Morning Briefing
Summaries of health policy coverage from major news organizations
What Will It Mean For Pharma If Democrats Take Control Of The House?
Stat: Pharma Braces For A Pelosi Speakership And Democrats' Drug Pricing Agenda
Nancy Pelosi marched into PhRMA’s offices this July with the law on her side. Never mind that the law in question has never been put to use: Pelosi spoke in detailed terms of a federal statute that allows the U.S. government to effectively strip drug companies of exclusive licenses to some blockbuster medicines. It was a head-turning threat from the woman likely to serve as speaker of the House next year, delivered straight to the drug lobby’s board of directors — executives from many of the country’s largest and most politically powerful pharmaceutical manufacturers. (Facher, 10/30)
The Hill: Physicians Group Urges FTC To Monitor Insulin Pricing
The American Medical Association is urging the Federal Trade Commission to take action against drug companies they say are contributing to high prices for insulin. In a letter to FTC Chairman Joseph Simons, the AMA said physicians are concerned that the rapid rise in the price of insulin for patients is unrelated to the actual costs of research, development, commercialization, or production. (Weixel, 10/29)
Bloomberg: Novartis Cuts 20% Of Drug-Research Projects After Review
Novartis AG has dropped about a fifth of its research projects as the drugmaker narrows its focus on the most cutting-edge medicines. The pharmaceutical giant has reduced its drug programs to 340 from 430 after completing a review of its portfolio, Jay Bradner, president of the Novartis Institutes for Biomedical Research, said in an interview Monday. Among the research projects it’s no longer pursuing are medicines for infectious diseases. (Paton, 10/30)
Stat: AbbVie, Abbott Pay $25 Million To Resolve Claims About A Cholesterol Pill
After several years of legal sparring, Abbott Laboratories (ABT) and AbbVie (ABBV) will pay $25 million to settle allegations of paying kickbacks to doctors and illegally marketing the TriCor cholesterol pill. The case began with a whistleblower lawsuit filed in 2009 by a former saleswoman for Abbott, which marketed the medicine at the time and later transferred the rights after spinning off AbbVie. The sales rep, Amy Bergman, alleged she was “trained, directed, incentivized, and encouraged” to promote TriCor for so-called off-label marketing and medically unnecessary uses. (Silverman, 10/29)
Stat: J&J Loses Patent Fight Over Key Cancer Drug, Teeing Up Generic Competition
In a challenge to Johnson & Johnson (JNJ), a federal court ruled that a patent on a key drug — the big-selling Zytiga prostate cancer treatment — is invalid, triggering the likely arrival of lower-cost generic competition, possibly in a matter of days. The Friday decision had largely been expected by Wall Street analysts, who noted that a U.S. Patent and Trademark Office review board earlier this year had invalidated the same patent after determining it was not sufficiently inventive. The patent, which is due to expire in 2027, covered a method for administering the drug. (Silverman, 10/29)
Stat: Pfizer, Novartis Pair Up On Fatty Liver Drug Trials As Rivals Near Finish Line
Pfizer (PFE) and Novartis (NVS) are pairing up on new clinical trials of combination therapies to treat the fatty liver disease known as NASH. The collaboration between the pharma giants announced Monday won’t yield significant clinical results for quite some time, but scientists working at both companies say attacking NASH with two or more drugs that act in the liver differently will ultimately bring the most benefit to patients. (Feuerstein, 10/29)
Stat: A New Drug Lowers Cholesterol. Can It Spoil A Multibillion-Dollar Market?
A small biotech company has a shot at shaking up a market roosted by giants, moving toward approval with a pill it believes can lower bad cholesterol at a discount to other medicines. On Sunday, Esperion Therapeutics said a combination of its once-a-day treatment and a maximum dose of statin lowered LDL cholesterol 18 percent more than statins alone after 12 weeks. The results come from the last of five successful trials on Esperion’s drug, called bempedoic acid. The company plans to submit all of its data to the Food and Drug Administration in the early months of 2019. (Garde, 10/28)
Stat: Novartis' CEO On Gene Therapy, Innovation, And The Company Pivot
When the drug maker Novartis announced last month that it would cut 2,200 jobs, it framed the decision not as a retreat but as a restructuring. The goal, CEO Vas Narasimhan said, was to reshape the company to focus on “specialized and more personalized innovative medicines.” Out with the company’s contact lens business, in with cancer immunotherapy. Novartis became the first company to secure approval for a CAR-T therapy last year. And in a sign of its coming ambitions, last month it agreed to buy the drug maker Endocyte for $2.1 billion — to gain control of its experimental prostate cancer drug, which uses an approach called radioligand therapy. (Weintraub, 10/29)
