Edition:
United States

Novartis AG (NVS.N)

NVS.N on New York Stock Exchange

84.99USD
21 Jul 2017
Change (% chg)

$-0.43 (-0.50%)
Prev Close
$85.42
Open
$85.12
Day's High
$85.13
Day's Low
$84.72
Volume
216,595
Avg. Vol
440,236
52-wk High
$86.90
52-wk Low
$66.93

Latest Key Developments (Source: Significant Developments)

Amgen says FDA accepts biologics license application for Aimovig
Thursday, 20 Jul 2017 04:30pm EDT 

July 20 (Reuters) - Amgen Inc :FDA accepts biologics license application for Aimovig™ (erenumab).Amgen Inc - FDA has set a prescription drug user fee act (PDUFA) target action date of May 17, 2018..Amgen Inc - Aimovig will be jointly commercialized in U.S. by Amgen and Novartis..  Full Article

Novartis 'cooperating fully' with DOJ, SEC probe of Alcon's Russia, Asia business
Tuesday, 18 Jul 2017 09:28am EDT 

July 18 (Reuters) - Novartis Ag :Says generic dermatology portfolio was hit more severely by u.s. Price pressure as competitors introduced.Ceo says capital market exit for alcon would hinge on 'a few quarters' of growth.Alcon head says intraocular lens issues have stabilized but situation likely to be bumpy in next quarters, 'not declaring victory'.Sandoz head says reception for biosimilar rituximab has been good two weeks after launch.Alcon head says market share losses stabilizing in contact lenses, now on 'a bit of a winning trend'.Cancer unit head says looking at outcomes-based models for pricing cancer cell therapy ctl019, will disclose at launch of product.Cfo says roche stake continues to be a financial investment with strategic component, seeks to maximize value of holding.Says two-thirds of entresto patients are on u.s. Government insurance program medicare.Sandoz unit head says expects speedy rollout of rituximab biosimilar.Ceo says does not know timing of trump administration action on outcomes-based pricing model, expects proposal 'this summer'.Ceo says valuations for m&a make it difficult to find acquisitions between $2 billion-$5 billion that add value, still focused on bolt-on targets to strengthen oncology or differentiated generics business.Alcon head says received u.s. Doj, sec subpoena focusing on alcon's asia and Russia business, covers period before and after novartis owned the business, says cooperating fully.  Full Article

Novartis CEO says growth at Alcon boosts options for eye surgery unit
Tuesday, 18 Jul 2017 02:00am EDT 

July 18 (Reuters) - Novartis Ag :Ceo reiterates entresto sales seen hitting $500 million in 2017.Ceo says expects ctl019 fda approval in pediatric all by october.Ceo says rising sales at alcon increase options for unit, including capital markets transaction.Ceo says don't expect big spike in rituxumab, etanercept biosimilars sales, but rather 'slow burn' following approval.Ceo says expects ongoing price pressure in generics.Ceo says glaxo joint venture is an asset for novartis that continues to appreciate, does not speculate when it would exercise put option.Ceo says plans to decide and announce pricing structure for ctl019 when drug is approved around october.  Full Article

Ophthotech and Novartis Pharma enters into a letter agreement with respect to licensing and commercialization agreement
Monday, 10 Jul 2017 07:59am EDT 

July 10 (Reuters) - Novartis AG ::Ophthotech - on July 3, co and Novartis Pharma entered into a letter agreement with respect to licensing and commercialization agreement dated May 19, 2014.Ophthotech - under 2014 agreement, co had granted novartis exclusive rights to develop and commercialize fovista products in all countries outside of U.S..Ophthotech - pursuant to July 3 letter agreement, parties agreed to suspend their affirmative obligations under 2014 agreement regarding fovista products.Ophthotech - agreement to suspend affirmative obligations regarding fovista products is pending receipt of oph1004 data and determination of a regulatory strategy.Ophthotech - letter agreement also provides Novartis with a shorter notice period in the event Novartis determines to terminate the 2014 agreement in certain circumstances.  Full Article

Conatus announces effectiveness of exclusive license with Novartis
Thursday, 6 Jul 2017 04:05pm EDT 

July 6 (Reuters) - Conatus Pharmaceuticals Inc -:Conatus Pharmaceuticals - exclusive license with Novartis for global development and commercialization of emricasan has become effective under terms.Conatus Pharmaceuticals - projecting a balance of cash, cash equivalents and marketable securities of between $55 million and $65 million at year-end 2017.Conatus Pharmaceuticals Inc - license became effective on July 5, 2017, upon conatus' receipt of a $7 million payment.Conatus Pharmaceuticals - believes current financial resources sufficient to maintain operations & ongoing clinical development activities through 2019 end.  Full Article

Vectura inks new U.S. deals for generic asthma therapy​
Wednesday, 28 Jun 2017 12:14pm EDT 

June 28 (Reuters) - Vectura Group Plc ::‍New development and licence agreement for a U.S. inhaled generic​.Signed exclusive development and licence agreement with Sandoz for development of a generic of an existing major inhaled combination therapy for asthma and COPD in U.S.​.‍responsible for development of formulation and manufacture of clinical batches for use in pilot clinical studies​.‍sandoz is responsible for clinical development, manufacture and commercialisation of vr2081​.Will receive an initial payment of $5 million from Sandoz.Eligible to receive up to further $5 million upon achievement of pre- determined development milestones​.‍Also eligible to receive a double digit percentage royalty on net sales in line with our other generic development programmes​.Total research and development cost borne by vectura is expected to be below $20 million up to regulatory filing and subsequent launch, which is seen in early to mid-2020's​.‍Expected that $5 million initial milestone will be recognised in revenues across 2017 and 2018​.‍Overall research and development guidance range of £65 million - £75 million for each of 2017 and 2018 remains unchanged​.  Full Article

EU medicines agency recommends approval of Aveo's kidney cancer drug
Friday, 23 Jun 2017 08:24am EDT 

June 23 (Reuters) - EU Medicines Agency::EU Medicines Agency recommendations for June 2017.EU Medicines Agency recommends approval of Merck KGAA multiple sclerosis drug.EU Medicines Agency recommends approval of Abbvie hepatitis C combination.EU Medicines Agency recommends approval of Novartis Kisqali drug for breast cancer.EU Medicines Agency recommends approval of Aveo drug for kidney cancer.EU Medicines Agency recommends approval of biosimilar drug by Samsung Bioepis UK for Abbvie's rheumatoid arthritis drug.  Full Article

EMA recommends approval of Merck's multiple sclerosis drug
Friday, 23 Jun 2017 07:43am EDT 

June 23 (Reuters) - EU Medicines Agency::EU Medicines Agency recommendations for June 2017.EU Medicines Agency recommends approval of Merck KGAA multiple sclerosis drug.EU Medicines Agency recommends approval of Abbvie Hepatitis C combination.EU Medicines Agency recommends approval of Novartis Kisqali drug for breast cancer.EU Medicines Agency recommends approval of Aveo drug for kidney cancer.EU Medicines Agency recommends approval of Abbvie biosimilar drug for rheumatoid arthritis.  Full Article

Novartis combination targeted therapy Tafinlar + Mekinist receives FDA approval for BRAF V600E mutant metastatic NSCLC
Thursday, 22 Jun 2017 05:42pm EDT 

June 22 (Reuters) - Novartis Ag :Novartis combination targeted therapy tafinlar + mekinist receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC).Approval provides first targeted treatment in U.S. specifically for BRAF V600E mutation-positive metastatic NSCLC.  Full Article

Novartis says RTH258 met endpoints in late-stage trials
Tuesday, 20 Jun 2017 01:19am EDT 

June 20 (Reuters) - Novartis AG :Novartis says rth258 (brolucizumab) demonstrates robust visual gains in namd patients with a majority on a 12-week injection interval.Says 57% and 52% of patients receiving rth258 6 mg in respective trials were maintained exclusively on a q12w interval immediately following loading phase and continuing through week 48.Says rth258 (brolucizumab) 6 mg met primary and key secondary endpoints in two phase iii studies, hawk and harrier.Says rth258 3 mg, evaluated in hawk, also met these endpoints.  Full Article

U.S. jury sides with Amphastar over Momenta in drug patent trial

BOSTON A federal jury handed Amphastar Pharmaceuticals Inc a big win on Friday after it was accused of infringing on a patent held by Momenta Pharmaceuticals Inc through its production of a generic version of the blood-thinner Lovenox.