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September 05, 2017


Today's Rundown

  1. FDA hits Cellectis’ off-the-shelf CAR-T program with clinical hold after first patient treated in phase 1 trial dies

  2. Takeda joins CAR-T chasing pack with Noile-Immune alliance

  3. Destiny pulls off IPO to fund infection prevention trial

  4. OrbiMed rolls out its third Asia biopharma fund with $551M up for grabs

  5. Using Zika virus to attack glioblastoma

  6. Tell us: Who are the fiercest women in life sciences?

  7. New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph


Featured Story

FDA hits Cellectis’ off-the-shelf CAR-T program with clinical hold after first patient treated in phase 1 trial dies

The FDA has placed a clinical hold on two phase 1 trials of Cellectis’ UCART123 after learning of the death of one patient. Development of the off-the-shelf CAR-T therapy is now in limbo while Cellectis works with the FDA to redesign the protocol to mitigate the risks identified in the first weeks of the trials.


Top Stories

Takeda joins CAR-T chasing pack with Noile-Immune alliance

With CAR-T therapies now reaching the market, Japanese drugmaker Takeda has made a play to grab a slice of the pie via a deal with biotech startup Noile-Immune.

Destiny pulls off IPO to fund infection prevention trial

Destiny Pharma has listed on London’s AIM exchange. The IPO gives Destiny £15.3 million ($19.8 million) to assess lead candidate XF-73 in the prevention of post-surgical staphylococcal infections in a phase 2b trial.

OrbiMed rolls out its third Asia biopharma fund with $551M up for grabs

OrbiMed has launched its third Asia-focused biopharma and healthcare fund with more than half a billion dollars’ worth of private equity.

Using Zika virus to attack glioblastoma

Most research efforts aimed at Zika virus seek to kill the pathogen. But researchers at Washington University School of Medicine in St. Louis and the University of California at San Diego are turning the anti-Zika pursuit on its head, finding a potentially useful role for the virus in treating gliobastoma.

Tell us: Who are the fiercest women in life sciences?

The life sciences field presents its own barriers to women's advancement, but in spite of these challenges, women can and do attain top-level positions, start their own companies and otherwise make their marks on the industry. Know a woman in biotech, pharma or medtech who is doing just that? Nominate her for this year's Fiercest Women in Life Sciences feature.

New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph

Novartis' drug-development chief, Vas Narasimhan, will take over as CEO in February 2018 from Joe Jimenez, who is retiring. Narasimhan will enjoy the fruits of Novartis' groundbreaking FDA approval of the first CAR-T treatment for cancer, but he will also be inheriting several challenges, not the least of which is pricing pressure on both branded and generic drugs.


Resources

[Whitepaper] Modernizing the Patient Journey


Uncover the true power of patient-centric data with this valuable industry resource. Click here to discover more

[Webinar] Five ways to make your patient support program a success


Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods.

[Whitepaper] The Impact of Contraceptive Requirements on Pediatric Clinical Trials


Children participating in pediatric clinical trials are included in the contraceptive requirements applied to women of child-bearing potential, creating significant challenges for sponsors, parents, investigators and study staff.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models


In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.


Events

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