Archive for the 'North America News' Category

Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

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More Cost Pressures for Pricey Drugs

Amy RitterIn an op-ed in the New York Times, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary, citing cost-benefit as their reason. The physicians said that because Zaltrap (ziv-aflibercept) made by Sanofi/Regeneron was no better at extending median survival in advanced metastatic bowel cancer patients than Avastin (bevacizumab) from Roche/Genentech but costs more than twice as much, it would no longer be given to patients at the hospital. Read more »

Stem-Cell Company Takes Steps Towards Compliance

Amy RitterLaboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »

Be Prepared

Amy RitterAs the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart, according to an announcement from HHS’s Office of the Assistant Secretary of Preparedness and Response. According to the announcement, HHS has awarded three-year contracts to all five US-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. HHS will choose the vaccine strains to be stockpiled, and expects that with vaccine seed stock already in hand, the government will be able to respond to a flu pandemic more quickly. Read more »

Funding for Embryonic Stem Cell Research Gets Green Light

Amy RitterA federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed. Read more »

FDA Eyes More Foreign Inspections

Stephanie Sutton Pharm Tech EuropeIt’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to. For a start, FDA only has a limited ability to require foreign establishments to allow inspectors into the facilities and logistical problems also mean that inspections cannot be performed unannounced.  In addition, the cost of overseas inspections can be a huge burden and regulators, like the rest of the pharmaceutical industry, are being squeezed by today’s unsettled economic environment. However, I was still surprised this week to learn at how infrequently these inspections are performed. Because of limited resources, FDA can only inspect generic-drug manufacturers outside of the US every 7 to 13 years. Read more »

Federal Judge Moves Forward with Meningococcal Vaccine Antitrust Suit Against Sanofi

Federal Judge Jose L. Linares of the District Court of New Jersey has ruled to move forward to hear an antitrust suit filed by a group of doctors against Sanofi in December 2011. The suit alleges that Sanofi is attempting to monopolize the US meningococcal vaccine market. As a result of the initial suit, Sanofi filed a countersuit in February 2012, which was later dismissed by Judge Linares.

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Different Ways of Structuring Pay-to-Delay Deals

Amy RitterOn the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.  Read more »

Generics Help Hold the Line on Healthcare Costs

Amy RitterImproving lives for less—that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines. The study, Generic Drug Savings in the US, found an impressive $1 trillion in savings over a ten-year period (2002 through 2011). Read more »

Limited Enforcement

Amy RitterThis week, KV Pharmaceuticals filed a lawsuit against FDA to force the agency to stop compounded versions of their synthetic progesterone drug, Makena (hydroxyprogesterone caproate), from being produced. Read more »

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