Apr. 17, 2014, 8:39 AM
- Aiming to capture a chunk of Janssen Pharmaceuticals' (JNJ) ORTHO EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System 150/35 mcg/day) $150M U.S. sales, Mylan (MYL) launches its generic equivalent XULANE.
- The product is indicated for the prevention of pregnancy in women who use a transdermal patch as a method of contraception.
- According to IMS Health, Mylan has 300 ANDAs pending FDA approval representing $104.5B in branded sales. 42 are first-to-file submissions representing over $25B in branded sales.
Apr. 15, 2014, 6:25 PM
- Surgical device maker ConMed (CNMD) is exploring a sale of the company, Reuters reported earlier today, after activist investors late last year took issue with its performance and corporate governance.
- The company's advisers, BoA Merrill Lynch and Greenhill, reportedly have contacted orthopedic device makers in recent weeks to gauge interest.
- CNMD has an attractive orthopedics and sports medicine business that could appeal to companies such as Zimmer Holdings (ZMH), Johnson & Johnson (JNJ), Stryker (SYK), Covidien (COV) and Medtronic (MDT).
- CNMD shares gained 7.2%, rallying from a loss before the report late in the session.
Apr. 15, 2014, 3:51 PM
- Johnson & Johnson's (JNJ +2%) hepatitis C drug Olysio (simeprevir) blew out Q1 expectations with its $354M in sales. Wells Fargo analyst Lawrence Biegelsen forecasted only $23M.
- Some observers believe that many physicians are prescribing the drug in combination with Gilead's (GILD +2.3%) Sovaldi (sofosbuvir) thereby inflating the full regimen cost to ~$150,000 in the U.S.
- A 12-week course of treatment of Olysio costs $66,360.
Apr. 15, 2014, 7:46 AM
- Johnson & Johnson (JNJ): Q1 EPS of $1.54 beats by $0.06.
- Revenue of $18.11B (+3.5% Y/Y) beats by $110M.
Apr. 15, 2014, 12:05 AM
Apr. 14, 2014, 5:30 PM
Apr. 14, 2014, 7:44 AM
- Johnson and Johnson (JNJ) discontinues its development of PurTox, a neurotoxin intended to compete with Allergan's (AGN) $2B anti-wrinkle blockbuster.
- The company acquired the rights to the drug in 2009 with its buy of Mentor Corp.
- The move will result in the loss of a small number of U.S.-based jobs.
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. 9, 2014, 8:33 AM
- The World Health Organization has joined those calling for a reduction in the prices of new Hepatitis C drugs, such as Gilead's (GILD) Sovaldi and Jonhson & Johnson's (JNJ) Olysio. In the U.S., Sovaldi costs $84,000 and Olysio $66,000.
- Around 150M people worldwide suffer from chronic hepatitis C, but the vast majority live in poor countries that can't afford the price.
- Pharmaceutical companies could follow the model that was used to bring the cost of HIV treatments down in the developing world, and Gilead is already giving Egypt a 99% discount on Sovaldi.
Apr. 8, 2014, 8:45 AM
- On the basis of results from the Phase 3 RESONATE clinical trial, Pharmacyclics (PCYC) files a supplemental NDA for its oral kinase inhibitor IMBRUVICA as a single therapeutic agent for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least one prior therapy.
- The trial compared IMBRUVICA (ibrutinib) to ofatumumab in 391 patients. Patients treated with IMBRUVICA alone showed a statistically significant improvement in the secondary endpoint of overall survival.
- The FDA granted accelerated approval status for the product as a single agent for the treatment of the cancers cited above.
- The company's development and commercialization partner is Janssen Biotech (JNJ).
Apr. 2, 2014, 11:30 AM
- 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)
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)
Apr. 1, 2014, 10:14 AM
- J&J's (JNJ) Janssen unit files an NDA a once-daily antiretroviral combo tablet containing the protease inhibitor darunavir and cobicistat an investigational pharmacokinetic enhancer developed by Gilead Sciences (GILD).
- If approved, the product will be marketed under a new brand name. It will eliminate the need to take a separate boosting agent (ritonavir) with darunavir, the most-prescribed HIV protease inhibitor in the U.S.
Mar. 31, 2014, 8:33 AM
- Johnson & Johnson (JNJ) has accepted Carlyle's (CG) $4.15B binding offer for J&J's Ortho-Clinical Diagnostics (OCD) business.
- J&J accepted the proposal, which the private-equity firm made in January, after consultation with the relevant works councils and trade unions.
- J&J expects the deal to close toward the middle of the year. (PR)
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. 28, 2014, 3:55 PM
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
Country: United States
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