- EMA sets clear rules for drug firms seeking clinical data redactions (outsourcing-pharma.com)
Drugmakers seeking to stop "commercially confidential information" being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause...The European Medicines Agency made the comments in guidelines designed to help marketing authorization holders comply with its policy on trial data dissemination...The document...details how drug firms should submit clinical reports, how they should make patient-level data anonymous and when they can ask for commercially confidential information to be redacted...Clinical trial data redaction is a controversial subject. The agency has faced both challenges from companies concerned sharing data would benefit rivals and criticism from European Ombudsman Emily O’Reilly about information it has allowed to be omitted to date...the guidance the EMA stresses that "the vast majority of the information contained in clinical reports is not considered CCI (commercially confidential information)." It also warned that drugmakers should not routinely make redaction requests every time the submit a study.
- Teaching old drugs new treatments (outsourcing-pharma.com)
Drugs currently being used to treat psychosis or depression may be able to treat emerging viruses, according to new research led by the University of Leeds...The researchers found that some common drugs were able to prevent a particular virus from infecting cells by blocking the ion channels that regulate potassium levels...drugs that were able to inhibit the potassium ion channels were effective against the Bunyamwera virus...which is increasing in prevalence in Mediterranean countries, and is endemic in Africa, the Middle East, and some Asian countries...There are many drugs targeting ion channels that are currently in use for a wide range of conditions. Our work shows that some of these might be suitable to treat virus infections...If existing drugs are confirmed to be effective against known members of a particular virus family, this opens up the possibility of using these 'off-the-shelf' treatments in a rapid response against dangerous new related virus strains that emerge...
- States Remove Barriers To Physician Assistants (forbes.com)
An increasing number of states are granting physician assistants more autonomy to increase access to patients amid a shortage of doctors and an influx of patients with health insurance under the Affordable Care Act...states are removing bureaucratic barriers that in the past led to redundant tasks or slowed the ability of patients to get the care they needed...for example, Gov. Chris Christie...signed into law legislation that removed the so-called "countersignature requirement," which previously required the PAs’ collaborating physician to countersign all medical orders...lawmakers passing such legislation say they are essentially granting physician assistants the ability to do what they are trained to do. Most have a two-year master’s degree, often from a program that runs about two years and includes three years of healthcare training...PAs are being granted "full prescriptive authority," which will allow them to write prescriptions for controlled substances. Legislation is wending its way through the Florida legislature that would make the state the 49th to have the ability to write such prescriptions.
- Pharmacist Job Market Plunges to 10-Year Low (pharmacytimes.com)
...the pharmacy job market took its steepest nosedive in 10 years, according to data collected by the Pharmacy Workforce Center...this drop was observed in every region of the country...More than half of the United States currently has a surplus of pharmacists, meaning the number of pharmacists looking for jobs outweigh the number of jobs available. This information comes from the Pharmacy Workforce Center’s January 2016 newsletter, which reflects the most recently collected data from November 2015...Information about the pharmacy job market is submitted confidentially by employer panelists on a monthly basis and collected as part of an ongoing project...let’s be clear about the source of the problem. There are too many pharmacy schools and they are graduating too many students. There is no mechanism for slowing down pharmacy school multiplication aside from the natural forces of supply and demand. Neither the American Association of Colleges of Pharmacy nor the National Association of Boards of Pharmacy have any tool to stop the proliferation of pharmacy schools...what this means for the future of pharmacy is lower wages, poorer working conditions, patient safety concerns, and fewer jobs. What we’re seeing is not unlike what other fields such as the legal profession have undergone...It would be great if pharmacy schools would come together and mutually agree to reduce their enrollment, but that’s unlikely...
- France raises concerns about heparin made by Dongying Tiandong (in-pharmatechnologist.com)
French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate...a report filed on the European Medicines Agency’s EudraGMP database last week , ANSM inspectors who visited the firm’s facility in Dongying City in December observed 10 deviations from good manufacturing practices standards...The ANSM inspectors said Dongying had used seven batches of out of specification crude heparin to make active pharmaceutical ingredients between 2014 and 2015, which they said indicated a misunderstanding of the basic GMP principles...According to Dongying's website, the firm passed a US Food and Drug Administration inspection in 2013 and was been cleared to supply heparin sodium and enoxaparin sodium APIs by Mexican authorities in 2014.
- High Drug Prices Prompt Demands for Transparency (realclearhealth.com)
Outraged by exorbitant prices for certain prescription drugs, lawmakers in at least 11 states have introduced legislation that would require pharmaceutical companies to justify their prices by disclosing how much they spend on research, manufacturing and marketing...The sponsors of the measures say they have a variety of goals: to educate policymakers and consumers about the reason for high prescription drug prices; to shame pharmaceutical companies into moderating their prices; and, in some states, including Massachusetts, to actually place a ceiling on prices that are determined to be unjustified...A handful of transparency bills were filed last year, but none of them passed...The industry insists that it is being unfairly targeted by the transparency measures, pointing out that prescription drugs account for only 10 percent of health care spending in the United States, $300 billion out of $3 trillion per year...Some experts in drug pricing who are sympathetic to the goals of the transparency bills are dubious that they will accomplish what their sponsors hope...
- The Declining Revenues of GlaxoSmithKline’s Pharmaceutical Segment (finance.yahoo.com)
GlaxoSmithKline’s Pharmaceutical segment has declined substantially in 2015 due to the divestment of its oncology business to Novartis...The...segment reported revenues of $14.17 billion in 2015, compared to about $15.5 billion in 2014...revenues declined by 1% following lower sales of Seretide and Advair, partially offset by increased sales of HIV products Triumeq and Tivicay, and new pharmaceutical products...the...segment’s contribution to total revenues declined from 67.3% in 2014 to ~59.2%...GlaxoSmithKline’s Pharmaceuticals segment is classified into the following two franchises:
- HIV products are marketed under ViiV healthcare, a company with GSK as a major shareholder, while Pfizer and Shionogi are other shareholders. The company completed the acquisition of Bristol-Myers Squibb’s R&D HIV assets on February 22...HIV products reported growth of 54%...about $3.2 billion...partially offset by declining sales of Epzicom/Kivexa.
- Global pharmaceuticals - respiratory, cardiovascular, metabolic and urology, immuno-inflammation, and established products...key numbers:
- ...the respiratory franchise, the drugs Seretide and Advair are losing their market share to the generic competition...revenue decline of 7%
- ...the cardiovascular, metabolic, and urology franchise, the drugs Duodart and Jalyn have shown strong performances, while Avodart...is exposed to generic competition since October 2015...sales declined by 9%
- ...the immuno-inflammation franchise, Benlysta is driving growth...sales improved by ~24% while the franchise sales improved by 16%
- ...the established products franchise are losing their market share to generic competition...a revenue fall of 15%...due to lower sales across global markets.
- Other pharmaceuticals franchise include few key products...Augmentin, Relenza, Dermatology products, and rare disease products...revenues...declined by 4%...lower sales for Augmentin, dermatology, and rare disease products, partially offset by the strong performance of Relenza
- UCLA will get hundreds of millions for rights to prostate cancer drug (latimes.com)
A prostate cancer drug developed at UCLA will provide hundreds of millions of dollars for research under a record-setting deal...Royalty Pharma...a...pharmaceutical investment company, paid $1.14 billion for royalty rights to the drug known as Xtandi (enzalutamide). It was the largest-ever technology transfer deal involving a University of California invention...UCLA pocketed $520 million of the proceeds for its 43.9% ownership stake in the drug. The funds will be placed in a portfolio that is expected to generate $60 million a year to fund campus research, scholarships for undergraduates and fellowships for graduate students. The annual haul will continue until 2027, when major patents on the drug expire.
- Moody’s cuts pharma, medical tech sector outlooks to stable (cnbc.com)
Moody's Investors Service has reduced its outlook from positive to stable for both the pharmaceutical and medical device industries...The ratings agency...cited multiple headwinds, topped by two impacting both sectors. The strong dollar is reducing company sales outside the U.S., and insurers and other payers are pressing manufacturers to reduce prices in the U.S. and many other countries...Drugmakers also have been hurt by slower-than-expected uptake for many drugs anticipated to eventually produce annual sales in the billions, excepting a new generation of cancer drugs which stimulate the immune system. That's mainly because insurers and some foreign government health programs have been limiting or delaying patient access to new products that cost tens of thousands of dollars a year or more...Moody's...expects growth in earnings...will be 3 percent to 4 percent, down from 4 percent to 5 percent.
- Telling docs they overprescribe addicting drugs doesn’t make them stop (reuters.com)
Government letters informing doctors they're prescribing vastly more addictive drugs than their peers fall on deaf ears...The doctors...were all writing far more prescriptions for drugs like opioid painkillers than doctors in similar specialties practicing nearby - but the letters didn't lead to changes in prescribing...I think if there is a way to make these letters effective it may be one tool in the arsenal to curb the high rate of opioid deaths...