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Latest News

Asembia 2025: Understanding the Inflation Reduction Act
Asembia 2025: Understanding the Inflation Reduction Act
By Nicholas Saraceno, Editor

April 30th 2025

A seminar shares key observations and learnings from the first round of direct price negotiations.

Asembia 2025: A General Landscape of the Pharmaceutical Industry
Asembia 2025: A General Landscape of the Pharmaceutical Industry
By Nicholas Saraceno, Editor

April 29th 2025

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

A Rocky Road for Regulation
A Rocky Road for Regulation
By Mike Hollan

December 16th 2024

With the Inflation Reduction Act now in flux, how will the government and industry respond?

Biden-Harris Administration Proposes Expansion to Medicare and Medicaid to Include Anti-Obesity Medications
Biden-Harris Administration Proposes Expansion to Medicare and Medicaid to Include Anti-Obesity Medications
By Don Tracy, Associate Editor

November 26th 2024

The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.

MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
By Don Tracy, Associate Editor

October 25th 2024

Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.

More News


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Counterfeit Drugs, One Click Away

Bruce Longbottom, Eli Lilly;Mark Mutterperl, Fulbright & Jaworski
September 1st 2007

If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.


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Legal: Foreign Policy

Jonathan B. Leiken;R. Christopher Cook
June 1st 2007

Compliance requires overcoming cultural barriers. To start with, in some countries the taboo against bribery is not as strong as it is here.


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Legal: E-headache

Jeffrey Brown;Mark Yacano
December 1st 2006

Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.


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Legal: Keyword: "Infringement?"

November 1st 2006

When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site.


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Legal: Going to Court

October 1st 2006

In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence.


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Legal: Authorized Generics: Still Legal—and Holding

September 1st 2006

Indeed, at this time, we are aware of no evidence that the practice of authorized generics has actually deterred any Paragraph IV certification or post-180 day generic entry, let alone a challenge to an invalid patent.


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Toolkit: Safety in Numbers

June 1st 2006

Scott Gottlieb called RFID implementation "disappointing." Now, FDA is moderating its view of RFID as a cure-all for the industry.


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Legal: The Kickback Effect

R. Christopher Cook;Jesse A. Witten
May 1st 2006

Criminal penalties for violating the Foreign Corrupt Practices Act can be substantial. Businesses found guilty may be fined upwards of $2.5 million for each offense, or twice the amount gained as a result of the violation.


Legal: Hey, Good Lookin': Sex Discrimination in Hiring Reps

Legal: Hey, Good Lookin': Sex Discrimination in Hiring Reps

James McDonald, Jr.
March 1st 2006

Drug manufacturers should have policies against sexual harassment of sales reps. Such a policy may also help counter charges that a company is implicitly encouraging its reps to use their sexuality as a sales tool.


Legal: Shifting Perspective on Off-Label Promotion

Legal: Shifting Perspective on Off-Label Promotion

Jack Cinquegrana;Diana K. Lloyd
January 1st 2006

The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies engaged in off-label marketing.


Legal: State Compulsory Licenses

Legal: State Compulsory Licenses

Tamsen Valoir
November 1st 2005

Under one bill, states could license patented drugs to generics companies, paying patent holders a royalty.


Legal: Jumping the Pond

Legal: Jumping the Pond

Mark Herrmann;Richard Elks
September 1st 2005

Class actions threaten industries that deal with the public. If European lawmakers remove the restriction on class-action suits, consumers will be free to file cases. Pharma companies should take heed.


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Legal Forum: Loss Causation

Pamela S. Palmer;Jeff G. Hammel
July 1st 2005

Plantiffs did not try to establish a link between the purported misconduct and the decline in share price. Rather, their sole allegation was that they had paid artificially inflated prices for Dura securities.

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