- Senate Panel Punts on Big Medical Bill (morningconsult.com)
The Senate will not put forth a comprehensive medical innovation bill that would be a companion measure to the House’s 21st Century Cures bill. Instead, lawmakers are opting to work on several smaller bills that have bipartisan support. In recent weeks, aides said committee members hit partisan snags when discussing a bigger bill...The Health, Education, Labor, and Pensions Committee will hold three separate markups, deliberating a few “easier” bills in February to “get our sea legs on working on bipartisan FDA/NIH bills,” according to a senior GOP committee aide. The overall goal of the committee’s work will be to accelerate the development and approval of new medical cures...The House passed its 21st Century Cures bill last summer. Energy and Commerce Chairman Fred Upton guided the bill to a 344-77 passage on the floor, but HELP Committee Chairman Lamar Alexander has long said the Senate would produce its own version...Both chambers’ goals overlap, including giving the National Institutes of Health additional funding and reforming drug approvals at the Food and Drug Administration.
- Compounding Pharmacy Forced to Stop Production Due to Insanitary Conditions (specialtypharmacytimes.com)Federal judge enters consent decree against Downing Labs (fda.gov)FDA sues to stop a wayward drug compounder (statnews.com)
Compounding pharmacy Downing Labs LLC (formerly known as NuVision Pharmacy), its co-owners, and its pharmacist-in-charge have been issued a consent decree of permanent injunction...The Texas-based company is allegedly in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act...Downing Labs is accused of manufacturing and distributing adulterated drugs that were made in insanitary conditions, meaning they were bad enough to endanger public health...“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,”...“The FDA pursued appropriate and aggressive action to protect the public health.”...Downing Labs said it has worked "collaboratively and cooperatively” with the FDA to reach an agreement that will enable it to resume the production of compounded sterile medication...also noted that, as part of the consent decree, it voluntarily agreed to participate in a regular program of testing, audit, and inspection “to ensure it is achieving and exceeding its quality goals.”
- 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...
- Cadila Healthcare shares plunge after FDA warns of violations (reuters.com)
Cadila Healthcare Ltd (Zydus Cadila)has received a U.S. Food and Drug Administration warning letter for violating manufacturing standards at two of its production facilities, the latest in a series of Indian companies to face such action....The warning letter cites issues with Cadila's plants in Gujarat, including at the Moraiya facility, which makes up about 60 percent of the company's total sales in the United States, its largest market...Dozens of Indian drug plants have faced warnings and bans in recent years, as the FDA improved inspections of foreign facilities. More than 40 percent of the generic and over the counter medicines available in the United States comes from Indian facilities such as Cadila's Moraiya plant...Cadila Managing Director Pankaj Patel told analysts...the FDA, during an inspection of the Moraiya plant...found deficiencies with the way the company investigated market complaints about a medicine made there...The company is working on a response to the warning letter and will then ask the FDA to reinspect both facilities...It has 15 days to respond to the FDA, as per standard procedures, after which the FDA will decide its response including whether to impose an import ban.
- Two Indian states halt sales of Roche’s Avastin drug (reuters.com)
Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.
- Senate panel approves Dr. Robert Califf as FDA commissioner (hosted.ap.org)
President Obama's choice for commissioner of the Food and Drug Administration won easy approval from a Senate panel Tuesday, but two senators - a Republican and Democratic presidential candidate Bernie Sanders - threatened to block the nominee...Sen. Lisa Murkowski said she will hold up a vote on the Senate floor until she has reassurances from the agency that it will write rules for labeling genetically modified salmon. The Alaska Republican has said the engineered salmon approved by the FDA last year could be harmful to her state's wild salmon industry...Sanders has said the country needs an FDA commissioner who will stand up to the pharmaceutical industry and that Califf is "not that person." He said he is also considering a hold on the nomination...Califf's nomination does have the support of the Republican chairman of the Health, Education, Labor and Pensions Committee. Tennessee Sen. Lamar Alexander said Califf has been thoroughly vetted, and he is confident that Califf can lead the agency "fairly and impartially."
- Drug approvals at 19-year high belie industry challenges (reuters.com)
2015 was a good year for innovation in medicine with the Food and Drug Administration approving 45 novel drugs, four more than in 2014 and the most since the all-time record of 53 set in 1996...the European Medicines Agency recommended 93 new products, including generics, up from 82 in 2014...the prospect for further progress in 2016, the pharmaceuticals industry faces challenges, with increased political focus on drug pricing having punctured both biotech and specialty pharma valuations in recent months...The rapid pace of new approvals reflects accelerated review times by regulators, who want to get life-saving treatments to patients, especially in cancer, as well as an improved scientific understanding of diseases...Full drug pipelines at many companies suggest the strong rate of new drug launches is likely to continue for a while yet, with IMS Health forecasting a total of 225 new drug approvals between 2016 and 2020.
- FDA Takes Action Against Medical Device Hacking (newsmax.com)Postmarket Management of Cybersecurity in Medical Devices (fda.gov)
Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in the devices...Cybersecurity threats to medical devices are a growing concern...The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices...The draft guidance, which is not legally binding, recommends companies take a number of actions, including monitoring and assessing risk, adopting a coordinated vulnerability disclosure policy, and taking measures to address cybersecurity risk early.
- Illumina Launches New Company To Develop Gene-Based Blood Test To Detect Early-Stage Cancers (ibtimes.com)A revolutionary blood test that can detect cancer Liquid biopsies: A $20 billion market ready to explode. (cnbc.com)
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...
- Critics continue pounding 21st Century Cures Act for threatening patient safety (fiercehealthcare.com)The last word: Will 21st Century Cures Act harm patient safety? (medicaleconomics.modernmedicine.com)21st Century Cures: What You Need to Know (energycommerce.house.gov)
Opponents argue that drugs, devices will be less safe if legislation eases FDA approval rules...Opponents of the 21st Century Cures Act, which is intended to accelerate the transfer of scientific advances in genetics into treatment for patients, say the legislation will threaten patient safety by easing FDA rules intended to protect patients from unproven therapies...Critics argue looser FDA rules will result in drug approvals without the level of rigorous testing currently required...new drugs and medical devices will be less safe and effective and cost more, and that the bill sacrifices long-term value to public health.