- The latest ADA skinny, with hot CV data from J&J, plus Lilly, Novo, and BI (fiercepharma.com)
At the American Diabetes Association Scientific Sessions in San Diego, drugmakers have been rolling out studies that illustrate how competitive every class in the diabetes field has become. For instance, partners Merck & Co. and Pfizer, Eli Lilly and Boehringer Ingelheim, and solo flyer AstraZeneca all unveiled SGLT2 drug studies, with more to come...we’ve gathered the top stories here…
- Johnson & Johnson's Invokana outcomes study makes it the second heart-helping SGLT2 on the block.
- Novo Nordisk and its long-acting insulin Tresiba have a tough task: going up against Sanofi's blockbuster insulin Lantus.
- Lilly and Boehringer have reason to believe their SGLT2 inhibitor, Jardiance, may improve outcomes for chronic kidney disease patients—so they’re putting the med to the test.
- Sanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients.
- Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent, which is in a heated battle with Amgen’s Repatha.
- Novo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s similar Soliqua.
- Boehringer and Lilly still don’t know what’s responsible for the dramatic reduction in cardiovascular death risk that Jardiance (empagliflozin) posted in the Empa-Reg outcomes trial.
- Merck and Pfizer last year rolled out positive results from two phase 3 studies they hoped would buoy SGLT2 candidate ertugliflozin once it got to market.
- Supreme Court speeds copycat biologic drugs to market (reuters.com)
The decision has major implications for the pharmaceutical industry because it will dictate how long brand-name makers of biologic drugs can keep near-copies, called biosimilars, off the market. Even the six months at issue in the case can mean hundreds of millions of dollars in sales...Health insurers expect biosimilars to be cheaper than original brands, like generics, saving consumers billions of dollars each year...Novartis said in a statement that the ruling "will help expedite patient access to life-enhancing treatments."...Amgen spokeswoman Kelley Davenport said the company was disappointed but "will continue to seek to enforce our intellectual property against those parties that infringe upon our rights."...The companies disagreed on how to apply that law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval, a ruling the Supreme Court reversed...Writing for the court, Justice Clarence Thomas said that the decision was not based on policy arguments, but rather, the "plain language" of the biosimilar law itself...
- Korea issues third set of punishments in Novartis bribery case (fiercepharma.com)
South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After a separate agency fined the drugmaker nearly $50 million over kickback payments in April, antitrust authorities in the country have just issued a new fine and complaint against the Swiss drug giant...South Korea’s Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint over payments the company offered doctors between March 2011 and August 2016, according to the Korea Times...The developments come shortly after the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won—approximately $50 million—and suspended reimbursement of Exelon and Zometa for three months, alleging the company’s employees provided approximately $2.3 million in unlawful kickbacks…
- Healthcare satirist ZDoggMD headlines NCPA Annual speaker lineup (drugstorenews.com)
ZDoggMD, also known as Zubin Damania, will be the keynote speaker at the National Community Pharmacists Association Annual Convention October 14-18, according to a YouTube video posted by the satirical doctor..."Our nation's at a crossroads in health care today," he opens in the video. "As pharmacists, y'all know that the system ain't working. It's fractured. It rewards these silos of activity instead of awarding caregivers to actually work together on a team to do what they do best at the top of their license in service of patients."...ZDoggMD has a creative message of bringing everyone in health care together to create a better system of care that both incorporates fair payment and treatment for clinicians like pharmacists and inspires both personal and system transformation.
- Researchers aim to repurpose former experimental cancer therapy to treat muscular dystrophy (unr.edu)
Researchers at the National Institutes of Health's National Center for Advancing Translational Sciences and the University of Nevada, Reno School of Medicine have demonstrated that a drug originally targeted unsuccessfully to treat cancer may have new life as a potential treatment for Duchenne muscular dystrophy...The candidate drug, SU9516, represents a different kind of approach for treating DMD, a degenerative muscle disease that usually begins in childhood and has no known cure...NCATS Chemical Genomics Center Acting Branch Chief Juan Marugan, Ph.D., and UNR Med Professor of Pharmacology Dean Burkin, Ph.D., led a team that screened more than 350,000 compounds to find SU9516, which had been previously developed as a treatment for leukemia. The research demonstrated that this compound improved muscle function in both laboratory and animal DMD models. The results, published recently in Molecular Therapy, may provide a promising approach against the disorder and other muscle-wasting conditions...Our findings open the door to develop new drug treatments for DMD...
- Cancer drug prices are so high that doctors will test cutting doses (washingtonpost.com)
A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness...they point to their pilot study involving a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount…Szmulewitz (University of Chicago oncologist) and others now want to run full trials to see whether the doses of other oral oncology drugs can be ratcheted back because of the “food effect,” which can alter how a medication is absorbed. They also plan to explore whether the duration of some prescriptions can be shortened and whether some cheaper non-cancer drugs can be substituted for expensive cancer ones. They recently created a nonprofit organization, the Value in Cancer Care consortium, to organize their work...
- NACDS urges Congress to pass provider status legislation (drugstorenews.com)
The National Association of Chain Drug Stores this week shared with the House Ways and Means Committee the important role pharmacy plays in the nation’s healthcare system in an effort to encourage passage of legislation giving pharmacists provider status under Medicare Part B...The Pharmacy and Medically Underserved Areas Enhancement Act has been introduced in both the House and Senate, and NACDS’ statement looked to drum up support by outlining the work pharmacists do for patients, particularly in medically underserved areas..."We urge you to increase access to much-needed services for underserved Medicare beneficiaries by supporting H.R. 592/S. 109, the Pharmacy and Medically Underserved Areas Enhancement Act, which will allow Medicare Part B to utilize pharmacists to their full capability by providing those underserved beneficiaries with services, subject to state scope of practice laws, not currently reaching them," NACDS said...
- Top 10 complaints about working in Biopharma (worldofdtcmarketing.com)
Most professional consulting groups have all commented about the serious shortfall of working for a biopharma company...the most common complaints about working in marketing for pharma.
- 1ne: Too many damn meetings! By far this is the top complaint we have heard.
- 2wo: Takes too long to implement programs.
- 3hree: Too many “lifers”. A lifer is someone who goes from pharma company to company with outdated ideas.
- 4our: Our CEO is too far removed from our business and is too concerned about Wall Street rather than Main Street.
- 5ive: Good job, but you’re being laid off. Too many pharma companies still lay off the wrong people when one of their products comes off patent or sales decline.
- 6ix: No work/life balance.
- 7even: Benefits have become more expensive.
- 8ight: Open office concepts.
- 9ine: Too heavy a workload.
- 10en: Finally, there is the annual team building events which seem to install a belief that you’re building a cohesive team.
- Saint Mary’s Reno office building sold for $66 million to a property trust (rgj.com)
Saint Mary’s Center for Health & Fitness, an office building on the hospital campus in downtown Reno, sold for $66.2 million. The center and Saint Mary's Regional Medical Center operations and existing tenants will not change...The building is a class A, 190,750 square-foot medical office building built in 2005. It sold to a Real Estate Investment Trust, which is a type of property-owning entity that allows people to buy shares of the trust instead of owning the building outright...Medical Properties Trust, is the REIT that now owns the office building...
- ASCO 2017: What you missed (biopharmadive.com)
Loxo Oncology opened this past weekend's annual conference of the American Society for Clinical Oncology with compelling data showing its drug's efficacy across an array of 17 different cancers...the results were unquestionably positive for Loxo, larotrectinib's performance also marks another step forward in the lofty and still yet unrealized goal of precision oncology...Merck's flagship immunotherapy Keytruda (pembrolizumab) won a landmark approval from the Food and Drug Administraiton for tumors with a specific biomarker...Treating cancer based on solely on the genetic profile of a patient's cancer has been a long-talked about objective, and progress from Merck, Loxo and others show what's possible beyond the molecularly targeted therapies that have advanced clinical care in the past decades...improving precision could also be seen in data presented by Bluebird Bio and Nanjing Legend Biotech, which showed the broader potential for CAR-T therapy outside of leukemia and lymphoma. While checkpoint inhibitors have transformed oncology by broadly unlocking the immune system, CAR-Ts specifically engineer patient's T-cells to seek out specific targets expressed by different cancer types...for a round-up of some of the biggest developments from oncology's biggest conference.
- CAR-Ts steal the show - Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas.
- Roche's Perjeta cuts risk in Aphinity, but is it enough? - The large Phase 3 study has been closely watched as potentially practice changing but the modest benefit could limit its impact in adjuvant treatment of breast cancer.
- Loxo shows promise of biomarker approach to cancer - Clinical data presented Saturday showed treatment with Loxo Oncology's larotrectinib shrank tumors in three-quarters of patients with a range of 17 different advanced cancers.
- Juno marks progress with second-gen CAR-T - Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program.
- J&J seeks label expansion for Zytiga - The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.
- Incyte pads its IDO numbers - IDO inhibitors have been pegged as the next step in immuno-oncology combinations, but Incyte's rising market value prompts questions over what that's worth.
- Roche's Alecensa bests Xalkori in lung study - The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care.
- AstraZeneca's Lynparza stays step ahead of PARP rivals - Data showing a 42% risk reduction in disease worsening compared to chemo in breast cancer patients should help build Lynparza's profile outside of ovarian cancer.
- Merck touts Keytruda bladder benefit post Tecentriq failure - Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space.
- Chi-Med, Lilly tout cancer med's efficacy in the colorectal setting - Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.