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  • Sat, Nov. 12, 4:43 PM
    • Barron's speaks with several prominent money managers.
    • They are hopeful that Donald Trump will enact pro-growth tax and fiscal-stimulus policies, while avoiding overly protectionist measures.
    • Even though biotech stocks have already rallied 10%, fund manager Arun Daniel believes that the benefits of a Trump administration on the bottom lines of biotech and drug companies are not yet fully priced in.  ETFs: IBB, XBI, BIB, BBH, FBT, HQL, PBE, BIS, LABU, BBC, BBP, CNCR, LABD, UBIO, ARKG, ZBIO, LABS
    • He's also bullish on stocks leveraged to government-backed infrastructure spending, his favorites being Jacobs Engineering (NYSE:JEC) and Martin Marietta Materials (NYSE:MLM).
    • Some companies will likely be allowed to repatriate billions of dollars of profits at a low tax rate. Major beneficiaries could include Nike (NYSE:NKE), Procter & Gamble (NYSE:PG), Caterpillar (NYSE:CAT), Visa (NYSE:V) and Mastercard (NYSE:MA).
    • Neuberger Berman's Joseph Amato says that a Trump administration will be better for stocks than bonds. "If [Trump] takes a measured approach and gets some level of concessions for U.S. workers, the trade concerns may be much ado about nothing," Amato says. "But that's a big if."
    | Sat, Nov. 12, 4:43 PM | 211 Comments
  • Wed, Nov. 9, 6:38 AM
    • Fears of government meddling with drug prices have apparently dissipated with Mr. Trump as President. Biotechs are ready to rally. The iShares Nasdaq Biotechnology Index Fund (NASDAQ:IBB) is up 6% premarket on increased volume.
    • ETFs: GRX, BIS, IRY, IXJ, BME, CNCR, THW, ARKG, GNRX
    | Wed, Nov. 9, 6:38 AM | 6 Comments
  • Mon, Jul. 18, 7:19 AM
  • Wed, Jan. 27, 3:30 PM
    • As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
    • Only Biogen and Abbott have bucked the trend.
    • Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
    • ETFs: BIB, BIS, CNCR
    | Wed, Jan. 27, 3:30 PM | 63 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.
    • ETFs: BIB, GRX, IRY, BIS, IXJ, BME, CNCR, THW
    | 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.
    • ETFs: BIB, GRX, IRY, BIS, IXJ, BME, CNCR, THW
    | 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.
    • ETFs: BIB, GRX, IRY, BIS, IXJ, BME, CNCR, THW
    | Tue, Jan. 12, 11:26 AM
  • 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.
    • ETFs: BIB, BIS GRX, IRY, IXJ, BME
    | Nov. 12, 2015, 11:59 AM | 61 Comments
  • Oct. 21, 2015, 1:22 PM
    • As if anyone following biotechs needs reminding, sellers are overwhelming the space. The iShares Nasdaq Biotechnology ETF (IBB -2.8%) is down 6% since Monday.
    • Key tickers: (BIB -6.5%)(BIS +6.3%)(VRX -38.5%)(AGN -5.9%)(BIIB -0.1%)(AMGN -1.7%)(GILD -1%)(CELG -2%)
    | Oct. 21, 2015, 1:22 PM | 66 Comments
  • Oct. 5, 2015, 5:41 PM
    • Top gainers, as of 5.25 p.m.: ARNA +6.1%. DD +5.3%. RKUS +4.0%. BIS +3.5%. JCP +1.4%.
    • Top losers, as of 5.25p.m.: ILMN -14.0%. HAE -12.1%. TCS -10.0%. ABY -5.3%. RIG -4.1%.
    | Oct. 5, 2015, 5:41 PM | 10 Comments
  • Sep. 22, 2015, 2:07 AM
    • Democratic presidential candidate Hillary Clinton is scheduled to outline a plan to rein in prescription drug costs in Iowa later today, after vowing on Twitter to go after "price-gouging" by drug companies.
    • The tweet brought down the biotech sector yesterday, with the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) plunging 4.5%.
    • Several details of the new plan have been provided by the Clinton campaign ahead of the speech: A $250 monthly cap on the amount chronic pain patients would have to pay for prescription medications, approving more generic/imported drugs, forcing pharmaceutical companies to reinvest their profits into R&D and ending their ability to write off consumer advertising as a business expense.
    • ETFs: XBI, BIB, BBH, FBT, HQL, PBE, BIS, SBIO, BBC, BBP, UBIO, LABU, LABD, ZBIO
    • Previously: Biotechs take it on the chin after Hillary tweet about plan to address drug price gouging; IBB down 5% (Sep. 21 2015)
    | Sep. 22, 2015, 2:07 AM | 49 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.
    • ETFs: UNG, USO, OIL, UGAZ, UCO, DGAZ, UWTI, BIB, SCO, BNO, BOIL, GAZ, DBO, DWTI, DTO, UGA, KOLD, USL, GRX, UNL, IRY, BIS, IXJ, DNO, BME, UHN, DBE, OLO, SZO, DCNG, GRN, RJN, FUE, OLEM, JJE, ONG, UBN
    | Jul. 31, 2015, 7:52 AM | 1 Comment
  • Jun. 23, 2015, 9:22 AM
    | Jun. 23, 2015, 9:22 AM | 11 Comments
  • 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.
    • ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
    • 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. 29, 2015, 12:42 PM
    • The biotech sector heads south again today, continuing the move that began in earnest on Monday. The iShares Biotechnology ETF, for example, is down over 8% from the March 29 high of 374.97 and down almost 7% from the intermediate high of 368.25 on April 23. This phase of the down move is particularly bearish considering the high volume driving the drops on Monday and Tuesday (2.3x normal volume both days).
    • A correction is not that surprising in light of the uninterrupted one-year uptrend. On a technical basis, IBB longs should look for support at 320.
    • ETFs: IBB, BIB, BIS
    | Apr. 29, 2015, 12:42 PM | 5 Comments
  • Apr. 27, 2015, 11:19 AM
    • Drug manufacturers have long defended their pricing by citing the need to recoup ultra-high development costs. Now another price-raising scheme is drawing attention. In a report by the Wall Street Journal, there are a growing number of examples where companies acquire drugs they perceive as undervalued and then significantly raise the prices.
    • In February, Valeant Pharmaceuticals (VRX -1.5%) purchased the rights to two heart drugs, Isuprel and Nitropress, from privately-held Marathon Pharmaceuticals for an undisclosed sum. It then immediately raised the prices 525% and 212%, respectively, based on the recommendations of a consultant who researched the price/benefit of each. According to Truven Health Analytics, the cost of a 1mL vial of Isuprel went from $215.46 to $1,346.62 while a 2mL vial of Nitropress went from $257.80 to $805.61.
    • Last year, Mallinckrodt (MNK -0.7%) bought Cadence Pharmaceuticals to gain access to its Ofirmev pain meds. A short time later, the list price for a package of 24 vials jumped 2.5-fold to over $1,019.52.
    • In 2013, Horizon Pharma increased the price of Vimovo pain tablets, after acquiring the rights from AstraZeneca, almost 600% to $959.04.
    • Valeant is apparently leading the price-raising pack. It has boosted list prices by at least 20% about 122 times since early 2011.
    • ETFs: IBB, BIB, BIS, DRGS
    | Apr. 27, 2015, 11:19 AM | 12 Comments
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