Industry News

Biocon Ltd. announced today that the European Medicines Agency has accepted for review Mylan's Marketing Authorization Application for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe."/>
Mylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Trastuzumab Accepted for Review by European Medicines Agency
SCYNEXIS revealed on Wednesday the receipt of the orphan drug designation from the US Food and Drug Administration has for the novel triterpenoid broad-spectrum antifungal agent, SCY-078, for the treatment of invasive Aspergillus infections. Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem..."/>
SCYNEXIS passes US FDA orphan drug designation for SCY-078 for invasive aspergillus infections
Mylan NV. The anger over a 400 percent increase in EpiPen's price in the last nine years renewed simmering resentment over the relocation of the company's corporate address to a foreign country to lower its taxes and about CEO Heather Bresch's compensation,..."/>
Firestorm grows over price hikes on EpiPen [The Pittsburgh Tribune-Review]
Innovus Pharmaceuticals' FlutiCare™ in the nasal allergy market following the recent approval of Bayer AG's ClariSpray™. Bayer AG expanded its allergy portfolio in the United States to include ClariSpray™, a 24- hour nasal spray to treat allergy symptoms, in..."/> Bayer's ClariSpray Success Bodes Well for Innovus Pharmaceuticals' FlutiCare
Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions today announced that researchers will present scientific data at PAINWeek 2016 on September 8 in Las Vegas. Four presentations will be on abuse-deterrent product candidate ARYMO™ ER Extended-Release Tablets; one presentation will address..."/>
Egalet Announces Scientific Presentations at PAINWeek 2016 Meeting
Mallinckrodt revealed on Wednesday the launch of a definitive agreement to divest its Nuclear Imaging business for about USD690m before tax impacts, including up-front and contingent consideration and the assumption of long-term obligations, to IBA Molecular. Mallinckrodt added that the total consideration of approximately USD690m consists of approximately USD574m of up-front consideration, the assumption of approximately USD39m of..."/>
Mallinckrodt to sell USD690m Nuclear Imaging business
Exelixis Inc on Wednesday announced that it has called for redemption of approximately USD48.1m of its 4.25% convertible senior subordinated notes due 2019, representing all remaining notes outstanding. Reportedly, this redemption will be made in accordance with the terms of the indenture governing the notes and the terms of the redemption notice. Any notes outstanding on 2 November 2016 will be redeemed in cash for 100% of the principal amount thereof, plus accrued and..."/>
Exelixis to redeem all remaining 4.25% convertible senior subordinated notes due 2019
Nordic Nanovector ASA on Wednesday reported a comprehensive loss of NOK51.1m for the second quarter of 2016.. This was a decline over comprehensive loss of NOK 47.7 m in Q2 2015.. Revenues for the quarter amounted to NOK0.079m, as compared with NOK 0.142 m in Q2 2015.."/>
Nordic Nanovector widens loss in Q2 2016
Inotek Pharmaceuticals reported on Wednesday that it has completed the recruitment under the first pivotal Phase 3 trial of trabodenoson for the treatment of glaucoma, MATrX-1 study, with expected Top-line data in December 2016.. The company's lead clinical candidate Trabodenoson is a first-in-class selective adenosine A1 mimetic under investigation for reduction of intraocular pressure which has been observed in Phase 2 clinical trials..."/>
Inotek Pharmaceuticals concludes recruitment under first pivotal Phase 3 MATrX-1 trial of trabodenoson for the treatment of glaucoma
NeuroVive Pharmaceutical AB, a mitochondrial medicine company, announced on Wednesday the departure of its chief operating officer, Jan Nilsson. According to the company, it is entering into a very important period and is expecting exciting developments during this autumn. Over the past several months, the business strategy and organisation have been re-oriented to optimise the way forward."/>
NeuroVive Pharmaceutical's COO leaves
Cardax reported on Wedneday the availability of its first commercial product, ZanthoSyn, a safe anti-inflammatory for general health. Available via the company's commercial website,, ZanthoSyn is a novel astaxanthin dietary supplement with superior absorption and purity. The company said Astaxanthin is a clinically studied ingredient with safe anti-inflammatory activity that supports joint health,..."/>
Cardax unveils first, safe anti-inflammatory product for general health ZanthoSyn
Exelixis said on Wednesday that it intends to redeem about USD48.1m of its 4.25% convertible senior subordinated notes due 2019, representing all remaining notes outstanding, under the terms of the indenture governing the notes and the terms of the redemption notice. Any notes outstanding on 2 November 2016 will be redeemed in cash for 100% of the principal amount thereof, plus accrued and unpaid interest on the notes redeemed to, but excluding, the redemption date, added the..."/>
Exelixis to redeem all remaining 4.25% convertible senior subordinated notes due 2019
Pulse Biosciences revealed on Wednesday the election of Edward Ebbers as vice president and general manager of its dermatology products. In the new positions, Ebbers will oversee the development of the company's Nano-Pulse Electro-Signaling technology for application in dermatologic conditions. Most recently, Ebbers has served as chief commercial officer and vice president of Marketing at Capnia, where he led worldwide product development,..."/>
Pulse Biosciences appoints Edward Ebbers as VP & GM of Dermatology Products
Tata Global Beverages' China operations. Tata Group chairman Cyrus Mistry on Wednesday indicated that Tata Global Beverages might sell its loss-making Chinese subsidiary, reported Times of India."/>
Deals Buzz: Tata Global Beverages may sell Chinese subsidiary [Mint, New Delhi]
Zealand's interim report for the first half of 2016 (unaudited)
Aurobindo Pharma Ltd's share rose 7% on Wednesday, reacting to its June quarter results. The spike was somewhat surprising, as its sales growth and improvement in profitability was not unexpected. Perhaps, Aurobindo's ability to hit the target at a time when front line pharmaceutical companies are finding the going difficult is being rewarded."/>
Aurobindo Pharma: high expectations [Mint, New Delhi]
Aurobindo Pharma Ltd on Wednesday said it plans to introduce at least 19 products, addressing a market size of $6.8 billion in the US. All the 19 products, including 16 oral and three injectables, were approved by US Food and Drug Administration and await launch as the company is faced with capacity constraints. Aurobindo said it is pinning its hopes on big launches such as heartburn pill esomeprazole or generic Nexium, broad spectrum antibiotic meropenem, acid..."/>
Aurobindo Pharma to launch 19 products in US [Mint, New Delhi]

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