18).

September 17, 2018 | Daily News

Following months of legislative debate involving myriad committees, the Senate on Monday (Sept. 17) passed an extensive package of opioid legislation by a vote of 99-1 but a new version privately hammered out by senators from both parties will be taken to conference with the House, a Senate aide told Inside Health Policy.

September 17, 2018 | Daily News

The Senate voted 98-to-2 for legislation to stop all health plans and pharmacy benefit managers in the commercial market from using gag orders to prevent pharmacists from telling customers, unless asked, when it is cheaper to buy drugs without insurance.

September 17, 2018 | Daily News

The Justice Department’s antitrust division approved, without conditions, Cigna’s proposed $67 billion purchase of Express Scripts, despite concerns that allowing the insurer and pharmacy benefit manager to merge could lead to higher drug prices.

September 17, 2018 | Daily News

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

September 17, 2018 | Daily News

Seven major health organizations, including the Consumer Healthcare Products Association, Pew Charitable Trusts and American Academy of Pediatrics, are urging Congress to swiftly pass legislation that would reform the system under which over-the-counter (OTC) drugs are regulated and brought to market.

Pages