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News Breaks
January 31, 2014
11:32 EDTSNY, LLYEli Lilly does not believe new insulin glargine product infringes Sanofi patents
Eli Lilly (LLY) provided a statement regarding a lawsuit filed by Sanofi (SNY) in the United States District Court for the District of Delaware alleging patent infringement with respect to LY2963016, a new insulin glargine product for which Lilly is currently seeking approval from the U.S. Food and Drug Administration. Lilly's general patent counsel said, "Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents." Lilly, and its alliance partner Boehringer Ingelheim, recently announced the FDA had accepted the filing of the New Drug Application for LY2963016, an investigational basal insulin, the company noted.
News For LLY;SNY From The Last 14 Days
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May 28, 2015
11:02 EDTLLYEli Lilly granted FDA orphan status for treatment of sickle cell disease
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10:38 EDTSNYSanofi announces agreement with NHS England on cabazitaxel
Sanofi announced that it has reached agreement with NHS England that cabazitaxel will once more be available on the NHS to clinically eligible men with advanced prostate cancer. Cabazitaxel was de-listed from the Cancer Drugs Fund by NHS England on March 12, however in order to support access to cabazitaxel during the transition period to a formal NICE appraisal outcome, Sanofi and NHS England have come to an agreement that will enable provision of cabazitaxel to patients in England. NICE has agreed to review the Technology Appraisal for cabazitaxel and we expect a result in 2016. Sanofi has submitted a Patient Access Scheme as part of the re-appraisal of cabazitaxel by NICE. Sanofi also plans to re-submit cabazitaxel to the Scottish Medicines Consortium in 2015 to allow patients in Scotland access to this important medicine.
08:35 EDTLLYEli Lilly reports final results of Phase III trial for Alimta
Eli Lilly announced final results of the Phase III PROCLAIM trial, a randomized, Phase III superiority study of patients with locally-advanced, nonsquamous non-small cell lung cancer, which evaluated Lilly's Alimta in combination with cisplatin with concurrent radiation followed by maintenance Alimta in comparison with etoposide and cisplatin plus concurrent radiation, followed by consolidation chemotherapy of the oncologist's choice. Those treated on the pemetrexed arm achieved a median overall survival of 26.8 months as compared to 25 months for those treated on the etoposide arm. Median progression-free survival was 11.4 months on the pemetrexed arm versus 9.8 months on the etoposide arm and an overall response rate of 35.9% on the pemetrexed arm and 33% on the etoposide arm.
08:09 EDTLLYEli Lilly to present data from several trials of Cyramza for cancer
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May 27, 2015
12:36 EDTSNYOn The Fly: Top stock stories at midday
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08:32 EDTLLYEli Lilly's Humalog KwikPen approved by FDA
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08:01 EDTSNYRetrophin agrees to sell Pediatric PRV to Sanofi
Retrophin (RTRX) announced an agreement to sell its Rare Pediatric Disease Priority Review Voucher to Sanofi (SNY). Retrophin received the Pediatric PRV when Cholbam was approved by the U.S. FDA for the treatment of pediatric and adult patients suffering from bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. Upon closing of the transaction, Retrophin will receive a payment of $150M, followed by two equal installments of $47.5M in 2016 and 2017. The company will receive a total consideration of $245M in cash from Sanofi in exchange for the Pediatric PRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
May 26, 2015
08:14 EDTSNYBoston Biotech Conferences to hold a conference
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08:01 EDTSNYSanofi's Genzyme to present Aubagio, Lemtrada data at CMSC
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May 22, 2015
10:52 EDTLLY, SNYJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
14:48 EDTSNYRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
07:37 EDTLLYPfizer replaces AbbVie as top global pharma pick at Jefferies
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05:15 EDTSNYRegeneron, Sanofi announce positive topline results from sarilumab Phase 3 study
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May 19, 2015
06:55 EDTSNYGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
12:34 EDTSNYRegeneron, Sanofi announce positive pivotal Phase 2b dupilumab data in asthma
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May 17, 2015
14:59 EDTSNYL'Oreal CEO 'ready' to sell Sanofi stake if needed, Barron's says
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May 15, 2015
10:29 EDTSNYAmerican Urological Association to hold an annual meeting
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May 14, 2015
09:22 EDTLLYLeerink pharma/biotech analysts hold an analyst/industry conference call
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07:44 EDTLLYInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
06:04 EDTLLYEli Lilly, Sanford-Burnham to investigate immunological therapies
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