BioSpace News Archive

DBV Technologies Resubmits BLA for Peanut Allergy Treatment

The company withdrew its initial BLA in December after the FDA requested more information regarding manufacturing procedures and quality controls.

August 8, 2019

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2 min read

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Alex Keown

BioCapital

CMS Releases New Rules Overseeing CAR-T Immuno-Oncology Therapy

The Centers for Medicare and Medicaid Services announced the agency would cover CAR-T so patients would have “consistent and predictable access” to the therapy.

August 8, 2019

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3 min read

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Mark Terry

FDA

Akcea and Ionis Gear Up for Second Attempt at Getting Waylivra FDA Approval

Waylivra was rejected by the FDA last year but gained approval in Europe in May. The publication of final Phase III data in the New England Journal of Medicine could support a potential bid for regulatory approval in the U.S.

August 8, 2019

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3 min read

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Alex Keown

Genetown

Sarepta Announces Second-Quarter Losses with Focus on Expanded R&D

The company, best known for Exondys 51 (eteplirsen) for Duchenne muscular dystrophy (DMD), reported a net loss of $276.4 million for the quarter compared to a loss of $109.3 million in the same period in 2018. For the six-month period ending June 30, Sarepta reported a net loss of $353 million.

August 8, 2019

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2 min read

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Mark Terry

Business

2019 Best Cities for Work-Life Balance

Landing a job that provides a positive work-life balance is essential for many would-be employees and is also an attractive feature that many hiring managers point to when trying to fill a position. A recent survey reveals that geography may play a key role in that sought-for balance.

August 8, 2019

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4 min read

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Alex Keown

Policy

Microbiome-Focused Companies Find New Ways to Protect IP

Biopharma companies working with the microbiome are running into patent obstacles due to the difficulty in using the system to protect naturally-occurring substances.

August 8, 2019

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2 min read

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Alex Keown

Business

BioSpace Movers and Shakers, Aug. 9

Biopharma companies strengthen their senior leadership teams and boards of directors.

August 8, 2019

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8 min read

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Alex Keown

Deals

Cambrex to be Acquired by the Permira Funds for $60.00 per Share in Cash

Cambrex Corporation announced that it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately $2.4 billion, including Cambrex’s net debt.

August 8, 2019

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9 min read

Business

Vericel Reports Second Quarter 2019 Financial Results and Raises Full Year 2019 Revenue Guidance

Vericel Corporation reported financial results for the second quarter ended June 30, 2019, and recent business highlights.

August 8, 2019

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10 min read

Genetown

Shimmer Wins Two GHP International Life Sciences Awards for its Wearable Sensor Technology

Awards recognize Shimmer’s advances in developing wearable sensors tailored for specific uses, such as clinical trials and consumer neuroscience research

August 8, 2019

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3 min read