Bluebird’s sickle cell gene therapy hits FDA’s desk

Today's Big News

Apr 24, 2023

Novartis pens $425M biobucks deal with German biotech, scooping up more radiopharmaceutical tech


Medtronic's MiniMed 780G insulin pump lands long-awaited FDA approval


After delays, bluebird's sickle cell gene therapy finally lands at the FDA's desk


Apellis hits setback in ALS trial after pair of pegcetacoplan approvals


‘Slow start’ to UK biotech investment in 2023 as companies ‘work harder’ for funding: report


Philips sets aside €575M ahead of U.S. class-action suit over CPAP recall


Mount Sinai launches regenerative medicine outpost to translate research into medicines

 

Featured

Novartis pens $425M biobucks deal with German biotech, scooping up more radiopharmaceutical tech

Novartis is doling out $40 million cash for exclusive licensing rights to 3B Pharmaceuticals’ cancer-targeting tech, wrapping up some loose ends for a radiotherapy picked up from Clovis Oncology at the end of last year.
 

Top Stories

Medtronic's MiniMed 780G insulin pump lands long-awaited FDA approval

Two years after submitting the latest version of its insulin pump technology for FDA approval—and three years after it was first made available in Europe—Medtronic has finally secured the agency’s signoff to begin selling the MiniMed 780G system in the U.S.

After delays, bluebird's sickle cell gene therapy finally lands at the FDA's desk

After a partial clinical hold caused bluebird to miss its own first-quarter FDA filing goal, the company says its sickle cell disease gene therapy application is in.

Apellis hits setback in ALS trial after pair of pegcetacoplan approvals

Developing meds for amyotrophic lateral sclerosis (ALS) is challenging under the best of circumstances. Now, Apellis Pharmaceuticals has run into a setback for its candidate.

‘Slow start’ to UK biotech investment in 2023 as companies ‘work harder’ for funding: report

U.K. biotech investment got off to a “slow start” this year, with the amount raised in the first quarter dropping 39%, according to the latest report from an industry body.

Philips sets aside €575M ahead of U.S. class-action suit over CPAP recall

In a first-quarter earnings report released Monday, Philips clocked a net loss of 665 million euros, thanks in large part to ongoing restructuring efforts and the still-rippling effects of the June 2021 recall of 5.5 million of the company’s respiratory devices.

Mount Sinai launches regenerative medicine outpost to translate research into medicines

Mount Sinai is bolstering its regenerative medicine research with the establishment of a new institute. The Institute of Regenerative Medicine will have three related wings with the overarching goal of turning novel research into medicines.

See you later, Baqsimi: Lilly sells low blood sugar rescue treatment to Amphastar for $500M-plus

Eli Lilly is selling Baqsimi to California’s Amphastar for $500 million in cash upfront. Amphastar is on the hook for an additional $125 million upon the one-year anniversary of the deal’s close, expected in the third quarter. Further, Lilly is in line to receive sales-based milestones worth up to $450 million, the companies said Monday.

Boston Scientific eyes Shockwave Medical for potential cardiovascular megadeal: Bloomberg

The deal could become one of Boston Scientific’s largest deals ever, possibly ranking in the double-digit billions, the report said.

Ionis, AstraZeneca's polyneuropathy med improved patients' quality of life in phase 3, teeing up battle with Alnylam

Ionis and AstraZeneca are providing the first detailed look at phase 3 data of eplontersen, a treatment for ATTR polyneuropathy that's going toe-to-toe against Alnylam's franchise. AstraZeneca signed a collaboration deal worth up to $3.5 billion to co-develop and commercialize the drug.

Johnson & Johnson eyes $40B valuation for consumer health group Kenvue: WSJ

As its Kenvue spinoff nears, J&J is conducting an IPO roadshow this week to drum up interest from investors, sources told The Wall Street Journal. They also said J&J hopes to raise at least $3.5 billion in the offering at a valuation of $40 billion.
 
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'The Top Line': Pfizer's record-breaking sales, plus headlines

This week on "The Top Line," we talk about how Pfizer became the first company in Big Pharma history with $100 billion in sales. We also dive into a J&J data leak, Eli Lilly's manufacturing spending plan and more of this week's top headlines.

 

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