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Illumina, the world’s largest manufacturer of DNA sequencing machines, announced Sunday the formation of a new company that will develop blood tests that can detect a broad variety of early stage cancers long before symptoms arise. The new company, named Grail, has so far raised $100 million, mostly from Illumina and venture capital firm Arch Venture Partners, but also from Microsoft co-founder Bill Gates, and Amazon founder Jeff Bezos...The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage...Illumina’s sequencing technology now allows the detection of circulating nucleic acids originating in the cancer cells themselves, a superior approach that provides a direct rather than surrogate measurement...We hope today is a turning point in the war on cancer...By enabling the early detection of cancer in asymptomatic individuals through a simple blood screen, we aim to massively decrease cancer mortality by detecting the disease at a curable stage...

Several leading pharmaceutical companies are joining forces in an effort to speed the testing of new types of cancer drugs that harness the body’s immune system to battle tumors...The cooperative effort, announced Monday, will include Amgen, Celgene, GlaxoSmithKline, Pfizer, Merck...and some smaller companies. The effort, known as the National Immunotherapy Coalition, will try to rapidly test various combinations of such drugs...“The challenge of cancer is far too great for any of us to tackle alone,”...Perhaps the most exciting development in oncology now is the sudden success, after decades of failure, of efforts to unleash the immune system to control cancer...The announcement of the coalition came on the first day of the huge J.P. Morgan Healthcare Conference in San Francisco, when numerous companies make announcements. Besides the coalition announcement on Monday, one company said Sunday it was aiming for what it called the holy grail of oncology — a blood test to detect all cancers at the early, most treatable, stage...

The first issue of Elsevier's new open access journal Contemporary Clinical Trials Communications features a new method to make cancer clinical trials more effective, a better way of determining whether a trial was successful and a dashboard that helps patients enroll in trials... Contemporary Clinical Trials Communications publishes methodology and statistics that answer these questions, helping researchers build on each other's work and design better trials...I trust that the readers will find the journal a valuable source of recent advancements in clinical trials...this knowledge can facilitate the design, conduct and analysis of their trials...The journal also aims to tackle the problem of publication bias towards positive results by making all trial data open access...A major objective of the journal is to reduce publication bias, which is a major issue in the field of clinical trials...provides a platform for trialists around the world to share their knowledge on all aspects of clinical trials. We're making scientifically valid and technically sound original research findings freely accessible regardless of their perceived importance or impact.

Walgreens Boots Alliance Inc. beat analysts’ earnings estimates of fiscal first-quarter earnings estimates, as strong prescription drug trends made up for a retail slump that continues to affect the company...Walgreens drew in shoppers with a better experience and more high-end products after renovating its stores. In the U.S., the drugstore chain’s biggest market, same-store retail shrank fell 0.6 percent in the quarter ended Nov. 30 compared with a year before, Walgreens said in a statement Thursday. It’s a lackluster figure that hasn’t kept up with gains in the prescription drug dispensing business.

• drugstore sales were $20.4 billion, up 4.2 percent from a year ago.
• same-store sales rose 5.8 percent, with pharmacy sales gaining 9.3 percent and retail declining 0.6 percent, Walgreens said, “primarily due to a reduction in unprofitable promotions and the transitioning of seasonal items away from holiday decorations and toward higher quality, giftable items.”
• pharmacies filled 231 million prescriptions in the quarter, up 4.1 percent from a year ago.
• Total sales were $29 billion, up 48 percent, thanks to the merger of Walgreen Co. and Alliance Boots GmbH in Dec. 2014.
• The company raised the low end of its earnings guidance for fiscal year 2016 by 5 cents, to $4.30 to $4.55 per adjusted share.

“Any kind of vertical integration is good,” though Walgreens is focused on digesting its current acquisitions...In October, the company agreed to acquire Rite Aid Corp. for about $9.4 billion and expects the deal to close in the second half of 2016.

A group of 50 congressional lawmakers wants the Obama administration to develop guidelines that would require drug makers to license their patents to others in a bid to end “price gouging.”...In their letter, they argue that the National Institutes of Health has the ability to issue so-called march-in rights, which refer to overriding a patent. Under federal law, this allows an agency that funds private research to require a drug maker to license its patent to another party in order to “alleviate health and safety needs which are not being reasonably satisfied” or when the benefits of a drug are not available on “reasonable terms.”...the lawmakers argue that “reasonable guidelines can discourage price gouging.” The letter was released...by the Affordable Drug Pricing Task Force...their reasoning, the lawmakers emphasized that march-in rights should only be used when “wrongdoing occurs” and that “innovation should not be threatened.” By issuing guidelines, they argue the NIH would help drug makers make “better-informed pricing decisions.”

Exhausted. Depressed. These are the words biotech analysts and investors are using to describe their moods coming out of 2015. Which means this year's JPMorgan Health Care Conference, which kicks off next week, could take on a more muted tone than in previous years...Thousands of investors, analysts, executives and entrepreneurs head to San Francisco...for the conference, considered a barometer of sentiment across the industry as the year gets underway. More than 450 companies are slated to present to investors at the meeting...Sentiment will be weary, but not funeralesque...Normally, sentiment is extremely bullish at JPMorgan, but once every few years you get a situation like this...a 23 percent decline in biotech stocks from highs in July, driven by concerns over pressure on drug prices, valuations that have been rising for six years, and some stock-crushing clinical trial setbacks toward the end of the year. The Nasdaq biotechnology index sank 9.4 percent this week through Thursday…Despite the somber mood, 2015 wasn't as bad as it sounds. The Food and Drug Administration approved 45 new medicines, the most in 19 years. Deal activity was explosive, at more than 530 transactions worth more than $296 billion, according to MergerMarket, up 29 percent from 2014...It was also the sixth-straight year biotech outperformed the broader market...

Pfizer Inc, which plans a $160-billion merger with Ireland-based Allergan Plc to slash its U.S. tax bill, on Jan. 1 raised U.S. prices for more than 100 of its drugs, some by as much as 20 percent, according to statistics compiled by global information services company Wolters Kluwer…Pfizer confirmed a 9.4 percent increase for…Lyrica, which generated $2.3 billion in 2014 U.S. sales; a 12.9 percent increase for…Viagra, which had 2014 U.S. sales of $1.1 billion; and a 5 percent increase for Ibrance…launched last year at a list price of $9,850 per month, or $118,200 per year…Company spokesman Steven Danehy could not immediately confirm the remaining price increases…Pfizer is by no means the only drugmaker to raise prices. Research firm Truveris found that U.S. prescription drug prices rose 10.9 percent in 2014, including a 15 percent increase for brand-name products.

Drugmaker Shire Plc clinched its six-month pursuit of Baxalta International Inc on Monday with an agreed $32 billion cash and stock offer, catapulting it to a leading position in treating rare diseases...The deal marks a strong start to mergers and acquisitions in healthcare in 2016 after the sector had its biggest deal-making streak in history last year, with global transactions totaling $673 billion...It also highlights the appeal of medicines for rare diseases targeting small groups of patients for which drug companies can charge prices running into hundreds of thousands of dollars a year...Together we will have the number one platform in rare diseases with a strong foundation for future growth...the two companies said they expected to deliver double-digit sales growth with more than $20 billion in annual revenues by 2020.

2016 has officially arrived...Big changes are afoot in the biopharma industry. Yet, many of the trends we saw in 2015—large-scale M&A activity, payer pushback against drug prices, and a focus on category leadership and big-data analytics—will continue to unfold...BioPharma Dive tapped into the expertise of top thought leaders in the industry to get their takes on what comes next in pricing, M&As, drug development, transparency, and much more.

• Dr. Rachele Berria, Vice President and Head of Diabetes Medical Unit, Sanofi -  we will witness additional strides in artificial pancreas-related discoveries.
• Dr. Bert Liang, Chair of Biosimilars Council & CEO of Pfenex - we will see a greater degree of consolidation, with small molecule generics companies considering biosimilar investment as a growth engine that drives innovation...
• Michael A. Griffith, Executive Vice President at inVentiv Health and President, Commercial Division -  Transparency in pricing will reach beyond the pharmaceutical company narrative and drug WAC
• Brian Overstreet, CEO, Advera Health Analytics -we will see data and technology-driven systems drive healthcare the same way data drives the financial markets.
• Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development, Novocure -  look forward to the emergence of new combinations of existing and new treatment modalities in the treatment of cancer.
• Kevin Robert Frost, CEO, amfAR, The Foundation for AIDS Research - we’ll see some exciting advances in several areas of HIV cure research, such as latency reversing agents and gene therapy.
• Dr. Barry Mennen, Washington, D.C.-based physician - this will be the year that genomic-based personalized medicine will impact certain of the common genetically complex diseases...
• Dr. Hugo Stephenson, Executive Chairman, DrugDev - increased focus on improving payments processes will shape the coming year for the biopharma industry.
• Ashish Singh, Partner and Head of Bain’s Global Healthcare practice - Bain has demonstrated how biopharma leaders have created the most shareholder value by focusing on a few, sustainable leadership positions in Product Categories..
• Ruchin Kansal, Executive Director of Business Innovation at Boehringer Ingelheim -  industry’s increasing focus on patient centricity is transforming the way companies think and approach the market.
• Dr. Michael Kiebish, Vice President of Systems Medicine at Berg - increased focus on combination therapies between immuno-oncology and targeting metabolism in cancer.

Prescription drug distributor McKesson Corporation is the target of a complaint alleging it fueled West Virginia's prescription drug addiction problem by "failing to identify, detect, report and help stop the flood of suspicious drug orders into the state," Attorney General Patrick Morrisey said…the...complaint…alleges McKesson flooded West Virginia with highly addictive prescription medications, delivering roughly 99.5 million doses of hydrocodone and oxycodone…McKesson…"made no efforts to determine whether the volume of prescription pain killers it was shipping ...was excessive and whether any of the orders it filled qualified as suspicious orders, which should have been refused."…Sales agents and managers received commissions and bonuses based on sales numbers, and made "little to no effort to visit pharmacies" to ensure shipments weren't being diverted to illegal use…"In the near future, the office will seek to join this case with the ongoing matter in Boone County involving 12 other drug wholesaler defendants," he said in a prepared statement…in order to coordinate the Amerisource and McKesson cases and to ensure adequate resources are available to prosecute the McKesson case, the state has awarded an outside counsel appointment...Morrisey also announced Jan. 8 he will be handing off the management of both the Amerisource and McKesson cases to...Anthony Martin and...Vaughn Sizemore and will voluntarily step aside, going further than the rules require. Morrisey has had ties to Cardinal Health, one of the nation's largest drug distributors.