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MedNess: FDA Approvals, Label Expansions and International Market

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Hello and welcome to MedNess. This edition of MedNess covers the latest from small and big biotech and pharma companies. Stay tuned for MedNess Asco Coverage. In the meantime, please subscribe to ClubSciWri for our other articles and blog posts!

Celgene supports Dragonfly in enhancing NK-cell based immunotherapy

The discovery-stage company, Dragonfly Therapeutics, aims to enhance immunotherapy using Natural Killer (NK)  cells. Dragonfly aims to harness the power of body’s innate immune system to vastly improved patient outcomes. They plan to stimulate NK cells so that these cells can attack tumors directly with support of T and B cells. This strategy has attracted the attention of a leading global pharmaceutical company, Celgene along with the Duke of Bedford, Disney family members and other organizations.

Celgene bagged the option on four NK cell based cancer therapeutics to treat myeloid leukemia, multiple myeloma and other hematological cancers by investing over $33 million in Dragonfly. This collaboration by Celgene shows that they saw immense potential in this discovery stage biotech to develop innovative therapies for cancer patients (Dragonfly Therapeutics, Fierce Biotech).

MedNess: Celgene recently reported positive data from Lupus trial. Its shares have been soaring with an overall gain of 19.8% in the last one year. As per Zack’s index, Celgene stocks are a strong hold. At the present, the shares are sold for $124.82 (Zacks).

Europe, US, and Japan joins hands to boost antibiotic development

The three drug regulators of the world; European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA,) and the Food and Drug Administration (FDA) participated in the tripartite meeting in Vienna, Austria  to consider a robust response to boost antibiotic development.

They agreed to align their data requirements for certain aspects of the clinical development of new antibiotics so that the new meds can come in the global market. Also, in the meeting, they discussed in detail clinical trial recommendations for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. Even the areas of differences were talked about in this meeting, and an effort to work together to minimize them was discussed.

While all three of them are now working on updating their respective guidance documents, they are also willing to provide suggestions to the individual biopharma companies. The next meeting is scheduled for October 2017 ( Fierce biotech, EMA).

Astrazeneca terminates the plan for NASH drugs with SoCal’s Regulus

California based biopharmaceutical company, Regulus aims to discover and develop innovative medicines targeting microRNAs. They recently announced their pipeline updates and advancement in which a major setback was when Astrazenenca terminated the clinical development program for AZD4076 (RG-125) which is involved in the treatment of nonalcoholic steatohepatitis (NASH) in Type 2 Diabetes/Pre-diabetes.

Regulus also planned to discontinue clinical development of RG-101 for Hepatitis C Virus (HCV) upon completion of the one remaining clinical study, which is expected to occur in July 2017. Now, the company is majorly focussing on keeping the plans of the Phase II clinical programs for RG-012 which is used for the treatment of Alport syndrome on track. Also, the IND for RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD) is on track for filing by year end 2017 (Regulus, Fiercebiotech).

AstraZeneca’s Lynparza slows breast cancer progression, now a potential precision drug against prostate cancer

AstraZeneca announced statistically significant positive results from Phase 3 OlympiAD tested against breast cancer patients with BRCA gene mutations. The results demonstrated a clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Lynparza (olaparib) tablets (300mg twice daily), compared to chemotherapy. In addition, a 42% reduction in disease worsening or death (HR 0.58; 95% CI 0.43-0.80; p=0.0009; median 7.0 vs 4.2 months) was observed in patients treated with Lynparza when compared to those who received chemotherapy. The results were reported in New England Journal of Medicine. Lynparza was earlier approved for ovarian cancer that is caused by BRCA. Now, in another study being carried out at the Institute of Cancer Research, London, Lynparza is showing a potential towards precision drug in prostate cancer. According to the researchers, the test designed by them, could distinguish the disease severity, treatment response and if prostate cancer is evolving genetically and can potentially become drug resistant. The results of these tests were reported in Cancer Discovery (AstraZeneca, Reuters)

MedNess: AstraZeneca has a strong pipeline of drug candidates.  The stock has a market capitalization of $87 billion. Lynparza generated $218 million in sales in 2016. The current share price is a little over $34 with overall gain of 0.26% (Forbes, CNNMoney).

Clovis Oncology announces positive results from late stage ovarian cancer trial

Clovis Pharma’s, Rubraca, met its primary endpoint and a key secondary endpoint. The company is planning to request label expansion for Rubraca and gain approval for second line treatment and maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Clovis Pharma’s drug is directly in competition with Tesar Inc’s Zejula and AstraZeneca Plc’s Lynparza. All the drugs belong to the class of PARP inhibitors, that blocks enzymes poly ADP ribose polymerases. These enzymes are involved in repairing damaged DNA (Clovis Oncology).

MedNess: Clovis Pharma’s shares are soaring. It shutdown at $59.97 on Friday, June 15. The stock opened at $87.73 (~ 50% surge in price) on Monday, June 19.

MedNess Asia:

Promising addition in cancer therapy from Chi-Med with a huge investment from U.S. partner Eli Lilly

Last week, Hutchison China MediTech Limited (Chi-Med) has submitted its New Drug Application (NDA) to China Food and Drug Administration (CFDA) for fruquintinib, developed jointly with Eli Lilly to treat advanced cases of colorectal cancer (CRC). In addition, fruquintinib is being tested to treat non-small cell lung cancer and gastric cancer. The drug selectively inhibits vascular endothelial growth factor receptor and helps preventing angiogenesis, i.e. development of new blood vessels essential for tumor growth and metastasis.

Chi-Med aims to break the Active Pharmaceutical Ingredient (API) manufacturer’s stereotype of Chinese pharma companies, and establish itself in bringing innovative and modern drugs in international market. The other drug that the company is evaluating at phase II trial for cancer research is sulfatinib, that also targets tumor angiogenesis and immune evasion. (Reuters, Chi-med press releases)

MedNess: CRC is the second most common cancer with 380,000 cases in China and 1.5 mn cases globally. Reports suggest that the number of new cases of CRC will increase by 13% over the next three years by 2020. Hopes are that fruquintinib can be used in combination with chemotherapy and targeted cancer therapy. Since the application of NDA for the drug on 12th June, Chi-Med has seen a surge of 2.6% in its stock prices (within two days).

Market for internationally manufactured aesthetic medicine in China

Austria-based Croma-Pharma becomes the only second European producers of intradermal fillers approved in China. Intradermal fillers (biodegradable – like different forms of collagen and hyaluronic acid, semi-permanent – like different polymers and permanent – like silicone) help in skin aging management by restoring facial volume or treating wrinkles.

Croma-Pharma (CP) has registered Princess® VOLUME, a hyaluronic acid based filler in China by joining hands with Sihuan Pharmaceutical (SP)  – CP brings in its products, experience and related intellectual property rights, whereas SP will provide its multi-channel distribution and marketing knowledge, being one of the largest pharma corporations and drug franchises in China. This joint venture aims to compete against the local manufacturers in the country and increase the quality of beauty products in China. (Croma news, Bloomberg)

MedNess: China has the largest market for aesthetic medicine in Asia-Pacific region growing at 20% annually, with its aging population, increasing awareness about aesthetic treatment and rise in disposable incomes. By taking advantage of a Chinese company’s distribution channels, Croma-Pharma hopes to reach a considerable market share, by competing against local manufacturers – an issue that has been bothering most foreign manufacturers in China.

Generic anticoagulant launched by Dr. Reddy’s Laboratories for US market

Indian multinational pharma company Dr. Reddy’s Laboratories launched bivalirudin, a therapeutic equivalent generic version of Angiomax® by the Medicines Company. Approved by US-FDA, it is to be used for injection as a blood anticoagulant.

Angiomax, a direct thrombin inhibitor (DTI) structurally similar to hirudin, is used for acute cardiovascular care. DTIs show a higher specificity in reaction with thrombin and lesser complications arising from its use, and hence are preferred over indirect thrombin inhibitors like heparin . Angiomax and its generics registered US sales of around $198 mn over the last year till March 2017. (Dr. Reddy’s Laboratories press release, The Medicines Company)

MedNess:  The anticoagulants market is expected to grow at a CAGR of more than 6% by 2020. Within a week after the launch (on 6th June) by Dr. Reddy’s its stock prices went up by 4.5%.

 

Featured Image: Vinita Bharat

About the Authors:

 Imit Kaur, Ph.D. is a freelance scientific advisor, medical writer, editor, and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development. Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)

Somdatta Karak, PhD is interested in pharma and healthcare sector in Asia. She also works with PhD Career Support Group / Club SciWri as its project coordinator. She aims to make a more and better informed world for all, and hence experiments with making effective platforms of education. She can be reached here.

Vinita Bharat Ph.D., is currently a postdoctoral research fellow at European Neuroscience Institute, Göttingen, Germany and had been an International Max Planck Research School (IMPRS) student here. Her research area focuses on cellular and molecular neuroscience. Other than enjoying ‘being a scientist’, she has also been working on science education. Presenting science in easy and fun way is what she loves doing through her platform “Fuzzy Synapse” (one can find fuzzy synapse on Facebook, Instagram and Twitter). She is a fun, enthusiastic and curious person, passionate about traveling, loves celebrations and bringing smiles around her.

 

 

The week that it was – 23rd to 30th April, 2017

in ClubSciWri by
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The week in the scientific community has been hugely highlighted with plans and meetings around ensuring that the March for Science momentum doesn’t fizzle out. And communication of unaltered facts has clearly gathered a lot of attention and has been rightly prioritized. Wikipedia co-founder Jimmy Wales launches Wikitribune to provide ‘correct facts’. University of Split, Croatia and Rita Allen Foundation with WGBH could not have been better in timing the announcement of their Summer School in Science Communication and fellowship in science communication, respectively. Plos Pathogens has started a new series – Research Matters – for researchers to write how their fundamental research matters. NASA goes public with its 104,000 pictures, videos and audio files. The European Research Council is actively gathering data from researchers in Europe as well as outside to know how to get the community more engaged in publishing in open access journals. Mozilla has offered paid fellowships for 10 months to train those with ideas in open access science and help them materialize their ideas. Chan Zuckerberg Initiative has joined hands with BioArxiv (the open access repository for life science research from Cold Spring Harbor Laboratory). On a local scale, initiatives like Pint of Science and Pune drunk on Science (details available on Facebook, at the moment) are gaining popularity. After all, open access to science is going to be beneficial to all – lay public to entrepreneurs and industrialists.

Another benefit of having science in open repositories will also help in better peer review. The current way of evaluating research is killing the risk appetite among researchers, limiting scientific progress. It becomes imperative to discuss this now as Springer decided to retract 107 of its papers from Tumor Biology for being published with ‘fake reviews’. On the other hand, the field of oncology is also going through one of its most exciting times – Nanoparticle vaccine for immunotherapy, to target multiple types of cancers, developed by researchers at UT Southwestern, is the talk of the town now. And for novices in this area, you can’t miss the overview of the exciting and inspiring development of this field, from Allison and Sharma‘s eyes, the successful couple of the field.

Potentially entrepreneurial ideas are regularly being churned out of IITs, with IIT Madras this time, developing a hand glove to study the hand kinematics – a promise to help detecting the severity of Parkinson’s disease, and also translate the hand movements into speech. An MIT graduate student- an MIT – Tata fellow – is working in Mumbai towards developing ready to use therapeutic food to fight malnutrition in India. WHO is ready to start clinical trials for its malaria vaccine in three African countries. It might now be possible to think of growing premature human fetuses, of 23 weeks and above, outside wombs. If you are buzzing with an idea that can be translated, it might interest you to know that Millipore Sigma has joined hands with LabCentral, a nonprofit startup incubator in Massachusetts.

Despite these, hardships of traditional academicians haven’t changed much yet, with the indecisiveness of a postdoctoral tenure and the heavily unfavorable ratio of academic positions available with the number of applicants for tenure track. The first draft of Trump’s budget for this fiscal year is out, with sizable cuts in biomedical funding. The proposal claims that better planning will ensure achievements aren’t compromised. It has been a year since Germany announced plans to introduce 1000 tenure track positions in academia. University of Göttingen is trying to set an example by inviting suggestions from the current postdoctoral fellows in penning the proposal.

And finally let’s talk of the jobs available around –

  • Immunologists, take note of scientist positions at Biogen, Antibody Discovery, MA, NIBR Biologics Centre, MA, and multiple positions open at CSIR-IMTECH, Chandigarh in areas of therapeutic R&D and drug discovery
  • Electrophysiology experts might want to check the scientist position, at Synapses and Circuits, Roche, Basel, Switzerland
  • Check the exciting scope of ‘designing your own role’ at Chan Zuckerberg Biohub
  • In this age of CROs, know what are the skills that are sought for in a Clinical investigator, and see if the position of Clinical Trial Manager at Celgene suits you.
  • For those interested in advancing and revamping science education, check this interesting postdoctoral fellowship at Yale-NUS College, Singapore
  • Those interested in exploring industrial collaborations while being in academia, take a look at calls from Boehringer Ingelheim for research proposals around GPR68, and an industrial postdoctoral position at Biogen, MA to study neurodegeneration
  • Interested in working on RNA mediated gene regulation? Check the Research Associate position at Cambridge, UK
  • For the non-biologists wanting to transition into biomedicine, Francis Crick Institute is looking for group leader positions in physical sciences
  • For the psychologists among us, there is a lecturer position open at University of Reading, UK
  • For those imaging lovers with commendable interpersonal skills, see if the Microscopy Specialist position at PicoQuant, Berlin, Germany interests you
  • Those without a PhD and wanting to explore industry might want to consider the Scientific Assistant position at the Biorefinery department, Luxembourg Institute of Health

And if you are confused among what to choose from, do consider the possibilities of having multiple careers at once – there are many now who can vouch for its merits.

Nevertheless know the essentials of effective networking from the uber successful in the industry – Chris Fralic talks of his networking stories in the pre-LinkedIn era. And today with technology helping you in your pursuit, you really don’t have to wait for an opportunity to open up to express your will to work with someone – just cold email, the right way though. But at the same time, it has also become more common to have not-in-person interviews. Know how to ensure you make the best impressions on the telecommunication based interviews.

And when this gets too daunting and overwhelming, make sure you are getting enough of that sun. With the regular CSG meets happening all around, here is an interesting outdoorsy and nerdy enough an idea that you might want to consider. Happy May coming soon – we will ensure that you use the summer cheer to the fullest to grow personally and professionally!

About the author:

Somdatta Karak works with Club SciWri as a project co ordinator and Corporate Liaison. She is a doctorate in neuroscience from Georg August University, Göttingen, Germany and has been a Teach for India fellow (2014-16). She loves putting her analytical skills to build newer and more sustainable solutions, enjoys traveling and communicating and takes every opportunity to expand her horizon.

You can reach her here.

 

 

The week that it was 3rd April-8th April 2017

in ClubSciWri by
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    Tejeswini Padma's vision of dynein regulation in fission yeast via Myo1

This week we applaud Indian scientists in various parts of the world putting themselves on the World science map with their amazing discoveries and innovative ideas.

From cancer to drinking water

An India researcher at Johns Hopkins develops world’s first 5D ultrasound system to assist cancer detection and treatment while Indian scientist at the University of Manchester have used graphene oxide sieves to desalinate sea water by 97%. This technology if used commercially could contribute significantly to drinking water issues in different parts of the world.

More jobs in New York

1.2 billion-biotech development promises to generate 12,000 jobs in New York City area.

Greens are good for the heart!!

Greens have always made it to our meals since childhood claiming they are ‘good for health’. While we despised them as kids, this innovation by scientist transforming spinach leaves to a beating human heart surely puts greens on our favourites list as scientists.

Sci-Art for the younger generation

As Tejaswini unveils a brilliant piece of Sci-art describing ‘gut feeling‘ in her own way ,  Ipsa Jain inspires younger minds to interpret science more creatively as she conducted the first 2 sessions of her Workshop series titled Summer Sci-Art Workshop for kids.

Resume Roadmap

Leading pharma companies’ pen down characteristics of outstanding candidates, LinkedIn makers share how to tweak your profile to attract recruiters and successful women share their strategies of effective networking.

Story of the Week

For young parents who are pushed to choose between career and kids, here’s an inspiring story of how who can take ‘kids to work’ and call it ‘management-skills’ to improve your CV.

Opportunities

Academic

Postdoctoral position in macromolecular crystallographic computing at NE-CAT, Cornell University

 Postdoctoral position atin the laboratory of Dr. Guocan Wang at MD Anderson Cancer Center

Post doctoral jobs in John Hopkins School of Medicine

Postdoc position is available at Mallikaratchy lab of Lehman College , City University of New York 

Assistant Professor positions at University of Warwick,UK

Industry

Esco Ventures Singapore is hiring Associates with data science/bioscience background.

CRO position in SF bay area

Associate Scientist : ImmunoOncology Research at Amgen

Senior/Lead Scientist at one of my local Biotech clients in Central NJ.

Senior Associate Scientist/Scientist I Biology, Fibrosis Research at Celgene

Scholarships and Grants

Early Stage Researcher with Marie-Curie fellowship at the National Research Council, Institute of Genetics and Biophysics A. Buzzati-Traverso – Naples, Italy.

PhD openings in IIT Kharagpur

Workshops and courses

Women in Science Career Development Workshop in San Diego.

Cell modelling workshop in Pittsburgh Supercomputing Center.

Annual meeting of Experimental Biology Interest group is scheduled in Chicago on April 22, 2017.

For data scientists Neural Networks for Machine Learning bring together 30 free courses by  Geoffrey Hinton, a computer science professor at the University of Toronto.

A three-day insider’s look into management consulting at McKinsey for those considering a job in consulting

Call for PhDs and MSc graduates with analytical background to kick-start their career in data science with a 5-week programme.

Loreal Young Women in Science Scholarship, India

 

About the cover image

Title: Dynein regulation in fission yeast via Myo1.

Made for Dr.Vaishnavi Ananthanarayanan, INSPIRE Faculty Fellow, BSSE,IISc

Scientific Depiction by Tejeswini Padma.

Medium: Acrylic on Canvas

Explanation: The oscillations of the horsetail nucleus of fission yeast, along with the participating proteins- dynein(purple men) , Mcp5( green coloured anchor protein), Myo1 (in pink) , microtubule (blue rope along the diagonal) and PIP2  (pink circles in the cell membrane)  is depicted here.

Reference paper: Fission Yeast Myosin I Facilitates PI(4,5)P2-mediated Anchoring of Cytoplasmic Dynein to the Cortex’, Proceedings of the National Academy of Sciences (2017)

 

About the author

Nisha Peter is a recent PhD graduate from Genome Damage and Stability Centre,UK and is now working as Research Fellow at Sussex Drug Discovery Centre,UK. Her research interest involves cell biology (I’ve spend a lifetime admiring mitotic cells during my PhD!!) and oncology. She works for Club SciWri as a freelance writer to pursue her love for “words”. Apart from being bench scientist she actively participates in science communication events, enjoys teaching, globetrotting and experimenting with music.

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