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Rx Drugs

December 15, 2017 | Daily News

The Federal Circuit dealt what appears to be the final death blow against Amgen's arguments in the suite of cases between the company and Sandoz over interpretation of the so-called biosimilar patent dance.

December 15, 2017 | Daily News

Congressional Medicaid advisers on Thursday (Dec. 14) debated the merits of policies on the calculation and oversight of drug rebates, including giving CMS more power over classifying drugs as brands for determining rebate amounts.

December 15, 2017 | Daily News

Despite bipartisan interest in the House and Senate to provide additional funding to combat the opioid epidemic, neither chamber has any concrete plans to add money to a year-end budget deal as Congress runs up on the final weeks of the year.

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

December 13, 2017 | Daily News

Representatives of the drug-distribution sectors argued over the causes of drug prices at a House Energy & Commerce health subcommittee hearing Wednesday (Dec. 13), but lawmakers were left with unanswered questions and committee Chair Greg Walden (R-OR) said the subcommittee will likely hold another hearing on drug prices early next year.

December 13, 2017 | Daily News

Next year the administration will continue to divvy up set-aside funds for states to fight the opioid epidemic based on a state's population, rather than need, Assistant Secretary for Mental Health and Substance Use Elinore McCance-Katz told senators Wednesday (Dec. 13).

December 13, 2017 | Daily News

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

December 13, 2017 | Daily News

The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.

December 13, 2017 | Daily News

Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.

December 12, 2017 | Daily News

A bipartisan group of six senators recently urged the upper chamber's leadership to include a provision to prevent a cut to hospital reimbursement for 340B drugs in an end-of-the-year package -- though it is unclear what legislation lawmakers may look to pass once the current continuing resolution runs out Dec. 22.

December 12, 2017 | Daily News

Sen. Rand Paul (R-KY) on Tuesday (Dec. 12) proposed letting drug companies offer varying up-front discounts because doing so would move industry away from rebates that are blamed for obscuring business deals many lobbyists and policy analysts say contribute to price increases.

December 12, 2017 | Daily News

FDA will hold a meeting Jan. 30 weighing a number of steps FDA Commissioner Scott Gottlieb called unprecedented to deal with the opioid crisis, including requiring sponsors create nationwide Prescription Drug Monitoring Programs (PDMPs).

December 12, 2017 | Daily News

Drug industry lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) on Monday (Dec. 11) threw its support behind a number of policy proposals to tackle the opioid crisis, including limits on prescribing, a ban on prescribing of Schedule II opioids in an office setting, ongoing prescriber training, expanded access to addiction treatment options, and development of abuse-deterrent formulations (ADFs) of opioids.

December 11, 2017 | Daily News

FDA approved Monday (Dec. 11) the first fast-acting insulin to go through the abbreviated 505(b)(2) pathway, Sanofi-Aventis U.S.'s Admelog, a follow on to Lilly's blockbuster Humalog.

December 11, 2017 | Daily News

Brand drug makers on Friday (Dec. 8) challenged the constitutionality of a California drug-price transparency law.

December 08, 2017 | Daily News

In recent months three compounding executives have been criminally charged after producing harmful medicines, including morphine for infants that was over 2,000 percent more potent than labeled, and FDA’s top lawyer said Wednesday (Dec. 6) that the agency is dedicating significant resources to enforcing compounding regulations and is working with the Department of Justice in certain situations to shut down out-of-compliance compounders.

December 08, 2017 | Daily News

President Donald Trump's nominee to head the Patent and Trademark Office was hesitant during his recent nomination hearing to endorse criticisms of the inter partes review process and declined to give his view on the constitutionality of the process.

December 06, 2017 | Daily News

A National Academy of Sciences report on ways to cut drug prices -- to be featured at a Senate health committee hearing next Tuesday (Dec. 12) -- includes proposals that run counter to the interests of brand drug makers, pharmacy benefit managers and health plans.

December 05, 2017 | Daily News

A recently released draft guidance outlining the potential expedited pathways available to gene therapy sponsors assuaged concerns that therapies promising solely durable, rather than permanent, changes in a patient may not be eligible for the 21st Century Cures-created Regenerative Medicine Advanced Therapy (RMAT) designation, according to a new blog from attorneys at Hogan Lovells.

December 05, 2017 | Daily News

FDA's biologics center will encourage flexible clinical trial designs for regenerative medicine by considering trials that incorporate adaptive designs, enrichment strategies or novel endpoints.

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