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6:55 am CVS Health reports EPS in-line, beats on revs; guides FY15 EPS in-line; guides FY16 EPS below consensus (CVS) : - Reports Q3 (Sep) earnings of $1.29 per share, in-line with the Capital IQ Consensus of $1.29; revenues rose 10.3% year/year to $38.64 bln vs the $37.9 bln Capital IQ Consensus.
- Co raises low end of guidance range for FY15, sees EPS of $5.14-5.18 vs. $5.16 Capital IQ Consensus Estimate (prior range $5.11-5.18). Reaffirms expectation for 2015 free cash flow of $5.9 billion to $6.2 billion, and 2015 cash flow from operations of $7.6 billion to $7.9
billion.
- Co issues downside guidance for FY16, sees EPS of $5.68-5.88 vs. $5.96 Capital IQ Consensus Estimate. This range is in line with the five-year growth targets the Company provided at its Analyst Day in December of 2013 for the years 2013 through 2018.
6:50 am Nokia and China Mobile (CHL) agree to to a $1 bln contract for mobile communications equipment and services (NOK) : Nokia Networks and China Mobile (CHL) have announced a comprehensive framework agreement for mobile communications equipment and services valued at more than $1 bln (EUR930 million). - Deliveries under the agreement commenced in Q1 2015, and will continue in 2016
- Framework agreement includes Nokia Networks 4G TD-LTE technology and wireless network equipment, core solutions, software and services
6:46 am Mylan Labs reports that a US district court has denied Perrigo's (PRGO) motion for a preliminary injunction, concerning a possible acquisition (MYL) : Co announces that the U.S. District Court for the Southern District of New York has denied the motion by Perrigo Company plc (PRGO) for a preliminary injunction concerning co's proposed acquisition of Perrigo, ruling that co had provided adequate public disclosures regarding the synergies expected to be achieved from the combination. - The court also ruled that co's disclosures regarding its intention to de-list Perrigo from the NYSE and the TASE as soon as practicable following the consummation of the offer were appropriate.
6:39 am Steris beats by $0.07, reports revs in-line; reaffirms FY16 guidance (STE) : - Reports Q2 (Sep) earnings of $0.83 per share, excluding non-recurring items, $0.07 better than the Capital IQ Consensus of $0.76; revenues rose 5.9% year/year to $489.9 mln vs the $487.8 mln Capital IQ Consensus; FX headwind 2%.
- Co reaffirms guidance for FY16, sees EPS of $3.15-3.30, excluding non-recurring items, vs. $3.26 Capital IQ Consensus Estimate; sees FY16 revs of +6-7% to ~$1.96-1.98 bln vs. $2 bln Capital IQ Consensus Estimate.
- The Synergy Health acquisition is anticipated to close on Monday, November 2, 2015. STERIS plans to provide an outlook inclusive of Synergy Health as soon as practical.
6:39 am Progessive Waste beats by $0.07, reports revs in-line; reaffirms FY15 revs guidance (BIN) : - Reports Q3 (Sep) earnings of $0.36 per share, $0.07 better than the Capital IQ Consensus of $0.29; revenues fell 6.3% year/year to $488.5 mln vs the $489.3 mln Capital IQ Consensus.
- Co reaffirms rev guidance for FY15 and lowers EPS guidance, sees EPS of $1.18-1.22 vs. $1.11 Capital IQ Consensus Estimate, down from prior guidance of $1.20-1.34; sees FY15 revs of $1.925-1.945 bln vs. $1.93 bln Capital IQ Consensus Estimate.
6:36 am PNM Resources beats by $0.01, reports revs in-line; narrows FY15 EPS in-line (PNM) : - Reports Q3 (Sep) earnings of $0.76 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of $0.75; revenues rose 0.8% year/year to $417.4 mln vs the $417 mln single analyst estimate.
- Co issues in-line guidance for FY15, sees EPS of $1.56-1.61 from $1.50-1.62, excluding non-recurring items, vs. $1.57 Capital IQ Consensus Estimate.
6:35 am Buckeye Partners misses by $0.13, misses on revs (BPL) : - Reports Q3 (Sep) earnings of $0.78 per share, $0.13 worse than the Capital IQ Consensus of $0.91; revenues fell 53.7% year/year to $728.4 mln vs the $1.12 bln Capital IQ Consensus.
- "We are pleased to report that our 1.1 million barrels of refrigerated LPG storage capacity at our BTP facility in South Texas is now
in-service. In addition, we are nearing completion of the commissioning phase
for our 50,000 barrel per day splitter facility. We believe both will
contribute substantial additional cash flows in the fourth quarter."
6:33 am Aon reports EPS in-line, misses on revs (AON) : - Reports Q3 (Sep) earnings of $1.24 per share, in-line with the Capital IQ Consensus of $1.24; revenues fell 5.0% year/year to $2.74 bln vs the $2.85 bln Capital IQ Consensus.
6:33 am Eaton misses by $0.01, misses on revs; guides Q4 EPS in-line; expands restructuring (ETN) : - Reports Q3 (Sep) earnings of $0.97 per share, excluding non-recurring items, $0.01 worse than the Capital IQ Consensus of $0.98; revenues fell 9.2% year/year to $5.2 bln vs the $5.32 bln Capital IQ Consensus.
- The sales decline consisted of 6 percent from negative currency translation and 3 percent from a decline in organic sales.
- Co issues in-line guidance for Q4, sees EPS of $1.10-1.15, excluding non-recurring items, vs. $1.12 Capital IQ Consensus Estimate.
- "As we begin to plan for 2016, it is apparent that markets are likely to remain soft," said Cutler. "To deal with such weak markets, we will be expanding our 2016 restructuring program. We had been planning on this second restructuring program, in addition to the $145 million program we announced in the second quarter of 2015, to be on the order of $50 million to $60 million, but in light of current market weakness we are expanding the program to between $90 million and $100 million."
6:32 am First Niagara to be acquired by KeyCorp (KEY) for $11.40/share, or ~$4.1 bln (FNFG) : KeyCorp (KEY) and First Niagara Financial
Group announced that they
have entered into a definitive agreement
under which KeyCorp will acquire First Niagara in a cash and stock transaction
for total consideration valued at approximately $4.1 billion. - Under the terms of the agreement, which
was unanimously approved by the Boards of
Directors of each company, the merger consideration will be approximately $4.1 billion.
First Niagara shareholders will receive 0.68 KeyCorp shares and $2.30 in cash for each First Niagara common share.
The per share consideration is valued at $11.40
per share based on the closing price of KeyCorp common stock on October 29, 2015. In conjunction
with the closing of the transaction, three members of the First Niagara Board of
Directors are expected to join the KeyCorp Board, which will be expanded
accordingly.
- The acquisition diversifies KeyCorp's loan portfolio, strengthens its core
retail deposit franchise and provides expanded scale. Upon completion of the
transaction, the combined company will have approximately $99.8 billion in
deposits, $83.6 billion in loans and 1,366 branches across
15 states. The combined company will have approximately $135 billion of
pro forma assets providing increased
operating leverage to deliver improved financial performance.
- KeyCorp expects the acquisition to be accretive to earnings per share in 2017, excluding one-time
charges, and expects the transaction to deliver an attractive Internal Rate of
Return of approximately 15%.
The announcement confirms a WSJ article yesterday that the two were in advanced talks. 6:30 am On The Wires (:WIRES) : - Violin
Memory (VMEM) announced that a major
online retailer of consumer electronics has deployed the Violin 7300 Flash
Storage Platform to improve its online transaction processing, critical to
maintaining rapid, reliable and secure responsiveness to its customers
worldwide.
- Petrobras (PBR) announces the
proposed terms for the signature of new amendments to the naphtha supply agreements
to Braskem (BAK), allowing supply to continue during negotiations for a
long-term contract. Petrobras has been negotiating with Braskem for more than
two years, seeking a balanced and equitable solution for both companies.
- Xueda Education Group (XUE) announced that it has called an extraordinary general meeting
of shareholders, to be held on December 16, 2015 at 10:00 a.m. . The meeting will be held to consider and vote on, among
other things, a proposal to authorize and approve the previously announced agreement and plan of merger dated July 26, 2015 by and among the
Company, Xiamen Insight Investment Co., and Xueda
Acquisition Limited, the
plan of merger required to be filed with the Registrar of Companies of the Cayman Islands and the transactions contemplated by the merger agreement, including the merger
6:20 am Iron Mountain beats by $0.05, misses on revs; reaffirms FY15 FFO guidance, revs guidance; guides FY16 FFO in-line, revs above consensus (IRM) : - Reports Q3 (Sep) funds from operations of $0.55 per share, $0.05 better than the two analyst estimate of $0.50; revenues fell 4.6% year/year to $746.5 mln vs the $761.37 mln Capital IQ Consensus; +2% ex-FX; storage rental +.2%, service rev -1.3%.
- Co reaffirms guidance for FY15, sees FFO of $2.00-2.20 vs. $2.01 Capital IQ Consensus Estimate; sees FY15 revs of $3.0-3.06 bln vs. $3.04 bln Capital IQ Consensus Estimate.
- Co issues guidance for FY16, sees FFO of $2.15-2.45 vs. $2.25 Capital IQ Consensus Estimate; sees FY16 revs of $3.165-3.265 vs. $3.14 bln Capital IQ Consensus Estimate.
6:18 am Pengrowth Energy receives non-compliance notice from the NYSE relating to its stock being under the $1.00 requirement (PGH) : Under the NYSE's rules, Pengrowth has a period of six months from the date of the NYSE notification to regain compliance with the NYSE's price listing standard and avoid delisting. 6:16 am Greenbrier beats by $0.24, misses on revs; guides FY16 EPS in-line, revs above consensus; authorizes $100 mln increase to share repurchase program; increases quarterly div 33% (GBX) : - Reports Q4 (Aug) earnings of $2.02 per share, $0.24 better than the Capital IQ Consensus of $1.78; revenues rose 23.8% year/year to $765.5 mln vs the $815.76 mln Capital IQ Consensus. Q4 New railcar deliveries totaled 6,200 units for the quarter vs 5,700 units last year,
- Co issues guidance for FY16, sees EPS of $5.65-6.15 vs. $6.01 Capital IQ Consensus Estimate; sees FY16 revs of $2.8 bln vs. $2.72 bln Capital IQ Consensus Estimate. Co sees FY16 deliveries between 22.0-22.5K.
- Board authorizes $100 mln increase to share repurchase program, bringing cumulative repurchase authorizations to $225 million since October 31, 2013. Quarterly dividend increases 33% to $0.20/share.
- Co also announces that William Furman, Chairman and CEO intends to make certain sales of common stock of the Company in accordance with the Company's policies regarding stock transactions, which may include future sales pursuant to a pre-arranged stock trading plan.
6:16 am Anheuser-Busch InBev misses by $0.24, misses on revs; expects FY15 revenue per hl will grow ahead of inflation due to higher than expected premium brand volumes (BUD) : - Reports Q3 (Sep) earnings of $1.02 per share, $0.24 worse than the Capital IQ Consensus of $1.26; revenues fell 7.1% year/year to $11.38 bln vs the $11.54 bln Capital IQ Consensus.
- Revenue grew by 7.9% organically in 3Q15, with solid revenue per hl growth of 6.3%, driven by revenue management and premiumization initiatives. On a constant geographic basis, revenue per hl grew by 7.8%. I
- Volume: Total volumes grew by 1.5% in 3Q15, with own beer volumes up 2.3%, and non-beer volumes down 6.1%. The growth in beer volumes was driven mainly by strong performances in Mexico and Latin America North, as well as an easier comparable in the US.
- Outlook: Co is amending guidance.
- Co's previous guidance was for revenue per hl to grow organically in line with inflation, on a constant geographic basis, as a result of revenue management initiatives and continued improvements in mix.
- Co now expects revenue per hl will grow ahead of inflation due to higher than expected premium brand volumes
- Proposed combination with SABMiller: On 13 October 2015, the boards of AB InBev and SABMiller announced that they had reached an agreement in principle on the key terms of a possible recommended offer to be made by AB InBev for the entire issued and to be issued share capital of SABMiller.
- The board of SABMiller has indicated to AB InBev that it would be prepared unanimously to recommend the all-cash offer of GBP 44.00 per SABMiller share to SABMiller shareholders, subject to their fiduciary duties and satisfactory resolution of the other terms and conditions of the Possible Offer.
6:12 am Dorian LPG beats by $0.11, beats on revs (LPG) : - Reports Q2 (Sep) earnings of $0.72 per share, $0.11 better than the Capital IQ Consensus of $0.61; revenues rose 267.2% year/year to $74.9 mln vs the $68.35 mln Capital IQ Consensus.
- "Going forward, we anticipate higher profits and cash generated from operations as a result of our larger fleet, assuming continued favorable market conditions. We will continue to evaluate ways to best return that cash to our investors, underscoring the commitment of both the board and management to increasing shareholder value."
6:09 am Genesee & Wyoming beats by $0.06, reports revs in-line (GWR) : - Reports Q3 (Sep) earnings of $1.09 per share, $0.06 better than the Capital IQ Consensus of $1.03; revenues rose 26.3% year/year to $546.3 mln vs the $550.02 mln Capital IQ Consensus. Excluding $4.0 million of revenues from new operations and a $5.0 million decrease due to the impact of foreign currency depreciation, North American Operations same railroad revenues decreased by $29.5 million, or 8.7%, primarily due to declines in coal and metals shipments.
- North American Operations traffic decreased 42,771 carloads, or 9.3%, to 419,571 carloads in the third quarter of 2015.
- Excluding 8,683 carloads from new operations, same railroad traffic decreased 51,454 carloads, or 11.1%.
- "Our outlook for the second half of 2015 remains unchanged from August, with third quarter results stronger than planned and fourth quarter outlook expected to be weaker than planned. As we finish the year and look ahead to 2016, our management team is concentrated on optimizing the strong free cash flow that underpins the value of our 120 railroads. In addition, we continue to evaluate potential acquisitions and investments worldwide."
6:01 am WisdomTree to acquire GreenHaven Commodity Services for $11.75 mln (WETF) : The co announced it entered into an agreement to
acquire GreenHaven Commodity Services, LLC, the managing owner of the GreenHaven
Continuous Commodity Index Fund (GCC),
and GreenHaven Coal Services, LLC, the sponsor of the GreenHaven Coal Fund
(TONS), from GreenHaven, LLC and
GreenHaven Group, LLC, respectively. - WisdomTree will retain GreenHaven Advisors, LLC as the sub-advisor to the
funds to conduct portfolio management services. The transaction consideration is $11.75 million in cash. GCC has $247 million in
assets under management and TONS has $1 million in assets under management, as of
October 28, 2015.
- The financial impact of the transaction is not material to
WisdomTree earnings per share.
6:01 am Theravance announces a modified dutch tender auction for $75 mln of its common stock, at a price between $8.50/share and $9.25/share, as part of its previously disclosed plan (THRX) : Co expects to fund the purchase of shares in the tender offer with existing cash and cash equivalents 5:48 am S&P futures vs fair value: +4.50. Nasdaq futures vs fair value: +11.80. : 5:48 am European Markets : FTSE...6388.14...-7.50...-0.10%. DAX...10816.72...+15.90...+0.20%. 5:48 am Asian Markets : Nikkei...19083.10...+147.40...+0.80%. Hang Seng...22640.04...-179.90...-0.80%. 5:48 am On The Wires (:WIRES) : - Gilead
Sciences (GILD) and WuXi PharmaTech (WX)
announced that they have entered into a strategic partnership to conduct
analytical and stability studies of small-molecule new chemical entities to
support global marketing applications and commercial products. Under the agreement, WuXi
will equip and operate a dedicated, fully cGMP-compliant 12,500-square-foot
analytical testing facility in Shanghai.
- Delek Group's (DGRLY) gas
subsidiaries announced that they have accepted a request by DEFA (a Governmental
gas company owned by the Government of Cyprus) to postpone the period of
validity of a proposal for the supply of natural gas from October 31, 2015 to
December 18, 2015. The proposal is for the supply of natural gas through
pipelines from the Leviathan project. Accordingly, the commercial examination process and the
negotiation between DEFA and the bidders are expected to continue in the near
future.
- Sasol (SSL) confirms that two of its three applications in
Mozambique's 5th Licensing Round were successful. Sasol (70% interest,
operator) and Empresa Nacional de Hidrocarbonetos, the state oil company
(30% carried interest), were awarded the onshore Area PT5-C, which is 3,012
square kilometres, adjacent to the Pande and Temane fields.
5:45 am Asciano: Qube Holdings acquires 19.99% stake, says purchased the shares to decide on ownership of Asciano's Australian terminal assets (AANOF) : Qube Holdings Limited announces that, with the support of two co-investors, Global Infrastructure Partners and Canada Pension Plan Investment Board, it has acquired an aggregate interest representing 19.99% of the shares in Asciano Limited. Qube has entered into this transaction to participate in deciding the ownership of Asciano's first class Australian terminal assets. It believes a strategic combination of Qube with the Patrick Containers Terminals business as well as a small number of assets in the bulk, automotive and general stevedoring businesses currently owned by Asciano has the potential to create significant value. Qube has no present interest in acquiring any of Asciano's businesses beyond the Patrick Businesses. - In August, Brookfield Infrastructure (BIP) entered into an agreement to acquire Asciano for ~AUD 12 bln
Brookfield Infrastructure |
5:00 am Valeant Pharma announces it will terminate its relationship with Philidor (VRX) : The co announced that it is severing all ties with Philidor Rx Services, LLC, and that Philidor has informed Valeant that it will shut down operations as soon as possible, consistent with applicable laws. - "The newest allegations about activities at Philidor raise additional questions
about the company's business practices. We
have lost confidence in Philidor's ability to continue to operate in a manner
that is acceptable to Valeant and the patients and doctors we serve."
- Valeant intends to develop a plan to ensure patients' access to drugs is
minimally disrupted. Valeant has informed Philidor that to the extent that
managed care plans will no longer reimburse prescriptions in process, Valeant
will fill them at the company's expense.
- In Q3, Philidor represented 6.8% of total Valeant revenue.
4:24 am On The Wires (:WIRES) : - MorphoSys AG announced that it has received
a milestone payment from Bayer HealthCare (BAYRY) in connection with the
initiation of a Phase 1 clinical trial of a HuCAL antibody in the field of bleeding
disorders. The antibody targets the tissue factor pathway inhibitor, a major
inhibitor of tissue factor-initiated blood clotting.
- Hutchison China MediTech (Pending IPO: HCM)
announced its drug R&D subsidiary will present further scientific data
on sulfatinib, fruquintinib and savolitinib at
the International Conference on Molecular Targets and Cancer Therapeutics,
which will be held in Boston, Massachusetts, USA from 5 to 9 November 2015. The
co also announced has successfully completed its
first-in-human Phase I clinical trial of HMPL-523. HMPL-523 is a novel,
highly selective and potent small molecule inhibitor targeting spleen tyrosine
kinase, also known as Syk, a key component in B-cell receptor signalling. The preliminary safety profile of HMPL-523 was in-line with our
expectations.
- 3E Company, a Verisk Analytics (VRSK) business, and
Airsweb announced a strategic alliance aimed at promoting seamless access to
critical hazard communication documentation, substance-level regulatory
content, and chemical regulatory data.
- Saint-Gobain (CODYY) has
signed an agreement with In Group, a local building distribution player, to
sell its businesses in the Czech Republic and Hungary. These businesses
reported sales of 138 million in 2014. Following the 2013-2014 sale of its
tiling operations in Slovakia, Poland and the Czech Republic along with the
sale of Raab Karcher in Poland, the Building Distribution sector has completed
the optimization of its portfolio in Eastern Europe.
- Fairfax Financial Holdings (FRFHF) announced that it has agreed with its joint
venture partner, ICICI Bank Limited, to acquire an additional 9.0% of the
issued and outstanding shares of ICICI Lombard General Insurance Company Limited. The proposed transaction values the Company at
Rs. 17,225 crore ($2.6 billion), is subject to governmental and regulatory
approvals and is expected to close in the first quarter of 2016.
- NorthWestern
Energy (NWE) announced that the South
Dakota Public Utility Commission has formally approved its
stipulated settlement agreement with
staff and intervening parties. The approval is the final step in the company's
first general rate adjustment request in 34 years. Under the agreement,
NorthWestern will be allowed to increase base
rates by $20.2 million annually compared to the original request of $26.5 million and
includes recovery for the recently acquired Beethoven wind project.
4:21 am Eldorado Gold misses by $0.02, beats on revs, raises production guidance (EGO) : Reports Q3 (Sep) loss of $0.01 per share, $0.02 worse than the Capital IQ Consensus of $0.01; revenues fell 19.7% year/year to $211.5 mln vs the $197.84 mln Capital IQ Consensus. - Gold production for 2015 is forecast to be 710,000 ounces of gold with average
cash costs for commercial production of $565 per
ounce and all-in sustaining cash costs of $870
per ounce. Previous mid-year guidance was production of 690,000 ounces at
average cash costs of $590 per ounce and all-in
sustaining cash costs of $925 per ounce.
Forecasted sustaining capital spending remains unchanged at $110.0 million. New project development capital
spending is now forecast at $225.0 million,
compared with previous guidance of $300.0
million. The forecast for new project development capital is lower than
previous guidance mainly due to presently projected lower capital spending at
Skouries.
- The company also announced that in light of the current gold price, and as a part of continued cost savings,
it will implement a reduction in the base salary for its CEO, the Executive Team, and a reduction in the annual retainer fee for the Board effective November 1, 2015
- Regarding Greece: Activities recommenced in October after the Council of State -- Greece's Supreme Court on
administrative and environmental matters -- issued an injunction against
enforcement of the decision of the Ministry of Energy and Environment. This is
an interim injunction which will be in effect pending the final decision of the
Council of State in the proceedings in which the interim injunction was granted.
4:13 am Weyerhaeuser beats by $0.08, reports revs in-line (WY) : - Reports Q3 (Sep) earnings of $0.35 per share, $0.08 better than the Capital IQ Consensus of $0.27; revenues fell 5.0% year/year to $1.82 bln vs the $1.84 bln Capital IQ Consensus.
Q4 Outlook - Weyerhaeuser expects comparable earnings from the Timberlands segment in the
fourth quarter. In the West, the company expects slightly higher fee harvest
volumes and improved mix primarily due to increased shipments to Japan. In the South, the company
anticipates comparable fee harvest volumes and higher logging costs.
- Weyerhaeuser expects significantly lower earnings
from the Wood Products segment in the fourth quarter. The company anticipates
seasonally lower sales volumes, reduced operating rates, and additional planned
maintenance primarily in oriented strand board. The company also expects lower
average sales realizations for lumber and higher average sales realizations for
oriented strand board.
- Weyerhaeuser expects lower earnings from the
Cellulose Fibers segment in the fourth quarter. The company anticipates lower
average pulp sales realizations, increased scheduled maintenance, and seasonally
higher fiber costs.
4:09 am UTStarcom expects Q3 revs ahead of prior guidance (UTSI) : The co announced that it expects Q3 revs of $25-27 mln vs $20.22 mln two analyst estimate and prior guidance for $18-22 mln. The company will host a conference call to discuss the Company's financial results for the third quarter 2015 before U.S.
markets open on Monday, November 9, 2015. 4:06 am Arkansas Best misses by $0.06, reports revs in-line (ARCB) : - Reports Q3 (Sep) earnings of $0.74 per share, $0.06 worse than the Capital IQ Consensus of $0.80; revenues fell 0.3% year/year to $709.38 mln vs the $712.01 mln Capital IQ Consensus.
- "While softer freight demand amid an increasingly sluggish economy impacted our third quarter results, revenue growth in our asset-light logistics businesses confirms that our customers find value in our expanded supply chain, moving and fleet maintenance offerings."
4:00 am Schneider Electric confirms it had sold its Juno Lighting unit to Acuity Brands (AYI) for ~$385 mln (SBGSY) : The transaction would generate a capital loss/ impairment of up to $300m (c. 270m). Such loss/impairment would be
excluded from the basis of calculation for Schneider Electric's 2015 dividend. 3:58 am Celgene announces that the European Commission has approved VIDAZAfor the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (CELG) : The co announced that the European Commission has approved VIDAZA for the treatment of adult patients aged 65 years or older with acute
myeloid leukaemia who are not eligible for haematopoietic stem cell
transplantation. The VIDAZA Marketing Authorisation has been updated to include this new indication in AML,
covering patients who have >30% myeloblasts according to the WHO
classification; previously, the indication covered AML patients with 3:54 am New York Community prices offering of ~40.6 mln shares of its common stock at $16.00/share (NYCB) : 3:52 am MiMedx Group comments on the FDA Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (MDXG) : The co commented on the proposed Draft Guidance on
Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products
that the Food and Drug Administration published for comment on October 28, 2015
and the Notice of Public Hearing and Request for Comments released today
indicating the agency would hold a public hearing on April 13, 2016 to obtain
input on that Guidance as well as three
other recently issued guidance documents on
HCT/Ps. - "It is our management's opinion that we are and have been in compliance with the
homologous use requirements. We have always marketed our products with general
intended uses that have been documented by the FDA as being homologous use for amniotic
tissue. Our marketing does not reflect statements about our membranes being
intended for use for specific indications such as dermal ulcers. Our materials
are much more general, and reflect uses that the FDA has already declared as homologous use for
amniotic tissue."
3:47 am Target launches international version of its website, will deliver to international consumers this holiday season; separately announces free shipping for the holidays (TGT) : The new site, which Target recently began
testing, also will allow U.S. customers to ship Target orders to around the
world, just in time for this holiday season. Target has partnered with Borderfree, a Pitney
Bowes (PBI) company to be able to ship globally. Countries where shipping from Target is now
available include China, India, Canada, Mexico, European Union countries and more. Target also announced that beginning Nov. 1 through Dec. 25, Target
will bring back free shipping and returns. Beginning next week, Target is expanding
Instacart, the popular on-demand grocery delivery service from Minneapolis, where it was
first piloted, to San
Francisco.
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