To view this email as a web page, click here

May 09, 2017

Subscribe

Our Team

Contact Us

FierceBiotech Logo

 

Today's Rundown

  1. Sanofi inks €250M bispecific small molecule diabetes deal

  2. Investors spooked by Kite CAR-T death, but biotech remains confident

  3. Parexel seeking $4B sale: WSJ

  4. [Sponsored] A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

  5. Takeda pens GammaDelta Therapeutics $100M pact, with M&A option

  6. Feldan Therapeutics, Elasmogen in Amgen tie-up for intracellular biologics

  7. FDA rejects TherapeuticsMD, citing lack of long-term data

  8. Soon-Shiong's IO outfits get FDA nod to start cancer vaccine trials

  9. Aspirin, other antiplatelet drugs boost T-cell therapy in mice with melanoma

  10. Abbott debuts smartphone-compatible insertable cardiac monitor

  11. Sanofi vows to limit 2017 price hikes to 5.4% as part of new 'holistic' policy

Featured Story

Sanofi inks €250M bispecific small molecule diabetes deal

Sanofi has teamed up with Exscientia to discover and develop bispecific small molecules that treat diabetes and its comorbidities. The agreement will see Sanofi hand over up to €250 million ($274 million) in return for small molecules designed to hit two targets involved in glucose control, NASH, weight management and other areas relevant to diabetics.

Investors spooked by Kite CAR-T death, but biotech remains confident

Kite Pharma was off by 15% in morning trading after it announced the death of a patient in late April of cerebral edema—the very same fatal outcome that beset rival Juno’s Rocket trial, killing five people and its CAR-T program for JCAR015.

Parexel seeking $4B sale: WSJ

Not a week seems to go by without a CRO sale rumor: Chiltern, INC Research and PPD (which in fact was recapitalized last week) are two of the most recent, and now the Wall Street Journal is adding Parexel to that list.

[Sponsored] A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

Biosimilars development in the U.S. is still rapidly growing and shifting. We discuss the key issues sponsors face today – from nonclinical testing to commercialization – along with considerations for a strategic regulatory approach.

Takeda pens GammaDelta Therapeutics $100M pact, with M&A option

In what is becoming an increasingly common pattern, Takeda has signed up to a collab with a small and very young biotech with an option to buy the company down the road.

Feldan Therapeutics, Elasmogen in Amgen tie-up for intracellular biologics

Biopharmas from Scotland, Canada and the U.S. have come together in a new pact deisgned to deliver intracellular candidates for two drug targets.

FDA rejects TherapeuticsMD, citing lack of long-term data

The FDA has rejected a filing for approval of TherapeuticsMD’s treatment for vaginal pain during sexual intercourse because of the lack of 12-month safety data. The news leaves TherapeuticsMD looking down the barrel of an expensive, time-consuming safety study for TX-004HR unless it can persuade FDA to accept another route to approval.

Soon-Shiong's IO outfits get FDA nod to start cancer vaccine trials

Biotech billionaire Patrick Soon-Shiong has been through the media wringer in the last few months, so will welcome an FDA green light that will draw attention back to his immuno-oncology programs.

Aspirin, other antiplatelet drugs boost T-cell therapy in mice with melanoma

Engineered T-cell therapies, a promising way to “prime” a patient’s immune system against cancer, don’t work for everyone. Scientists from the Medical University of South Carolina found one possible explanation that can be targeted: blood platelets.

Abbott debuts smartphone-compatible insertable cardiac monitor

Abbott announced the CE mark and launch of its smartphone-compatible insertable cardiac monitor, designed to help physicians remotely diagnose arrhythmias, such as atrial fibrillation, and guide their therapy decisions.

Sanofi vows to limit 2017 price hikes to 5.4% as part of new 'holistic' policy

Sanofi may be late to the pricing-pledge party but it’s come up with some benchmarks that beat its rivals. Rather than limiting price hikes to less than 10%, the French drugmaker promises to keep any price increases at or below an official U.S. health inflation measure that’s projected to hit 5.4% in 2017.

News of Note

Alnylam has taken on former Moderna head of R&D non-clinical Peter Smith as its new SVP of early development. Release

Kymab has taken on immunologist and former Novartis and Merck Serono executive Sonia Quaratino as its first chief medical officer. Statement

Preclinical cancer biotech Aravive Biologics has poached Astellas' VP of oncology medical sciences Stephen Eck as its president and CEO. Release

Resources

[Whitepaper] Monitoring Risk for ICH GCP Compliance

The ICH GCP E6 guideline has been revised to address the complexities associated with today’s clinical trials, and this concise white paper will help you understand the recent guideline changes. Learn how use of risk-based monitoring can help you comply with the guidelines and achieve efficiency in clinical trial design, implementation and reporting.

[Whitepaper] Run the Trial You Want with Modern EDC

To thrive in a fiercely competitive market, life sciences companies need to set themselves apart by designing and executing the best trial and successfully deliver drugs to market first. Learn how a modern EDC can help.

[Whitepaper] Solving the Knowledge Management Puzzle in Biopharma

Puzzled by Scientific Literature Access? Here is your guide for navigating knowledge management’s twists and turns! If yours is a small- or medium-sized biopharma business, we can help you putting the pieces together. Learn the secrets of top knowledge management experts who will show you how to search, discover, acquire and manage knowledge in new ways.

[Whitepaper] Immuno-Oncology and the Role of Biomarkers, Companion and Complementary Diagnostics

The recent evolution of immunotherapies and their potential applications have greatly impacted patients’ options for effective oncology treatments. These advances have been powered in part by the use of biomarkers, companion diagnostics (CDx) and complementary diagnostics. Read the white paper.

[Whitepaper] The Paperless Future of Healthcare and Life Sciences

DocuSign’s eSignature solutions modernize healthcare and life science organizations by eliminating paper and antiquated signature processes while meeting compliance requirements and reducing costs and errors.

[Whitepaper] DocuSign Life Sciences eBook: Reducing Cycle Time with Digital Transaction Management

The patients who rely on your scientific leadership are expecting more.

[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

Events

.