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  • Thu, Jun. 9, 11:13 AM
    • The FDA, along with international regulatory and law enforcement agencies in an initiative called Operation Pangea IX, took action against 4,402 websites engaged in the illegal selling of unapproved prescription drugs to U.S. consumers. The operation was part of a global coordinated effort led by INTERPOL called IIWA to stop the sale and distribution of illegal and potentially counterfeit medications on the internet.
    • The goal of Operation Pangea IX was to identify the manufacturers and distributors of the illegal meds and to remove the products from the supply chain. The FDA's enforcement action, which ran from May 31 to June 7, included formal complaints to domain registrars requesting the suspension of 4,402 websites, including 110 sites that sell 2,4-Dinitrophenol (DNP), typically used as a dye, wood preserver and herbicide, but never approved in the U.S. as a drug.
    • The FDA has been investigating the distribution of DNP for some time. Last month, a Bakersfield, CA man pleaded guilty to interstate commerce of an unapproved drug based on the work by an agency task force. In 2013, one of his DNP customers died after ingesting it.
    | Thu, Jun. 9, 11:13 AM | 2 Comments
  • Wed, Jan. 20, 12:03 PM
    • Even critics of Roche's (OTCQX:RHHBY -2.1%) consistent opposition to the off-label use of cancer med Avastin (bevacizumab) for wet age-related macular degeneration (wet AMD) instead of the pricier Lucentis (ranibizumab) now must concede that its view is credible as it relates to patient safety.
    • In cost conscious India, two states have suspended sales of Avastin after 15 wet AMD patients experienced pain and swelling in their eyes after receiving the medication. The company's India unit stands behind the drug while emphasizing that it does not promote Avastin for unapproved uses which, of course, have not been satisfactorily vetted via clinical trials.
    • A number of countries in Europe have been receptive to the off-label use of Avastin for wet AMD considering Lucentis is 30x more expensive. France, for example, would save the equivalent of $273M each year by switching.
    • Manufacturers have fought back. In September, an industry group filed a complaint with the European Commission arguing that French regulators' approval of Avastin for wet AMD is contrary to the EU approval process for medicines and "puts patients' health at risk."
    • The differing cost/benefit viewpoints will, no doubt, persist indefinitely as more and more expensive biologics reach the market.
    | Wed, Jan. 20, 12:03 PM | 1 Comment
  • Thu, Jan. 14, 10:57 AM
    • Biotechs are moving in sync with the market today. The iShares Nasdaq Biotech Index Fund (IBB +1.8%) is up ~4% from its low of 273.47, outpacing the Nasdaq Composite's 2.6% jump from its intraday low of 4,470.59. The IBB had lost over 20% of its value since late December.
    | Thu, Jan. 14, 10:57 AM | 2 Comments
  • Tue, Jan. 12, 11:26 AM
    • The FDA approved 45 new drugs in 2015, second only to 1996's 53. 16 (36%) were first-in-class treatments and 21 (47%) were for rare diseases.
    • Among the new molecular entities cleared last year were Novartis' Cosentyx (secukinumab) for psoriasis, Farydak (panobinostat) for multiple myeloma and Entresto (sacubitril/valsartan) for heart failure, Pfizer's Ibrance (palbociclib) for breast cancer, Sanofi/Regeneron's Praluent and Amgen's Repatha for lowering cholesterol and Eli Lilly's Portrazza (necitumumab) for lung cancer.
    • 2016 should be another strong year for drug approvals, stoked by the FDA's accelerated review designations: Fast Track, Breakthrough Therapy and Priority Review.
    | Tue, Jan. 12, 11:26 AM
  • Nov. 19, 2015, 3:25 PM
    • The FDA issues its first approval for a genetically engineered (GE) food, AquaAdvantage Salmon grown by Maynard, MA-based AquaBounty Technologies, a majority-owned subsidiary of Intrexon (XON +4.5%). The company introduces a recombinant DNA construct into the fish which enables them to grow faster and reach market size more quickly.
    • Based on its comprehensive review of the scientific evidence, the FDA determined that the GE salmon is nutritious and safe to consume with no biologically relevant differences in the nutritional profile of AquaAdvantage Salmon and other farm-raised Atlantic salmon.
    • The approval applies to only two land-based hatcheries, one in Canada and the other in Panama. No AquaAdvantage Salmon are allowed to be bred and raised in the U.S.
    • The agency regulates genetically engineered animals under the Federal Food, Drug and Cosmetic Act because the rDNA construct meets the definition of a drug.
    • ETFs: KXI, IPS
    • ETFs: GRX, IRY, IXJ, BME
    | Nov. 19, 2015, 3:25 PM | 1 Comment
  • Nov. 12, 2015, 11:59 AM
    • A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
    • Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
    • The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
    • Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
    • BI is in the process of expanding its rankings to include other years.
    • On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
    | Nov. 12, 2015, 11:59 AM | 61 Comments
  • Sep. 23, 2015, 8:25 AM
    • GE Healthcare (NYSE:GE) creates an new business unit, Sustainable Healthcare Solutions (SHS), that will develop high-value, low-cost technologies and healthcare delivery solutions across multiple care settings. It will invest an initial $300M as part of a multi-phase effort to develop a more robust and affordable healthcare portfolio for customers. The business will combine GE Healthcare operations in India, South and Southeast Asia and Africa.
    • SHS's aim is to improve access to quality and affordable healthcare around the world by leveraging GE's Fastworks methodology to rapidly develop and commercialize pertinent and affordable technologies. It plans to work with governments, clinicians, private operators and NGOs to deliver value-based solutions that improve outcomes for patients and health systems.
    • ETFs: GRX, IRY, IXJ, BME
    | Sep. 23, 2015, 8:25 AM | 11 Comments
  • Jul. 31, 2015, 7:52 AM
    • According to Reuters, the value of merger and acquisition deals through July 30 was $436.4B, including 14 deals worth over $5B apiece. Although down from June's torrid pace of $546.8B, it still ranks as the seventh busiest month on record. Leading the pack was Teva's $40.5B purchase of Allergan's generic drugs business.
    • The top investment bank in terms of the total value of transactions was Goldman Sachs (NYSE:GS), involved in 35 deals worth $148.8B, including half of the top ten. JP Morgan (NYSE:JPM) was second with 30 deals worth $116.1B while Morgan Stanley (NYSE:MS) was third with 33 deals valued at $95.9B.
    • Global M&A so far this year is $2.64T, up 41% from last year. The action in the U.S. is up 66%.
    • Energy and healthcare are the leading sectors. There have been 1,557 deals in energy worth $407B. Healthcare is close behind with 1,577 deals worth $395B.
    | Jul. 31, 2015, 7:52 AM | 1 Comment
  • May 7, 2015, 11:13 AM
    • Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
    • Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
    • The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
    • Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
    • Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
    • Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
    • Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
    | May 7, 2015, 11:13 AM | 6 Comments
  • Apr. 14, 2015, 7:28 AM
    • According to the IMS Institute for Healthcare Informatics, U.S. spending for prescription drugs rose 13% last year to $374B, driven by manufacturer price hikes, pricey breakthrough medicines and millions of newly insured individuals under the Affordable Care Act. The increase was the largest since 2001. Total spending rose by $43.4B, including $10B from price increases and $20.3B from new drugs. led by Gilead Sciences' hepatitis C drug Sovaldi. Specialty medicines, those for complex, chronic disorders, accounted for one third of spending.
    • A record 4.3B prescriptions were filled last year. Those covered by Medicaid rose by almost 17% which accounted for 70% of the growth in prescriptions filled at retail pharmacies. 8.4M fewer prescriptions were filled at retail pharmacies compared to 2013 for patients with commercial insurance due to high out-of-pocket costs.
    • The number of novel medicines launched in 2014 was 42, including 18 for rare diseases. Ten were designated as Breakthrough Therapies by the FDA.
    • Generic drugs reduced spending by only $11.9B.
    • The IMS data is based on list prices for branded drugs. Wholesalers usually get discounts of ~6%.
    | Apr. 14, 2015, 7:28 AM | 9 Comments
  • Mar. 24, 2015, 4:42 PM
    • The FDA will hold a public hearing April 20 - 21 seeking information and comment on the use of products labeled "homeopathic" and the agency's regulatory framework for such products. The hearing will cover prescription drugs, biological products and over-the-counter (OTC) medicines labeled homeopathic, a multi-billion dollar industry in the U.S.
    • There has been considerable debate over the years concerning whether homeopathic medicines actually work. Recently, an Australian government study concluded that they do not. Last week, the FDA issued a warning about the potential health risks of homeopathic OTC asthma products considering they have not been evaluated for safety and effectiveness.
    • Homeopathy is considered pseudoscience. No remedy has ever been proven to be more effective than placebo.
    | Mar. 24, 2015, 4:42 PM | 11 Comments
  • Mar. 19, 2015, 11:45 AM
    • In a report published by EP Vantage (the editorial arm of market intelligence firm Evaluate), 2014 was the year of biotech. Highlights include:
    • $212B in M&A transactions, eclipsing 2009's $152B; 87 IPOs that raised $6.3B (almost double the floats done in 2013 and more than 2x money raised); $6.5B in venture funding (+33%).
    • FDA approved a record 50 new drugs.
    • So far in 2015, ~$3B has been raised through secondary offerings.
    | Mar. 19, 2015, 11:45 AM | 7 Comments
  • Dec. 5, 2014, 7:19 AM
    • Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work.  Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
    • The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
    • ETFs: IRY, IXJ
    | Dec. 5, 2014, 7:19 AM | 8 Comments
  • Dec. 2, 2014, 10:22 AM
    • Based on data collected from the analysis of medical records, the Centers for Medicare and Medicaid Services (CMS) report that U.S. hospitals saved 50,000 lives in 2013 by making 17% fewer medical mistakes. The improvement includes a 9% decline in hospital-acquired conditions such as infections, bedsores and pneumonia.
    • Secretary of Health and Human Services (HHS) Sylvia Burwell is scheduled to announce the findings today at the CMS Healthcare Quality Conference in Baltimore.
    • In 1999, the Institute of Medicine estimated that almost 100K people die each year from medical mistakes and poor quality of care. In 2010, the HHS inspector general estimated that poor care contributed to the deaths of 180K Medicare patients.
    • One motivator for the improvement is a change in the way Medicare pays hospitals. Under updated rules, CMS reduces the reimbursement rate for hospitals that readmit too many patients within 30 days of discharge, an indicator of substandard care the first time.
    • ETFs: IRY, IXJ,
    • Hospital tickers: (HUM)(HCA +0.2%)(UHS -0.3%)(SEM +0.8%)(LPNT +0.4%)(CYH +0.3%)(SSY -0.2%)
    | Dec. 2, 2014, 10:22 AM | 8 Comments
  • Nov. 28, 2014, 9:23 AM
    • The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
    • Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
    • Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
    • Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
    • Previously: BI begins enrollment in Phase 3 CRC trial
    | Nov. 28, 2014, 9:23 AM | 1 Comment
  • Nov. 25, 2014, 8:18 AM
    • Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
    • Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
    • Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
    • Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
    • Previously: Roche's Gazyvaro not NICE in the UK
    • Previously: Global drug tab will breach trillion dollar mark this year
    | Nov. 25, 2014, 8:18 AM | 24 Comments
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