Aug. 19, 2014, 4:49 PM
- The FDA clears Genzyme's (SNY -0.3%) Cerdelga (eliglustat) an oral therapy for the treatment of adult patients with Type 1 Gaucher disease, a rare genetic disorder caused by the underproduction of the enzyme glucocerebrosidase. The enzyme deficiency causes fatty materials to accumulate in the spleen, liver and bone marrow. The drug's mechanism of action slows down the production of the fatty materials by inhibiting the metabolic process that forms them.
- Genzyme's first drug for Type 1 Gaucher disease was Ceredase (alglucerase injection) which was approved on March 11, 1985.
Aug. 19, 2014, 10:42 AM
- The FDA grants tentative approval for Eli Lilly (LLY +0.5%) and Boehringer Ingelheim's Basaglar (insulin glargine injection) as a treatment to improve glycemic control in adults with type 2 diabetes and in combination with prandial insulin in adult and pediatric patients with type 1 diabetes.
- While the FDA has determined that Basaglar meets all the criteria for market clearance, it is tentative because of the automatic 30-month stay due to Sanofi's (SNY -0.8%) patent infringement suit. The agency cannot issue final approval until the stay ends (mid-2016) or unless the court finds in Lilly's favor before then.
Aug. 13, 2014, 1:25 PM
- Shares of InterMune (ITMN +14.3%) spike on a 2x surge in volume in response to rumors that Roche (OTCQX:RHHBY +0.4%), Sanofi (SNY +0.7%), Glaxo (GSK -0.1%) and Actelion (OTCPK:ALIOF) (OTC:ACIOY) are preparing offers. Trading in ITMN shares was halted briefly at 1:00 pm EDT due to abnormal volatility.
Aug. 11, 2014, 3:42 AM
- Sanofi (NYSE:SNY) and MannKind (NASDAQ:MNKD) have agreed to a worldwide licensing deal to develop and market inhaled insulin therapy Afrezza for adults with diabetes.
- Under the terms of the agreement, MannKind will receive an upfront payment of $150M and potential milestone payments of up to $775M.
- Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%.
- The two companies plan to launch the drug in the U.S. in the first quarter of 2015.
Aug. 6, 2014, 9:12 AM
Aug. 1, 2014, 1:50 PM
- The FDA approves the use of Genzyme's (SNY +1.7%) Lumizyme (alglucosidase alfa) for the treatment of patients with infantile-onset Pompe disease who are less than 8 years old. Previously, Lumizyme's labeling restricted its use for patients who are 8 years old and older.
- The agency also eliminates the REMS requirement.
Aug. 1, 2014, 12:54 PM
- The FDA approves Boehringer Ingelheim and Eli Lilly's (LLY -1.3%) Jardiance (empagliflozin) as a treatment for glycemic control in addition to diet and exercise in adults with type 2 diabetes.
- Empagliflozin is a sodium glucose co-transporter 2 inhibitor. It blocks the reabsorption of glucose by the kidney thereby increasing glucose excretion and lowering the level of glucose in the blood.
- Diabetes-related tickers: (MNKD -3.3%) (MRK -0.6%)(SNY +1%)(NVO -2.6%)(GSK -1.4%)(MDT -0.8%)
Jul. 31, 2014, 11:31 AM
- Sanofi (SNY +1.1%) (OTCQB:SNYNF +3.4%) Q2 results (€M): Total Sales: 8,075 (+0.9%), U.S. Sales: 2,569 (+9.4%), Western Europe: 1,908 (-2.8%), ROW: 743 (-11.2%); Gross Profit: 5,538 (+2.3%); Operating Income: 1,246 (+82.2%); Net Income: 804 (+63.4%); EPS: 0.59 (+73.5%); CF Ops: 3,471 (+7.1%).
- 2014 Guidance: EPS growth: 6 - 8%.
Jul. 31, 2014, 9:15 AM
Jul. 30, 2014, 4:24 PM
- Regeneron Pharmaceuticals (REGN +5.8%) and partner Sanofi (SNY +1.4%) (OTCQB:SNYNF +0.3%) intend to use an FDA-issued rare pediatric disease review voucher for their alirocumab BLA. The voucher entitles the holder to designate a BLA for a six-month priority review instead of the standard 10-month review period.
- Regeneron subsidiary Regeneron Ireland purchased the voucher from a subsidiary of BioMarin Pharmaceuticals who received it through the FDA's program. The companies will each pay half of the $67.5M price. They intend to submit the BLA before the end of the year.
Jul. 30, 2014, 9:13 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and partner Sanofi (NYSE:SNY) (OTCQB:SNYNF) report that their PCSK9 inhibitor alirocumab met its primary endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator in nine Phase 3 clinical trials involving over 5,000 patients (including the MONO trial). The results were consistent with earlier alirocumab trials.
- Three additional Phase 3 trials are ongoing.
Jul. 28, 2014, 5:02 PM
- Sanofi Pasteur (SNY +0.5%) (OTCQB:SNYNF) terminates its collaboration and licensing agreement with KaloBios Pharmaceuticals (KBIO -1%) for KB001-A. Sanofi had been developing the monoclonal antibody as a treatment for Pseudomonas aeruginosa ((Pa)) pneumonia prevention while KaloBios was developing it as a treatment for chronic Pa lung infections in cystic fibrosis patients.
- Sanofi agreed to terminate in consideration of low single-digit royalties on KB001-A net sales, subject to a $40M cap.
Jul. 9, 2014, 5:22 PM
- Regeneron (REGN +0.1%) and development partner Sanofi (SNY +0.8%) report encouraging Phase 2b results for their investigational mAb dupilumab as a treatment for adults with moderate-to-severe atopic dermatitis. All doses of dupilumab met the primary endpoint of a greater improvement in Eczema and Severity Index (EASI) scores from baseline compared to placebo. The mAb works by blocking the signaling of IL-4 and IL-13, two cytokines that play important roles in the pathogenesis of moderate-to-severe atopic dermatitis.
- At week 16 in the 380-patient study, 12 - 33% of the test group achieved clearing or near-clearing of skin lesions and experienced a 16.5 - 47% reduction in itching.
Jul. 8, 2014, 1:49 PM
- In an attempt to halt Lilly's (LLY -0.7%) U.S. commercial launch of Abasria, a direct competitor to its top-selling Lantus, Sanofi (SNY -0.7%) files a patent infringement suit in the U.S. District Court of Delaware. It accuses Lilly of violating seven patents related to insulin and the devices used to deliver it.
- Lantus is the world's number one insulin generating $7.8B in sales last year. It will come off patent in February 2015. The filing of Sanofi's original lawsuit triggered the automatic 30-month stay of an FDA decision so Lilly's drug will not be on the market until at least mid-2016.
- Europe's CMHP issued a positive opinion on Lilly's Abasria MAA on June 27.
Jul. 8, 2014, 10:20 AM
- The U.S. regulator accepts Sanofi's (SNY -0.3%) NDA for its investigational basal insulin Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL).
- The European Medicines Agency accepted the company's MAA for Toujeo on May 27, 2014.
- Toujeo will replace Lantus, which loses patent protection in February 2015.
- Related ticker: (LLY -0.8%)
Jun. 30, 2014, 8:31 AM
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