News & Analysis as of

Prescription Drugs

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

Senate report assails Big Pharma for payments to patient groups for opioid-friendly messaging

A U.S. Senate Committee has ripped Big Pharma for making millions of dollars in pernicious payments to patient advocacy groups, so they could legitimize and assist in promoting powerful prescription painkillers, a practice...more

340B Update: Trump Administration’s 2019 Budget and White House Council of Economic Advisors Signal Further Changes to 340B...

by K&L Gates LLP on

On February 12, 2018, the Trump Administration released its fiscal year (“FY”) 2019 budget request to Congress outlining several proposals related to the 340B Drug Pricing Program (the “340B Program”) including a modification...more

Senator Collins to Propose Legislation to Lower Drug Costs

by Goodwin on

After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the...more

Orexigen Therapeutics, Inc. v. Actavis Laboratories Fl, Inc.

by Robins Kaplan LLP on

Case Name: Orexigen Therapeutics, Inc. v. Actavis Laboratories Fl, Inc., Civ. No. 15-451-RGA, 2017 U.S. Dist. LEXIS 169570 (D. Del. Oct. 13, 2017) (Andrews, J.)....more

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Sanofi v. Lupin Atl. Holdings S.A.

by Robins Kaplan LLP on

Case Name: Sanofi v. Lupin Atl. Holdings S.A., Civ. No. 15-415-RGA (consol.), 2017 U.S. Dist. LEXIS 174931 (D. Del. Oct. 23, 2017) (Andrews, J.)....more

Off-Label Marketing MDL Winds Down With Some Summary Judgment

by Reed Smith on

We have written extensively on the travesty of the Neurontin trilogy and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric...more

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

by Hogan Lovells on

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about...more

From 2020, Russia will introduce a compulsory system for tracking pharmaceuticals from manufacturer to end user

by Dentons on

On December 29, 2017, the RF President signed Federal Law No. 425-FZ of December 28, 2017 On Amendments to the Federal Law On the Circulation of Pharmaceuticals ("Law 425-FZ"). Under Law 425-FZ, in order to ensure effective...more

Big Pharma firm, under fire in drug abuse epidemic, scales back opioid’s hype

Purdue Pharma, which built a multi-billion-dollar family empire, in part, by overcoming doctors’ resistance to prescribing powerful painkillers like its own powerhouse OxyContin, has decided to curb its quarter-century of...more

White House Unveils Proposal on Drug Pricing

by Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Allergan Sales, LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-1471-JRG-RSP (Lead), 2017 U.S. Dist. LEXIS 176262 (E.D. Tex. Oct. 24, 2017) (Gilstrap, J.)....more

Blog: Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

by Cooley LLP on

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are...more

Lupin Announces Positive Results For Etanercept Biosimilar

by Goodwin on

On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese...more

Congress Makes Key Changes to Medicare Physician Payment Programs as Part of Short-Term Government Funding Bill

• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

Significant New York Drug and Device 2017 Product Liability Decisions

by Harris Beach PLLC on

To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...more

Otsuka Pharm. Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: Otsuka Pharm. Co. v. Mylan Inc., Civ. No. 14-4508 (JBS-KMW), 2017 U.S. Dist. LEXIS 184160 (D.N.J. Nov. 7, 2017) (Simandle, J.)....more

CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D...more

2017 Year in Review: State Laws Target Pharma Manufacturers

by King & Spalding on

States Sharpen Their Focus on Prescription Drug Costs and Industry Relationships with Health Care Providers - In the past year, we have seen a nearly unprecedented focus by state legislatures on prescription drug...more

Sovereign Immunity for State Plaintiffs in Antitrust Class Actions?

The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can...more

Galderma Labs., L.P. v. Teva Pharms USA, Inc.

by Robins Kaplan LLP on

Case Name: Galderma Labs., L.P. v. Teva Pharms USA, Inc., Civ. No. 3:17-cv-01076-M (N.D. Tex. Nov. 11, 2017) (Lynn, J.). Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 8,815,816 (“the ’816...more

Manatt on Medicaid: 10 Trends to Watch in 2018

Medicaid has entered a period of volatile change, unprecedented in its 51-year history. With 74 million members nationwide,1 Medicaid provides health coverage to more than one in four Americans, ensuring access to...more

JPM Conference Takeaways: Biotech and Biopharma Set for Growth in 2018

Coming off a year that saw a record number of new drug approvals, significant scientific breakthroughs and a year-end tax reform package that both significantly lowers corporate taxes and provides the long-awaited tax...more

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