1) FDA clears Vertex’s new treatment for cystic fibrosis – The Boston Globe, 7/2/2015
Vertex Pharmaceuticals Inc. won US regulatory approval Thursday for a medicine that eventually could treat roughly half of the estimated 30,000 Americans who suffer from cystic fibrosis, the life-threatening lung disease.
2) Biogen plans $1 billion plant in Switzerland – The Boston Globe, 7/1/2015
The Cambridge biotechnology giant Biogen Inc. plans to invest $1 billion in a new manufacturing plant in northern Switzerland that would triple the company’s global capacity to produce large protein-based drugs known as biologics.
3) Baxalta sets sail with blockbuster ambitions for its growing pipeline – FierceBiotech, 7/1/2015
More than a year after announcing plans to spin out its drug business, Baxter ($BAX) has begotten Baxalta ($BXLT), a $6 billion standalone company with plans to elbow its way into the upper ranks of biopharma.
4) Kite, Leukemia & Lymphoma Society Partner to Develop Drug Candidate – GEN News, 7/1/2015
The Leukemia & Lymphoma Society (LLS) will partner with Kite Pharma in developing the company’s lead product candidate KTE-C19 for patients with refractory aggressive non-Hodgkin lymphoma.
5) Celgene pays $1B in landmark deal to buy into Juno’s pipeline of CAR-T drugs – FierceBiotech, 6/29/2015
Celgene ($CELG) is paying about $1 billion to move to the front of the hectic race to build new CAR-T cancer therapies. The Big Biotech is shelling out $150 million upfront and paying $93 a share–a huge premium–to snap up 9.1 million shares of Juno Therapeutics ($JUNO), inking a global collaboration to develop and commercialize new immuno-oncology therapies.
On Wednesday, June 24th, MassBio hosted the Good Promotional Practices Before & After Approval Forum geared towards helping audience members in a range of drug development stages think about how to best promote their therapies.
Missed the Forum? We’ve compiled a list of key takeaways that are important to keep in mind as you move through the drug development process!
1) Be Different
“Differentiation is key. Walk out of a therapeutic space if you can’t differentiate from what’s out there” – Damon Harrell
Damon Harrell, Senior Director of New Product Planning at Alkermes, Inc. stressed that it is imperative to ensure your product has a unique therapeutic value. If you find you are unable to differentiate yourself, you should reconsider moving on. In the words of Damon: “Good science doesn’t always mean a desirable product.”
2) Channel the Patient Voice
“Be the voice of your customer as early on as possible and let the clinical team figure out how to get you that data.” – Harrell
Ensure the clinical team is aware of patient needs and their perspective. Help push the patient voice into the conversation and then let the clinical team work their magic to make a life-changing product.
“Your product should be aspirational, you want to meet the needs of patients.” – Harrell
By striving towards an aspirational goal and keeping the patient at the heart of the process, the team will stay focused on that goal and you will end up with a marketable product that makes a powerful difference in a patient’s life.
Side note: The panel also encouraged the audience to only speak in aspirational terminology in the pre-approval stages. Don’t promise any specifics! Read the rest of this entry
Bone Therapeutics is a biotechnology company with a unique approach to the development of cell therapy products for bone fracture repair and fracture prevention. We are creating a new and unique treatment approach using differentiated bone-forming cells (osteoblasts) administered via a minimally invasive percutaneous procedure that is expected to offer significant benefits over the current standard-of-care. Website
Kanyos Bio was founded with the goal of developing antigen-specific immune tolerance technology for two specific autoimmune indications, type-1 diabetes and celiac disease. Our technology originated at EPFL (Ecole Polytechnique Fédérale Lausanne) in Switzerland with our sister company, Anokion. Kanyos and Anokion are collaborating in this effort with Astellas Pharma, Inc. (“Astellas”). As an independent affiliate, Kanyos aims to develop antigen-specific, disease-modifying therapies for patients with type-1 diabetes and celiac disease by leveraging the immunotechnology expertise of Anokion and the clinical translation experience of Astellas. Website
We work with clinicians to make Fecal Microbiota Transplantation (FMT) easier, cheaper, safer and more widely available. We do so by providing hospitals with screened, filtered, and frozen material ready for clinical use. This service eliminates the time, staff, protocols, and facilities needed to screen and prepare material from new donors for each treatment. We also work to catalyze research into the microbiome and its role in human health. We provide tailored assistance in molecular characterization, computational analysis, clinical trial design, and regulatory support for scientific and clinical research. Website
The MassBioHQ is thrilled to announce the launch of our new Industry Innovators Blog Series where we will share the stories of incredible individuals and companies making an impact in the life sciences industry! If you are interested in being interviewed or contributing a guest post to our blog please email firstname.lastname@example.org.
At one of MIT’s recent major career fairs, only 3% of the employers in attendance represented the life sciences. Surprising? Yes, considering that MIT is in the heart of Kendall Square, recently named the number one hub for life sciences in the world. It certainly shocked James W. Weis and Nathan Stebbins, PhD students at the prestigious institution and co-founders of the MIT Biotech Group.
There’s a lot of anxiousness towards careers [you hear statements like] ‘there’s no faculty jobs’ and ‘what’s everyone going to do’. James and I originally started digging around to understand what resources exist at MIT for students that want to get connected to the biotechnology industry and what avenues exist for students who want to be entrepreneurs in the lifesciences. We actually found that MIT students, surprisingly, have a small connection with the outside biotechnology world.” – Stebbins.
About 25% of PhD students at MIT are doing research directly involved in the life sciences and many more are doing tangential work. Weis and Stebbins recognized a need to close the gap between academia and industry at MIT, and decided to take the necessary steps to make it happen. After countless hours of brainstorming and meetings with high level executives from academia and industry, the empowered entrepreneurs launched the MIT Biotech Group in April of this year – with the full support and encouragement of MIT’s administration. Their hard work has paid off. Within a few days of the inaugural email invitation, over 200 students signed up to get a taste of the life sciences industry. The group currently has over 500 members comprised of undergrads, graduates, and PhD students. Read the rest of this entry
1) Supreme Court Allows Nationwide Health Care Subsidies – New York Times, 6/25/2015
The Supreme Court ruled on Thursday that President Obama’s health care law allows the federal government to provide nationwide tax subsidies to help poor and middle-class people buy health insurance, a sweeping vindication that endorsed the larger purpose of Mr. Obama’s signature legislative achievement.
2) Three Bay State biotechs go public in IPOs – Boston Globe, 6/26/2015
Seres Therapeutics Inc., a Cambridge biotech developing a new class of drugs to treat infections and metabolic disorders, is set to make its debut as a publicly traded company Friday after raising nearly $134 million in an initial public offering.
The company was one of three Massachusetts life sciences startups that went public this week as the strong IPO market of the past two years extended into mid-2015.
3) Bristol-Myers is the next big tenant in biotech’s hottest neighborhood – FierceBiotech, 6/26/2015
Bristol-Myers Squibb’s ($BMY) latest R&D reshuffle calls for a consolidated presence in Cambridge, MA’s booming Kendall Square, and the drugmaker has signed on to serve as anchor tenant in the area’s next big research facility, joining Big Pharma’s ongoing colonization of a biotech hotbed.
4) Interim chief named for Massachusetts Life Sciences Center – Boston Globe, 6/24/2015
The Massachusetts Life Sciences Center board Wednesday named Baker administration economic development official Michael J. Kennealy as interim chief executive of the quasi-public agency that administers state efforts to expand the life sciences sector.
5) Sen. Warren Holds Roundtable With FDA Acting Commissioner – Framingham Patch, 6/22/15
United States Senator Elizabeth Warren held a roundtable discussion in Boston with U.S. Food and Drug Administration Acting Commissioner Dr. Stephen Ostroff and members of the Massachusetts Medical Device Industry Council (MassMEDIC), on Monday morning, June 22.