- Roche CEO fears hit to UK drug research from Brexit vote (reuters.com)
Britain's decision to leave the European Union threatens to undermine its position as a center for drug research and UK patients could fall behind others in Europe in getting access to new drugs, Roche's chief executive said..."If certain cutting edge innovative medicines do not become part of the standard of care in the UK, this hampers research and development," Roche CEO Severin Schwan said...Britain has a strong reputation for medical research but it is already a difficult market for launching expensive new drugs, such as the modern cancer treatments produced by Roche...
- Teva, one of the biggest generic makers, joins the the brand-name club (statnews.com)
In a move that underscores the changing landscape of the pharmaceutical industry, the chief trade group has officially accepted one of the world’s largest generic drug makers into its ranks...Teva Pharmaceuticals became a member of the Pharmaceutical Research and Manufacturers of America, which has burnished its reputation on Capitol Hill and elsewhere as a staunch defender of brand-name companies...The decision to accept Teva...came as a surprise to some industry watchers, given the historical rivalry between brand-name and generic manufacturers...The move, however, isn’t all that unexpected, if only because the lines are beginning to blur.
- UNLV’s vision for medical school moving closer to reality (reviewjournal.com)
It’s been a vision of UNLV leaders for years: A widely supported medical school educating the region’s future doctors and bearing the university’s name..."We’re ahead of where we thought we would be," Atkinson said (Dr. Barbara Atkinson, dean of UNLV School of Medicine). "I never thought we’d be this far ahead at this point."...Exactly a year from its anticipated debut date of July 17, 2017, the medical school is moving forward...
ACCREDITATION - Atkinson said the (accreditation) committee is expected to consider the report as well as documents provided by UNLV and make a decision on the school’s preliminary accreditation request between Oct. 17 and 19...If the medical school is awarded preliminary accreditation, it can begin recruiting its first class of students and would become the first accredited M.D.-granting, or allopathic, program based in Southern Nevada.
A NEW BUILDING - UNLV has also commissioned a conceptual design and renderings for a permanent building across from Valley Hospital Medical Center in the Las Vegas Medical District, and those plans should be complete by September...University Medical Center CEO Mason VanHouweling said the placement of the UNLV school in the heart of the medical district will bring a new look and feel to the area...He added that UMC is excited to try to develop its own facilities to help shape the future of the area and looks forward to furthering its partnership with the UNLV school.
- Pfizer strikes second deal this year for drug production in Russia (fiercepharma.com)
Pfizer was a little behind some of its peers in establishing local manufacturing in Russia but it's on a roll now, having just announced its third deal in several years. It is hammering out an agreement with Russia’s NovaMedica for a new manufacturing plant...Construction will begin this year on a plant in Russia’s Kaluga region with the expectation that the plant will be producing drugs by 2020...Pfizer...not yet disclosing how big of an investment the New York company will make in the manufacturing facility...The Pfizer deal calls for NovaMedica to license technology for production of more than 30 products including treatments for cancer, inflammatory disease and fungal infections, it said. Most of the drugs are on Russia’s essential medicines list...
- U.S. regulators sue to block Anthem-Cigna, Aetna-Humana insurer mergers (reuters.com)
U.S. antitrust officials on Thursday moved to block an unprecedented consolidation of the national health insurance market, filing suit against Anthem Inc's proposed purchase of Cigna Corp and Aetna Inc's planned acquisition of Humana Inc...The U.S. Department of Justice said the two mergers would reduce competition, raise prices for consumers and stifle innovation if the number of large, national insurers were to fall from five to three..."We will not hesitate to intervene. We will not shy away from complex cases," U.S. Attorney General Loretta Lynch told a news conference. "We will protect the interests of the American people."
- Lawyers for Roche, Biocon trade contempt charges in Herceptin biosim case (fiercepharma.com)
A long-running court case filed in India by Roche seeking to prevent the use of label language by...Biocon and Mylan from claiming similarity to its aging breast cancer med Herceptin (trastuzumab) has turned tense--with both sides now seeking contempt-of-court charges...In the case of Roche...Biocon "violated a previous court order" temporarily barring any claims to similarity by using such language in a presentation at an international scientific conference on clinical trials with trastuzumab...At the same time, Biocon accused Roche of "disparaging statements" about the company as part of a campaign to block approval efforts for a trastuzumab biosimilar by Biocon in other countries...noting that Phase III trials are underway in the U.S. for a version of the breast cancer therapy...At the heart of the case is...that Biocon and...Mylan could not use the label biosimilar for versions of Roche's med.
- Takeda says Ka-Pow! to IBD in new Marvel comics campaign (fiercepharma.com)Selling Side Effects: Pharma's Marketing Machine (drugwatch.com)
The latest Marvel-created superhero, Samarium, has the power to suit up instantly in magnetic and impenetrable full-body armor. But like most superheroes, he also has a secret. And in this Takeda Pharmaceuticals-sponsored comic, it’s inflammatory bowel disease...Takeda worked with the Crohn’s and Colitis Foundation of America and Marvel Custom Solutions to create its first-ever pharma company-sponsored superhero to shine a light on the many sufferers of IBD who hide their disease. The disease awareness campaign includes the graphic illustration series with IBD-suffering hero Samarium, as well as digital paid ads and social media shares...
- U.S. Said Readying Suits Against Anthem, Aetna Insurer Deals (bloomberg.com)
U.S. antitrust officials are poised to file lawsuits to block Anthem Inc.’s takeover of rival health-insurer Cigna Corp. and Aetna Inc.’s deal to buy Humana Inc...Justice Department officials, who are responsible for protecting competition, are concerned that the deals, which would transform the health-insurance industry by turning its five biggest companies into three, would harm customers, according to several people familiar with the situation. While the companies may offer to sell assets to gain approval for the deals, that’s unlikely to sway antitrust officials...The final decision on whether to sue to block the deals could come this week or next, another of the people said. The companies could settle a lawsuit before or after one is filed...
- Lax FDA Oversight Of ‘Compounded Drugs’ Is A Matter Of Life And Death (forbes.com)
People naturally assume that the medicines prescribed by doctors are tightly regulated and have been approved by the Food and Drug Administration, but that’s not true. Loopholes in the regulations that set the standards for a practice called "drug compounding" have enabled dangerous products to injure and kill untold numbers of unsuspecting patients...FDA exempted compounding pharmacies from many of the manufacturing, labeling and other requirements other drugs are subject to...FDA does not require pharmacies to report adverse events associated with compounded drugs...the FDA has the authority to take action when compounding pharmacies violate the law and can act quickly if there is an "imminent hazard to public health," regulators have failed in several critical areas, including inspecting pharmacy records, enforcing quality standards and being able to identify the facility that made a particular drug...In order to create an acceptable risk-benefit paradigm for drug compounding, FDA needs to increase its scrutiny over compounding pharmacies. When a pharmacy is allowed to morph into a large-scale drug manufacturer without adequate oversight, it’s a matter of life and death.
- Medicare fraud investigators wary of soaring compounded drug prices (medcitynews.com)
Government spending on compounded drugs that are handmade by retail pharmacists has skyrocketed, drawing the attention of federal investigators who are raising fraud and overbilling concerns...Spending on these medications in Medicare’s Part D program, for example, rose 56 percent last year, with some of the costliest products, including topical pain creams, priced at hundreds or thousands of dollars per tube. The federal workers’ compensation program has also seen a recent spike in spending...The spending jump, along with a sharp increase in the number of patients getting the compounded drugs "may indicate an emerging fraud trend,"...