- FDA castigates China’s Zhejiang Hisun for ‘systemic data manipulation’ (fiercepharmamanufacturing.com)
A Chinese drugmaker that has a joint venture with Pfizer to produce generic drugs and plans to separately make biosimilars, has been savaged by the FDA in a warning letter for serious data manipulation and shipping to the U.S. products that repeatedly failed follow-up testing by customers...A warning letter posted by the FDA today shows why the agency last September decided to ban products coming out of the Zhejiang Hisun Pharmaceutical plant in Taizhou City. "We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs,"...its concerns over data manipulation were "heightened by the significant number of customer complaints for subpotency and out-of-specification impurity levels the company received from 2012-2014." There were more than 60 complaints for impurity problems...The FDA said the explanations that Zhejiang Hisun Pharmaceutical gave for why data was deleted and raw data was no longer available were completely inadequate, as were the responses to other issues. It said it will continue to prevent the company's products from coming into the U.S. until the agency is satisfied with the steps the drugmaker has taken to bring up its manufacturing standards and can convince the FDA that its test data is authentic.
- 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."
- Health Care in 2016: Eight Charts You Need to Follow the Sector (bloomberg.com)
Next (this) week bankers, investors, companies and researchers from around the world will gather in San Francisco for the J.P. Morgan Healthcare Conference, a massive gathering that sets the tone for the rest of the year. These are the charts that will help you keep up with the industry in 2016.
- Remember, You've had It Pretty Good
- Health Care Grows as a Share of GDP
- Are Obamacare's Gains Petering Out?
- Biotech, Insurers, Hospitals and Pharma All Gain Since 2010
- Venture Capital Investment Is at a Record
- Boom Years for Biotech
- The IPO Class of 2015
- Health Care's Big Deals
- NIH asked to fight price gouging by overriding drug patents (statnews.com)
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.”
- Anthem Takes $3 Billion Express Scripts Fight Public (bloomberg.com)
Health insurer Anthem Inc. wants $3 billion a year more in savings on drugs from Express Scripts Holding Co., and is threatening to ditch the company in a move that would depose the pharmacy benefit manager as the country’s biggest...The insurer, which contracts with Express Scripts to manage prescription drug costs for its members, said the pharmacy manager should be passing along about $3 billion a year more in the savings it negotiates from drug companies... The two may be running out of time. “We have a very involved dispute resolution process in the contract that has been fully exhausted”...Anthem took the dispute public because the company wasn’t getting the savings it needed to offer more competitive products, such as Medicare drug plans..."Both of us have to step back and see whether we’re honoring the contractual terms of the agreement"...If not, “you have your legal remedies.”
- English doctors strike for first time in 40 years (reuters.com)Industrial action: junior doctors provide emergency-only care (bma.org.uk)
English doctors staged their first strike in 40 years on Tuesday over government plans to reform pay and conditions for working anti-social hours, in a move health chiefs have warned could put patients' lives at risk...Junior doctors, or doctors in training, who represent just over half of all doctors in the state-funded National Health Service, said they would only deliver emergency care during the 24-hour walkout..."This strike is not necessary, it will be damaging," Prime Minister David Cameron said on Monday. "We will do everything we can to mitigate its effects but you cannot have a strike on this scale in our NHS without real difficulties for patients and potentially worse."...Most people in England are supportive of the strikes, as long as emergency care is still provided...The doctors' union the British Medical Association said the contract does not provide proper safeguards against doctors working dangerously long hours.
- How much are junior doctors paid, and why are they threatening to strike? (telegraph.co.uk)Junior doctors row: David Cameron asks doctors to call off strike (bbc.co.uk)
As the British Medical Association prepares for industrial action, ending in the first 'all out' strike by medics in the history of the NHS, we examine the issues...Junior doctors are on the verge of their first day of industrial action, marking the first of three days that ends next month with the first "all out" strike by medics in the history of the NHS...Under the plans, junior doctors will provide "emergency care only" action for Tuesday 12 January, and Tuesday 26 January, followed by a full walk out from 8am to 5pm on Wednesday 10 February...What's caused such ire in the medical community? Is it all about pay? How justified is their anger? Read on for all you need to know.
- Why are they so cross?
- What do the current proposals look like?
- What will strike action involve?
- Is the dispute all due to the 7-day NHS idea?
- Why won't the two sides talk?
- Weren't doctors meant to strike in December?
- How much do junior doctors get paid?
- How does this compare to other starting salaries?
- But what about cuts to their pay?
- Would doctors be put off certain specialities?
- How will their pay supplements change?
- What about working hours?
- When would these new contracts come into force?
- What happens next?
- Drug Makers Dismiss Outrage over High Prices as ‘Abomination’ (realclearhealth.com)
The protesters carried handwritten signs accusing drug maker Gilead Sciences of greed for pricing its breakthrough hepatitis C drug at $84,000 per treatment...a Gilead executive was asked how he lives with himself...the executive vice president for corporate and medical affairs, joked that he goes running...the drug industry’s biggest showcase, the J.P. Morgan Healthcare conference...As executives and investors shuttled from meeting to meeting, seeking deals, many dismissed public outrage at the industry as misguided...Public anger at drug companies is “an abomination,” Ron Cohen, chairman of the big industry group BIO, said at the Biotech Showcase...All the talk about pharma profiteering, Cohen said, is “a perversion of reality.”...Outside the stately old hotel where the...conference is being held, a handful of protesters marched with signs declaring “Gilead = Greed,” “Public Health Not Private Wealth,” and “Jail Gilead Drug Profiteers.”...“If Gilead’s approach is the future of how blockbuster drugs are launched in America, it’s going to cost billions and billions of dollars to treat just a fraction of patients in America,” Senator Ron Wyden said...
- Drug Price Policy Can’t Discourage R&D: Biogen CEO (bloomberg.com)
George Scangos, chief executive officer at Biogen, talks with Betty Liu about the company's drug pipeline and explains the complications related to drug pricing and research and development. He speaks on "Bloomberg Markets." (Source: Bloomberg)
- 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...