Apr. 21, 2014, 5:35 PM
Apr. 21, 2014, 12:02 PM
Apr. 21, 2014, 10:52 AM
- Cubist Pharmaceuticals (CBST -0.3%) submits its NDA for the antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.
- Last year the FDA granted the drug Fast Track status.
- The company plans to file a Marketing Authorization Application with the European Medicines Agency in the second half of this year.
Apr. 17, 2014, 3:41 PM| Comment!
Apr. 15, 2014, 7:55 AM
- Merck's (MRK) Grastek sublingual allergy pill gets the nod from the U.S. regulator. The company will launch the immunotherapy product later this month.
- It contains extracts of the timothy grass allergen. It was approved in Canada in February and has been available in Europe since 2006 under the brand name Grazax.
- The FDA approved the French firm Stallergene's immunotherapy treatment for five types of grass pollen earlier this month.
- The U.S. market could be as large as $1B.
Apr. 10, 2014, 9:32 AM
- In its recent healthcare budget, French lawmakers introduced a measure that will allow pharmacists to substitute generics for prescribed brand-name biotech drugs. This has rattled the industry since France is Europe's #2 pharmaceutical market behind Germany.
- A decree must be passed before it becomes effective.
- France is the first European country to pursue biologic substitution. Big Pharma fears a domino effect if it is successful despite the heretofore slow uptake of biosimilars.
- The initiative applies only to patients starting a new course of treatment. Doctors will still retain the ability to demand the branded product.
- Unsurprisingly, Big Pharma is upset at not being consulted prior to the law's passage.
- Some analysts believe France could save up to $1.4B by 2020 by using generics.
- Substitutions only apply to retail pharmacies. 40% of biotech prescriptions are filled in hospitals.
- (RHHBY) (AMGN) (NVS) (SNY) (LLY) (PFE) (BMY) (MRK) (GSK) (JNJ) (HSP) (ABBV) (AZN) (BAYRY)
Apr. 10, 2014, 7:13 AM
- Merck's (MRK) two-drug combination pill for Hepatitis C stopped the virus in 43 out of 44 newly treated patients in a Phase II trial; there were also few major side effects.
- When given with an older treatment called Ribavirin, the drugs - MK-5172 and MK-8742 - cleared Hepatitis C in 94% of 85 patients who received the combo for 12 week and in 83% of 30 patients treated for eight weeks.
- Results of how well the combo fared in harder-to-treat cases are due out tomorrow.
- The results, if repeated in Phase III, will put Merck on course to compete with Gilead (GILD) - whose Sovaldi is already approved - AbbVie (ABBV) and Bristol-Myers Squibb (BMY), which are also developing Hepatitis C drugs
- Merck shares are +1.3% premarket.
Apr. 9, 2014, 4:18 AM
- Profits that major U.S. corporations have parked overseas in order to avoid taxes at home jumped 93% to $2.1T in 2008-2013, research firm Audit Analytics has calculated.
- GE (GE) held the most amount of money abroad with $110B and Microsoft (MSFT) was second with $76.4B, after which comes Pfizer (PFE) with $69B, Merck (MRK) with $57.1B and Apple (AAPL) with $54.4B.
- The numbers have prompted fresh calls for an overhaul of the tax code, including from Senate Finance Committee Chairman Ron Wyden.
Apr. 4, 2014, 2:16 PM
- Merck (MRK +0.4%) wants to feed its controversial additive to almost a quarter of a million cattle to prove it is safe. The only glitch is that major meat processors lack enthusiasm for animals fed with the drug.
- Feedlot owners are glad to participate if they have assurances from the slaughterhouses that they will buy the animals.
- The company intends to sign up 5 to 15 feedlots per slaughterhouse that agrees to process the cattle.
- Raising a few eyebrows is Merck's silence regarding the identity of the study's lead investigator. Some observers perceive that its lack of disclosure implies the study's outcome is a foregone conclusion.
- Since the firm pulled Zilmax in August, many feedlots have switched to ractopamine-based Optaflexx made by Eli Lilly's (LLY +0.6%) Elanco Animal Health Unit.
Apr. 2, 2014, 9:43 AM
- Various donors, including the Bill & Melinda Gates Foundation and the World Bank, commit $240M to fighting neglected tropical diseases.
- Two years ago some major pharmaceutical companies agreed to donate medicines targeting 10 parasitic and bacterial infections that threaten one in six people in the world.
- (SNY) (GSK) (MRK) (JNJ) (NVS) (BAYRY)
Mar. 31, 2014, 11:34 AM
Mar. 31, 2014, 7:36 AM
- The Anti-Infective Drugs Advisory Committee reviews Durata Therapeutics' (DRTX) dalbavancin and Cubist Pharmaceuticals' (CBST) tedizolid today.
- The FDA granted both products priority review status under the less-rigorous "non-inferiority" method.
- Dalbavancin is comparable to vancomycin, but it is administered via two IV infusions a week apart and enables the patient to avoid two weeks of hospitalization.
- Tedizolid is also comparable to an existing drug but it will be evaluated for hospital-acquired MRSA infections.
- Two other antibiotics given the accelerated review have a heightened risk of serious adverse events and/or death.
- (JNJ) (PFE)
Mar. 27, 2014, 9:19 AM
- Merck (MRK) has appointed Robert Davis as CFO to replace replace Peter Kellogg as of April 23.
- Davis is joining Merck from Baxter, where he is president of the company's medical products business.
- News of Davis' appointment comes as Baxter announces that it's splitting into two companies, with one focused on biopharmaceuticals and the other on medical products. (PR)
Mar. 27, 2014, 8:38 AM
- The Anti-Infective Drugs Advisory Committee meets on Monday to review Cubist Pharmaceuticals' (CBST) antibiotic TR-701 (tedizolid phosphate).
- The company acquired the rights to the drug via its acquisition of Trius Therapeutics last year.
- PDUFA date is June 20.
- Consensus 2014 and 2015 estimates for the firm are earnings of $0.62/share on revenues of $1.25B and $1.92/share on revenues of $1.48B, respectively.
- 649 mutual funds have positions, up from 598 a year earlier.
- Meeting materials.
Mar. 26, 2014, 8:33 AM
- Large cap pharma and biotech firms have regenerative therapy R&D programs underway according to a recent survey.
- 69% of respondents are focused on developing cellular-based therapies.
- Wound healing and burns have the greatest near-term potential.
- Long term areas of interest are cardiovascular disease, oncology, neurodegenerative disease, monogenic disorders and ocular disease.
- (AGN) (AMGN) (BAX) (BIIB) (CELG) (LLY) (GSK) (JNJ) (NVS) (NVO) (PFE) (RHHBY) (SNY) (MRK) (SHPG)
Mar. 25, 2014, 7:26 AM
- Sanofi (SNY) has joined the auction for Merck's (MRK) over-the-counter health-products business, Bloomberg reports.
- Final offers could value the unit at $10-12B and are due in next week.
- Reckitt Benckiser (RBGLY) is the frontrunner, having become the most aggressive bidder.
- "OTC assets are highly desirable for market incumbents as almost no additional infrastructure is required," says Barclays. Merck's unit would be a "good fit" geographically for Sanofi, as 70% of its revenue comes from the U.S.
- Other interested parties include Bayer (BAYRY).
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