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Business Wire (Tue, 7:00PM)
Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis CBusiness Wire (Apr 7, 2014)
Business Wire (Apr 1, 2014)
at CNBC.com (Mar 14, 2014)
at MarketWatch.com (Mar 4, 2014)
Business Wire (Mar 3, 2014)
at Fox Business (Feb 24, 2014)
BMY vs. ETF Alternatives
Monday, Apr 2112:02 PM
Monday, Apr 149:04 AM
Monday, Apr 149:04 AM| 4 Comments
- Bristol-Myers Squibb (BMY) submits its NDA for a fixed-dose combination of the protease inhibitor Reyataz (atazanavir sulfate) and the investigational pharmacokinetic enhancer cobicistat (GILD) for the treatment of HIV-1.
- The once-daily therapy is indicated for patients 6 years of age and older.
- Reyataz was launched in 2003. 245K patients have been treated with the drug which is most commonly used with the pharmacokinetic enhancer ritonavir.
Thursday, Apr 109:32 AM
Thursday, Apr 109:32 AM| 12 Comments
- 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)
Thursday, Apr 108:00 AM
Thursday, Apr 108:00 AM| Comment!
- Bristol-Myers Squibb's (BMY) combination oral therapy of Daclatasvir and Asunaprevir cleared Hepatitis C in 90% of previously untreated patients in a Phase III trial.
- The combo also cured HCV in 82% of those who didn't respond to prior therapy and 84% of those who had cirrhosis, which accounted for almost one third of subjects.
- Around 5-7% of patients suffered serious side effects, such as an increase in liver enzymes, although this is reversible and was resolved following treatment. (PR)
- See: Merck Hepatitis C combo pill impresses in Phase II
Thursday, Apr 107:13 AM
Thursday, Apr 107:13 AM| 1 Comment
- 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.
Monday, Apr 79:43 AM
Monday, Apr 79:43 AM| Comment!
- Bristol-Myers Squibb (BMY +0.2%) submits new drug applications to the FDA for its NS5A replication complex inhibitor daclatasvir (DVC) and its NS3 protease inhibitor asunaprevir (ASV) for the treatment of Hepatitis C.
- The regulatory agency recently designated the drugs Breakthrough Therapies.
- The European Medicines Agency and Japan's Pharmaceutical and Medical Devices Agency are also reviewing the products under accelerated processes.
Wednesday, Apr 211:30 AM
Wednesday, Apr 211:30 AM| 3 Comments
- Last summer's dust up between GlaxoSmithKline (GSK) and Chinese regulators over accusations of corruption has quietly subsided. Drug firms perceive the China market has returned to its "business as unusual."
- Glaxo responded to the matter by replacing its sales targets for individual reps with broader performance-rating criteria such as improved patient care.
- Although far from assured, other members of Big Pharma don't expect the authorities to rattle their sabers again any time soon.
- Analysts expect the nation's drug market to continue its annual 15% growth rate and emerge as the globe's second largest pharmaceutical market behind the U.S. by 2016 on the basis of $165B in sales.
- (SNY) (LLY) (NVS) (AZN) (PFE) (BMY) (JNJ) (BAYRY) (RHHBY) (NVO) (ABBV)
Friday, Mar 281:54 PM
Friday, Mar 281:54 PM| 14 Comments
- The Federal Trade Commission wants to extract least $1B from pharmaceutical companies for their alleged efforts to thwart the entry of cheaper generic drugs by paying generic makers to delay introducing their offerings.
- Last June, the U.S. Supreme Court ruled that the FTC may legally challenge the deals.
- (NVO) (PFE) (SNY) (ABBV) (JNJ) (RHHBY) (GSK) (AZN) (BMY)
Monday, Mar 177:28 AM
Monday, Mar 177:28 AM| Comment!
- Five Prime Therapeutics (FPRX) and Bristol-Myer Squibb (BMY) sign a collaboration deal for the discovery, development and commercialization of immuno-oncology therapies directed toward two immune checkpoint pathways using FPRX's target discovery platform.
- Drug candidates may be single agents or used in combination with existing BMY therapies.
- FPRX will receive an upfront payment of $20M plus up to $9.5M over the course of the research term. BMY will also acquire 4.9% of Five Prime's common stock for $21M.
- Five Prime will be eligible to earn up to $300M in milestone payments for each collaboration target plus tiered royalty payments on net sales of commercialized products.
- FPRX shares are up 15% premarket.
Friday, Mar 141:52 PM
Friday, Mar 141:52 PM| Comment!
- The FDA approves Bristol-Myers Squibb (BMY) and Pfizer's (PFE) sNDA for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis for patients who have undergone knee or hip replacement surgery.
- In the U.S., 719,000 knee replacement and 332,000 hip replacement surgeries are performed each year.
- The product is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Monday, Mar 1010:00 AM
Monday, Mar 1010:00 AM| 1 Comment
- The WSJ profiles "pharmaceutical scouts," who, like talent-spotters in baseball "trying to pick tomorrow's big-leaguers from farm teams," search outside their companies to find drug candidates that have the potential to become blockbusters.
- In 2011, for instance, Johnson & Johnson's (JNJ) Peter Lebowitz helped his company beat competitors such as Novartis (NVS) to buy the rights to a blood-cancer drug from Pharmacyclics (PCYC) called Imbruvica.
- The treatment was eventually approved in November for a rare lymphoma and for chronic lymphocytic leukemia in February. J.P. Morgan forecasts Imbruvica will generate $1.3B in revenue for J&J in 2017.
- Half of J&J's drug pipeline is from outside the company, up from 20% in 2002.
- Other related tickers: MRK, RHHBY, BMY, SNY, CELG, GSK
Thursday, Mar 68:46 AM
Thursday, Mar 68:46 AM| 1 Comment
- Bristol-Myers' (BMY) BMS-663068 helped control the HIV virus as well as its older Reyataz treatment in a Phase IIB study.
- BMS-663068 lowered the presence of HIV to undetectable levels in up to 80% of patients who received one of four doses vs 75% for those who were given Reyataz.
- Both therapies were administered in combination with Bristol's Sustiva and Gilead's Viread.
- BMS-663068 is the first in a new set of compounds known as attachment inhibitors, which stop HIV from connecting to immune system cells. (PR)
- See also: Sangamo's ZFN targets HIV resistance
Monday, Mar 34:31 PM
Tuesday, Feb 259:37 AM
Tuesday, Feb 259:37 AM| Comment!
- The FDA has approved Bristol-Myers Squibb's (BMY -0.1%) Myalept drug for treating generalized lipodystrophy, a rare and potentially fatal disorder that is associated with a lack of fat tissue.
- Instead, fat builds up in the blood and organs such as liver and muscle, and can cause diabetes, pancreatitis and fatty liver disease.
- Bristol-Myers Squibb will have to carry out seven post-marketing studies on Myalept. (PR)
Monday, Feb 249:05 AM
Monday, Feb 249:05 AM| Comment!
- The FDA has granted breakthrough designation to Bristol-Myers Squibs' (BMY) Daclatasvir and Asunaprevir combination oral treatment for Hepatitis C.
- Specifically, the designation applies to the treatment of genotype 1b chronic hepatitis C and is based on the results of an ongoing Phase III trial.
- The FDA's decision comes after European regulators said they would give an accelerated review to Daclatasvir when used in combination with other drugs. (PR)
Tuesday, Feb 48:28 AM
Tuesday, Feb 48:28 AM| 4 Comments
- Ten major pharmaceuticals companies are getting together with the National Institutes of Health and other organizations in a five-year partnership that will look to understand the science behind Alzheimer's, Type 2 diabetes, rheumatoid arthritis and lupus.
- In an unusual move, the normally secretive participants will share scientists, tissue, blood samples and data, with the aim being to identify targets for new drugs.
- The firms involved include Bristol-Myers Squibb (BMY), Johnson & Johnson (JNJ), GlaxoSmithKline (GSK), Takeda (TKPHF) and Sanofi (SNY).
- Those that haven't joined include Amgen (AMGN), Roche (RHHBY) and AstraZeneca (AZN).