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Today's Big News

Apr 3, 2023

FTC reverses course, orders Illumina to unravel Grail deal


BioNTech pays $170M to add would-be Enhertu rival to pipeline, expanding into ADCs in the process


#FierceMadness 2023: Vote for your ad tournament winner as Intra-Cellular’s Caplyta faces GSK’s Shingrix in the championship decider


CSL's new CEO McKenzie charts course for growth amid expansions in gene therapy, kidney diseases

 

Featured

FTC reverses course, orders Illumina to unravel Grail deal

The DNA sequencing giant now has six months to completely divest its holdings in the company. The $8 billion acquisition deal closed in August 2021 before receiving a final sign-off from regulators. Illumina has maintained that it has kept Grail’s operations at arms’ length.
 

Top Stories

BioNTech pays $170M to add would-be Enhertu rival to pipeline, expanding into ADCs in the process

BioNTech is putting its COVID-19 vaccine dollars to work to add a new modality to its pipeline. Sitting on $15 billion, the German biotech has doled out $170 million upfront for the rights to two antibody-drug conjugates (ADC) in development at China’s Duality Biologics.

#FierceMadness 2023: Vote for your ad tournament winner as Intra-Cellular’s Caplyta faces GSK’s Shingrix in the championship decider

If it’s March, it must be #FierceMadness, Fierce Pharma Marketing’s annual take on the March Madness NCAA basketball tournament and bracket mania—with a pharma twist.

CSL's new CEO Paul McKenzie charts course for growth amid expansions in gene therapy, kidney diseases

With a new CEO in Paul McKenzie, a new subsidiary, a newly approved gene therapy and three R&D centers under construction on three different continents, change is coming fast for CSL Limited. McKenzie and CSL’s chief medical officer Bill Mezzanotte shared their outlook for the drugmaker in an interview last week.

FDA grants medical device clearance to Snoo robotic baby bassinet

Already popular with the parents of newborns, the makers of the Snoo motorized bassinet hope it will become the favored choice among hospitals and, perhaps one day, insurance providers.

Sumitomo Pharma tidies up 7 units into 1 combined U.S. entity in spring cleaning

Sumitomo Pharma is doing a little bit of spring cleaning to bring a handful of biopharma units under one consolidated company to be named Sumitomo Pharma America.

Amid dispute with FDA, Akebia proposes new dosing for oral anemia drug in kidney disease

Just as Akebia Therapeutics challenges an FDA complete response letter for oral anemia drug vadadustat, the biotech has offered top-line data for a regimen with a reduced dosing frequency.

Vedere Bio II, unable to replicate past work that led to Novartis acquisition, closes up shop

Opthamology-focused gene therapy biotech Vedere Bio II, the successor to a Novartis-bought biotech that was scooped up in 2020, is closing up shop after failing to impress in preclinical studies.

FDA approves biodegradable metal screw implant for fixing broken bones

In its announcement, the Finnish developer Bioretec said its RemeOs inserts were the first bioresorbable metal implants to score a green light from the agency.

Viatris maintains legal winning streak with yet another EpiPen antitrust victory

A New York federal court tossed investors’ claims against Viatris “in their entirety,” granting the company’s bid for summary judgement in a nearly 7-year-old lawsuit. The securities fraud case, first lobbed at Mylan in 2016, asserted the company “misled investors by obscuring underlying violations of antitrust law and regulatory law."

Pixium Vision's bionic eye implant nets FDA breakthrough label in dry AMD

The Prima system aims to partially restore the ability to see at the center of a person’s visual field, the area most affected by the type of age-related macular degeneration known as dry AMD.
 
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'The Top Line': Biotech's 2023 trends, plus this week's headlines

This week on "The Top Line," we discuss how 2023 is shaping up to be much the same as last year when it comes to financing trends for biotechs. We also cover Emergent's Narcan winning the first over-the-counter approval for an opioid-overdose drug and more of this week's top headlines.

 

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