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Category Archives: Biotech Trends in 2010

Biotech Trends Update — IP Constituencies: Indian Industry Lobbies to Keep IP Out of Free Trade Agreement with EU

Leave a Comment Posted by Jeremy Grushcow on December 7, 2010

An article in yesterday’s Hindu Business Line says the Indian Drug Manufacturers’ Association is lobbying heavily to keep data protection and other innovator-friendly IP provisions out of the free trade agreement being negotiated between India and the EU. But, with Glenmark and Jubilant on the rise, and with even Biocon carrying the R&D water in its [...]

Biotech Trends in 2010, Jeremy Grushcow, News data protection, EU, Free Trade Agreement, India, intellectual property

Approval Pathway for Biosimilars and Interchangeable Biological Products: Issues from the FDA’s Public Hearing

1 Comment Posted by Mark Curtis on November 10, 2010

On November 2nd and 3rd the FDA held a public hearing to address the challenges it will face in the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This act established an abbreviated pathway for follow-on biologics (a.k.a. biosimilars) that are either “highly similar” or “interchangeable” with previously approved biologics. [...]

Biotech Trends in 2010, Mark Curtis, News Alliance for Affordable Medicine, American Academy of Pediatrics, Biologics Price Competition and Innovation Act, Declaration of Helsinki, European Medicines Agency, Reditux, rituximab, Teva, World Medical Association

Biotech Trends Update — Biosimilars Blur IP Constituencies: Novartis and Pfizer-Biocon are Featured in the Economist

5 Comments Posted by Jeremy Grushcow on October 21, 2010

Two 9-figure announcements this week mark a turning point for the biosimilars market, and one highlights the increasingly important role India plays in innovation. Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in development of four biosimilar insulin products that gives Biocon $200 million up front. Coverage of [...]

Biotech Trends in 2010, Jeremy Grushcow, News Biocon, Biosimilars, enoxaparin, Follow-On Biologics, Lovenox, Novartis, Pfizer, Sandoz, Sanofi-Aventis

Biotech Trends Update — Personalized Medicine: Duncan’s Personalized Health Manifesto is Primarily Preventative

Leave a Comment Posted by Jeremy Grushcow on October 14, 2010

Journalist David Ewing Duncan’s “Personalized Health Manifesto” was published this week by the Ewing Marion Kauffman Foundation. The most interesting thing about the manifesto* is that it assumes that the technical hurdles to generating and understading a full set of personalized health data have been overcome, and focuses on how that information can be deployed [...]

Biotech Trends in 2010, Jeremy Grushcow, News Kauffman Foundation, Personalized Effectiveness, Personalized Health Manifesto, Personalized Medicine

Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars

1 Comment Posted by Jeremy Grushcow on October 5, 2010

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were [...]

Biotech Trends in 2010, Jeremy Grushcow, News Biosimilars, EMA, European Medicines Agency, FDA, Follow-On Biologics

Biotech Trends Update — IP Constituencies: Endo’s Qualitest Purchase Shows Full Integration of Innovator and Generic Strategies

1 Comment Posted by Jeremy Grushcow on September 29, 2010

Endo Pharmaceuticals (NASDAQ: ENDP) announced yesterday morning that it will spend $1.2 billion to buy U.S. generics company Qualitest Pharmaceuticals. Endo also has an active pipeline of “innovative” products in development, emphasizing the industry trend we’ve been following of a narrowing distinction between innovator and generics companies. Endo began its modern existence after being spun [...]

Biotech Trends in 2010, Jeremy Grushcow Bioniche, Endo Pharmaceuticals, HealthTronics, Qualitest Pharmaceuticals

Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

3 Comments Posted by Jeremy Grushcow on September 20, 2010

Adam Feuerstein at TheStreet.com reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation. The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure [...]

Biotech Trends in 2010, Jeremy Grushcow, News BCPI, Biologics Price Competition and Innovation Act, Biosimilars, FDA, Follow-On Biologics, Health Care Reform, Subsequent Entry Biologics

Patent Cliff Will Not Save Biotech: Abbott Buys Indian Generics Company Piramal Healthcare

1 Comment Posted by Jeremy Grushcow on May 25, 2010

I often hear how the upcoming loss of patent protection for current blockbusters creates an insatiable demand at pharma companies for new pipeline products from biotechs. Here’s an example from 2007. Here’s one from last week. This is not true. Upcoming loss of patent protection creates a insatiable demand for revenue, but new products are not [...]

Biotech Trends in 2010, Jeremy Grushcow, News Abbott, Aspen Pharmacare, Biosimilars, branded generics, generics, GlaxoSmithKline, GSK, Merck, Novartis, Pfizer, Piramal Healthcare, Sanofi, Solvay, Zydus

Trends Update — Synthetic Biology: JCVI’s First Synthetic Cell (or, A Goat Walked Into a Lab)

Leave a Comment Posted by Jeremy Grushcow on May 20, 2010

World, meet "Mycoplasma mycoides JCVI-syn1.0", 1.08-Mbps of synthetic life. Today’s issue of Science contains an article by scientists at the J. Craig Venter Institute, who have synthesized a Mycoplasma genome from scratch and transplanted it to a recipient cell. Those recipients have since reproduced using entirely the synthetic DNA. In the quest to create novel [...]

Biotech Trends in 2010, Jeremy Grushcow, News J. Craig Venter Institute, JCVI, synthetic biology

Grand Challenges Canada to Mobilize $225 Million Over 5 Years For Global Health

1 Comment Posted by Jeremy Grushcow on May 11, 2010

A new nonprofit organization called Grand Challenges Canada has been formed to deploy the Canadian government’s $225 million Development Innovation Fund. In a fabulous marriage of theory and practice, Grand Challenges will be run by Peter Singer, who is also the Director of the McLaughlin-Rotman Centre for Global Health. It also draws on an impressive [...]

Biotech Trends in 2010, Jeremy Grushcow, News CIHR, Gates Foundation, Grand Challenges Canada, IDRC, McLaughlin-Rotman Centre for Global Health, point-of-care diagnostics

BIO Panel on Comparative Effectiveness Research Notes “Silver Lining” of Personalized Medicine

1 Comment Posted by Jeremy Grushcow on May 4, 2010

Speakers Daniel Todd, from EMD Serono, and Steve LaPierre, from Boston Scientific, were led by Foley Hoag lawyer Jayson Slotnik in a discussion of the final CER legislation and predictions about implementation. The overall tone was skeptical — the panel noted the potential for CER data to ultimately contribute to CMS coverage decisions, and worried about [...]

Biotech Trends in 2010, Jeremy Grushcow BIO 2010, Comparative Effectiveness, Personalized Effectiveness, Personalized Medicine

Biotech Trends Update: Non-Dilutive Financing and Fundraising by Partnering with Nonprofits

2 Comments Posted by Jeremy Grushcow on May 3, 2010

As noted in the lead up to BIO, several of the conference sessions touch on industry trends we’ve been following here on the blog. One of these was today’s session entitled “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits,” which we’ve been following as commercialization by non-profit foundations. Our coverage of that trend [...]

Biotech Trends in 2010, Jeremy Grushcow, News BIO 2010, Gates Foundation, Leukemia & Lymphoma Society, non-dilutive financing, nonprofits

Biotech Trends at BIO 2010

Leave a Comment Posted by Jeremy Grushcow on April 28, 2010

As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions. Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on [...]

Biotech Trends in 2010, Jeremy Grushcow, News BIO 2010, BIO2010, Biosimilars, commecialization, Comparative Effectiveness, conference, FOB, Follow-On Biologics, foundations, IP Constituencies, nonprofits, Personalized Medicine

Biotech Trends Update — Commercialization by Foundations: Lymphoma and Leukaemia Society’s Preclinical Program Has Advantages for Companies

1 Comment Posted by Jeremy Grushcow on April 19, 2010

In my first post noting the trend of non-profit foundations stepping in to support commercial projects, I held out the Leukemia & Lymphoma Society (LLS)’s Therapy Acceleration Program as a key example. LLS recently made another investment from that program, giving $3.2 million to get Avila Therapeutics’ AVL-292 into trials for B-cell cancers (pdf). In writing about this [...]

Biotech Trends in 2010, Jeremy Grushcow Avila Therapeutics, Leukemia & Lymphoma Society

Comparative Effectiveness and Personalized Medicine are “Part of the Same Question” Collins Confirms

1 Comment Posted by Jeremy Grushcow on April 6, 2010

In a very informative Kaiser Health News interview (via GenomeWeb), Francis Collins says that “personalized medicine strategy and CER strategy are part of the same question. … There will often be more than one therapeutic intervention, so you have to compare them. But you also want to know what’s different about the individual that might have an [...]

Biotech Trends in 2010, Jeremy Grushcow Comparative Effectiveness, Francis Collins, Personalized Effectiveness, Personalized Medicine

Biotech Trends Update: A Personalized Critique of Comparative Effectiveness Misses the Mark

3 Comments Posted by Jeremy Grushcow on March 18, 2010

As the U.S. and Canada move to invest and rely more on comparative effectiveness research (CER), lack of personalization has been the loudest and most frequent objection. That is why we have been following the interaction between comparative effectiveness and personalized medicine as a key industry trend. Yesterday, an opinion piece in the WSJ by Leonard [...]

Biotech Trends in 2010, Jeremy Grushcow CER, Comparative Effectiveness, Personalized Effectiveness, Personalized Medicine

Biotech Trends Update — IP Constituencies: India’s Courts Nix Drug Patents while India Courts Innovation

Leave a Comment Posted by Jeremy Grushcow on March 2, 2010

This blog has been tracking increasing innovative activity in India and China as part of our Biotech Trends series, the idea being that as innovative activity increases, the host countries will take a kinder view of property rights. The trend toward innovation in India is undeniable — as the WSJ’s Venture Capital Blog noted recently, India even [...]

Biotech Trends in 2010, Jeremy Grushcow China, Delhi High Court, India, Innovation, Merck, Nexavar, Y Combinator

Biotech Trends Update — Personalized Medicine: The Limits of Genomic Analysis

Leave a Comment Posted by Jeremy Grushcow on February 17, 2010

A great report on GenomeWeb yesterday by Andrea Anderson reviews two JAMA papers that failed to show a clinically useful role for SNP genetic testing in predicting heart disease risk. Instead, “traditional risk information based on factors such as family history and plasma biomarker levels were better for predicting heart disease.” Anderson ties these results back [...]

Biotech Trends in 2010, Jeremy Grushcow, News BMJ, heart disease, JAMA, SNP, type 2 diabetes

Biotech Trends Update — Commercialization by Foundations: $500k to AVI BioPharma from DMD Organizations

Leave a Comment Posted by Jeremy Grushcow on February 16, 2010

Continuing a trend by nonprofits to invest directly in commercialization of relevant products, CureDuchenne and the Foundation to Eradicate Duchenne each awarded grants of $250,000 to AVI BioPharma, Inc. (NASDAQ: AVII) to support continued research and development of the Company’s drug candidates for the treatment of Duchenne Muscular Dystrophy (DMD). One interesting note here is the collaboration [...]

Biotech Trends in 2010, Lumira Capital, News AVI BioPharma, CureDuchenne, DMD, Duchenne Muscular Dystrophy, FED, Foundation to Eradicate Duchenne

Biotech Trends Update: Costs Savings from Personalized Medicine Sought by PBMs, Employers, Pharma Face Legal and Privacy Hurdles

Leave a Comment Posted by Jeremy Grushcow on February 4, 2010

When AstraZeneca announced a companion diagnostics collaboration recently, their head of oncology development said the goal was to get “the right treatment, to the right patient, the first time,” a nice turn of phrase* that is becoming a chorus in the healthcare industry. This week, giant PBM Medco purchased DNA Direct, saying “[o]ur whole thing at Medco [...]

Biotech Trends in 2010, Jeremy Grushcow, News AMA, American Medical Association, AstraZeneca, Comparative Effectiveness, DNA Direct, Genetic Information Nondiscrimination Act, GINA, Medco, Navigenics, Personalized Effectiveness, Personalized Medicine, Procter & Gamble

Biotech Trends Update: Teva’s BLA for Neupoval is Accepted at the FDA

4 Comments Posted by Jeremy Grushcow on February 2, 2010

Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today. Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of [...]

Biotech Trends in 2010, Jeremy Grushcow, News Amgen, Biosimilars, BLA, FDA, Follow-On Biologics, Neulasta, Neupogen, Neupoval, Teva, TevaGrastim

Biotech Trends Update: Jubilant’s R&D Success Continues Drive Toward Innovation in Asia

4 Comments Posted by Jeremy Grushcow on January 28, 2010

One of the biotech trends we’re following in 2010 is the increasing innovative activity in India and China. Both are booming not only as low cost manufacturing centers but also as innovative hubs adding R&D expertise and specialized know-how. This week, the Indian company Jubilant and Endo Pharmaceuticals announced that they are expanding thier partnership following early and [...]

Biotech Trends in 2010, Jeremy Grushcow, News AstraZeneca, Biocon, China, Duke University, Eli Lilly, Endo Pharmaceuticals, India, Jubilant Biosys, Singapore, UAB, University of Alabama at Birmingham

Biotech Trends Update — Personalized Medicine: The Case for Diagnostics Focuses on Cost and Effectiveness

5 Comments Posted by Jeremy Grushcow on January 20, 2010

A report in FierceBiotech today distilled the views of three life science VCs on trends to watch in 2010. Along with other worthwhile observations (and I’d encourage you to read the whole thing) was this bullet pointing out the value of personalized medicine in addressing comparative effectiveness concerns: “Interest in molecular diagnostics is heating up. It’s [...]

Biotech Trends in 2010, Jeremy Grushcow, News AstraZeneca, Comparative Effectiveness, Dako, Health Care Reform, Personalized Medicine, reimbursement, venture capital

Biotech Trends Update — Commercialization by Foundations: JDRF, J&J and DexCom Collaborate on Artificial Pancreas

Leave a Comment Posted by Jeremy Grushcow on January 14, 2010

One of the industry trends we’re following in 2010 is the increasing commercialization activity by non-profit foundations. The Juvenile Diabetes Research Foundation has been taking active and creative approaches to funding treatments for their constituents. Last month, JDRF in Canada partnered with a government funding agency to create a clinical trials network in Ontario; and [...]

Biotech Trends in 2010, Jeremy Grushcow, News Animas, artifical pancreas, DexCom, J&J, JDRF

Biotech Trends Update — IP Constituencies: Innovators and Generics Continue to Blur Pharma Lines

2 Comments Posted by Jeremy Grushcow on January 11, 2010

Two stories noted by the WSJ’s Health Blog highlight the trend we’ve been following of blurring lines between branded/innovator pharma and generics companies: The biggest development I’d cite is Pfizer’s deal to sell 40 generics made by India’s Strides Arcolab and South Africa’s Aspen. This deal seems to go a step farther than other innovator/branded deals with [...]

Biotech Trends in 2010, Jeremy Grushcow, News Aspen, China, generics, India, Pfizer, Pfizer Established Products Business Unit, Strides Arcolab, Teva

Biotech Trends Update — Personalized Medicine: A Big Market, If We Can Just Figure Out How to Get People to Use It

3 Comments Posted by Jeremy Grushcow on January 7, 2010

Late last year, a PwC report made the rounds with a big headline number — $232 billion — as the size of the personalized medicine market. FierceBiotech called it a “tipping point,” for personalized medicine. George Church called us “the first genomic generation” in Newsweek, and Francis Collins’ new book ”offers practical advice on how to [...]

Biotech Trends in 2010, Jeremy Grushcow, Trends in 2009 AACN, American Association of Colleges of Nursing, Duke University Medical Centre, Francis Collins, Genetic Information Nondiscrimination Act, George Church, GINA, HHS, OCR, Office of Civil Rights, Personal Genomes Project, Personalized Medicine, PwC, tamoxifen, UK Centre for Medical Research and Innovation, UKCMRI, Valparaiso University

Biotech Trends Update — DTC Genetics: The Future of Direct-to-Consumer Genetic Testing

2 Comments Posted by Jeremy Grushcow on January 5, 2010

A Popular Mechanics article in the January issue is entitled “How to Create a Designer Baby.” It is an interesting and seemingly accurate view of the state of the art, but when it says “women undergoing in vitro fertilization (IVF) could one day choose to have a baby boy with perfect vision, an aptitude for [...]

Biotech Trends in 2010, Jeremy Grushcow deisgner baby, ELSI, ethical legal social implications, Genetic Information Nondiscrimination Act, GINA, In Vitro Fertilization, IVF, Personalized Medicine, PGD, Popular Mechanics, Pre-Implantation Genetic Diagnosis

Trends Update — Social Media: Upopolis Keeps SickKids’ Patients Connected

Leave a Comment Posted by Jeremy Grushcow on December 22, 2009

One of the fantastic uses for social media in healthcare (a trend we will be following this coming year) is to connect communities of patients to each other and to their friends and families when those connections would be difficult to make or maintain IRL (in real life). The Hospital for Sick Children (SickKids) in Toronto [...]

Biotech Trends in 2010, Jeremy Grushcow healthcare, Kids Health Links Foundation, McMaster Children's Hospital, SaaS, SickKids, Social Media, software as service, Telus, Upopolis

Trends Update — Electronic Medical Records: Importance of Telemedicine, Implementation and Data Security

1 Comment Posted by Jeremy Grushcow on December 15, 2009

Since the Canadian and U.S. stimuli directed fuding towards electronic medical records (EMR), we’ve been following developments in the area as part of our Biotech Trends series here on the blog and have noted successes and failures. A few recent stories highlight risks and benefits: A recent Scientific American story (H/T @mikesgene) turned an analytical [...]

Biotech Trends in 2010, Jeremy Grushcow, News, Trends in 2009 American Telemedicine Association, data security, DocTalker, EHR, electronic health records, electronic medical records, EMR, Kaiser Permanente, Microsoft, Montreal Heart Institute, NIST, Patrick Gallagher, personal health records, PHR, Sentillion, St. Jude Medical, telemedicine, UPMC

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