Biotech and pharma investing often focuses on the potential approval and marketability of drugs. This can involve short-term investors trading on binary events or long-term investors weighing the marketability of several products to determine a company’s overall potential.
A Food and Drug Administration approval doesn’t guarantee a product’s success. Some drugs are obviously heading out into a blockbuster market -- such as the all-oral hepatitis C treatments coming more »
The phrase “PDUFA date” is thrown around frequently when discussing biotech and pharma companies. PDUFA stands for the Prescription Drug User Fee Act, which is a law allowing the Food and Drug Administration to charge companies that file new drug applications. The money goes towards expediting the review process that takes six months for drugs with an accelerated approval and ten months for a standard filing. Adding the appropriate number more »
Santarus (NASDAQ: SNTS) has risen over 300% in the past year partly based on sales optimism for ulcerative colitis drug Uceris, which launched in the first quarter. The company already had four products on the market and has a trio of pipeline projects in development. Is now a good time to buy Santarus -- or has it become overvalued?
Strong second quarter
Second quarter revenues at Santarus grew 89% year-over-year to more »
Eli Lilly (NYSE: LLY) closed last Tuesday up nearly 3% following positive phase 3 results for cancer drug necitumumab. The company had previously halted a different necitumumab trial for safety issues. This positive bit of news was particularly welcome in the wake of Lilly's late-stage pipeline crashes. And with two blockbuster drugs set to expire in the next year, Eli Lilly needs all the signs of strength it can more »
Ariad Pharmaceuticals (NASDAQ: ARIA) reported its second quarter results last week and focused the associated conference call on the company’s two drugs. Leukemia drug Iclusig is growing in sales but faces a market saturated with generics and a long-standing blockbuster from Novartis (NYSE: NVS). And the oncologic pipeline project lost out on a Food and Drug Administration acceleration, which will put it further behind the competition.
Are Ariad’s more »
Domino’s Pizza (NYSE: DPZ) recently reported its second quarter with a year-over-year sales increase of 10% to about $414 million and an EPS growth of 21%. It was an upbeat quarter driven by the popularity of the fairly new Handmade Pan Pizza. And the results showed that the slow and steady approach could win the pizza wars.
Pan pizza proves patience
That’s enough alliteration for a Strawberry Shortcake more »
Regeneron Pharmaceuticals (NASDAQ: REGN) closed Tuesday down over 6% following a second quarter report that missed estimates. A particular cause for concern was the slowed sales growth for macular degeneration drug Eylea. Were investors right to run away?
If you Google Regeneron’s second quarter right now, you’ll see an odd mix of headlines touting either Eylea’s slowdown or its sales jump. So which is it? It’s more »
Zynga (NASDAQ: ZNGA) fell over 14% after hours Thursday following its second quarter report. The company has earned bad press since its IPO in 2011. But CEO Mark Pincus stepped aside this month to allow Microsoft's Don A. Mattrick to take over the reins.
Mattrick has a long battle in front of him that will require a lot of reconstruction. Here are four key takeaways from Zynga's second more »
Dow component UnitedHealth Group (NYSE: UNH) closed last week up over 6% thanks to a mostly positive second quarter report. Revenues grew 12%, year-over-year, to $30 billion. Health services business Optum saw a 21% revenue growth, and a nearly 70% growth in operating earnings.
But there’s more buried slightly deeper in the quarter’s results. UnitedHealth’s involvement in Obamacare will continue to evolve over the next year. And more »
Yahoo (NASDAQ: YHOO) made waves in May by announcing the $1.1 billion all-cash purchase of Tumblr, a popular microblogging service and social network. The company’s past mishandling of acquisitions made Tumblr users so nervous that Yahoo had to promise “not to screw [Tumblr] up” in the announcement. It took Yahoo less than two months to break that promise. The associated backlash made Yahoo reverse its course, but there more »
Big pharma placed its bets on a new class of diabetes drugs called SGLT2. Last year, buzz surrounded late-stage projects from Johnson and Johnson (NYSE: JNJ), Eli Lilly (NYSE: LLY), and the partnership of Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN). But the path to market proved tricky.
Johnson and Johnson's Invokana earlier this year became the first SGLT2 approved in the United States. Bristol-Myers and AstraZeneca’s more »
Johnson & Johnson (NYSE: JNJ) reported its second quarter on Tuesday, and turned in some positive numbers. Revenue grew 8.5%, year-over-year, up to $17.9 billion. The EPS was higher than analyst estimates, and the company upped its full-year guidance.
But the details are where things get interesting. Here are three key takeaways from the earnings report -- and what they mean for Johnson & Johnson’s future.
1. Infectious disease and more »
The Food and Drug Administration cancelled an advisory meeting planned for Merck’s (NYSE: MRK) post-surgery drug sugammadex. It’s another blow to Merck as investors pay close attention to the beleaguered R&D department now turned over to Roger Perlmutter.
Merck highlighted its top five late-stage projects during the full-year 2011 conference call last February: sugammadex, insomnia treatment suvorexant, HPV vaccine V503, osteoporosis drug odanacatib, and cholesterol drug Tredaptive more »
Sanofi (NYSE: SNY) appeared at the American Diabetes Association meeting last month, touting data for the new insulin U300 and a combo therapy involving its approved drugs Lyxumia and Lantus. Could these new drugs keep Sanofi near the top of the diabetes market heap?
Lantus is Sanofi’s top-selling product, earning 5 billion euros (or about $6.5 billion at current exchange rates) in sales last year. But the drug more »
The pharmaceutical industry had a rough 2012 as about $35 billion worth of drugs fell off the patent cliff. This year’s cliff isn’t quite as steep, but there are still some upcoming expirations that could spell long-term trouble for their manufacturers.
The upcoming all-oral hepatitis C treatments earned well-deserved attention for some staggering cure rates, particularly in patient groups who haven’t responded well to the current drugs.
Merck (NYSE: MRK) was one of the big HCV players -- but that’s about to change with Gilead (NASDAQ: GILD) and AbbVie (NYSE: ABBV) leading the new guard. How much does an HCV foothold mean to the overall health of these companies?
Defending more »
Note: This version has been amended to better reflect Victoza's dosage recommendations.
At the American Diabetes Association meeting last month, Eli Lilly (NYSE: LLY) presented promising data for the GLP-1 agonist dulaglutide. GLP-1s are a well-established diabetes drug class dominated by Novo Nordisk (NYSE: NVO) and Bristol-Myers Squibb (NYSE: BMY).
GLP-1 agonists are typically used as a second-line combo therapy for type 2 diabetes patients not responding to metformin more »
The Centers for Disease Control recently released a study showing that the introduction of human papillomavirus vaccines has significantly reduced infection rates among teenaged girls. That’s good news for the manufacturers of the only two HPV vaccines approved in the United States: Merck’s (NYSE: MRK) Gardasil and GlaxoSmithKline’s (NYSE: GSK) Cervarix.
The global HPV vaccine market has recently swayed towards one of these companies -- but what does more »
What’s the best way to choose the biotech winner and loser of the past week?
The easiest route would involve the companies with the biggest share price movements. That would make Idenix (NASDAQ: IDIX) the obvious loser with its over 30% drop after the FDA requested additional preclinical safety information for a hepatitis C drug. But that movement came from volatility that arose despite the fact that this wasn more »
Shares of biotech Alnylam Pharmaceuticals (NASDAQ: ALNY) have soared over 160% in the past year. The company's a leader in developing drugs and delivery systems centered on RNA interference, or RNAi, It's an emerging area that could see major gains in the future for the companies at the forefront. And Alnylam's at the forefront.
The past year has ushered in new drug alliances with The Medicines Company more »
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