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News Breaks
April 15, 2014
08:06 EDTGSK, MYLProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
Prosonix announced that it has entered into a global licensing agreement with Mylan (MYL) for its leading inhaled respiratory products, PSX1001 and PSX1050. PSX1001 and PSX1050 are being developed as generic versions to GlaxoSmithKline's (GSK) pressurised metered dose inhalers Flixotide and Flovent, respectively. According to IMS Health, Flixotide and Flovent had global brand sales of approximately $1.3B for the 12 months ending Dec. 31, 2013. A first marketing authorisation application for PSX1001 is expected to be submitted in the European Union in 2014.
News For MYL;GSK From The Last 14 Days
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February 10, 2016
16:09 EDTMYLMylan acquires Meda Aktiebolag for $9.9B
Mylan announced a recommended public offer to the shareholders of Meda Aktiebolag to tender all their shares in Meda to Mylan. The total offer consideration consists of a combination of cash and Mylan ordinary shares with a value at announcement of SEK 165 per Meda share. The total value of the offer for all Meda shares, including Meda net debt, is approximately $9.9B which represents a multiple of approximately 8.9x 2015 adjusted EBITDA with synergies. The company said, "The combination of Mylan and Meda will create a diversified global pharmaceutical leader with an expansive portfolio of branded and generic medicines and a strong and growing portfolio of over-the-counter (OTC) products. The combined company will have a balanced global footprint with significant scale in key geographic markets, particularly the U.S. and Europe. The acquisition of Meda also provides Mylan with entry into a number of new and attractive emerging markets, including China, Southeast Asia, Russia, the Middle East and Mexico, complemented by Mylan's presence in India, Brazil and Africa." The offer has been unanimously approved by Mylan's board of directors and unanimously recommended by Meda's board of directors. Meda's two largest shareholders, representing in the aggregate approximately 30% of Meda's outstanding shares, have undertaken to accept the offer, subject to certain conditions. Meda's shares are listed on Nasdaq Stockholm, Large Cap. The offer is not subject to approval by Mylan shareholders and is not subject to any financing conditions. The transaction is expected to be immediately accretive to Mylan earnings, with accretion increasing significantly after the first full year as synergies are realized. The transaction creates an opportunity to achieve 35c-40c accretion in 2017 and to accelerate achievement of Mylan's previously stated $6.00 in adjusted diluted EPS target in 2017 versus 2018.
15:46 EDTMYLMylan to announce acquisition of Meda, FT says
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14:32 EDTMYLNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Cisco (CSCO), consensus 54c... Tesla (TSLA), consensus 8c... Twitter (TWTR), consensus 12c... Whole Foods (WFM), consensus 40c... Mylan (MYL), consensus $1.27... Expedia (EXPE), consensus $1.00... Prudential Financial (PRU), consensus $2.30... O'Reilly Automotive (ORLY), consensus $2.08... Pioneer Natural Resources (PXD), consensus (30c)... Skechers (SKX), consensus 20c... Zynga (ZNGA), consensus 0c.
13:19 EDTMYLMylan volatility elevated into Q4 and outlook
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08:12 EDTMYLTheravance achieves 50% enrollment in three Phase 3 studies of COPD treatment
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08:10 EDTMYLMomenta announces early HSR clearance for biosimilars collaboration with Mylan
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February 9, 2016
13:26 EDTMYLMylan volatility elevated into Q4 and outlook
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08:40 EDTGSKVBI Vaccines announces research collaboration with GlaxoSmithKline
VBI Vaccines (VBIV) has entered into a research collaboration with GlaxoSmithKline Biologicals SA (GSK) to evaluate VBI's LPV Platform. VBI's LPV Platform is a proprietary formulation and process that enables the development of vaccines and biologics with improved stability and preserved potency. Under the terms of the research collaboration, GSK has the option to negotiate an exclusive license to VBI's LPV Platform for use in a defined field. Further terms of the collaboration were not disclosed.
February 8, 2016
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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06:13 EDTMYLPfizer insists Allergan deal won't be thwarted by U.S. politicians, FT says
Pfizer (PFE) has insisted that its $160B acquisition of Allergan (AGN) will not be stifled by political opposition, amid criticism that the deal will cost the U.S. Treasury billions of dollars in future tax revenues, the Financial Times reports. Pfizer CEO Ian Read also reiterated his intention to postpone until 2018 a decision on whether to break of the combined entity into two or three smaller companies, but has said that he would be open to offers for its generics unit, the report says. Mylan (MYL) has been connected to a potential acquisition of Pfizer's generic drugs business after it failed in its attempt to buy Perrigo (PRGO) last year, the report says. Reference Link
February 2, 2016
08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
February 1, 2016
08:04 EDTMYLTeva Mylan not seeing same negative trends as Sandoz, says Bernstein
After Novartis (NVS) reported weak results for its generics unit, Sandoz, and blamed it on industry trends, Bernstein quotes Mylan (MYL) and Teva (TEVA) as saying that they are seeing only "slight adjustments back to normal levels" from "mildly favorable" results in 2014 and 2015. Bernstein says that Sandoz has lost a number of fairly profitable products and has had fewer approvals than its peers. Bernstein keeps Outperform ratings on Teva and Mylan.
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