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November 21, 2012
10:20 EDTPFE, OREX, RHHBY, ARNA, GSK, AET, VVUSVIVUS rallies after Aetna revises obesity drug policy
In a Clinical Policy Bulletin revision dated November 20, 2012, Aetna (AET) specified criteria under which the insurer considers weight reduction medications as "medically necessary" for treatment of obesity. Aetna stated, "For members whose medical policies do not exclude weight reduction medications or services and supplies for or related to weight reduction programs, Aetna covers [the following] drugs under the medical benefit, not the pharmacy benefit." Among the medications that have been approved by the FDA for weight reduction which would be covered under its policy, Aetna listed Qsymia, marketed by VIVUS (VVUS), Belviq from Arena Pharmaceuticals (ARNA), Didrex from Pfizer's (PFE) Pharmacia unit, Roche's (RHHBY) Xenical, and GlaxoSmithKline's (GSK) Alli. Early session strength in shares of VIVUS and Arena has been attributed to Aetna's policy revision, and shares of Orexigen Therapeutics (OREX), which is developing a weight loss treatment that is being considered by the FDA for approval, have also moved higher. In early morning trading, VIVUS advanced $1.58, or 15.27%, to $11.93, Arena gained 20c, or 2.24%, to $9.13 and Orexigen added 30c, or 6.88%, to $4.66.
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September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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07:33 EDTPFEBIND says Pfizer exercises option to obtain license for Accurin drug candidate
BIND Therapeutics (BIND) announced that Pfizer (PFE) exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies' global collaboration agreement. The actively targeted Accurin is designed to impart cellular targeting capability and was engineered by BIND using one of Pfizer's proprietary kinase inhibitors and one of BIND's proprietary ligands. As a result of the option exercise, BIND will receive a $2.5 million option exercise fee from Pfizer. In parallel with exercising its first option, Pfizer informed BIND that it will not exercise its option for the second compound in the collaboration. Under terms of the original collaboration agreement, which was established in April 2013, Pfizer was granted options to obtain exclusive licenses to pursue development and commercialization of two Accurins that incorporate specified Pfizer small molecular targeted therapies. For the Accurin that has been selected, both companies will work together on preclinical research; Pfizer will have responsibility for development and commercialization, and BIND will conduct chemistry, manufacturing and control activities. In addition to the $2.5 million option exercise fee, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million preclinical development milestone for the selected Accurin in December 2014. BIND has the potential to receive additional milestone payments for the selected Accurin of up to $86.0 million in aggregate upon the achievement of additional specified development and regulatory events under the Pfizer collaboration agreement. BIND may also receive additional milestone payments for the selected Accurin of up to $110 million in aggregate for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of the selected Accurin, if any.
05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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September 23, 2015
13:09 EDTGSKEU could green light GlaxoSmithKline's new asthma drug this week, Reuters says
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08:39 EDTOREXOrexigen receives payments for $22M from U.S. and Korean partners
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08:11 EDTAETLeerink sees less political risk for Managed Care mergers after hearings
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05:32 EDTPFE, GSKViiV Healthcare announces Triumeq Phase IIIb study met primary endpoint
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September 22, 2015
20:02 EDTPFE, AETClinton vows $250 cap on monthly drug costs in blast against biotechs, insurers
Democratic presidential candidate Hillary Clinton railed against biotech companies as well as health insurers at a community health care forum in Iowa on Tuesday. Clinton began her speech by praising the Affordable Care Act, but quickly noted that she wants to strengthen it due to what she called the rising cost of prescription drugs. She explained, "Our pharmaceutical and biotechnology industries deserve credit... [But] too often, these drugs cost a fortune. Now, sometimes there is a good reason for that. Scientific breakthroughs are often the result of major investment... so it may makes sense, for a short period of time, to have to charge a lot of money for a drug. But when a drug has no competition, when there aren't any other treatments that can do what it does, pharmaceutical companies can charge astronomical fees far beyond anything that it would take to recoup their investment, and far beyond what they charge consumers anywhere else in the world outside of America." Referencing the recent criticism against Turing Pharmaceuticals, Clinton went on to say that "pharmaceutical companies that acquire an existing affordable drug that people rely on, and then turn around and charge a fortune for it, [are just betting] on the fact that desperate people will find some way to pay for it." Preemptively responding to questions of whether greater regulation will dampen investment, Clinton commented that "some people worry that my proposals will threaten innovation, but I have designed a plan that will do exactly the opposite... Under my plan, drug companies that want to keep getting federal support will have to redirect more of their profits into meaningful investments in research and development." Clinton also criticized incremental drug improvements, saying that "too often, so-called new drugs are really old drugs that have just been tweaked a little bit, but then they're marketed as breakthrough drugs and they're sold for high prices." The Democratic candidate went on to condemn advertising in the drug industry, remarking that "I also want to tackle direct to consumer advertising... Other countries ban these ads because they are so often misleading. But at the very least, we shouldn't be encouraging them with corporate write-offs... Under my plan, we will instead use that taxpayer money to fund innovation... I would also like to make sure any ads the drug industry does run are approved by the FDA." Moving more broadly onto Medicaid and health insurers, Clinton stated, "I believe Medicare should be able to negotiate for lower prices for its members... I will require drug companies to provide higher rebates for prescription drugs to low income Medicare patients, just like they have to do for Medicaid patients... I think the insurance companies need to be put on notice." Providing more concrete details of her plan, Clinton concluded, "I will cap out of pocket drug costs for working families. You won't have to pay more than $250 a month for covered medications... Particularly for people who have a chronic illness. Also under my plan, you will be able to import cheaper drugs from other countries legally. If the medicine you need costs less in Canada, you should be able to buy it from Canada or any other country that meets our safety standards... I will also make sure we have more generics on the market [by boosting funding for] the FDA's office of generic drugs."
18:56 EDTVVUSOn The Fly: After Hours Movers
HIGHER AFTER EARNINGS: Copart (CPRT), up 1.48%. ALSO HIGHER: Heron Therapeutics (HRTX), up 22.9% after announcing its Phase 2 study of HTX-011 met its primary endpoint... First Niagara (FNFG), up 7% after a report stated the company was exploring strategic alternatives. LOWER: VIVUS (VVUS), down 1.2% after the company expressed no opinion and remained neutral toward the unsolicited tender offer by IEH Biopharma, a wholly-owned subsidiary of Icahn Enterprises Holding (IEP), to purchase any and all of VIVUS's 4.50% convertible senior notes.
17:35 EDTPFEHillary Clinton vows to cap out-of-pocket drug costs at $250 per month
Presidential candidate Hillary Clinton said in a tweet that, "Under my plan, I'll cap out-of-pocket drug costs for families. You won't have to pay more than $250/month for covered medications." Reference Link
16:08 EDTVVUSVIVUS neutral on Icahn Group's offer to purchase convertible notes
VIVUS (VVUS) announced that its Board of Directors has determined that it expresses no opinion and remains neutral toward the unsolicited tender offer by IEH Biopharma, a Delaware limited liability company and wholly-owned subsidiary of Icahn Enterprises Holding (IEP) , to purchase any and all of VIVUS's 4.50% Convertible Senior Notes due 2020. The Company noted that its Board believes each noteholder should make their own decision as to whether to tender in connection with the Icahn Group's unsolicited tender offer based on the noteholder's particular circumstances. It further indicated that its Board believes the determination is a financial decision to be made by each noteholder based on the terms of the tender and the cash price being offered by the Icahn Group. Accordingly, the Board concluded that it would be appropriate to remain neutral as to whether the noteholders should or should not tender the notes. The Board, however, strongly urges the Company's noteholders to consider carefully all aspects of the Icahn Group's offer before deciding for themselves whether to tender.
14:52 EDTAETAetna plans to raise Humana wages after merger, Bloomberg says
Aetna (AET) CEO Mark Bertolini plans to raise wages to $16 per hour for about 10,000 low-wage Humana (HUM) employees if the prospective merger of the two companies goes through, reports Bloomberg, citing written testimony at a U.S. Senate subcommittee hearing. "Our hope is these initiatives will help reduce employee turnover," explained Bertolini. Reference Link
08:37 EDTAETAetna, Anthem CEOs set to testify to Senate committee, WSJ reports
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08:23 EDTPFEAnalysts say buy select biotech stocks ahead of Clinton drug plan
Ahead of Presidential candidate Hillary Clinton laying out her plan to tackle "price gouging" in the specialty drug market at an event in Iowa later today, analysts at research firms Jefferies and Piper Jaffray are recommending select biotech stocks that they view as buys amid the weakness in the space. DEBATE: Biotech stocks broadly declined yesterday, with the NASDAQ Biotechnology index (IBB) sliding roughly 4.4%, after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on a 62-year-old drug that fights complication of AIDS and cancer. Furor around the sudden price hike for Turing's Daraprim reignited a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. The news also follows Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Pfizer's (PFE) Hospira, in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. Presidential candidate Hillary Clinton sent the debate to center stage yesterday by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan today to tackle "price gouging" in the specialty drug market. Clinton's proposal, which she'll outline in a speech in Iowa later today, would force pharmaceutical companies to reinvest their profits into research, allow for more generic and imported drugs and allow Medicare to negotiate lower drug costs and cap out-of-pocket expenses, according to details of the plan shared with USA Today. Zeke Emanuel, chair of medical ethics and health policy at the University of Pennsylvania, appeared on Nightly Business Report to discuss the problem of high drug prices and his suggested solutions. During his interview, Emanuel contended that giving Medicare the ability to negotiate drug prices may drive up prices for everyone else. DEFENSES: The Jefferies Biotechnology research team, led by Brian Abrahams, Eun Yang and Biren Amin, say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). Meanwhile, Piper Jaffray analyst Edward Tenthoff recommends buying shares of Vertex Pharmaceuticals (VRTX) following yesterday's selloff. Tenthoff believes that drugs like Vertex's Orkambi will maintain premium pricing because of the disease modifying value to patients and payors. Orkambi is approved to treat cystic fibrosis in patients 12 years and older. The analyst reiterates an Overweight rating on Vertex with a $163 price target. DOWNGRADE: Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, said Yang, who views the stock as more risky than in the past. PRICE ACTION: Horizon closed yesterday down $2.93, or 9.2%, at $28.99, while Vertex dropped $5.97, or 4.8%, to $118.19. A number of the biggest stocks in biotechnology were also weak yesterday, with Gilead sliding about 2.5%, Amgen (AMGN) dropping 2.3%, Celgene declining 2.8% and Biogen (BIIB) falling more than 5.5%.
07:47 EDTAETSenate Judiciary Committee to hold a hearing
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07:43 EDTPFE, RHHBY, GSKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTPFE, GSK, RHHBYClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:28 EDTGSK, PFE, RHHBYTuring CEO says will not change Daraprim price despite criticism
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11:24 EDTRHHBY, PFE, GSKHillary Clinton vows to take on 'outrageous' specialty drug pricing
Hillary Clinton, on the heels of a Wall Street Journal report detailing Turing Pharmaceuticals' price hike to $750 from $13.50 per pill of a drug called Daraprim which treats a life-threatening parasitic infection, vowed to lay out a plan tomorrow to take on what she calls "price gouging" of specialty drugs. The presidential nominee stated in a tweet, "Price gouging like this in the specialty drug market is outrageous. Tomorrow I'll lay out a plan to take it on." The iShares Nasdaq Biotechnology Index (IBB) moved lower following Clinton's tweet.
08:03 EDTPFEPfizer says two Phase 3 tofacitinib 10mg trials met primary endpoints
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