News & Analysis as of

Biotechnology Prescription Drugs

UK Government Given Additional Powers to Control NHS Medicine Prices

by Hogan Lovells on

The new Health Service Medical Supplies (Costs) Act 2017 came into force on 27 April 2017, giving the Department of Health greater powers to control the cost of medicines supplied to the National Health Service (NHS)....more

What Is The Trump Pharmaceutical Policy?

by Foley & Lardner LLP on

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

by Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

by Goodwin on

Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY...more

AGG Food and Drug Newsletter - April 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Legislative Developments in Post-Grant Proceedings

by Fish & Richardson on

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

3D Printing and the Renaissance of Local Economies

by Benesch on

The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

Three Pressing Challenges for Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

by FPA Patent Attorneys on

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

by Cooley LLP on

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Court Report - February 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

by Morrison & Foerster LLP on

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

Massachusetts Enacts New Biosimilars Substitution Law

by Foley Hoag LLP on

On June 23, 2014, Governor Deval Patrick signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (now Chapter 143 of the Acts of 2014). The new Act authorizes pharmacists to...more

Nanotech Drug Formulations Drive Dealmaking

by Foley & Lardner LLP on

Some of the most commercially successful products to arise out of nanotechnology in terms of sheer size of revenues generated are nanotech drug formulations. This area continues to be hot in the wake of two recent deals, both...more

GEN and FiercePharma Compile Lists of Top Selling Drugs for 2013

Earlier this month, Genetic Engineering & Biotechnology News released its list of the top 25 best-selling drugs worldwide for 2013. GEN's list, which the journal released on March 3 (see "The Top 25 Best-Selling Drugs of...more

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

by K&L Gates LLP on

On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

MoFo BioMeter - Vol. 2, Issue 4, November 2013 - Q3 BioMeter Shows Strong Early Stage Deals

by Morrison & Foerster LLP on

The average BioMeter value in the third quarter of 2013 was $30.4 million, an increase from the $22.2 million value in the second quarter. Like last quarter, Phase 1 and Phase 2 transactions showed very strong results, with...more

Tufts Report Shows Dramatic Shift from Small Molecule to Biologic Drugs

Last week, the Tufts Center for the Study of Drug Development (CSDD) at Tufts University released a report showing that the pharmaceutical industry has dramatically shifted its focus from a historical concentration on small...more

BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics

Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

BakerHostetler Patent Watch: Novozymes A/S v. DuPont Nutrition Biosciences APS

by BakerHostetler on

On July 22, 2013, in Novozymes A/S v. DuPont Nutrition Biosciences APS, the U.S. Court of Appeals for the Federal Circuit (Rader, Schall,* Bryson) affirmed the district court's judgment as a matter of law that U.S. Patent No....more

Court Report -- June 30, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more

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