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Stock Market & Financial Investment News

News For VVUS;JNJ;AZN;PFE From The Last 14 Days
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May 22, 2015
16:24 EDTAZNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
10:52 EDTAZN, PFE, JNJJPMorgan says Actavis shares cheap compared to peers
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08:17 EDTJNJJohnson & Johnson reports STELARA receives CHMP positive opinion
Janssen-Cilag announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending approval for the use of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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12:40 EDTAZNHayman's Bass requests review of POZEN patents
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10:58 EDTAZNDeutsche Bank biotech analyst holds an analyst/industry conference call
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07:37 EDTAZN, PFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
16:26 EDTJNJOn The Fly: Top stock stories for Wednesday
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11:51 EDTAZNExpress Scripts' Medco to pay $7.9M to resolve kickback allegations
Medco Health Solutions, a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company (ESRX), of Missouri, has agreed to pay the government $7.9M to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced. Medco provides pharmacy benefit management services to clients who receive subsidies under the Medicare Retiree Drug Subsidy program. The settlement resolves allegations that Medco solicited remuneration from AstraZeneca, a pharmaceutical manufacturer, in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on certain of Medco’s prescription drug lists known as formularies. The United States alleged that Medco received some or all of the remuneration from AstraZeneca in the form of reduced prices on the following AstraZeneca drugs: Prilosec, Toprol XL and Plendil. The United States contended that this kickback arrangement between Medco and AstraZeneca (AZN) violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program. In January 2015, the United States and AstraZeneca reached a $7.9M settlement to resolve kickback allegations arising out of the same conduct. This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, whose share of the settlement has not been determined. The settlement with Medco was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office of the District of Delaware and HHS-OIG.
10:26 EDTJNJJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
09:07 EDTJNJJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
08:49 EDTJNJJohnson & Johnson: Priorities for free cash flow include dividends, repurchases
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08:30 EDTJNJAchillion price target lowered to $16 from $25 at Leerink
Leerink says Achillion's deal with Johnson & Johnson (JNJ) increases the probability that it will be a competitive commercial-stage player in hepatitis C. The firm believes the collaboration limits share downside as well as upside by making the "home-run scenario of great combo data leading to an acquisition less likely." It lowered its price target for Achillion shares to $16 and keeps an Outperform rating on the name.
08:15 EDTJNJJohnson & Johnson CEO Alex Gorsky says won't pursue pure-play strategy
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08:02 EDTJNJJohnson & Johnson to hold a meeting
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07:51 EDTJNJAchillion shares remain undervalued after HCV pact with J&J, says Cowen
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07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
07:33 EDTJNJJ&J to file more than 10 new '$1B potenital' products by 2019
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07:30 EDTJNJAchillion downgraded on valuation at JMP Securities
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06:17 EDTJNJAchillion downgraded to Neutral from Buy at UBS
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May 19, 2015
16:10 EDTJNJAchillion enters into collaboration for HCV with Janssen
Achillion (ACHN) announced that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus, or HCV, assets which include ACH-3102, ACH-3422, and sovaprevir. Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets. A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation – JJDC, Inc. will invest $225M in Achillion and, in return, receive approximately 18.4M newly issued, unregistered shares of Achillion at a price of $12.25 per share. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.
15:05 EDTAZNArdelyx scheduled for end Phase 2 meeting with FDA scheduled in June
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06:55 EDTPFEGenocea 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
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
06:13 EDTAZNAstraZeneca to invest $285M in new biologics manufacturing facility in Sweden
AstraZeneca announced that it plans to invest approximately $285M in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019. Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organisation. By locating the new manufacturing plant in Södertälje, the company will combine its expertise in biologics with the well-established culture of operational excellence that exists within the Sweden Operations unit. The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, Maryland, announced in November.
May 17, 2015
15:49 EDTAZNAstraZeneca reports Movantik shows 'similar' adverse event rate vs. placebo
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May 15, 2015
09:31 EDTPFE, AZNAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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May 14, 2015
14:54 EDTJNJJohnson & Johnson unit reports results of VENTURE-AF trial
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12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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09:41 EDTJNJLeerink medical devices analyst holds a cardiology luncheon meeting
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09:22 EDTAZNLeerink pharma/biotech analysts hold an analyst/industry conference call
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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17:50 EDTJNJPharmacyclics to showcase new 'promising' Imbruvica data at ASCO
Pharmacyclics announced that ibrutinib, also known as Imbruvica, single-agent and combination data will be featured in seven oral and poster sessions at the 51st American Society of Clinical Oncology, ASCO, Annual Meeting being held May 29-June 2 in Chicago, IL. According to a statement from ASCO, Imbruvica data will also be included in the official press program during the meeting for the second time in two years. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a Johnson & Johnson (JNJ) subsidiary. Data being presented include, among others, an oral presentation from the Phase III HELIOS study of ibrutinib in combination with bendamustine and rituximab in relapsed or refractory chronic lymphocytic leukemia, a poster presentation of ibrutinib in steroid-dependent or refractory chronic graft-versus-host-disease as well as a dose adherence analysis of ibrutinib 420 mg administered to previously treated CLL patients. "We look forward to sharing promising data at this year's ASCO that examines the use of Imbruvica across a broad range of hematologic disease settings from our clinical studies," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics.
17:24 EDTAZNAstraZeneca to update progress with immuno-oncology pipeline at ASCO
AstraZeneca and MedImmune, the company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology, or ASCO, Annual Meeting, May 29-June 2. 61 scientific abstracts will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.
17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
07:31 EDTPFEHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
May 11, 2015
17:58 EDTJNJJ&J's Janssen gets complete response letter regarding sNDA for Invega Sustenna
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17:36 EDTPFEAthersys down 10.1% after Pfizer notified that it will terminate agreement
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17:34 EDTPFEAthersys receives notification that Pfizer will terminate agreement
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16:33 EDTPFEPfizer takes minority interest in AM-Pharma, secures option to acquire company
AM-Pharma and Pfizer announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. There are no drugs currently approved for this condition and the only treatment option is dialysis and supportive care. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, Pfizer has made an upfront payment of $87.5M for the minority equity interest and exclusive option, with additional potential payments of up to $512.5M upon option exercise and potential launch of any product that may result from this agreement. Other terms of the transaction were not disclosed. “Pfizer is committed to advancing the science to address the high unmet medical need in Acute Kidney Injury,” said Mikael Dolsten, M.D., Ph.D., president, Worldwide Research and Development at Pfizer. “Clinical data for recAP show the potential to uniquely address Acute Kidney Injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in-class treatment for patients.”
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