Monday, August 31, 2015

POSTED: Thursday, August 13, 2015, 9:07 AM
A view of the Merck & Co. campus in Linden, New Jersey. Merck's Keytruda, which costs about $150,000 a year, sold $83 million in the first quarter. (Reuters File Photo / Jeff Zelevansky)

     Merck & Co., said Thursday it struck a deal to collaborate with the University of Texas MD Anderson Cancer Center  to evaluate Merck’s immunotherapy cancer drug Keytruda (generic name is pembrolizumab) when combined with other treatments, such as chemotherapy, radiation therapy and other new anti-tumor medicines.

     Keytruda is approved for advanced stage melanoma and MD Anderson, which is based in Houston, was involved in that research.

     The tumor types to be studied over three years in the new agreement are gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma.

POSTED: Wednesday, August 12, 2015, 8:19 AM
Kim Kardashian, taking her daughter to a ballet class in Tarzana. (WENN.com)

     Reality (?) TV star Kim Kardashian has run afoul of the Food and Drug Administration.

     Kardashian has been shilling for a Canadian drugmaker that makes a morning sickness drug, using her millions of followers on Instagram and Facebook.

     But - and this will shock you - Kimmy did not mention the less happy aspects of the drug, Diclegis, made by Duchesnay Inc., beyond linking to information that included the FDA approved label. Duchesnay's U.S. headquarters is in the Philadelphia suburb of Rosemont.

POSTED: Wednesday, August 12, 2015, 6:58 AM
A British Airways airplane flies past a signage for pharmaceutical giant GlaxoSmithKline in London April 22, 2014. (REUTERS / Luke MacGregor)

Drugmaker GlaxoSmithKline, which shut down a North Carolina manufacturing plant Tuesday after routine testing discovered bacteria related to Legionnaire's disease in a stand-alone cooling tower, said late Wednesday afternoon that it hoped to resume production within the next three days.

About 850 employees work at the facility in Zebulon, near Raleigh, and most were told to stay home until the situation is resolved.

A GSK spokeswoman said in a statement that the problem posed no risk to medicine or employees.

POSTED: Tuesday, August 11, 2015, 10:36 AM
Microsoft founder Bill Gates. (REUTERS / Francois Lenoir)

Bill Gates, through the Bill and Melinda Gates Foundation, has been donating money for years in health and education programs to try to solve numerous seemingly intractable problems in those areas, in the United States and the developing world.

Yes, some disagree with Bill Gates' approaches on particular issues, but it is hard to argue with the basic concept of a really, really rich guy arguing for other really, really rich people to join him in giving their money to charity.

Anyway, Bill set up a company in 2008 to invest in stuff that interests him.

POSTED: Tuesday, August 11, 2015, 6:40 AM

     The debate about the appropriate price for medicine now includes a new group of drugs designed to treat ultra high cholesterol, called PCSK-9 inhibitors.

     Praluent - made by Regeneron and distributed by its partner Sanofi - is the first of the group to hit the market. It is meant to lower the LDL - "bad" cholesterol - of patients with hypercholesterolemia. Amgen is working on a similar drug that might be approved soon.

     However, what some suggest were vague FDA guidelines included in the approval and relatively old prescribing guidelines from cardiologists, mean that a $15,000 per year drug might become a life-long treatment for millions of people, even if they are outside the original parameters.

POSTED: Monday, August 10, 2015, 10:07 AM
Endo CEO Rajiv De Silva.

     Drug pricing is the biggest commercial issue in the pharmaceutical industry and Endo International CEO Rajiv De Silva said Monday his company sees a mixed bag of opportunities to raise prices.

     Drug company critics - among patients, doctor groups, Congressional leaders - question the price increases generally, but stockholders benefit from revenue increases and Wall Street analysis is based on that.

     De Silva said Endo has about 700 generic products and the company has been able to raise prices on some more complicated specialty generic drugs, such as those requiring injections, and older products where competitors have dropped out.

POSTED: Monday, August 10, 2015, 7:57 AM
AstraZeneca's campus in Wilmington, Del.

Local drugmakers - big and small - struck a deal to try to develop a vaccine to prevent a form of cervical, head and neck cancer.

MedImmune, which is the biologics and research division within AstraZeneca, said Monday it will collaborate with Inovio Pharmaceuticals to develop an early stage cancer vaccine designed to treat human papillomavirus.
AstraZeneca will pay Inovio $27.5 million upfront. If the compound reaches development and commercial milestones, Inovio could get up to $700 million, along with "double-digit tiered royalties" on product sales. However, sales are a long way off because the compound is only in phase I and phase II of what is normally a three-phase clinical trial process.
AstraZeneca is moving its headquarters from London to Cambridge in the United Kingdom, and has operations in Wilmington and Fort Washington. The MedImmune division is headquartered in Gaithersburg, Md.
Inovio is based in Blue Bell and its basic scientific premise is to use DNA to develop vaccines, unlike most current vaccines.
The companies have worked together before. The compound at the heart of the latest deal is called
INO-3112. The early clinical trials are examining cervical and head and neck cancers and the compound tries to generate "killer T-cell responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 per cent of cervical pre-cancers and cancers," according to the statement.
The full statement from AstraZeneca is here.

POSTED: Friday, August 7, 2015, 4:32 PM
A mural on the Martin Luther King Center in North Philadelphia is reflected in the glass of Project HOME's Stephen Klein Wellness Center. (David Sell, staff)

Under chief executive Steve Collis, AmerisourceBergen has tried to broaden its business beyond that of an anonymous-but-huge pharmaceutical wholesaler, including a more visible public element that manifested itself in $250,000 to build a pharmacy that opens Saturday at Project HOME's Stephen Klein Wellness Center in North Philadelphia.

Project HOME’s mission is to break the cycle of poverty afflicting many people in the city and affordable healthcare is one element of that.

“Our new pharmacy, made possible through the AmerisourceBergen Foundation, is key in our effort to provide quality healthcare and wellness for the second poorest zip code in Philadelphia,” Sister Mary Scullion, executive director of Project HOME, said in a statement.

About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com or 215-854-4506.

David Sell
Also on Philly.com:
letter icon Newsletter