Yesterday, 6:32 PM
- The U.S. Federal Trade Commission (FTC) OKs Mylan N.V.'s (NASDAQ:MYL) $9.9B acquisition of Swedish specialty pharma outfit Meda AB, subject to Mylan divesting certain products following the consummation of the deal. According to Mylan, the products are not significant contributors to its earnings.
- Previously: Mylan to buy Swedish specialty pharma firm for $9.9B (Feb. 10)
Thu, Jul. 21, 10:56 AM| Thu, Jul. 21, 10:56 AM
Wed, Jul. 20, 12:53 PM
Fri, Jul. 15, 10:10 AM
- Wells Fargo ticks off 20 S&P 500 stocks with the most upside potential vs. consensus, and the 20 with the most downside risk vs. consensus.
- The list is compiled by comparing the midpoint of Wells Fargo Securities valuation ranges to consensus fair value estimates, volatility adjusting the percentage difference, and ranking the resulting score.
- Upside: AEE, BEN, CCL, DVA, EIX, ES, EXC, FTR, HUM, INTC, JNJ, LNT, PEG, PNW, SCG, T, WEC, WU, XEL, XOM.
- Downside: ANTM, C, CI, COF, EQT, FOXA, FSLR, GS, KIM, LH, MON, MSI, MYL, NVDA, NWSA, SLG, TIF, TSO, UA, WLTW.
Mon, Jul. 11, 8:11 AM
- Mylan N.V. (NASDAQ:MYL) announces the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, a generic version of Merck's (NYSE:MRK) Temodar.
- Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
- According to IMS Health, total U.S. sales of Temozolomide Capsules was ~$177M for the 12 months ending May 31, 2016.
Wed, Jul. 6, 7:59 AM
- Mylan N.V. (NASDAQ:MYL) announces the U.S. launch of Fenofibrate Tablets USP, 40 mg and 120 mg, a generic version of Santarus's Fenoglide.
- The product is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
- According to IMS Health, total U.S. sales were ~$28.6M for the year ending April 30. Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4B in annual brand sales.
Fri, Jun. 24, 12:07 PM| Fri, Jun. 24, 12:07 PM
Fri, Jun. 10, 5:41 PM
- Mylan (NASDAQ:MYL) fell 2.7% in today's trade after Wells Fargo said the drugmaker has raised prices more than 100% on seven products and more than 20% on two dozen others in the last six months, which the firm considers risky and having the potential to lead to regulatory scrutiny.
- Fargo analyst David Maris, who has been among the most vocal critics of Valeant Pharmaceuticals, question whether MYL's aggressive price increases are being used to make EPS targets or to offset disappointing sales in other areas.
- MYL tells TheFly.com that the "flawed analysis" focused on a small number of products out of the more than 1,400 products it sells globally and that its business model "is not today, nor has it ever been, premised on price hikes."
Wed, Jun. 1, 9:50 AM
- Theravance (TBPH +0.7%) completes the enrollment of more than 2,300 patients across its three Phase 3 studies assessing revefenacin, a long-acting muscarinic antagonist (LAMA), for the treatment of chronic obstructive pulmonary disease (COPD). The three trials, two efficacy studies and one safety study, will support an NDA filing in the U.S.
- Top-line results from the efficacy trials should be available in late Q3/early Q4 while data from the safety study will follow in 2017. If all goes well, a New Drug Application will be submitted to the FDA in late 2017.
- The company and its affiliates have partnered with Mylan N.V. (MYL +0.1%) and its affiliates for the development and commercialization of nebulized revefenacin for COPD and other respiratory diseases. Theravance Biopharma is leading the development in the U.S. for the revefenacin inhalation solution product with Mylan reimbursing all costs until the first NDA is approved. Afterward, costs will be shared. Mylan is responsible for ex-U.S. development and commercialization. Theravance is eligible to receive up to $220M in development- and sales-related milestones and double-digit royalties on ex-U.S. sales. Theravance retains global rights to revefenacin delivered through other dosage forms (e.g., metered dose inhaler or dry powder inhaler) as well as the rights to nebulized revefenacin in China.
Tue, May 31, 6:29 PM
- Mylan N.V. (NASDAQ:MYL) prices its private placement of $6.5B aggregate principal amount of senior notes as follows: $1.0B of 2.50% senior notes due 2019 at 99.888%; $2.25B of 3.15% senior notes due 2021 at 99.884%; $2.25B of 3.95% due 2026 at 99.231% and $1.0B of 5.25% senior notes due 2046 at 99.984%.
- Net proceeds will fund the Meda AB acquisition. Closing date is June 9.
Fri, May 13, 1:25 PM
- Mylan N.V. (MYL +1%) acquires the non-sterile topicals-focused specialty and generics business of privately held Renaissance Acquisition Holdings, LLC for $950M in cash plus up to an additional $50M in contingent payments. The transaction should close by the end of Q3.
- The deal adds 25 branded and generic products, a 25-candidate pipeline and an established dermatology-focused sales and marketing organization to Mylan. In addition, Mylan gets an integrated manufacturing and development platform and a leading topicals-focused contract development and manufacturing organization.
- The acquired business has ~1,200 employees and generated ~$370M in revenues in 2015.
Tue, May 3, 11:10 AM
Tue, May 3, 9:45 AM
- Mylan (MYL +1.2%) Q1 results: Revenues: $2,191.3M (+17.1%); R&D Expense: $253.6M (+49.3%); SG&A: $549.3M (+13.7%); Operating Income: $105.6M (-33.7%); Net Income: $13.9M (-75.4%); EPS: $0.03 (-76.9%); Non-GAAP EPS: $0.76 (+8.6%); Quick Assets: $1,199.4M (-3.0%); CF Ops: $202M (-39.9%).
- 2016 Guidance: Revenues: $10.5B - 11.5B; Adjusted EPS: $4.85 - 5.15.
Tue, May 3, 5:07 AM
Mon, May 2, 5:30 PM
- ABMD, ACW, ADM, AFSI, ALE, ALLT, AMAG, AMG, APLP, AROC, ARRY, ARW, AUDC, BBW, BCC, BCO, CARB, CEQP, CFX, CIE, CLX, CMI, COTY, CVLT, CVS, DUK, ECA, ECL, EIGI, EL, EMR, EXAS, FDP, FIS, FMS, FSS, FTR, GLDD, GLT, GRUB, H, HAL, HCA, HCN, HEP, HOT, HRS, HSIC, HW, KEM, KMT, LXRX, MNK, MNTA, MYL, NI, NTI, NWN, NXST, NYT, OZM, PBI, PFE, Q, RDWR, RHP, RRD, S, SALE, SALT, SGNT, SMG, SSH, TAP, TECH, TICC, VLO, VMC, VSH, WAC, WCG, WEC, WLK, WNR, WNRL, WWW, XYL
Wed, Apr. 27, 11:13 AM
- Privately held Sunovion Pharmaceuticals announces successful results from two Phase 3 clinical trials, GOLDEN-3 and GOLDEN-4, assessing an inhalable mist formulation of SUN-101 (glycopyrrolate) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). Both studies (25 mcg and 50 mcg doses) met their primary endpoints of a statistically valid change from baseline to week 12 versus placebo in trough forced expiratory volume in one second (FEV1). Full results will be presented at future medical conferences.
- SUN-101 is a nebulized (mist) long-acting muscarinic antagonist (LAMA) delivered via an inhalation device called eFlow, developed by the German firm PARI.
- The company intends to file a New Drug Application (NDA) with the FDA this year. According to the company, SUN-101/eFlow, if approved, will be the first nebulized LAMA available for COPD patients, but AstraZeneca (AZN -0.9%) just received FDA approval of its LAMA/LABA offering, Bevespi Aerosphere.
- Related tickers: (GSK +1.7%)(MYL -1.5%)(NVS -0.2%)(TEVA -0.2%)(THRX)(AQXP -3.3%)
- Previously: AstraZeneca up 1.6% as FDA approves COPD treatment (April 25)
Mylan N.V., is a pharmaceutical company which develops, licenses, manufactures, markets and distributes generic, branded generic and specialty pharmaceutical products. It operates through the following businesses: Generic Products, Rx Products, Active Pharmaceutical Ingredients, and Access... More
Industry: Drugs - Generic
Country: United States
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