Biotech / Finance

Fairchild (Taiwan) Corp. v. Power Integrations, Inc.

Apr 24 5:12pm Biotechnology Patent Law Blog | Patents4Life by Warren Woessner
In my last post, I discussed estoppel in the context in inter partes review, in which defendant filed for IPR after losing in the courts. The Board found the claims-in-suit to be obvious. The Federal Circuit affirmed that the courts and … Continue reading → The post Fairchild (Taiwan) Corp. v. Power Integrations, Inc. appeared first on Patents4Life | Warren Woessner.
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Organovo Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Apr 24 5:00pm Biotech
SAN DIEGO, April 24, 2017 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO) ( Organovo or the Company ), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, announced the grant of inducement awards on April 24, 2017 to Taylor J. Crouch, its new chief executive officer and president.  The inducement awards were approved by the compensation committee of the Company's board of directors and issued as a material inducement to Mr. Crouch agreeing to join the Company in accordance with NASDAQ Listing Rule 5635(c)(4). Pursuant to the terms of his offer letter, Mr. Crouch received a stock option to purchase 2,088,212 shares of Organovo's common stock (the Stock Option ) and a performance-based restricted stock unit award for 208,822 shares of common stock (the PBRSU ).  The Stock Option has an exercise price of $2.73 per share, which is equal to the closing price of Organovo's common stock on April 24, 2017.  One-fourth of the option shares will vest on April 24, 2018, and the remaining option shares will vest on a quarterly basis over the next three years, subject to Mr. Crouch's continuous service through the applicable vesting date.  The PBRSU will vest according to the Company's achievement of performance metrics approved and certified by the compensation committee.  The Stock Option and PBRSU both have ten year terms.  While the Stock Option and PBRSU were issued as inducement grants outside of the Company's 2012 Equity Incentive Plan (the Plan ), the terms and conditions applicable ...Full story available on Benzinga.com...
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Vetr Crowd Urges Sell For Impax Laboratories

Apr 24 4:51pm Biotech
The Vetr crowd downgraded its rating for Impax Laboratories Inc (NASDAQ: IPXL) from 5 stars (Strong Buy), issued two days ago, to 1 star (Strong Sell). Crowd sentiment at the time of the downgrade was still generally positive, with 62 percent of Vetr user ratings bullish. The sharp downgrade in the pharmaceutical company's rating comes the same day as its stock reached a recent level of resistance below the $13.75 mark. The stock hit a sharp upswing at the end ...Full story available on Benzinga.com...
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White House says vote on health-care plan may not come for weeks

Apr 24 2:34pm Health Care
Any vote on healthcare legislation would be determined by Republican leaders when they have enough votes, White House spokesman Sean Spicer said.
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Earnings: Caterpillar, Lockheed Martin, and Eli Lilly Report Tomorrow

Apr 24 1:45pm Biotech
Overall, first-quarter earnings have been pretty positive and many CEOs struck an optimistic tone discussing outlooks for the remainder of 2017. Two industrial bellwethers, General Electric Company (NYSE: GE) and Honeywell International Inc. (NYSE: HON), just beat Wall Street analyst expectations on Friday and credit card companies American Express Company (NYSE: AXP) and Visa Inc (NYSE: V) also reported strong results—some are taking that as a sign that consumer confidence could be translating into consumer buying. Next up in Q1, Eli Lilly and Co (NYSE: LLY), Lockheed Martin Corporation (NYSE: LMT), and Caterpillar Inc. (NYSE: CAT) report before market open on April 25. Eli Lilly & Co. Earnings: New Arthritis Drug in Focus LLY recently suffered a setback when approval for the company’s new arthritis drug, co-developed with Incyte Corporation (NASDAQ: INCY), faced delays from the FDA. LLY and INCY disagreed with the FDA’s findings in a company press release and are confident the drug will still be approved in the future. Despite the company’s confidence in the drug, LLY stock dropped about 5\% in trading the day the news came out. Even with that drop, it’s still up a little over 11\% on the year, outperforming the S&P 500 (SPX) and some of its pharma peers: Merck & Co., Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), and Johnson & Johnson (NYSE: JNJ). For Q1, LLY is expected to report earnings of $0.96 per share on revenue of $5.28 billion, according to consensus third-party analyst estimates. Earnings per share are expected to increase just over 15\% and revenues are expected to increase about 8.5\% compared to the same quarter a year ago. The options ...Full story available on Benzinga.com...
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Sanofi files US antitrust lawsuit against Mylan over EpiPen

Apr 24 12:19pm Health Care
Sanofi on Monday sued Mylan, accusing the pharmaceutical company of engaging in illegal conduct to squelch competition to its EpiPen allergy treatment...
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Caterpillar found to eat shopping bags, suggesting biodegradable solution to plastic pollution

Apr 24 11:11am Nanowerk Biotech News
A common insect larva that eats beeswax has been found to break down chemical bonds in the plastic used for packaging and shopping bags at uniquely high speeds. Scientists say the discovery could lead to a biotechnological approach to the polyethylene waste that chokes oceans and landfills.            ...
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DSM Sinochem to up capacity at Delft antibiotic intermediates plant

Apr 24 8:36am in-PharmaTechnologist RSS
DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.
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CBIs 13th Commercial Contract & Chargeback Excellence

Apr 24 7:30am Drug Channels
CBI's 13th Commercial Contract & Chargeback ExcellenceJune 21-22, 2017 | Parsippany, NJTake a deep dive into improving the wholesaler chargeback, navigating class of trade schema complexities, streamlining membership management and optimizing contract administration at CBI’s 13th Commercial Contract & Chargeback Excellence. By illustrating software solutions, case studies and perspectives from leading distribution partners, this conference is a comprehensive forum for pharmaceutical professionals to learn best practices and gain strategies to improve contract operations and administration.Gain Actionable Takeaways From Speakers Including:Marijo Bustos, Director, Government Programs and Commercial Compliance, ProMetic BioTherapeutics, Inc.Lisa Ellington, Senior Manager, Contract and Chargeback Operations, McKessonLeonard Fairfield, Director, Contract Operations and Analytics, Actelion Pharmaceuticals USHarry Norsworthy, Associate Principal, VizientTodd Cox, Senior Manager, Government Pricing and Contracts, Gilead SciencesDonna White, Vice President, Contracts and Compliance, Chiesi USA Inc.Sherice Koonce, Director, Contracts, West-Ward PharmaceuticalsPaula Martins, Director, Commercial Operations, Helsinn Therapeutics (U.S.), Inc.Mandy Talley, Manager, Contract Administration – Managed Healthcare Services, Lilly USA, LLCJill Page, Director, Government Pricing Strategy Analysis, Fresenius Medical CareAndrew Wilson, Vice President, 340B Solutions, McKessonAnd more!Interactive Discussions Surrounding: Changing dynamics impacting the commercial pricing and contracting landscapeNew strategies of risk-share agreements and value-based contracting340B Program changes impacting business operations and strategyBenchmarking and organizational best practices for membership efficiencyChargeback adjudication for 340B contract pharmaciesEfficiencies of med surg chargeback and roster managementChargeback management innovations, system automation and contract analyticsEnhancing communication to facilitate wholesaler, GPO and manufacturer alignmentDownload the complete agenda here, and visit www.cbinet.com/chargebacks for further details and to register. Drug Channels readers will save $400 off of the standard registration rate when they use discount code MHY489.* *Cannot be combined with other offers or used towards a current registration. Cannot be combined wit...
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Akari Therapeutics Demonstrates Positive Response with Coversin in Ongoing Phase 2 PNH Trial and in Additional Clinical Targets

Apr 24 7:15am Biotech
-Interim Phase 2 PNH data demonstrate positive response with Coversin™-Phase 3 PNH program expected to commence in 4Q2017-Data from preclinical aHUS model demonstrates positive results-New preclinical data demonstrates positive response of Coversin's combined C5 and LTB4 therapy in skin and eye models -Phase 2 programs in Mucous Membrane Pemphigoid (eye) and Bullous Pemphigoid (Skin) expected to commence in 1Q2018 -Company to webcast today's Research and Development Day at 8:00 am Eastern (details below)- NEW YORK and LONDON, April 24, 2017 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced that it will present data from an interim analysis of its ongoing Phase 2 trial of Coversin in paroxysmal nocturnal hemoglobinuria (PNH), as well as preclinical data for additional indications and other opportunities, at today's Research and Development Day. Positive Interim Phase 2 data in PNH In this 90 day, open label Phase 2 trial conducted at five centers in the EU, five patients with PNH who had not received prior anti-complement therapy were enrolled and treated with Coversin self-administered subcutaneous injections twice a day for approximately the first month and then switched to once daily injections. The primary endpoint in this trial is reduction in serum LDH to ≤1.8 X ULN or 500 I U/L whichever is the lower from day 1 (pre-dose) to day 28. Secondary endpoints are LDH at days 60 and 90, hemoglobin, CH50, quality of life, and transfusion independence. The objectives of our Phase 2 study are to validate the safety and efficacy of Coversin, confirm convenience of our dosing regimen, and study dose ranging to identify the correct treatment dose in advance of Phase 3. The 4 patients who remain on Coversin are characterized, to date, by: Symptom free LDH reductions 1.3, 1.4, 1.5 and 1.8X ULN No transfusions (2 of the 4 patients received transfusions in the 3 months prior to the study) CH50 below level of quantification (from day 1)   Once daily subcutaneous self-administration No neutralizing antibodies No serious adverse events (SAEs) In this dose ranging Phase 2 study, the protocol allowed for patients to be updosed from the 30mg starting dose. Of the 4 patients continuing on Coversin:  the first patient's  LDH went from 2.4X ULN at baseline to 2.1X ULN on...
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Biotech Stocks Facing FDA Decision In May

Apr 24 6:16am RTT - Biotech
The month of April witnessed the FDA approving the first ever drug for tardive dyskinesia, a neurological disorder characterized by involuntary muscle movements. Want to know which drugs are awaiting FDA decision in May?...
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Lack of demand forces uniQure to withdraw Glybera gene therapy in Europe

Apr 24 5:55am PBR - News
uniQure said that due to low patient demand it will not pursue a renewal of its European marketing authorization for Glybera (alipogene tiparvovec), which is due to expire on 25 October.
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NGM Bios NGM282 succeeds in nonalcoholic steatohepatitis phase 2 trial

Apr 24 5:50am PBR - News
NGM Bio’s NGM282 has met the primary and key secondary endpoints in a Phase 2 trial in nonalcoholic steatohepatitis (NASH) patients.
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Biosimilars to rituximab, etanercept recommended for approval in Europe

Apr 24 5:48am PBR - News
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.
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Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

Apr 24 4:20am in-PharmaTechnologist RSS
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
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FDA rejects Vernalis NDA for cough cold treatment

Apr 24 2:36am PBR - News
The US Food and Drug Administration (FDA) has rejected Vernalis’ new drug application for cough cold treatment, CCP-07.
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9 Reasons Celgene Could Be The World's Most Perfect Stock

Apr 23 8:00pm BioSpace.com Featured News and Stories
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Top 15 R&D Spenders In The World For 2017

Apr 23 8:00pm BioSpace.com Featured News and Stories
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Why Executive Order Could Rekindle M&A Feelings for Allergan, Pfizer

Apr 23 8:00pm BioSpace.com Featured News
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Medical Device Reading List (April 23, 2017)

Apr 23 5:21pm
Tons of exciting new product development and acquisition news from the likes of $MDT, $BSX, and $JNJ!Is Medtronic's Artificial Pancreas the Next Big Thing in Diabetes?Todd Campbell, Motley Fool ($MDT)​Boston Scientific Corporation  Plans Study on Subcutaneous Implantable Defibrillator​​Adam Russel, Market Exclusive ($BSX)Irish stroke medtech firm Neuravi snapped up by Johnson & JohnsonGordon Hunt, Silicon Republic ($JNJ)Medtronic’s Ishrak sees Chinese health refo [...]...
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How Long Does a Pregnancy Really Take?

Apr 23 3:18am Pregnancy Exercise
This may expose my lack of mathematical ability, but the whole “how far along are you?” question during my pregnancy has frequently flummoxed me. Everyone talks about pregnancy taking nine months, but I would get frustrated trying to marry up the number of weeks with the number of months. It never seemed to quite work […]...
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March for Science, Why I March

Apr 22 10:20am Pharma Marketing Blog
Live from Washington, D.C. I will be heading to a satellite march in Doylestown, PA and speaking there. Here's what I will say:My name is John Mack and I live in Newtown.On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories. We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone. In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK. A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration, WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives. We should not have to sacrifice science for security.DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic. We need leaders who believe in data and scientific evidence to help solve these problems.More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.There is a war being fought today – a war against science. We must defend science in THIS war.Marching together is a good first step. But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.Thank you for listening and may Science be with you!...
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Arbutus Announces ARB-1467 Data Presentation at EASL

Apr 22 4:00am Biotech
ARB-1467 Reduces Serum HBsAg in Both HBeAg Negative and HBeAg Positive PatientsResults of Biweekly Dosing from Cohort 4 Expected in 3Q17Additional Study Starting in 2H17 to Evaluate Longer Term Dosing with Immune Modulatory Agents VANCOUVER, British Columbia and WARMINSTER, Pa., April 22, 2017 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, presented results of the first three cohorts of a Phase II study of its RNAi agent, ARB-1467, at the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands. We are very pleased to present updated Phase II results for ARB-1467 that show a consistent reduction in HBsAg in HBV patients regardless of HBeAg status with a favorable safety profile. We look forward to a 3Q17 announcement of the results of Cohort 4, which is evaluating five bi-weekly doses of ARB-1467 with extended monthly dosing out to one year for patients who meet predefined response criteria, said Dr. Mark J. Murray, Arbutus' President and CEO. Furthermore, we are planning to initiate a new study of ARB-1467 in 2H17 to evaluate longer dosing of ARB-1467 combined with immunomodulatory agent. We believe that this study could pave the way for Phase IIb studies while we continue to advance the rest of our pipeline to enable new treatment regimens for further improvement in clinical outcomes. The presentation is titled "A Phase 2a Study Evaluating the Multi-Dose Activity of ARB-1467 in HBeAg Positive and Negative Virally Suppressed Subjects with Hepatitis B", and a copy of the poster can be accessed by visiting the Investor section of www.arbutusbio.com and selecting ‘Events and Presentations.' Cohort  ARB-1467 (mg/kg)  HBeAg  Single Dose HBsAg Reduction (log10 IU/mL) Multiple Dose HBsAg Reduction (log10 IU/mL)  N   Meana   Mean Maxb Maxc   N    Meana   Mean  Maxb   Maxc   >0.5 logd   >1.0 logd  1 0.2 Neg 6 -0.3 -0.4 -1.0 6 -0.6 -0.7 -1.3 5 1 2 0.4 Neg...
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Achillion Announces Additional Phase 2 Results Including 100% SVR24 for Genotype 1 HCV After 6-Weeks of Once Daily JNJ-4178

Apr 22 3:00am Biotech
AMSTERDAM, the Netherlands, April 22, 2017 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) announced today the presentation of updated results from the ongoing phase 2 ‘604 Study' being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen). These results were presented as an oral presentation during the European Association for the Study of the Liver (EASL) 2017 International Liver Congress in Amsterdam. These results demonstrate that the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally. The goal of the Janssen HCV development program is to optimize treatment outcomes by providing a novel, simplified therapeutic option with high efficacy, safety, and a shorter treatment duration to address a broad range of patients living with HCV. Importantly, in this study 100\% SVR12 was achieved despite the presence of NS5A polymorphisms, which can reduce the efficacy of other HCV regimens, that were observed at baseline," commented David Apelian, M.D., Ph.D., chief medical officer at Achillion. "The clinical community has expressed the need for more simplified treatment options, and these data with JNJ-4178 highlight the potential of this once daily regimen to achieve SVR24 for genotype 1 patients after only six weeks of therapy. Study results, presented by principal investigator Dr. Edward Gane, professor of medicine at the University of Auckland and chief hepatologist at Auckland City Hospital, included expanded safety and efficacy data and were made in a presentation entitled "Short duration treatment with AL-335 and odalasvir, with or without simeprevir, in treatment-naïve patients with hepatitis C virus (HCV) genotype 1 infection." It reports that 100\% of patients receiving treatment for six or eight weeks with a triple combination of once-daily AL-335 800 mg and simeprevir 75 mg with odalasvir 50 mg every other day achieved a sustained viral response 24 weeks after the completion of treatment (SVR24). Summary of Phase 2 '604 Study' Design and Interim Results The oral presentation features clinical trial data examining the safety, pharmacoki...
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Novartis AG, LTS et al. v. Noven Pharmaceuticals, Inc. Prior Judicial Opinions Dont Bind the PTAB

Apr 21 4:09pm Biotechnology Patent Law Blog | Patents4Life by Warren Woessner
After Novartis’ patents were found nonobvious by the Fed. Cir., affirming the Delaware District Court, defendant Noven filed for inter partes review (IPR) of U.S. Pat. Nos. 6316023 and 6335031, on rivastigmine and an antioxidant. The PTAB found the asserted … Continue reading → The post Novartis AG, LTS et al. v. Noven Pharmaceuticals, Inc. – Prior Judicial Opinions Don’t Bind the PTAB appeared first on Patents4Life | Warren Woessner.
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Cytokinetics Added to S&P SmallCap 600

Apr 21 4:00pm Biotech
SOUTH SAN FRANCISCO, Calif., April 21, 2017 (GLOBE NEWSWIRE) -- Cytokinetics (NASDAQ:CYTK) today announced it has been selected for addition to the S&P SmallCap 600 GICS Biotechnology Sub-Industry Index. The index, a member of the Dow Jones Total Stock Market Indices family, is designed to measure the performance of small-cap U.S. equity securities. About Cytokinetics Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics' lead drug candidate is tirasemtiv, a fast skeletal troponin activator (FSTA). Tirasemtiv is the subject of VITALITY-ALS, an international Phase 3 clinical trial in patients with ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. ...Full story available on Benzinga.com...
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Drug companies risk Trump's wrath as they march for science

Apr 21 2:37pm Health Care
This Saturday's March for Science is trying hard to be a nonpartisan event, but some may not see it that way.
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Diet soda and stroke & dementia news coverage: 3 key points werent always reported

Apr 21 11:20am Health News Review
The Framingham Heart Study group will turn 70 next year. That’s given them enough time to start studying the offspring of their original study cohort — which they have done since 1971 —  as well as know how to cautiously present results from their bread-and-butter: long-term observational studies. Which is what they do with a study […]...
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Physician Views Off-Label Use A 'Double-Edged Sword' For TG Therapeutics

Apr 21 10:57am Biotech
Reni Benjamin of Raymond James maintains a Strong Buy rating on TG Therapeutics Inc (NASDAQ: TGTX) after hosting an investor meeting with Charles Farber, a notable physician at the Summit Medical Group. Benjamin noted Farber's practice treats approximately 80 patients per week who suffer from chronic lymphocytic leukemia, of which up to 12 are being treated with TG Therapeutics' ibrutinib. The doctor also said that among new patients recently diagnosed with CLL, one-third need treatment right away, one-third will likely be treated anywhere from one to 10 years down the road and the remaining one-third don't receive any treatment. Among the patients who require therapy, Farber does not think there is a mandatory guideline in terms of which regimen needs ...Full story available on Benzinga.com...
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Atomic-level motion may drive bacteria's ability to evade immune system defenses

Apr 21 10:24am Nanowerk Biotech News
A new study has found evidence that extremely small changes in how atoms move in bacterial proteins can play a big role in how these microorganisms function and evolve.            ...
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EARTH MAMA & MOTHER EARTH #motherearth

Apr 21 10:23am Destination Maternity Blog
Today we thank the mother of all mothers… Mother Earth! Today is Earth Day and we like to celebrate by doing something good for our environment. From recycling to reusing, there are so many ideas and inspirations of how to help our earth. Check out Earth Day’s website for plans and ways to get involved. […]...
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Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Mercks ZEPATIER (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C

Apr 21 10:00am Prescription Medicine News
Dateline City: KENILWORTH, N.J. Study Evaluated VA Population with High Incidence of Co-Morbidities KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) infection who were administered ZEPATIER® in the U.S. Department of Veterans Affairs (VA) healthcare system. Language: English Contact: Merck & Co., Inc.Media:Doris Li, 908-740-1903orMichael Close, 267-305-1211orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more...
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Aurinia Pharma's Phase 2b Data Lifts Stock, Suggests Big Potential

Apr 21 9:16am Biotech
Elemer Piros of Cantor Fitzgerald maintains an Overweight rating on Aurinia Pharmaceuticals Inc (NASDAQ: AUPH)'s stock with a $14 price target after the company reported data from a Phase 2b study, which helped boost the stock higher by more than 5 percent. During the National Kidney Foundation Spring Clinical Meeting on Thursday, the company discussed results from a 48-week secondary analysis from a Phase 2B study. The study, called AURA, is exploring a therapy called voclosporin for the treatment of lupus nephritis. Aurinia reported that in addition to the therapy meeting its complete and partial remission endpoints at 48 weeks, all pre-specified ...Full story available on Benzinga.com...
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Valeant's SILIQ Will Be Priced At $3,500 A Month

Apr 21 8:53am Biotech
Troubled pharmaceutical company Valeant Pharmaceuticals Intl Inc (NYSE: VRX) announced on Friday pricing for its SILIQ (brodalumab) injection. What Is SILIQ? The U.S. Food and Drug Administration approved the Biologics License Application for SILIQ, which is a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis for the treatment of moderate to severe plaque psoriasis in adult patients. Valeant's Patient Access and Pricing Committee will list the ...Full story available on Benzinga.com...
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UK MHRA announces pre-election quiet period

Apr 21 7:41am in-PharmaTechnologist RSS
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
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How Manufacturers Can Benefit From Unified Specialty Support Services

Apr 21 7:30am Drug Channels
Today’s guest post comes from Tom Doyle, Executive Vice President of Commercial Solutions at H. D. Smith.To prepare for impending market changes, Tom suggests that a manufacturer’s commercial team partner with a flexible, integrated services provider to increase market share and optimize the patient journey. He also discusses mid-tier specialty products and the need for such cost-effective solutions as Triplefin's Hub-Lite approach.Click here to download H.D. Smith’s free white paper on specialty product launch planning. You can also visit H.D. Smith’s companies at Booth #200 during Asembia’s 2017 Specialty Pharmacy Summit in Las Vegas. Read on for Tom’s insights.Read more »Copyright © 2006-2017 Pembroke Consulting, Inc. and Copyright © 2006-2017 Drug Channels. This Feed is for personal non-commercial use only.         ...
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NewLink Genetics Announces Presentation of Two Abstracts at ASCO

Apr 21 7:00am Biotech
AMES, Iowa, April 21, 2017 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported that two abstracts will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Abstract 105 - A Phase 1b dose-escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors, to be presented by our partner on Sunday, June 4, 2017, 10:45 a.m. – 12:15 p.m. ET. Abstract 3066 - A Phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), to be presented on Monday, June 5, 2017, 9:00 a.m. – 12:30 p.m. ET. The complete text ...Full story available on Benzinga.com...
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Company Spotlight: Axovant Sciences

Apr 21 6:45am RTT - Biotech
Shares of Axovant Sciences Ltd. (AXON) are up an impressive 76\% year-to-date compared to a modest 9.41\% rise in the iShares NASDAQ Biotech Index ETF (IBB) during the same period.
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AbbVie's pan-genotypic HCV regimen achieves 99% cure rate in phase 3 study

Apr 21 4:23am PBR - News
A phase 3 study demonstrated that AbbVie's pan-genotypic ribavirin-free HCV regimen of glecaprevir/pibrentasvir (G/P) achieved a 99\% cure rate after 12 weeks of treatment.
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H3 Biomedicine, Foundation Medicine extend precision oncology collaboration

Apr 21 4:20am PBR - News
H3 Biomedicine has extended its multi-year collaboration, which was signed in February 2015, with Foundation Medicine to discover and develop precision medicines in oncology.
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Immune Pharmaceuticals licenses cancer treatment's Latin America rights to Pint

Apr 21 4:18am PBR - News
Immune Pharmaceuticals has entered into a letter of intent with Pint Pharma regarding license and commercializion of Ceplene in Latin America.
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Sawai to buy Upsher-Smiths generic pharmaceuticals business for $1.05bn

Apr 21 1:37am PBR - News
Japan-based Sawai Pharmaceutical has agreed to acquire Upsher‐Smith’s generic pharmaceuticals business from its parent firm Acova for around $1.05bn.
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ATRA Gains After-hours, ONTX Slumps, XBIT Disappointed, BPMX On Watch

Apr 21 1:25am RTT - Biotech
Shares of Atara Biotherapeutics Inc. (ATRA) were up more than 8\% in extended trading on Thursday, following positive interim results from its ongoing phase I trial of autologous Version of ATA188 in patients with primary and secondary progressive multiple sclerosis.
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Week 31: April fool me once

Apr 21 12:00am Knocked Up – Pregnancy & Newborn Magazine
April 18 came and went, and I did not have a baby! This is great news because my husband, daughter and younger son all share that birthday. There are more people in our house born on April 18 than not. … Continue reading → The post Week 31: April fool me once appeared first on Pregnancy & Newborn Magazine.
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Pregnancy Diary: The Final (Exercise) Countdown

Apr 20 8:37pm Pregnancy Exercise
I feel like I’ve spent this whole pregnancy writing posts about how terrible I have been at exercising. The irony of doing this on a website dedicated to exercise in pregnancy and beyond has not escaped me! While I would love to create the illusion I work out on the daily (and definitely never, ever […]...
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Gainers & Losers Of Apr.20: IMNP, AKTX, IMGN, ALDX, KMPH...

Apr 20 8:28pm RTT - Biotech
Here's why IMNP and IMGN soared today.
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Here's Why The Best Is Yet To Come for Exelixis

Apr 20 8:00pm BioSpace.com Featured News and Stories
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Unstoppable Celgene to Take Over Amgen's Former Space in Cambridge

Apr 20 8:00pm BioSpace.com Featured News
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8 weeks to go How am I Exercising?

Apr 20 7:59pm Pregnancy Exercise
I thought now might be a good time to check-in with where my exercise is at now that I am 32 weeks pregnant.  This pregnancy journey has been pretty interesting from an exercise point of view, some weeks I found running really uncomfortable, sometimes I found it great.  Same goes for swimming, I went through […]...
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The drug industry is addicted to price increases

Apr 20 5:15pm Health Care
Increases in the prices of drugs added $8.7 billion to 2016 net income for 28 companies analyzed, accounting for 100 percent of earnings growth last year.
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The 420 Investor Breaks Down The Marijuana Sector

Apr 20 4:39pm Biotech
Alan Brochstein, also known as the 420 Investor, joined Benzinga's PreMarket Prep to discuss some of the top marijuana stocks. The Popular Play When it comes to one of the most popular marijuana plays on the market, GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH), Brochstein says the stock will likely continue to trade sideways until the company submits its New Drug Application (NDA) for epidiolex. The NDA submission has already been delayed several times and is now expected to happen in mid-2017. “The good thing for investors is this company is doing everything it can to make sure that that NDA doesn’t have any sort of deficiencies that would lead to any delays, so I’m excited about the company’s long-term prospects,” he explained. Related Link: 2 New Ways To Invest In Marijuana Stocks: Cannabis ETFs Miracle Gro When ...Full story available on Benzinga.com...
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As Price Falls, Vetr Upgrades GlaxoSmithKline To Buy

Apr 20 2:35pm Biotech
The Vetr crowd on Thursday upgraded its rating for GlaxoSmithKline plc (ADR) (NYSE: GSK) from 3 stars (Hold), issued 527 days ago, to 4 stars (Buy). Crowd sentiment at the time of the upgrade was mostly positive, with 80 percent of Vetr user ratings bullish. Share price in GSK took a pronounced downturn throughout April, in part due to the company's recall of 600,000 defective ...Full story available on Benzinga.com...
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Exclusive: Idera CEO Discusses The Potential For His Company's Lead Drug Candidate

Apr 20 2:15pm Biotech
Idera Pharmaceuticals Inc (NASDAQ: IDRA) is a clinical stage biotech that has recently re-focused its pipeline to focus on oncology, starting with melanoma. The company has seen its share price rise 50 percent in 2017. In March, JMP Securities initiated coverage of the company at Market Outperform, and based on the $8 price target the firm announced at the time, JMP analyst Michael King sees another 254 percent of upside even from current levels. Shares recently received an added boost when the company reported successful completion of phase 1 of its ongoing clinical trial with its lead drug candidate, IMO-2125. Idera is among those pursuing the clinical viability of a new approach to cancer therapy — using the body's own immune system, a treatment called immunotherapy. Idera's IMO-2125 is what's called a toll-like receptor agonist. Simply put, these are a class of proteins that recognize certain microbes and activate immune cell responses. IMO-2125 is designed to be injected into a tumor in order to turn on an immune response. Describing IMO-2125 Benzinga recently had the opportunity to speak with Idera CEO Vin Milano about the promise of IMO-2125. "The field of immunotherapy has had some incredibly positive advancements," Milano said, "Melanoma has been one of the first to see the benefits." Specifically, Milano pointed to the advancement of checkpoint inhibitors — drugs often made up of antibodies that incite an immune system assault on cancer cells. Pd-1, a type of checkpoint protein, is sometimes found in cancer cells, allowing the cancer to avoid immune attack. By inhibiting checkpoints such as PD-1, immunotherapy seeks to leave cancer cells defenseless against the patient's T cells. Still, there are a number of patients still not seeing the benefits of these new therapies. These cases are called refractory metastatic melanoma, and it's here that Milano sees opportunity for Idera. In combination with Bristol-Myers Squibb Co (NYSE:...
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What Would A $5.8 Billion NIH Cut Look Like? Devastation

Apr 20 1:38pm FDA
Neither Republicans nor Democrats are eager to cut the National Institutes of Health funding by the president’s suggested $5.8 billion, but with the proposal still on the table, the sum is not yet safe. And as 18 percent of the current $31.7 billion budget hangs in the balance, more Americans ought to be on the edge of their seats. “That’s a huge number,” Jason Napodano, managing director of BioNap Consulting, told Benzinga. “That’s a big number, 18 percent, and I think it could have potentially devastating effects in the years to come.” Limiting Seeds The NIH provides grant money critical to health research and drug development. Funds generally support academic institutions, private research firms and small pharmaceuticals, which then purchase equipment and eventually sell preclinical candidates to major pharmaceuticals. “The NIH in some instances is the very beginning of a lot of discovery that eventually turns into an idea that turns into a drug that gets in a trial and wins approval, so [the cut] is at the very early stage,” FBB Capital's Mike Bailey said. A disruption early in the schedule, then, could generate sector-wide upheaval. Although, it may go unnoticed for some time. The chain of events between initial NIH funding and U.S. Food and Drug Administration approval sometimes takes between five and 20 years, so a delay in the foremost step is ultimately a delay in the decades-long process to get a drug into a patient’s system. Napodano drew this metaphor: A lush forest — or market of drugs — is the product of a small fraction of planted seeds — or early-stage research. Grant-reliant universities sow, while pharmaceutical companies reap. “I think it starts small, but what I think people need to be aware of is that these [molecules] are the seeds that start the forest,” he said. And when those seeds dry up, so does the spectrum of available drugs. Lab Droughts Essentially, the profitability of major industry players is largely tied to academic or private preclinical lab work — nearly all of which is grant-dependent. “People experiment and investigate at the university level, and then if something looks interesting, maybe one out of a thousand of molecules being investigated at the university level get spun out or scooped up into an actual biotech...
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Ultimate New Mom Giveaway!

Apr 20 12:40pm Pregnancy – Mama Natural
Growing up in Chicago, I always loved Oprah’s “My Favorite Things” shows. She has great taste, and she took such care picking out the best of the best products for her viewers. Well, today I’ve got a crunchy mama favorite things giveaway for ya! To celebrate the release of the Mama Natural Week By Week […] The post Ultimate New Mom Giveaway! appeared first on Mama Natural.
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Immune Design Announces Presentations at the 2017 ASCO Annual Meeting

Apr 20 11:01am Biotech
SEATTLE and SOUTH SAN FRANCISCO, Calif., April 20, 2017 (GLOBE NEWSWIRE) -- Immune Design (NASDAQ:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that new and updated data from two ongoing clinical trials of CMB305 and G100, as well as translational data examining the association of immunological response with improved survival in CMB305 and LV305 patients, will be presented in an oral and two posters presentations at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2 - 6, 2017 in Chicago. The ASCO presentation details are as follows: ORAL PRESENTATION Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS) Abstract # 11006 Session Title: Sarcoma Date: Friday, June 2, 2017 Time: 3 p.m. – 6 p.m. CT (oral session)  Location: S100bc Presenter: Neeta Somaiah, M.D., Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center POSTER PRESENTATIONS The Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival ...Full story available on Benzinga.com...
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PRE-SUMMER STYLE GUIDE

Apr 20 10:29am Destination Maternity Blog
There’s a boldness that comes from pastel. All eyes will still be on the bump, as our pre-summer collection takes on the lighter side to blue and pink. We are partial to baby blue, as we are partial to anything with the word baby in it. That’s just who we are! We especially love this […]...
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Read the full health-care proposal memo here

Apr 20 9:52am Health Care
The memo is a mid-April summation of the changes Republicans are negotiating for the new health-care bill.
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The Bull-Bear Debate In Therapeutics Rages From Research Notes To Twitter

Apr 20 9:24am FDA
TherapeuticsMD Inc (NYSE: TXMD) has waned as much as 40 percent since April 7, when the company received an FDA letter noting deficiencies in the new drug application for vulvovaginal atrophy treatment, Yuvvexy (TX-004HR). The regulatory agency said the deficiencies preclude talk of the drugs’ labeling and post-marketing commitments. The news and subsequent price action has inspired drastically diverse reactions from the stock’s bears and bulls. The Bulls “We interpret this sharp decline in TXMD's share price as an overreaction to unspecified NDA deficiencies that we view as likely due to technical aspects of the CMC section,” Oppenheimer’s Jay Olson wrote in a Tuesday note. He suspected that the FDA letter pertained to earlier, non-clinical questions regarding mere analytical methods and, if correct, foresees a two- ...Full story available on Benzinga.com...
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PODCAST: Wellness programs do they work?

Apr 20 8:39am Health News Review
Wellness programs in the United States are an $8 billion industry. Over 50 million Americans are enrolled in such programs. They are as variable in size and quality as the companies and organizations that offer them. In this podcast you’ll hear 3 voices: A skeptic who thinks the vast majority of these programs don’t work and may […]...
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