News & Analysis as of

Generic Drugs Pharmaceutical Industry

Capitol Hill Healthcare Update

by BakerHostetler on

AZAR ILLNESS DELAYS WHITE HOUSE ANNOUNCEMENT ON DRUG PRICING INITIATIVE - Health & Human Services (HHS) Secretary Alex Azar is recovering at his home in Indianapolis following his second hospitalization in less than a week...more

Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more

The State AG Report Weekly Update April 2018 #3

by Cozen O'Connor on

2018 AG Elections- Republican Gentner Drummond Announces Bid for Oklahoma Attorney General- Republican Gentner Drummond has declared his candidacy for Oklahoma AG in 2018. ...more

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

by Arnall Golden Gregory LLP on

In recent years, the Federal Trade Commission (FTC) has brought a series of cases involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See, e.g., F.T.C. v. Actavis, Inc., 570 U.S....more

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

China Announces New Initiatives to Level the Playing Field for Innovative and Generic Drugs

by Ropes & Gray LLP on

China’s Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs. The State Council, China’s cabinet, has decided not to apply any tariff on imported drugs,...more

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

FDA Releases Five-Year Plans for User Fee Programs

by Goodwin on

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more

Product Liability Update: April 2018

by Foley Hoag LLP on

Massachusetts Supreme Judicial Court Recognizes Claim Against Brand-Name Drug Manufacturer By Generic Drug User Where Failure To Warn Is Reckless - In Rafferty v. Merck & Co., 479 Mass. 141 (2018), plaintiff alleged...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Pharmaceutical Reforms in 2018-19 New York State Budget

by Farrell Fritz, P.C. on

Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more

Life sciences and health care horizons - March 2018

by Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Recent Biosimilar Industry Coverage

by Goodwin on

A number of media sources have covered new developments in the biosimilars space. Here is a round-up of some highlights from this month....more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Rafferty v. Merck Expands Potential Liability for Drug Manufacturers in Massachusetts

by Wilson Elser on

On March 16, 2018, Massachusetts’s highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability risk exposure for pharmaceutical manufacturers in the state. In the case of...more

Brand-Name Manufacturers Could Be Liable for Generic Drug Injuries, Says Massachusetts Supreme Court

by Faegre Baker Daniels on

On March 16, 2018, Massachusetts joined a growing minority of states — California, Vermont and Illinois — recognizing innovator liability of name-brand drug manufacturers. Rafferty v. Merck & Co., Inc., SJC-12347, 2018 WL...more

Massachusetts Supreme Judicial Court Allows Innovator Liability Claims to Proceed Under A Recklessness Standard

by Mintz Levin on

Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more

Massachusetts Supreme Judicial Court Recognizes ‘Innovator Liability’

On March 16, 2018, in a matter of first impression in Massachusetts, the Supreme Judicial Court (“SJC”) joined a minority of states in recognizing a tort theory of “Innovator Liability” – namely, that brand-name drug...more

Patent IPRs and Allergan’s Sovereign Immunity Defense

In an age of rising healthcare costs, pharmaceutical companies can be an easy target in calls for patent reform. Patent protection helps drug manufacturers recoup their investment in developing the new drug,. It also...more

AAM Publishes White Paper on Need for Increased Access to Biosimilars

by Goodwin on

A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication...more

Innovation In Hatch-Waxman And ANDA Litigation

by Seyfarth Shaw LLP on

The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more

Top Developments in Hatch-Waxman Litigation for March 2018

by Morrison & Foerster LLP on

This month, we highlight several significant decisions including The Medicines Company v. Hospira, Inc. and Index Pharmaceuticals, LLC v. Gilead Sciences, Inc. and the Trump administration’s legislative proposal to increase...more

PTAB Holds Indian Tribes Don’t Offer an Out from IPR

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs. The PTAB’s decision also...more

“A” Is For Preemption

by Reed Smith on

The Seventh Circuit taught us recently that the letter “A” is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary (“typical”) into the extraordinary (“atypical”), the melodic (“tonal”)...more

Original Drug Manufacturer Owes New Tort Duties When Generics Take Over

by Low, Ball & Lynch on

T.H., a Minor v. Novartis - Fourth Appellate District, Division One - The California Supreme Court upheld the Court of Appeal’s decision allowing individuals who were injured by a generic drug to sue the brand-name...more

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