- Drugmaker Shire wins Baxalta for $32 billion after six-month pursuit (reuters.com)
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.
- The year ahead: 11 execs & experts predict what’s in store for biopharma in 2016 (biopharmadive.com)
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.
- Pfizer hikes U.S. prices for over 100 drugs on January 1 (reuters.com)
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.
- Getting the Pill Without a Doctor: The Revolution Begins (bloombergview.com)
Oregon is making hormonal birth control legally available without a doctor's prescription, and California is set to follow suit. This is great policy, and the rest of the country should follow this example...Before I explain why they should, we should dispense with the policy hopes that easier access to birth control won’t fulfill:
- It won’t end the political fight over the contraception mandate.
- It won’t end the political fights over abortion, either. Easier access to birth control is a great thing. But there is surprisingly weak evidence that making birth control easier to get substantially reduces abortion rates.
- It won’t save the health-care system any significant amount of money.
There are still very good reasons to make birth control available without a doctor visit, starting with the fact that women like it...Absent a compelling reason that women need to see a doctor, it should be as easy as possible for them to get any form of birth control they might like to have...Advocates for keeping doctors involved in dispensing birth control have historically used two arguments.
- The first is that the drugs have side effects -- which is true, but of course, also true of over-the-counter medications...
- The second argument is that we need to keep doctors involved so that women will keep coming to the gynecologist to get their annual exam and pap smear.
- Drug Companies to Try a Unified Front Against Cancer (nytimes.com)Rival drug firms team up to test new approach to cancer treatment (statnews.com)
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...
- New open access journal highlights methods and clinical trial results (worldpharmanews.com)ScienceDirect (sciencedirect.com)
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.
- Complaint alleges McKesson shipped nearly 100 million doses of highly addictive RX drugs to WV, fueled drug epidemic (wvillustrated.com)Morrisey files suit against nation’s largest drug distributor (wvgazettemail.com)
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.
- JPMorgan’s big health-care confab: What to expect (cnbc.com)What to watch at J.P. Morgan Health Care Conference (video.cnbc.com)
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...
- Britain set for first mass strike by doctors in 40 years (reuters.com)Junior doctors strike: Talks with BMA lasted less than an hour, says Jeremy Hunt (dailymail.co.uk)
The British government said it was seeking to hold talks with doctors in its state-funded health service in a last-ditch bid to avert a series of mass walkouts, potentially the first such strikes for four decades…Junior doctors, or doctors in training who represent just over half of all doctors in the National Health Service, said…they would stage a 24-hour stoppage next week, followed by two further 48-hour strikes…It will affect non-emergency care and lead to the cancellations of many operations… Ninety-eight percent of more than 37,000 junior doctors had voted to take part in industrial action, including strikes, in protest against the new employment contract proposed by Health Secretary Jeremy Hunt…The BMA and doctors have criticized the contract, which changes the way they are paid for anti-social hours, saying it does not provide proper safeguards against doctors working dangerously long hours…The government says the new contract is part of measures to ensure patients get the "same quality of care across the week"…"Our absolute priority is patient safety and making sure that the NHS delivers high-quality care 7 days a week – and we know that's what doctors want too, so it is extremely disappointing that the BMA have chosen to take industrial action which helps no-one," Hunt said in a statement.
- Retail Pharmacist MTM Roles Supported by US House (pharmacytimes.com)
More than 40 members of the House of Representatives have expressed support for greater pharmacist roles in improvements made to Medicare Part D’s medication therapy management program...CMS announced plans to improve MTM with its Part D Enhanced MTM model in September 2015. The enhanced model aims to look at additional incentives and flexibilities to achieve the goals of the program...Some of those goals include increased communication with pharmacists, prescribers, and patients; improved patient knowledge; reduced medication problems; and improved compliance with medication protocols...The enhanced MTM model test will launch in January 2017...Some of the medication adherence concerns that the Congressional members noted were:
- Nonadherence costs the United States $290 billion annually and makes up 13% of total health care expenditures.
- Patients with several chronic conditions comprise two-thirds of all hospital admissions and are 100 times more likely to have a preventable admission.
- These patients with several chronic conditions visit many different physicians in a year and receive around 50 prescriptions annually on average.
- MTM is currently poorly integrated into health systems.
Congressional leaders called for retail pharmacists to be included in the enhanced MTM models that will be tested, citing how pharmacists have been shown to improve patient health, reduce costs through fewer hospitalizations and readmissions, and increase patient involvement in their own medication management...Our seniors deserve the most robust and effective MTM program possible—one that includes the utilization of the most trained and highly skilled providers medication management services: local retail community pharmacists...